Azithromycin
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets USP and other antibacterial drugs, azithromycin tablets USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Azithromycin tablets USP are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].
•Acute bacterial exacerbations of chronic bronchitis due to
Haemophilus influenzae
,
Moraxella catarrhalis,
or
Streptococcus pneumoniae
. •Acute bacterial sinusitis due to
Haemophilus influenzae
,
Moraxella catarrhalis.
or
Streptococcus pneumoniae
. •Community-acquired pneumonia due to
Chlamydophila pneumoniae
,
Haemophilus influenzae
,
Mycoplasma pneumoniae,
or
Streptococcus pneumoniae
in patients appropriate for oral therapy. •Pharyngitis/tonsillitis caused by
Streptococcus pyogenes
as an alternative to first-line therapy in individuals who cannot use first-line therapy. •Uncomplicated skin and skin structure infections due to
Staphylococcus aureus
,
Streptococcus pyogenes
, or
Streptococcus agalactiae
. •Urethritis and cervicitis due to
Chlamydia trachomatis
or
Neisseria gonorrhoeae
. •Genital ulcer disease in men due to
Haemophilus ducreyi
(chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
[see Use in Specific Populations (8.4) and Clinical Studies (14.2)]
•Acute otitis media (> 6 months of age) caused by
Haemophilus influenzae
,
Moraxella catarrhalis,
or
Streptococcus pneumoniae
•Community-acquired pneumonia (> 6 months of age) due to
Chlamydophila pneumoniae
,
Haemophilus influenzae
,
Mycoplasma pneumonia
, or
Streptococcus pneumoniae
in patients appropriate for oral therapy. •Pharyngitis/tonsillitis (> 2 years of age) caused by
Streptococcus pyogenes
as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
•patients with cystic fibrosis, •patients with nosocomial infections, •patients with known or suspected bacteremia, •patients requiring hospitalization, •elderly or debilitated patients, or •patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
History
There is currently no drug history available for this drug.
Other Information
Azithromycin tablets USP contain the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.
Azithromycin, USP has the following structural formula:
C38H72N2O12 M.W. 749
Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12•H2O and a molecular weight of 767.
Azithromycin tablets USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide.
The 500 mg tablets also contain FD&C blue #2.
Sources
Azithromycin Manufacturers
-
Remedyrepack Inc.
![Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Azithromycin | Remedyrepack Inc.
•
Adult Patients
Infection
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic bronchitis (mild to moderate)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days.
Acute bacterial sinusitis
500 mg once daily for 3 days.
Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitis
One single 1 gram dose.
Gonococcal urethritis and cervicitis
One single 2 gram dose.
•
Pediatric Patients Infection
Infection
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1
followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg-once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1 see dosing tables below for maximum doses evaluated by indication
Azithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL
(½ tsp)15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL
(¾ tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL
(½ tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
1 Day Regimen
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per TreatmentCourse
Total mg per TreatmentCourse
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL
(½ tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)
62.5 mL
2500 mg
-
Preferred Pharmaceuticals, Inc.
Azithromycin | Ohm Pharma Inc.
DIRECTIONS: Shake 10 times before use. Adults and children above 12 years of age: spray 3-4 times under the tongue 30 minutes before each meal or as directed by a health care professional. Children under 12: use half the adult dose.
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
12
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-55
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
13
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-35
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
14
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 15
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
12 (See 13 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 14 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
•
Adult Patients
Infection Recommended Dose/Duration of TherapyCommunity-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic bronchitis (mild to moderate)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days.
Acute bacterial sinusitis
500 mg once daily for 3 days.
Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitis
One single 1 gram dose.
Gonococcal urethritis and cervicitis
One single 2 gram dose.
•
Pediatric Patients
Infection Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
Infection* Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indication
Azithromycin can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITYACQUIRED PNEUMONIA
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight5
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1-3 Days 1-35
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen5
11
3.75 mL;(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;(3 tsp)
15 mL
600 mg
30
66
22.5 mL;(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
[See Indications and Usage (1)]
Not for pediatric use.
Pediatric Use
For pediatric patients, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets USP may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin tablets for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablets may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablets should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
-
American Health Packaging
Azithromycin | Macleods Pharmaceuticals Limited
The recommended starting dose of Memantine hydrochloride is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day.
Memantine hydrochloride can be taken with or without food. If a patient misses a single dose of memantine hydrochloride, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloride for several days, dosing may need to be resumed at lower doses and retitrated as described above.
Special Populations
Renal Impairment
A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation).
Hepatic Impairment memantine hydrochloride should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology (12.3)]. -
American Health Packaging
Azithromycin | American Health Packaging
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
1 DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]Infection 1
Recommended Dose/Duration of Therapy
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1 1 see dosing tables below for maximum doses evaluated by indication
2 DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]Infection2
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
Azithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY ACQUIRED PNEUMONIA
1 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body WeightOTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)1
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL; (1/2 tsp)
1.25 mL; (1/4 tsp)
7.5 mL
150 mg
10
22
5 mL;
(1 tsp)
2.5 mL; (1/2 tsp)
15mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (1/2 tsp)
15 mL
600 mg
30
66
7.5 mL; (1 1/2 tsp)
3.75 mL; (3/4 tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2 1/2 tsp)
6.25 mL; (1 1/4 tsp)
37.5 mL
1500 mg
1 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)1
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
15 mL
600 mg
30
66
7.5 mL; (1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2 1/2 tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
1 Day Regimen
5
11
3.75 mL; (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL; (1 1/2 tsp)
7.5 mL
300 mg
20
44
15 mL; (3 tsp)
15 mL
600 mg
30
66
22.5 mL; (4 1/2 tsp)
22.5 mL
900 mg
40
88
30 mL; (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL; (7 1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL; (1/2 tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1 1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2 1/2 tsp)
62.5 mL
2500 mg
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
12
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-55
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
13
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-35
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
14
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 15
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
12 (See 13 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 14 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Cardinal Health
Azithromycin | Cardinal Health
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
The recommended dose of Azithromycin for Injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250 mg tablets to complete a 7 to 10 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for Injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin for Injection.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations , Renal Insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
The infusate concentration and rate of infusion for Azithromycin for Injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. Azithromycin for Injection should not be given as a bolus or as an intramuscular injection.
Preparation of the solution for intravenous administration is as follows:
Reconstitution
Prepare the initial solution of Azithromycin for Injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since Azithromycin for Injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C (86°F).
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute this solution further prior to administration as instructed below.
Dilution
To provide azithromycin over a concentration range of 1 to 2 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:
Normal Saline (0.9% sodium chloride)
1/2 Normal Saline (0.45% sodium chloride)
5% Dextrose in Water
Lactated Ringer’s Solution
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
5% Dextrose in Lactated Ringer’s Solution
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
Normosol®-M in 5% Dextrose
Normosol®-R in 5% Dextrose
Final Infusion Solution
Concentration (mg/mL) Amount of Diluent (mL)
1 mg/mL 500 mL
2 mg/mL 250 mL
It is recommended that a 500 mg dose of Azithromycin for Injection, diluted as above, be infused over a period of not less than 60 minutes.
Azithromycin for Injection should not be given as a bolus or as an intramuscular injection.
Other intravenous substances, additives, or medications should not be added to Azithromycin for Injection or infused simultaneously through the same intravenous line.
StorageStore the white to off-white lyophilized cake at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
StorageStore the white to off-white lyophilized cake at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See
INDICATIONS AND USAGE
and
CLINICAL PHARMACOLOGY
.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC
0-120
was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
)
No dosage adjustment is recommended based on age or gender. (See
CLINICAL PHARMACOLOGY, Special Populations.
)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Proficient Rx Lp
Azithromycin | Avkare, Inc.
2.1 General InstructionsCarefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.4)].
After observing the response to initial therapy with meloxicam, adjust the dose to suit an individual patient's needs.
In adults, the maximum recommended daily oral dose of meloxicam is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Warnings and Precautions (5.6), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].
Meloxicam may be taken without regard to timing of meals.
2.2 OsteoarthritisFor the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.3 Rheumatoid ArthritisFor the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
-
Kaiser Foundation Hospitals
Azithromycin | Kaiser Foundation Hospitals
(See INDICATIONS AND USAGE.)
Pediatric UseFor pediatric patients, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC InfectionsThe recommended dose of azithromycin tablets for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablets may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC InfectionsAzithromycin tablets should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
-
Rebel Distributors Corp.
Azithromycin | Rebel Distributors Corp.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Dispensing Solutions Inc.
Azithromycin | Dispensing Solutions Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Physicians Total Care, Inc.
Azithromycin | Physicians Total Care, Inc.
(SeeINDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults Infection*
Recommended Dose/Duration of Therapy
Community-aquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on
Days 2 through 5. Acute bacterial exacerbations of chronic
obstructive pulmonary disease (mild to moderate) 500 mg QD × 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on
Days 2 through 5. Acute bacterial sinusitis 500 mg QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose *
DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR less than or equal to 80 mL/min). The mean AUC0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR less than 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment
Total mg per Treatment
Kg Lbs. Day 1 Day 2-5 Day 1 Days 2-5 Course Course 5
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1 1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50 and
above
110 and
above
12.5 mL
(2 1/2 tsp)
6.25 mL
(1 1/4 tsp)
37.5 mL
1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Total mg per Treatment Kg Lbs. Day 1-3 Day 1-3 Course Course 5
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1 1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and
above
110 and
above
12.5 mL
(2 1/2 tsp)
37.5 mL
1500 mg
* Effectiveness of the 5-day or 1-day regimen in pediatric patients wiht acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight
200 mg/5 mL Total mL per Treatment
Total mg per Treatment
Kg
Lbs.
Day 1
Course
Course
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1 1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4 1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7 1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–5
8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 25 mL 1000 mg 25 55 7.5 mL
(1½ tsp) 37.5 mL 1500 mg 33 73 10 mL
(2 tsp) 50 mL 2000 mg 40 88 12.5 mL
(2½ tsp) 62.5 mL 2500 mgConstituting instructions for azithromycin Oral Suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution
9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL 9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL 12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL 15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mLShake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
Apotex Corp.
Azithromycin | Apotex Corp.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
The recommended dose of azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250 mg tablets to complete a 7 to 10 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. Azithromycin for injection should not be given as a bolus or as an intramuscular injection.
Preparation of the solution for intravenous administration is as follows:
Reconstitution
Prepare the initial solution of azithromycin for injection by adding 4.8 mL of Sterile Water For Injection to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since azithromycin for injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C or 86°F.
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute this solution further prior to administration as instructed below.
Dilution
To provide azithromycin over a concentration range of 1 to 2 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:
Normal saline (0.9% sodium chloride)
1/2 Normal saline (0.45% sodium chloride)
5% Dextrose in water
Lactated Ringer’s solution
5% Dextrose in 1/2 normal saline (0.45% sodium chloride) with 20 mEq KCl 5% dextrose in Lactated Ringer’s solution
5% Dextrose in 1/3 normal saline (0.3% sodium chloride)
5% Dextrose in 1/2 normal saline (0.45% sodium chloride)
Normosol®-M in 5% dextrose
Normosol®-R in 5% dextrose
Final Infusion Solution Concentration (mg/mL) Amount of Diluent (mL) 1 mg/mL 500 mL 2 mg/mL 250 mLIt is recommended that a 500 mg dose of azithromycin for injection, diluted as above, be infused over a period of not less than 60 minutes.
Azithromycin for injection should not be given as a bolus or as an intramuscular injection.
Other intravenous substances, additives, or medications should not be added to azithromycin for injection, or infused simultaneously through the same intravenous line.
Storage
When diluted according to the instructions (1 mg/mL to 2 mg/mL), azithromycin for injection is stable for 24 hours at or below room temperature (30°C or 86°F), or for 7 days if stored under refrigeration (5°C or 41°F).
-
Wockhardt Usa Llc.
Azithromycin | Wockhardt Usa Llc.
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1,
followed by 250 mg once daily on
Days 2 through 5
Acute bacterial exacerbations of chronic
obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1,
followed by 250 mg once daily on
Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1 Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)] 1 see dosing tables below for maximum doses evaluated by indicationAzithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA(Age 6 months and above, [see Use in Specific Populations (8.4)])Based on Body Weight*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA:
(5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and
5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL;
(½ tsp)
1.25 mL;
( ¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1tsp)
2.5 mL;
(½ tsp)
15 mL
300 mg
20
44
5 mL;
(1 tsp)
2.5 mL;
(½ tsp)
15 mL
600 mg
30
66
7.5 mL;
(1½ tsp)
3.75 mL;
(¾ tsp)
22.5 mL
900 mg
40
88
10 mL;
(2 tsp)
5 mL;
(1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL;
(1¼ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS:
(3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per
Total mg per
Kg
Lbs.
Days 1 to 3
Days 1 to 3
Treatment Course
Treatment Course
5
11
2.5 mL;
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL;
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2 ½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL per
Total mg per
Kg
Lbs.
1-Day Regimen
Treatment Course
Treatment Course
5
11
3.75 mL; (¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL; (1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL; (3 tsp)
15 mL
600 mg
30
66
22.5 mL; (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL; (6 tsp)
30 mL
1200 mg
50 and above
110 and
above
37.5 mL; (7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin tablets for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, [see Use in Specific Populations (8.4)]) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per
Total mg per
Kg
Lbs.
Day 1 to 5
Treatment Course
Treatment
Course
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2½ tsp)
62.5 mL
2500 mg
-
Wockhardt Limited
Azithromycin | Wockhardt Limited
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Wockhardt Limited
Azithromycin | Wockhardt Limited
Pediatric UseFor pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin tablet for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablet may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablet should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of
15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.) Pediatric UseFor pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin tablet for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablet may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablet should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of
15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.) -
Wockhardt Usa Llc.
Azithromycin | Novartis Consumer Health, Inc.
• do not use more than directed • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctorAge
Dose
adults and children 12 years of age and over
one packet
children under 12 years of age
do not use
• dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat. -
Stat Rx Usa Llc
Azithromycin | Stat Rx Usa Llc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
DOSAGE AND ADMINISTRATION
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults
Infection *Recommended Dose/Durationof TherapyCommunity-acquired pneumonia (mild500 mg as a single dose on Dayseverity) Pharyngitis/ tonsillitis (second1, followed by 250 mg onceline therapy) Skin/skin structuredaily on Days 2 through 5.(uncomplicated)Acute bacterial exacerbations of500 mg QD x 3 days OR 500chronic obstructive pulmonarymg as a dingle dose on Day 1,disease (mild to moderate)followed by 250 mg once dailyon Days 2 through 5.Acute bacterial sinusitis500 mg QD x 3 daysGenital ulcer disease (chancroid)One single 1 gram doseNon-gonococcal urethritis andOne single 1 gram dosecervicitsGonococcal urethritis and cervicitisOne single 2 gram dose *DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).
Azithromycin tablets can be taken with or without food.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric Patients
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial Sinusitis
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired Pneumonia
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIREDPNEUMONIA: (5 Day Regimen)*Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/dayDays 2 to 5.Weight100 mg/ 5mL200 mg/ 5mLTotal mLTotal mgper Treat-per Treat-mentmentCourseCourseKgLbs.Day 1DaysDay 1Days2 to 52 to 55112.5mL1.25mL7.5 mL150 mg(tsp)(tsp)10225 mL2.5mL15 mL300 mg(1 tsp)(tsp)20445 mL2.5 mL15 mL600 mg(1 tsp)(tsp)30667.5 mL3.75mL 22.5 mL900 mg(1tsp)(tsp)408810 mL5 mL30 mL1200 mg(2 tsp)(1 tsp)5011012.56.2537.5 mL1500 mgandandmLmLaboveabove(2tsp)(1tsp) *Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS:(3 Day Regimen)*Dosing Calculated on 10 mg/kg/dayWeight100 mg/200 mg/Total mL perTotal mg per5 mL5 mLTreatmentTreatmentCourseCourseKgLbs.Day 1 toDay 1 to335112.5 mL7.5 mL150 mg(tsp)10225 mL15 mL300 mg(1 tsp)20445 mL15 mL600 mg(1 tsp)30667.5 mL22.5 mL900 mg(1tsp)408810 mL30 mL1200 mg(2 tsp)50 and110 and12.5 mL37.5 mL1500 mgaboveabove(2tsp) *Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1 Day Regimen)Dosing Calculated on 30 mg/kg as a single doseWeight200 mg/Total mL perTotal mg per5 mLTreatmentTreatmentCourseCourseKgLbs.Day 15113.75 mL3.75 mL150 mg(3/4 tsp)10227.5 mL7.5 mL300 mg(1tsp)204415 mL15 mL600 mg(3 tsp)306622.5 mL22.5 mL900 mg(4tsp)408830 mL30 mL1200 mg(6 tsp)50 and110 and37.5 mL37.5 mL1500 mgaboveabove(7tsp) *Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen)Dosing Calculated on 12 mg/kg/day for 5 days.Weight200 mg/Total mL perTotal mg per5 mLTreatmentTreatmentCourseCourseKgLbs.Day 1 to58182.5 mL12.5 mL500 mg(tsp)17375 mL25 mL1000 mg(1 tsp)25557.5 mL37.5 mL1500 mg(1tsp)337310 mL50 mL2000 mg(2 tsp)408812.5 mL62.5 mL2500 mg(2tsp)
-
American Health Packaging
Azithromycin | American Health Packaging
(See INDICATIONS AND USAGEand CLINICAL PHARMACOLOGY.)
Adults: * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.) Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. Kg Lbs. Day 1-3 Day 1-3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp ) 37.5 mL 1500 mg OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment course Total mg per Treatment course Kg Lbs. Day1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS (Age 2 years and above, see PRECAUTIONS-Pediatric Use.) Based on Body weight PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200mg/5mL Total mL per Treatment course Total mg per Treatment course Kg Lbs. Day 1-5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1 ½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2 ½ tsp) 62.5 mL 2500 mg Adults: * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.) Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. Kg Lbs. Day 1-3 Day 1-3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp ) 37.5 mL 1500 mg OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment course Total mg per Treatment course Kg Lbs. Day1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS (Age 2 years and above, see PRECAUTIONS-Pediatric Use.) Based on Body weight PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200mg/5mL Total mL per Treatment course Total mg per Treatment course Kg Lbs. Day 1-5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1 ½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2 ½ tsp) 62.5 mL 2500 mg -
Lake Erie Medical Dba Quality Care Products Llc
Azithromycin | Lake Erie Medical Dba Quality Care Products Llc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Physicians Total Care, Inc.
Azithromycin | Physicians Total Care, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Adults
Infection *
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild
severity) Pharyngitis/tonsillitis (second
line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*
DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR less than or equal to 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR less than 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen) * Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL
SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, see PRECAUTIONS: Pediatric Use.)
Based on Body WeightTotal mL
Per
Treatment
CourseTotal mg
Per
Treatment
Course
Kg
Lbs.Day
1Days
2-5Day
1Days
2-55
11
2.5 mL
(1/2 tsp)1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)2.5 mL
(1/2 tsp)15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)3.75 mL
(3/4 tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50
and
above110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
*
Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen) * Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mLTotal mL per
Treatment
CourseTotal mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-35
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)30 mL
1200 mg
50
and
above110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
*
Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 15
11
3.75 mL
(3/4 tsp)3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)7.5 mL
300 mg
20
44
15 mL
(3 tsp)15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)22.5 mL
900 mg
40
88
30 mL
(6 tsp)30 mL
1200 mg
50 and
above110 and
above37.5 mL
(7-1/2 tsp)37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mLTotal mL per
Treatment CourseTotal mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)12.5 mL
500 mg
17
37
5 mL
(1 tsp)25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)37.5 mL
1500 mg
33
73
10 mL
(2 tsp)50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)62.5 mL
2500 mg
-
Cardinal Health
Azithromycin | Cardinal Health
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
The recommended dose of azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin.
The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour.
Preparation of the Solution for Intravenous Administration is as Follows:
Reconstitution
Prepare the initial solution of azithromycin for injection by adding 4.8 mL of Sterile Water For Injection to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since azithromycin for injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 25°C or 77°F.
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute This Solution Further Prior to Administration as Instructed Below.
Dilution
To provide azithromycin over a concentration range of 1-2 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:
Normal Saline (0.9% sodium chloride)
1/2 Normal Saline (0.45% sodium chloride)
5% Dextrose in Water
Lactated Ringer’s Solution
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
5% Dextrose in Lactated Ringer’s Solution
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
Normosol®-M in 5% Dextrose
Normosol®-R in 5% Dextrose
Final Infusion Solution Concentration (mg/mL) Amount of Diluent (mL) 1 mg/mL 500 mL 2 mg/mL 250 mLIt is recommended that a 500-mg dose of azithromycin for injection, diluted as above, be infused over a period of not less than 60 minutes.
Azithromycin for injection should not be given as a bolus or as an intramuscular injection.
Other intravenous substances, additives, or medications should not be added to azithromycin for injection, or infused simultaneously through the same intravenous line.
StorageWhen diluted according to the instructions (1 mg/mL to 2 mg/mL), azithromycin for injection is stable for 24 hours at or below room temperature (25°C or 77°F), or for 7 days if stored under refrigeration (5°C or 41°F).
-
Dispensing Solutions, Inc.
Azithromycin | Dispensing Solutions, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Dispensing Solutions, Inc.
Azithromycin | Dispensing Solutions, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Dispensing Solutions, Inc.
Azithromycin | Dispensing Solutions, Inc.
(See INDICATIONS AND USAGE.)
Azithromycin for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. Not for pediatric use. For pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
The recommended dose of azithromycin for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) dose of azithromycin. This dose can be administered as one single dose packet (1 g).
Prevention of Disseminated MAC InfectionsThe recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC InfectionsAzithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
DIRECTIONS FOR ADMINISTRATION OF Azithromycin for oral suspension in the single dose packet (1 g)The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to assure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of azithromycin. This packet not for pediatric use.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.)
-
Rebel Distributors Corp.
Azithromycin | Rebel Distributors Corp.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults*DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD × 3 day OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse kg Lbs. Day 1 to 3 Day 1 to 3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course kg Lbs. Day 1 5 11 3.75 mL (¾ tsp) 3.75 mL 150 mg 10 22 7.5 mL (1½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4½ tsp) 22.5 mL 900 mg 40 88 30 mL (6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for pediatric patients with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course kg Lbs. Day 1 to 5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2½ tsp) 62.5 mL 2500 mgConstituting instructions for azithromycin for oral suspension USP, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution 9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL 9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL 12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL 15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mLShake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults:
Infection*Recommended Dose/Duration of TherapyCommunity-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial sinusitis500 mg QD x 3 daysGenital ulcer disease (chancroid)One single 1 gram doseNon-gonoccocal urethritis and cervicitisOne single 1 gram doseGonococcal urethritis and cervicitisOne single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFRmL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment CourseKgLbs.Day 1Days 2-5Day 1Days 2-55112.5 mL (tsp)1.25 mL (tsp)7.5 mL150 mg10225 mL (1 tsp)2.5 mL (tsp)15 mL300 mg20445 mL (1 tsp)2.5 mL (tsp)15 mL600 mg30667.5 mL (1tsp)3.75 mL (3/4tsp)22.5 mL900 mg408810 mL (2 tsp)5 mL (1tsp)30 mL1200 mg50 and above12.5 mL (2tsp)6.25 mL (1tsp)37.5 mL1500 mg*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1. Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment CourseKgLbs.Day 1-3Day 1-35112.5 mL (tsp)7.5 mL150 mg10225 mL (1 tsp)15 mL300 mg20445 mL (1 tsp)15 mL600 mg30667.5 mL (1tsp)22.5 mL900 mg408810 mL (2 tsp)30 mL1200 mg50 and above110 and above12.5 mL (2tsp )37.5 mL1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight200 mg/5 mLTotal mL per Treatment courseTotal mg per Treatment courseKgLbs.Day15113.75 mL (3/4 tsp)3.75 mL150 mg10227.5 mL (1tsp)7.5 mL300 mg204415 mL (3 tsp)15 mL600 mg306622.5 mL (4tsp)22.5 mL900 mg408830 mL (6tsp)30 mL1200 mg50 and above110 and above37.5 mL (7tsp)37.5 mL1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days Weight200mg/5mLTotal mL per Treatment courseTotal mg per Treatment courseKgLbs.Day 1-58182.5 mL (tsp)12.5 mL500 mg17375 mL (1 tsp)25 mL1000 mg25557.5 mL (1tsp)37.5 mL1500 mg337310 mL (2 tsp)50 mL2000 mg408812.5 mL (2tsp)62.5 mL2500 mg
-
Medvantx, Inc.
Azithromycin | Medvantx, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults * DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE). Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets USP can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg * Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 to 3 Day 1 to 3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course Kg Lbs. Day 1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per TreatmentCourse Total mg per TreatmentCourse Kg Lbs. Day 1 to 5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2½ tsp) 62.5 mL 2500 mg -
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Azithromycin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults:
Infection*Recommended Dose/Duration of TherapyCommunity-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial sinusitis500 mg QD x 3 daysGenital ulcer disease (chancroid)One single 1 gram doseNon-gonoccocal urethritis and cervicitisOne single 1 gram doseGonococcal urethritis and cervicitisOne single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFRmL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment CourseKgLbs.Day 1Days 2-5Day 1Days 2-55112.5 mL (tsp)1.25 mL (tsp)7.5 mL150 mg10225 mL (1 tsp)2.5 mL (tsp)15 mL300 mg20445 mL (1 tsp)2.5 mL (tsp)15 mL600 mg30667.5 mL (1tsp)3.75 mL (3/4tsp)22.5 mL900 mg408810 mL (2 tsp)5 mL (1tsp)30 mL1200 mg50 and above12.5 mL (2tsp)6.25 mL (1tsp)37.5 mL1500 mg*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1. Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment CourseKgLbs.Day 1-3Day 1-35112.5 mL (tsp)7.5 mL150 mg10225 mL (1 tsp)15 mL300 mg20445 mL (1 tsp)15 mL600 mg30667.5 mL (1tsp)22.5 mL900 mg408810 mL (2 tsp)30 mL1200 mg50 and above110 and above12.5 mL (2tsp )37.5 mL1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight200 mg/5 mLTotal mL per Treatment courseTotal mg per Treatment courseKgLbs.Day15113.75 mL (3/4 tsp)3.75 mL150 mg10227.5 mL (1tsp)7.5 mL300 mg204415 mL (3 tsp)15 mL600 mg306622.5 mL (4tsp)22.5 mL900 mg408830 mL (6tsp)30 mL1200 mg50 and above110 and above37.5 mL (7tsp)37.5 mL1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days Weight200mg/5mLTotal mL per Treatment courseTotal mg per Treatment courseKgLbs.Day 1-58182.5 mL (tsp)12.5 mL500 mg17375 mL (1 tsp)25 mL1000 mg25557.5 mL (1tsp)37.5 mL1500 mg337310 mL (2 tsp)50 mL2000 mg408812.5 mL (2tsp)62.5 mL2500 mg
-
H.j. Harkins Company, Inc.
Azithromycin | H.j. Harkins Company, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Avpak
Azithromycin | Avpak
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults * DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE). Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg * Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 to 3 Day 1 to 3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course Kg Lbs. Day 1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per TreatmentCourse Total mg per TreatmentCourse Kg Lbs. Day 1 to 5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2½ tsp) 62.5 mL 2500 mg -
Physicians Total Care, Inc.
Azithromycin | Physicians Total Care, Inc.
Pediatric UseFor pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin tablet for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablet may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablet should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of
15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.) Pediatric UseFor pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin tablet for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablet may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablet should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of
15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.) -
Physicians Total Care, Inc.
Azithromycin | Physicians Total Care, Inc.
(See INDICATIONS AND USAGE.)
Azithromycin for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. Not for pediatric use. For pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
The recommended dose of azithromycin for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) dose of azithromycin. This dose can be administered as one single dose packet (1 g).
Prevention of Disseminated MAC InfectionsThe recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC InfectionsAzithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
DIRECTIONS FOR ADMINISTRATION OF Azithromycin for oral suspension in the single dose packet (1 g)The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to assure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of azithromycin. This packet not for pediatric use.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.)
-
Unit Dose Services
Azithromycin | Unit Dose Services
(See and .) INDICATIONS AND USAGE CLINICAL PHARMACOLOGY
Adults:Azithromycin tablets can be taken with or without food. Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See ) Hepatic Insufficiency: The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See ) No dosage adjustment is recommended based on age or gender. (See ) Azithromycin for oral suspension can be taken with or without food. The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.) The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.) The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.) *Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose. The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.) Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
0-120 CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
CLINICAL PHARMACOLOGY, Special Populations.
Pediatric Patients:
Acute Otitis Media:
Acute bacterial Sinusitis:
Community-Acquired Pneumonia:
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course
Total mg per Treatment Course
Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg
OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs. Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
Pharyngitis/Tonsillitis:
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS (Age 2 years and above, see PRECAUTIONS-Pediatric Use.) Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs. Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults:Azithromycin tablets can be taken with or without food. Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See ) Hepatic Insufficiency: The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See ) No dosage adjustment is recommended based on age or gender. (See ) Azithromycin for oral suspension can be taken with or without food. The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.) The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.) The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.) *Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose. The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.) Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
0-120 CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
CLINICAL PHARMACOLOGY, Special Populations.
Pediatric Patients:
Acute Otitis Media:
Acute bacterial Sinusitis:
Community-Acquired Pneumonia:
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course
Total mg per Treatment Course
Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg
OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs. Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
Pharyngitis/Tonsillitis:
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS (Age 2 years and above, see PRECAUTIONS-Pediatric Use.) Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs. Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Azithromycin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Adults * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.) Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mLTotal mL
Per
Treatment
CourseTotal mg
Per
Treatment
Course
Kg
Lbs.Day
1Days
2-5Day
1Days
2-55
11
2.5 mL
(1/2 tsp)1.25 mL
(1/4 tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)2.5 mL
(1/2 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)2.5 mL
(1/2 tsp)15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)3.75 mL
(3/4 tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50
and
above110
and
above12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
* Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mLTotal mL per
Treatment
CourseTotal mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-35
11
2.5 mL
(1/2 tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)30 mL
1200 mg
50
and
above110
and
above12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 15
11
3.75 mL
(3/4 tsp)3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)7.5 mL
300 mg
20
44
15 mL
(3 tsp)15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)22.5 mL
900 mg
40
88
30 mL
(6 tsp)30 mL
1200 mg
50 and
above110 and
above37.5 mL
(7-1/2 tsp)37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mLTotal mL per
Treatment CourseTotal mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)12.5 mL
500 mg
17
37
5 mL
(1 tsp)25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)37.5 mL
1500 mg
33
73
10 mL
(2 tsp)50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)62.5 mL
2500 mg
-
American Health Packaging
Azithromycin | American Health Packaging
Pediatric UseFor pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin tablet for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablet may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablet should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.)
Pediatric UseFor pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin tablet for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablet may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablet should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.)
-
Unit Dose Services
Azithromycin | Unit Dose Services
(See and .) INDICATIONS AND USAGECLINICAL PHARMACOLOGY
Adults * (see ). DUE TO THE INDICATED ORGANISMS INDICATIONS AND USAGE Infection * Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets USP can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see , , ). 0-120CLINICAL PHARMACOLOGYSpecial PopulationsRenal insufficiency
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see , , ). CLINICAL PHARMACOLOGYSpecial PopulationsHepatic insufficiency
No dosage adjustment is recommended based on age or gender (see , ). CLINICAL PHARMACOLOGYSpecial Populations
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen) * Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg * Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen) * Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 to 3 Day 1 to 3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course Kg Lbs. Day 1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per TreatmentCourse Total mg per TreatmentCourse Kg Lbs. Day 1 to 5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2½ tsp) 62.5 mL 2500 mg -
Major Pharmaceuticals
Azithromycin | Major Pharmaceuticals
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Pd-rx Pharmaceuticals, Inc.
Azithromycin | Pd-rx Pharmaceuticals, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC 0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGEandCLINICAL PHARMACOLOGY.)
Adults
*
DUE TO THE INDICATED ORGANISMS (seeINDICATIONS AND USAGE).Infection *Recommended Dose/Duration of TherapyCommunity-Acquired Pneumonia (Mild Severity) Pharyngitis/Tonsillitis (Second Line Therapy) Skin/Skin Structure (Uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease (Mild to Moderate)500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute Bacterial Sinusitis500 mg QD x 3 daysGenital Ulcer Disease (Chancroid)One single 1 gram doseNon-Gonococcal Urethritis and CervicitisOne single 1 gram doseGonococcal Urethritis and CervicitisOne single 2 gram dose
Azithromycin tablets USP can be taken with or without food.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR less than or equal to 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin tablets USP are administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations,Renal Insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations,Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY,Special Populations).
Pediatric Patients
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial Sinusitis
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired Pneumonia
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS,Pediatric Use.) Based on Body Weight
*
Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5112.5 mL (tsp)1.25 mL (tsp)7.5 mL150 mg10225 mL (1 tsp)2.5 mL (tsp)15 mL300 mg20445 mL (1 tsp)2.5 mL (tsp)15 mL600 mg30667.5 mL (1tsp)3.75 mL (tsp)22.5 mL900 mg408810 mL (2 tsp)5 mL (1 tsp)30 mL1200 mg50 and above110 and above12.5 mL (2tsp)6.25 mL (1tsp)37.5 mL1500 mg
*
Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen) *Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourseKgLbs.Day 1 to 3Day 1 to 35112.5 mL (tsp)7.5 mL150 mg10225 mL (1 tsp)15 mL300 mg20445 mL (1 tsp)15 mL600 mg30667.5 mL (1tsp)22.5 mL900 mg408810 mL (2 tsp)30 mL1200 mg50 and above110 and above12.5 mL (2tsp)37.5 mL1500 mg
OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a Single Dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course Kg Lbs. Day 1 5113.75 mL (3/4 tsp)3.75 mL150 mg10227.5 mL (1tsp)7.5 mL300 mg204415 mL (3 tsp)15 mL600 mg306622.5 mL (4tsp)22.5 mL900 mg408830 mL (6 tsp)30 mL1200 mg50 and above110 and above37.5 mL (7tsp)37.5 mL1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS,Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per TreatmentCourse Total mg per TreatmentCourse Kg Lbs. Day 1 to 5 8182.5 mL (tsp)12.5 mL500 mg17375 mL (1 tsp)25 mL1000 mg25557.5 mL (1tsp)37.5 mL1500 mg337310 mL (2 tsp)50 mL2000 mg408812.5 mL (2tsp)62.5 mL2500 mg
-
Lake Erie Medical Dba Quality Care Products Llc
Azithromycin | Lake Erie Medical Dba Quality Care Products Llc
(SeeINDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.) Community-aquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic
obstructive pulmonary disease (mild to moderate) 500 mg QD × 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 5 11 2.5 mL
(½ tsp) 1.25 mL
(¼ tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 2.5 mL
(½ tsp) 15 mL 300 mg 20 44 5 mL
(1 tsp) 2.5 mL
(½ tsp) 15 mL 600 mg 30 66 7.5 mL
(1½ tsp) 3.75 mL
(¾ tsp) 22.5 mL 900 mg 40 88 10 mL
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. 5 11 2.5 mL
(1/2 tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 15 mL 300 mg 20 44 5 mL
(1 tsp) 15 mL 600 mg 30 66 7.5 mL
(1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL
(2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 5 11 3.75 mL
(3/4 tsp) 3.75 mL
150 mg 10 22 7.5 mL
(1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL
(3 tsp) 15 mL 600 mg 30 66 22.5 mL
(4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL
(6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL
(7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 25 mL 1000 mg 25 55 7.5 mL
(1½ tsp) 37.5 mL 1500 mg 33 73 10 mL
(2 tsp) 50 mL 2000 mg 40 88 12.5 mL
(2½ tsp) 62.5 mL 2500 mgConstituting instructions for azithromycin Oral Suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution 9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL 9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL 12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL 15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mLShake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
Pliva Inc.
Azithromycin | Pliva Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
The recommended dose of azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250 mg tablets to complete a 7 to 10 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of azithromycin for injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, RenalInsufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
The infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. Azithromycin for injection should not be given as a bolus or as an intramuscular injection.
Preparation of the Solution for Intravenous Administration is as Follows:
Reconstitution
Prepare the initial solution of azithromycin for injection by adding 4.8 mL of Sterile Water For Injection to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since azithromycin for injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 25°C or 77°F.
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute This Solution Further Prior to Administration as Instructed Below.
Dilution
To provide azithromycin over a concentration range of 1 to 2 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:
Normal Saline (0.9% sodium chloride)
1/2 Normal Saline (0.45% sodium chloride)
5% Dextrose in Water
Lactated Ringer’s Solution
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
5% Dextrose in Lactated Ringer’s Solution
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
Normosol®-M in 5% Dextrose
Normosol®-R in 5% Dextrose
Final Infusion Solution Concentration (mg/mL) Amount of Diluent (mL)
1 mg/mL 500 mL
2 mg/mL 250 mL
It is recommended that a 500 mg dose of azithromycin for injection, diluted as above, be infused over a period of not less than 60 minutes.
Azithromycin for injection should not be given as a bolus or as an intramuscular injection.
Other intravenous substances, additives, or medications should not be added to azithromycin for injection, or infused simultaneously through the same intravenous line.
StorageWhen diluted according to the instructions (1 mg/mL to 2 mg/mL), azithromycin for injection is stable for 24 hours at or below room temperature (25°C or 77°F), or for 7 days if stored under refrigeration (5°C or 41°F).
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(SeeINDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Infection* Recommended Dose/Duration of Therapy Community-aquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic
obstructive pulmonary disease (mild to moderate) 500 mg QD × 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2–5 Day 1 Days 2–5 5 11 2.5 mL
(½ tsp) 1.25 mL
(¼ tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 2.5 mL
(½ tsp) 15 mL 300 mg 20 44 5 mL
(1 tsp) 2.5 mL
(½ tsp) 15 mL 600 mg 30 66 7.5 mL
(1½ tsp) 3.75 mL
(¾ tsp) 22.5 mL 900 mg 40 88 10 mL
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–3 Day 1–3 5 11 2.5 mL
(1/2 tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 15 mL 300 mg 20 44 5 mL
(1 tsp) 15 mL 600 mg 30 66 7.5 mL
(1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL
(2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 5 11 3.75 mL
(3/4 tsp) 3.75 mL
150 mg 10 22 7.5 mL
(1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL
(3 tsp) 15 mL 600 mg 30 66 22.5 mL
(4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL
(6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL
(7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 25 mL 1000 mg 25 55 7.5 mL
(1½ tsp) 37.5 mL 1500 mg 33 73 10 mL
(2 tsp) 50 mL 2000 mg 40 88 12.5 mL
(2½ tsp) 62.5 mL 2500 mgConstituting instructions for azithromycin Oral Suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution 9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL 9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL 12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL 15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mLShake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
12 See 13 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 14 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE.)
Azithromycin for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. Not for pediatric use. For pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
The recommended dose of azithromycin for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) dose of azithromycin. This dose can be administered as one single dose packet (1 g).
The recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.
Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to assure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of azithromycin. This packet not for pediatric use.
No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.)
-
Sun Pharmaceutical Industries Limited
Azithromycin | Sagent Pharmaceuticals
2.1 Dosing InformationThe maximum single recommended adult dose of sumatriptan injection for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously. For the treatment of migraine, if side effects are dose limiting, lower doses (1 mg to 5 mg) may be used [see Clinical Studies (14.1)]. For the treatment of cluster headache, the efficacy of lower doses has not been established.
The maximum cumulative dose that may be given in 24 hours is 12 mg, two 6-mg injections separated by at least 1 hour. A second 6-mg dose should only be considered if some response to a first injection was observed.
2.2 Administration Using the Sumatriptan Injection Prefilled SyringeSumatriptan Injection is available for use in 6-mg prefilled syringes. The injection is intended to be given subcutaneously, and intramuscular or intravascular delivery must be avoided. Instruct patients on the proper use of sumatriptan injection prefilled syringe and direct them to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.
2.3 Administration of Doses of Sumatriptan Succinate Other than 6 mgIn patients receiving doses other than 6 mg, use the 6-mg single-dose vial; do not use the sumatriptan injection prefilled syringe. Visually inspect the vial for particulate matter and discoloration before administration. Do not use if particulates and discolorations are noted.
-
Medvantx, Inc.
Azithromycin | Medvantx, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults * DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE). Infection* Recommended Dose/Duration of Therapy Community-Acquired Pneumonia (Mild Severity) Pharyngitis/Tonsillitis (Second Line Therapy) Skin/Skin Structure (Uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease (Mild to Moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute Bacterial Sinusitis 500 mg QD x 3 days Genital Ulcer Disease (Chancroid) One single 1 gram dose Non-Gonococcal Urethritis and Cervicitis One single 1 gram dose Gonococcal Urethritis and Cervicitis One single 2 gram doseAzithromycin Tablets USP can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0 to 120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when Azithromycin Tablets are administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg * Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 to 3 Day 1 to 3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a Single Dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course Kg Lbs. Day 1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per TreatmentCourse Total mg per TreatmentCourse Kg Lbs. Day 1 to 5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2½ tsp) 62.5 mL 2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See
INDICATIONS AND USAGE
and
CLINICAL PHARMACOLOGY
.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC
0-120
was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
)
No dosage adjustment is recommended based on age or gender. (See
CLINICAL PHARMACOLOGY, Special Populations.
)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Sandoz Inc
Azithromycin | Sandoz Inc
[see Indications and Usage (1)]
2.1 Sexually Transmitted DiseasesThe recommended dose of azithromycin for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is a single 1000 mg dose of azithromycin.
2.2 Mycobacterial InfectionsPrevention of Disseminated MAC Infections
The recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
-
Preferred Pharmaceuticals, Inc
Azithromycin | Preferred Pharmaceuticals, Inc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See
INDICATIONS AND USAGE
and
CLINICAL PHARMACOLOGY
.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC
0-120
was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
)
No dosage adjustment is recommended based on age or gender. (See
CLINICAL PHARMACOLOGY, Special Populations.
)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See
INDICATIONS AND USAGE
and
CLINICAL PHARMACOLOGY
.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC
0-120
was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
)
No dosage adjustment is recommended based on age or gender. (See
CLINICAL PHARMACOLOGY, Special Populations.
)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
12
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-55
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
13
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-35
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
14
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs.
Day 1
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
12 (See 13 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 14 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See
INDICATIONS AND USAGE
and
CLINICAL PHARMACOLOGY
.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC
0-120
was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
)
No dosage adjustment is recommended based on age or gender. (See
CLINICAL PHARMACOLOGY, Special Populations.
)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
12
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-55
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
13
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-35
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
14
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs.
Day 1
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
12 (See 13 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 14 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Hospira, Inc.
Azithromycin | Hospira, Inc.
[see Indications and Usage (1) and Clinical Pharmacology (12.3)].
2.1 Community-Acquired PneumoniaThe recommended dose of Azithromycin for Injection, USP for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
2.2 Pelvic Inflammatory DiseaseThe recommended dose of Azithromycin for Injection, USP for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
2.3 Preparation of the Solution for Intravenous AdministrationThe infusate concentration and rate of infusion for Azithromycin for Injection, USP should be 2 mg/mL over 1 hour. Azithromycin for Injection, USP should not be given as a bolus or as an intramuscular injection.
Reconstitution
Instructions for Use
These instructions for use should be made available to the individuals who perform the reconstitution steps.
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
To Open
Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container:
(Use Aseptic Technique)
1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (See Figure 1.), then pull straight up to remove the cap. (See Figure 2.) NOTE: Once the breakaway cap has been removed, do not access vial with syringe.
b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (See Figure 3.) 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (See Figure 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.
NOTE: Once vial is seated, do not attempt to remove. (See Figure 4.) 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.To Reconstitute the Drug
1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (See Figure 5.) 3. Pull the inner cap from the drug vial. (See Figure 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. Mix container contents thoroughly and use within the specified time. 5. Look through the bottom of the vial to verify that the stopper has been removed and complete mixing has occurred. (See Figure 7.)If the rubber stopper is not removed from the vial and medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5.
Dilute this solution further prior to administration as instructed below.
Dilution
Azithromycin for Injection, USP ADD-VantageTM vials must be diluted prior to IV administration with the ADD-VantageTM diluent container [see Dosage and Administration (2.3)]. The ADD-VantageTM vial should be joined with a 250 mL ADD-VantageTM flexible diluent container (5% dextrose injection, 0.9% sodium chloride injection or 0.45% sodium chloride injection).
It is recommended that a 500-mg dose of Azithromycin for Injection, diluted as above, be infused over a period of not less than 60 minutes.
Other intravenous substances, additives, or medications should not be added to Azithromycin for Injection, or infused simultaneously through the same intravenous line.
Preparation for Administration
(Use Aseptic Technique)
1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.WARNING: Do not use flexible container in series connections.
Storage
When diluted according to the instructions (2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature (30°C or 86°F), or for 7 days if stored under refrigeration (5°C or 41°F).
-
Hospira, Inc.
Azithromycin | Greenstone Llc
2.1 Dosage for Postherpetic NeuralgiaIn adults with postherpetic neuralgia, gabapentin may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
2.2 Dosage for Epilepsy with Partial Onset SeizuresPatients 12 years of age and above
The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer gabapentin three times a day using 300 mg or 400 mg capsules, or 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
2.3 Dosage Adjustment in Patients with Renal ImpairmentDosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):
TABLE 1. Gabapentin Dosage Based on Renal Function Renal Function Creatinine Clearance
(mL/min) Total Daily Dose Range
(mg/day) Dose Regimen
(mg) TID = Three times a day; BID = Two times a day; QD = Single daily dose * For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). † Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table. ≥ 60 900 to 3600 300 TID 400 TID 600 TID 800 TID 1200 TID >30 to 59 400 to 1400 200 BID 300 BID 400 BID 500 BID 700 BID >15 to 29 200 to 700 200 QD 300 QD 400 QD 500 QD 700 QD 15* 100 to 300 100 QD 125 QD 150 QD 200 QD 300 QD Post-Hemodialysis Supplemental Dose (mg)† Hemodialysis 125† 150† 200† 250† 350†Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:
The use of gabapentin in patients less than 12 years of age with compromised renal function has not been studied.
2.4 Dosage in ElderlyBecause elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
2.5 Administration InformationAdminister gabapentin orally with or without food.
Gabapentin capsules should be swallowed whole with water.
Inform patients that, should they divide the scored 600 mg or 800 mg gabapentin tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of dividing the scored tablet should be discarded.
If the gabapentin dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
-
Sagent Pharmaceuticals
Azithromycin | Sagent Pharmaceuticals
[See Indications and Usage (1) and Clinical Pharmacology (12.3).]
2.1 Community-Acquired PneumoniaThe recommended dose of azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
2.2 Pelvic Inflammatory DiseaseThe recommended dose of azithromycin for injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
2.3 Preparation of the Solution for Intravenous AdministrationThe infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg per mL over 3 hours or 2 mg per mL over 1 hour. Azithromycin for injection should not be given as a bolus or as an intramuscular injection.
Reconstitution
Prepare the initial solution of azithromycin for injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial, and shaking the vial until all of the drug is dissolved. Since azithromycin for injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C (86°F).
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute this solution further prior to administration as instructed below.
Dilution
To provide azithromycin for injection over a concentration range of 1 to 2 mg per mL, transfer 5 mL of the 100 mg per mL azithromycin for injection solution into the appropriate amount of any of the diluents listed below:
Normal Saline (0.9% sodium chloride)
1/2 Normal Saline (0.45% sodium chloride)
5% Dextrose in Water
Lactated Ringer's Solution
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
5% Dextrose in Lactated Ringer's Solution
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
Normosol®-M in 5% Dextrose
Normosol®-R in 5% Dextrose
Final Infusion Solution Concentration (mg per mL) Amount of Diluent (mL) 1 mg per mL 500 mL 2 mg per mL 250 mLOther intravenous substances, additives, or medications should not be added to azithromycin for injection, or infused simultaneously through the same intravenous line.
Storage
When diluted according to the instructions (1 mg per mL to 2 mg per mL), azithromycin for injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
-
American Health Packaging
Azithromycin | American Health Packaging
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
* DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1,
followed by 250 mg once daily on
Days 2 through 5Acute bacterial exacerbations of chronic
obstructive pulmonary disease500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1,
followed by 250 mg once daily on
Days 2 through 5Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1 * DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1 see dosing tables below for maximum doses evaluated by indicationInfection
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
Azithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, [see Use in Specific Populations (8.4)]) Based on Body Weight * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA:(5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL;
(½ tsp)1.25 mL;
( ¼ tsp)7.5 mL
150 mg
10
22
5 mL; (1tsp)
2.5 mL;
(½ tsp)15 mL
300 mg
20
44
5 mL;
(1 tsp)2.5 mL;
(½ tsp)15 mL
600 mg
30
66
7.5 mL;
(1½ tsp)3.75 mL;
(¾ tsp)22.5 mL
900 mg
40
88
10 mL;
(2 tsp)5 mL;
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL;
(1¼ tsp)37.5 mL
1500 mg
* Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per
Treatment Course
Total mg per
Treatment Course
Kg
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL;
(½ tsp)7.5 mL
150 mg
10
22
5 mL;
(1 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)15 mL
600 mg
30
66
7.5 mL
(1 ½ tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2 ½ tsp)37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL per
Total mg per
Kg
Lbs.
1-Day Regimen
Treatment Course
Treatment Course
5
11
3.75 mL; (¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL; (1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL; (3 tsp)
15 mL
600 mg
30
66
22.5 mL; (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL; (6 tsp)
30 mL
1200 mg
50 and above
110 and
above37.5 mL; (7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin tablets for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, [see Use in Specific Populations (8.4)]) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per
Total mg per
Kg
Lbs.
Day 1 to 5
Treatment Course
Treatment
Course8
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(SeeINDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Infection* Recommended Dose/Duration of Therapy Community-aquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic
obstructive pulmonary disease (mild to moderate) 500 mg QD × 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD × 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose12
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2–5 Day 1 Days 2–5 5 11 2.5 mL
(½ tsp) 1.25 mL
(¼ tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 2.5 mL
(½ tsp) 15 mL 300 mg 20 44 5 mL
(1 tsp) 2.5 mL
(½ tsp) 15 mL 600 mg 30 66 7.5 mL
(1½ tsp) 3.75 mL
(¾ tsp) 22.5 mL 900 mg 40 88 10 mL
(2 tsp) 5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2½ tsp) 6.25 mL
(1¼ tsp) 37.5 mL 1500 mg13
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–3 Day 1–3 5 11 2.5 mL
(1/2 tsp) 7.5 mL 150 mg 10 22 5 mL
(1 tsp) 15 mL 300 mg 20 44 5 mL
(1 tsp) 15 mL 600 mg 30 66 7.5 mL
(1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL
(2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL
(2 ½ tsp) 37.5 mL 1500 mg14
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 5 11 3.75 mL
(3/4 tsp) 3.75 mL
150 mg 10 22 7.5 mL
(1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL
(3 tsp) 15 mL 600 mg 30 66 22.5 mL
(4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL
(6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL
(7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–5 8 18 2.5 mL
(½ tsp) 12.5 mL 500 mg 17 37 5 mL
(1 tsp) 25 mL 1000 mg 25 55 7.5 mL
(1½ tsp) 37.5 mL 1500 mg 33 73 10 mL
(2 tsp) 50 mL 2000 mg 40 88 12.5 mL
(2½ tsp) 62.5 mL 2500 mgConstituting instructions for azithromycin Oral Suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution 9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL 9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL 12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL 15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mLShake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
12 See 13 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 14 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Infection* Recommended Dose/Duration of Therapy Community-Acquired Pneumonia (Mild Severity) Pharyngitis/Tonsillitis (Second Line Therapy) Skin/Skin Structure (Uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease (Mild to Moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute Bacterial Sinusitis 500 mg QD x 3 days Genital Ulcer Disease (Chancroid) One single 1 gram dose Non-Gonococcal Urethritis and Cervicitis One single 1 gram dose Gonococcal Urethritis and Cervicitis One single 2 gram dose
11
Azithromycin Tablets USP can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0 to 120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when Azithromycin Tablets are administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg
12
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 to 3 Day 1 to 3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg
13
OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a Single Dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course Kg Lbs. Day 1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per TreatmentCourse Total mg per TreatmentCourse Kg Lbs. Day 1 to 5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2½ tsp) 62.5 mL 2500 mg
11 (see 12 Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. 13 Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Cardinal Health
Azithromycin | Cardinal Health
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults * DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE). Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseAzithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg * Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 to 3 Day 1 to 3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1 ½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course Kg Lbs. Day 1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1 ½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7 ½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per TreatmentCourse Total mg per TreatmentCourse Kg Lbs. Day 1 to 5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2½ tsp) 62.5 mL 2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See
INDICATIONS AND USAGE
and
CLINICAL PHARMACOLOGY
.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC
0-120
was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
)
No dosage adjustment is recommended based on age or gender. (See
CLINICAL PHARMACOLOGY, Special Populations.
)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Clinical Solutions Wholesale
Azithromycin | Clinical Solutions Wholesale
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults:Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per
Treatment CourseKg
Lbs.
Day 1
Days 2-5Day 1
Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg30
66
7.5 mL (1½ tsp)
3.75 mL (3/4tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment CourseKg
Lbs.
Day 1-3
Day 1-3
5
11
2.5 mL (½ tsp)7.5 mL
150 mg
10
22
5 mL (1 tsp)15 mL
300 mg
20
44
5 mL (1 tsp)15 mL
600 mg
30
66
7.5 mL (1½ tsp)22.5 mL
900 mg
40
88
10 mL (2 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg
Lbs.
Day15
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL (6tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp)
37.5 mL
1500 mg
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg
Lbs.
Day 1-58
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2 ½ tsp)
62.5 mL
2500 mg
Adults:Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per
Treatment CourseKg
Lbs.
Day 1
Days 2-5Day 1
Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg30
66
7.5 mL (1½ tsp)
3.75 mL (3/4tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment CourseKg
Lbs.
Day 1-3
Day 1-3
5
11
2.5 mL (½ tsp)7.5 mL
150 mg
10
22
5 mL (1 tsp)15 mL
300 mg
20
44
5 mL (1 tsp)15 mL
600 mg
30
66
7.5 mL (1½ tsp)22.5 mL
900 mg
40
88
10 mL (2 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg
Lbs.
Day15
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL (6tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp)
37.5 mL
1500 mg
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg
Lbs.
Day 1-58
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2 ½ tsp)
62.5 mL
2500 mg
-
Clinical Solutions Wholesale
Azithromycin | Clinical Solutions Wholesale
See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.
Adults *DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICALPHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY,Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL
(1/2 tsp)
1.25 mL (1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL (1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(½ tsp)
15 mL
600 mg
30
66
7.5 mL
(1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL
(½ tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
5
11
3.75 mL
(¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1½ tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4½ tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for oral suspension for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS, Pediatric Use.) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per
Treatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL
(½ tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)
62.5 mL
2500 mg
Constituting instructions for azithromycin for oral suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of
water to be added
Total volume after constitution (azithromycin content)
Azithromycin concentration after constitution
9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 25°C (41° to 77°F) and use within 10 days. Discard after full dosing is completed.
-
Fresenius Kabi Usa, Llc
Azithromycin | Sandoz Inc
Tamsulosin hydrochloride capsule USP, 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules, USP should not be crushed, chewed or opened.
For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules, USP can be increased to 0.8 mg once daily. Tamsulosin hydrochloride capsules, USP 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see WARNINGS AND PRECAUTIONS (5.2)].
If tamsulosin hydrochloride capsules, USP administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.
-
Aidarex Pharmaceuticals Llc
Azithromycin | Aidarex Pharmaceuticals Llc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Fresenius Kabi Usa, Llc
Azithromycin | Fresenius Kabi Usa, Llc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
The recommended dose of Azithromycin for Injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250 mg tablets to complete a 7 to 10 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for Injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin for Injection.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations , Renal Insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
The infusate concentration and rate of infusion for Azithromycin for Injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. Azithromycin for Injection should not be given as a bolus or as an intramuscular injection.
Preparation of the solution for intravenous administration is as follows:
Reconstitution
Prepare the initial solution of Azithromycin for Injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since Azithromycin for Injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C (86°F).
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute this solution further prior to administration as instructed below.
Dilution
To provide azithromycin over a concentration range of 1 to 2 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:
Normal Saline (0.9% sodium chloride)
1/2 Normal Saline (0.45% sodium chloride)
5% Dextrose in Water
Lactated Ringer’s Solution
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
5% Dextrose in Lactated Ringer’s Solution
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
Normosol®-M in 5% Dextrose
Normosol®-R in 5% Dextrose
Final Infusion Solution
Concentration (mg/mL) Amount of Diluent (mL)
1 mg/mL 500 mL
2 mg/mL 250 mL
It is recommended that a 500 mg dose of Azithromycin for Injection, diluted as above, be infused over a period of not less than 60 minutes.
Azithromycin for Injection should not be given as a bolus or as an intramuscular injection.
Other intravenous substances, additives, or medications should not be added to Azithromycin for Injection or infused simultaneously through the same intravenous line.
StorageStore the white to off-white lyophilized cake at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
StorageStore the white to off-white lyophilized cake at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
-
Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Azithromycin | Mckesson Packaging Services A Business Unit Of Mckesson Corporation
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Adults * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.5
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs.
Day 1
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See
INDICATIONS AND USAGE
and
CLINICAL PHARMACOLOGY
.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC
0-120
was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
)
No dosage adjustment is recommended based on age or gender. (See
CLINICAL PHARMACOLOGY, Special Populations.
)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See
INDICATIONS AND USAGE
and
CLINICAL PHARMACOLOGY
.)
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC
0-120
was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.
)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.
)
No dosage adjustment is recommended based on age or gender. (See
CLINICAL PHARMACOLOGY, Special Populations.
)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Pd-rx Pharmaceuticals, Inc.
Azithromycin | Pd-rx Pharmaceuticals, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Cardinal Health
Azithromycin | Cardinal Health
(See INDICATIONS AND USAGEand CLINICAL PHARMACOLOGY.)
Adults: * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.Kg
Lbs.
Day 1
Days 2-5
Day 1
Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL (3/4tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.Kg
Lbs.
Day 1-3
Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg
OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment course Total mg per Treatment courseKg
Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL (6tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS (Age 2 years and above, see PRECAUTIONS-Pediatric Use.) Based on Body weight PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200mg/5mL Total mL per Treatment course Total mg per Treatment courseKg
Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2 ½ tsp)
62.5 mL
2500 mg
Adults: * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia:
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.Kg
Lbs.
Day 1
Days 2-5
Day 1
Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL (3/4tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.Kg
Lbs.
Day 1-3
Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg
OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment course Total mg per Treatment courseKg
Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL (6tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS (Age 2 years and above, see PRECAUTIONS-Pediatric Use.) Based on Body weight PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200mg/5mL Total mL per Treatment course Total mg per Treatment courseKg
Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2 ½ tsp)
62.5 mL
2500 mg
-
Cardinal Health
Azithromycin | Cardinal Health
For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)
If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1 to 2 minute period.
Administration of Metoclopramide Injection, USP up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment.
For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy
Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses.
The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.
For doses in excess of 10 mg, Metoclopramide Injection, USP should be diluted in 50 mL of a parenteral solution.
The preferred parenteral solution is Sodium Chloride Injection (normal saline), which when combined with Metoclopramide Injection, USP, can be stored frozen for up to 4 weeks. Metoclopramide Injection, USP is degraded when admixed and frozen with Dextrose-5% in Water. Metoclopramide Injection, USP diluted in Sodium Chloride Injection, Dextrose-5% in Water, Dextrose-5% in 0.45% Sodium Chloride, Ringer’s Injection, or Lactated Ringer’s Injection may be stored up to 48 hours (without freezing) after preparation if protected from light. All dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation.
If acute dystonic reactions should occur, inject 50 mg Benadryl® (diphenhydramine hydrochloride) intramuscularly, and the symptoms usually will subside.
For the Prevention of Postoperative Nausea and Vomiting
Metoclopramide Injection, USP should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.
To Facilitate Small Bowel Intubation
If the tube has not passed the pylorus with conventional maneuvers in 10 minutes, a single dose (undiluted) may be administered slowly by the intravenous route over a 1 to 2 minute period.
The recommended single dose is: Pediatric patients above 14 years of age and adults – 10 mg metoclopramide base. Pediatric patients (6 to 14 years of age) – 2.5 to 5 mg metoclopramide base; (under 6 years of age) – 0.1 mg/kg metoclopramide base.
To Aid in Radiological Examinations
In patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine, a single dose may be administered slowly by the intravenous route over a 1 to 2 minute period.
For dosage, see intubation, above.
Use in Patients with Renal or Hepatic Impairment
Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
See OVERDOSAGE section for information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
ADMIXTURE COMPATIBILITIES
Metoclopramide Injection, USP is compatible for mixing and injection with the following dosage forms to the extent indicated below:
Physically and Chemically Compatible Up to 48 Hours
Cimetidine Hydrochloride (SK&F), Mannitol, USP (Hospira), Potassium Acetate, USP (Invenex), Potassium Phosphate, USP (Invenex).
Physically Compatible Up to 48 Hours
Ascorbic Acid, USP (Hospira), Benztropine Mesylate, USP (MS&D), Cytarabine, USP (Upjohn), Dexamethasone Sodium Phosphate, USP (ESI, MS&D), Diphenhydramine Hydrochloride, USP (Parke-Davis), Doxorubicin Hydrochloride, USP (Adria), Heparin Sodium, USP (ESI), Hydrocortisone Sodium Phosphate (MS&D), Lidocaine Hydrochloride, USP (ESI), Multi-Vitamin Infusion (must be refrigerated-USV), Vitamin B Complex with Ascorbic Acid (Roche).
Physically Compatible Up to 24 Hours (Do not use if precipitation occurs)
Clindamycin Phosphate, USP (Upjohn), Cyclophosphamide, USP (Mead-Johnson), Insulin, USP (Lilly).
Conditionally Compatible (Use within one hour after mixing or may be infused directly into the same running IV line)
Ampicillin Sodium, USP (Bristol), Cisplatin (Bristol), Erythromycin Lactobionate, USP (Hospira), Methotrexate Sodium, USP (Lederle), Penicillin G Potassium, USP (Squibb), Tetracycline Hydrochloride, USP (Lederle).
Incompatible (Do Not Mix)
Cephalothin Sodium, USP (Lilly), Chloramphenicol Sodium, USP (Parke-Davis), Sodium Bicarbonate, USP (Hospira).
-
Medvantx, Inc.
Azithromycin | Medvantx, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults * DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).Infection*
Recommended Dose/Duration of Therapy
Community-Acquired Pneumonia (Mild Severity) Pharyngitis/Tonsillitis (Second Line Therapy) Skin/Skin Structure (Uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease (Mild to Moderate)
500 mg QD × 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute Bacterial Sinusitis
500 mg QD × 3 days
Genital Ulcer Disease (Chancroid)
One single 1 gram dose
Non-Gonococcal Urethritis and Cervicitis
One single 1 gram dose
Gonococcal Urethritis and Cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0 to 120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for Oral Suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a Single Dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
Day 1
5
11
3.75 mL (¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4½ tsp)
22.5 mL
900 mg
40
88
30 mL (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2½ tsp)
62.5 mL
2500 mg
Constituting instructions for Azithromycin for Oral Suspension USP, 300, 600, 900, and 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of Water to be Added
Total Volume After Constitution (Azithromycin Content)
Azithromycin Concentration After Constitution
9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
Greenstone Llc
Azithromycin | Glaxosmithkline Llc
• Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate [see Indications and Usage (1)]. • Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA, and should continue this diet during treatment with LOVAZA. In clinical studies, LOVAZA was administered with meals.The daily dose of LOVAZA is 4 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).
Patients should be advised to swallow LOVAZA capsules whole. Do not break open, crush, dissolve, or chew LOVAZA.
-
Greenstone Llc
Azithromycin | Chattem, Inc.
Read insert (inside package) on how to:
get a new bottle ready (primed) before first use
prime bottle again if not used for more than 2 weeks
use the spray
clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12
years of age and older once daily, spray 2 times into each nostril while sniffing gently
once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN 2 TO UNDER 12 YEARS OF AGE the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. children 6 to under 12 years of age an adult should supervise use
once daily, spray 1 time into each nostril while sniffing gently
if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day. children 2 to under 6 years of age an adult should supervise use
once daily, spray 1 time into each nostril while sniffing gently children under 2 years of age do not use do not use more than directed
if you forget a dose, do not double the next dose
do not spray into eyes or mouth
if allergy symptoms do not improve after one week, stop using and talk to a doctor
do not use for the common cold
shake well before each use -
Baxter Healthcare Corporation
Azithromycin | Baxter Healthcare Corporation
[see Indications and Usage (1) and Clinical Pharmacology (12.3)]
2.1 Community-Acquired PneumoniaThe recommended dose of AZITHROMYCIN for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
2.2 Pelvic Inflammatory DiseaseThe recommended dose of AZITHROMYCIN for injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
2.3 Preparation of the Solution for Intravenous administrationThe infusate concentration and rate of infusion for AZITHROMYCIN for injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. AZITHROMYCIN for injection should not be given as a bolus or as an intramuscular injection.
Reconstitution
Prepare the initial solution of AZITHROMYCIN for injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial, and shaking the vial until all of the drug is dissolved. Since AZITHROMYCIN for injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C (86°F).
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute this solution further prior to administration as instructed below.
Dilution
To provide azithromycin over a concentration range of 1.0–2.0 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:
Normal Saline (0.9% sodium chloride)
1/2 Normal Saline (0.45% sodium chloride)
5% Dextrose in Water
Lactated Ringer's Solution
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
5% Dextrose in Lactated Ringer's Solution
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
Normosol®-M in 5% Dextrose
Normosol®-R in 5% DextroseWhen used with the Vial-Mate® drug reconstitution device, please reference the Vial-Mate® instructions for assembly and reconstitution.
Final Infusion Solution Concentration (mg/mL) Amount of Diluent (mL) 1.0 mg/mL 500 mL 2.0 mg/mL 250 mLOther intravenous substances, additives, or medications should not be added to AZITHROMYCIN for injection, or infused simultaneously through the same intravenous line.
Storage
When diluted according to the instructions (1.0 mg/mL to 2.0 mg/mL), AZITHROMYCIN for injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
-
Cardinal Health
Azithromycin | Cardinal Health
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
The recommended dose of Azithromycin for Injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250 mg tablets to complete a 7 to 10 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for Injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin for Injection.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
The infusate concentration and rate of infusion for Azithromycin for Injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. Azithromycin for Injection should not be given as a bolus or as an intramuscular injection.
Preparation of the solution for intravenous administration is as follows:
Reconstitution
Prepare the initial solution of Azithromycin for Injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since Azithromycin for Injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C (86°F).
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute this solution further prior to administration as instructed below.
Dilution
To provide azithromycin over a concentration range of 1 to 2 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:
Normal Saline (0.9% sodium chloride)
1/2 Normal Saline (0.45% sodium chloride)
5% Dextrose in Water
Lactated Ringer’s Solution
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
5% Dextrose in Lactated Ringer’s Solution
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
Normosol®-M in 5% Dextrose
Normosol®-R in 5% Dextrose
Final Infusion Solution
Concentration (mg/mL) Amount of Diluent (mL)
1 mg/mL 500 mL
2 mg/mL 250 mL
It is recommended that a 500 mg dose of Azithromycin for Injection, diluted as above, be infused over a period of not less than 60 minutes.
Azithromycin for Injection should not be given as a bolus or as an intramuscular injection.
Other intravenous substances, additives, or medications should not be added to Azithromycin for Injection or infused simultaneously through the same intravenous line.
StorageStore the white to off-white lyophilized cake at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
StorageStore the white to off-white lyophilized cake at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
-
Direct Rx
Azithromycin | Direct Rx
Adults
*DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE). Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram doseRenal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICALPHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY,Special Populations).
Pediatric Patients
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight *Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 112.5 mL
(1/2 tsp) 1.25 mL (1/4 tsp) 7.5 mL 150 mg 10 225 mL
(1 tsp) 2.5 mL (1/2 tsp) 15 mL 300 mg 20 445 mL
(1 tsp)2.5 mL
(½ tsp) 15 mL 600 mg 30 667.5 mL
(1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp)5 mL
(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg *Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 to 3 Day 1 to 3 5 112.5 mL
(½ tsp) 7.5 mL 150 mg 10 225 mL
(1 tsp) 15 mL 300 mg 20 445 mL
(1 tsp) 15 mL 600 mg 30 667.5 mL
(1½ tsp) 22.5 mL 900 mg 40 8810 mL
(2 tsp) 30 mL 1200 mg 50 and above 110 and above12.5 mL
(2½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 5 113.75 mL
(¾ tsp) 3.75 mL 150 mg 10 227.5 mL
(1½ tsp) 7.5 mL 300 mg 20 4415 mL
(3 tsp) 15 mL 600 mg 30 6622.5 mL
(4½ tsp) 22.5 mL 900 mg 40 8830 mL
(6 tsp) 30 mL 1200 mg 50 and above 110 and above37.5 mL
(7½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for oral suspension for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS, Pediatric Use.) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment CourseTotal mg per
Treatment Course Kg Lbs. Day 1 to 5 8 182.5 mL
(½ tsp) 12.5 mL500 mg
17 375 mL
(1 tsp) 25 mL1000 mg
25 557.5 mL
(1½ tsp)
37.5 mL1500 mg
33 7310 mL
(2 tsp) 50 mL2000 mg
40 8812.5 mL
(2½ tsp) 62.5 mL2500 mg
Constituting instructions for azithromycin for oral suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of
water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution 9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL 9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL 12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL 15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mLShake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 25°C (41° to 77°F) and use within 10 days. Discard after full dosing is completed.
-
Pd-rx Pharmaceuticals, Inc.
Azithromycin | Pd-rx Pharmaceuticals, Inc.
Cephalexin is administered orally.
Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Cephalexin should be administered for at least 10 days.
-
Aphena Pharma Solutions – Tennessee, Llc
Azithromycin | Aphena Pharma Solutions - Tennessee, Llc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Adults * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.5
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs.
Day 1
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
-
Sandoz Inc
Azithromycin | Sandoz Inc
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1 Infection* Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indication
Azithromycin can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITYACQUIRED PNEUMONIA
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight5
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1-3 Days 1-35
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen5
11
3.75 mL;(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;(3 tsp)
15 mL
600 mg
30
66
22.5 mL;(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
-
Fresenius Kabi Usa, Llc
Azithromycin | Fresenius Kabi Usa, Llc
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
The recommended dose of Azithromycin for Injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250 mg tablets to complete a 7 to 10 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for Injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7 day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin for Injection.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
The infusate concentration and rate of infusion for Azithromycin for Injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. Azithromycin for Injection should not be given as a bolus or as an intramuscular injection.
Preparation of the solution for intravenous administration is as follows:
Reconstitution
Prepare the initial solution of Azithromycin for Injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since Azithromycin for Injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C (86°F).
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute this solution further prior to administration as instructed below.
Dilution
To provide azithromycin over a concentration range of 1 to 2 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:
Normal Saline (0.9% sodium chloride)
1/2 Normal Saline (0.45% sodium chloride)
5% Dextrose in Water
Lactated Ringer’s Solution
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl
5% Dextrose in Lactated Ringer’s Solution
5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride)
5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride)
Normosol®-M in 5% Dextrose
Normosol®-R in 5% Dextrose
Final Infusion Solution
Concentration (mg/mL) Amount of Diluent (mL)
1 mg/mL 500 mL
2 mg/mL 250 mL
It is recommended that a 500 mg dose of Azithromycin for Injection, diluted as above, be infused over a period of not less than 60 minutes.
Azithromycin for Injection should not be given as a bolus or as an intramuscular injection.
Other intravenous substances, additives, or medications should not be added to Azithromycin for Injection or infused simultaneously through the same intravenous line.
StorageStore the white to off-white lyophilized cake at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
StorageStore the white to off-white lyophilized cake at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
-
Cardinal Health
Azithromycin | Cardinal Health
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
AZITHROMYCIN tablets can be taken with or without food.
2.2 Pediatric Patients1 Infection* Recommended Dose/Duration of Therapy 1 see dosing tables below for maximum doses evaluated by indication * DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
AZITHROMYCIN for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, [see Use in Specific Populations (8.4) ]) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL; (½ tsp)
1.25 mL;(¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1–3 Days 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.5
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen5
11
3.75 mL;(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;(3 tsp)
15 mL
600 mg
30
66
22.5 mL;(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of AZITHROMYCIN for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, [see Use in Specific Populations (8.4) ]) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–58
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
Constituting instructions for AZITHROMYCIN Oral Suspension 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
Preferred Pharmaceuticals, Inc.
Azithromycin | Preferred Pharmaceuticals, Inc.
(See INDICATIONS AND USAGE.)
Azithromycin for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. Not for pediatric use. For pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
The recommended dose of azithromycin for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) dose of azithromycin. This dose can be administered as one single dose packet (1 g).
Prevention of Disseminated MAC InfectionsThe recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC InfectionsAzithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
DIRECTIONS FOR ADMINISTRATION OF Azithromycin for oral suspension in the single dose packet (1 g)The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to assure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of azithromycin. This packet not for pediatric use.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.)
-
Preferred Pharmaceuticals, Inc.
Azithromycin | Preferred Pharmaceuticals, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults * DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).Infection*
Recommended Dose/Duration of Therapy
Community-Acquired Pneumonia (Mild Severity) Pharyngitis/Tonsillitis (Second Line Therapy) Skin/Skin Structure (Uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease (Mild to Moderate)
500 mg QD × 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute Bacterial Sinusitis
500 mg QD × 3 days
Genital Ulcer Disease (Chancroid)
One single 1 gram dose
Non-Gonococcal Urethritis and Cervicitis
One single 1 gram dose
Gonococcal Urethritis and Cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0 to 120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for Oral Suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a Single Dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
Day 1
5
11
3.75 mL (¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4½ tsp)
22.5 mL
900 mg
40
88
30 mL (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2½ tsp)
62.5 mL
2500 mg
Constituting instructions for Azithromycin for Oral Suspension USP, 300, 600, 900, and 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of Water to be Added
Total Volume After Constitution (Azithromycin Content)
Azithromycin Concentration After Constitution
9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
Preferred Pharmaceuticals, Inc.
Azithromycin | Preferred Pharmaceuticals, Inc.
See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.
Adults *DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICALPHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY,Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL
(1/2 tsp)
1.25 mL (1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL (1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(½ tsp)
15 mL
600 mg
30
66
7.5 mL
(1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL
(½ tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
5
11
3.75 mL
(¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1½ tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4½ tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for oral suspension for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS, Pediatric Use.) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per
Treatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL
(½ tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)
62.5 mL
2500 mg
Constituting instructions for azithromycin for oral suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of
water to be added
Total volume after constitution (azithromycin content)
Azithromycin concentration after constitution
9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 25°C (41° to 77°F) and use within 10 days. Discard after full dosing is completed.
-
Preferred Pharmaceuticals, Inc.
Azithromycin | Preferred Pharmaceuticals, Inc.
(SeeINDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Community-aquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic
obstructive pulmonary disease (mild to moderate)500 mg QD × 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Acute bacterial sinusitis
500 mg QD × 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL
(½ tsp)1.25 mL
(¼ tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)2.5 mL
(½ tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)2.5 mL
(½ tsp)15 mL
600 mg
30
66
7.5 mL
(1½ tsp)3.75 mL
(¾ tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2½ tsp)6.25 mL
(1¼ tsp)37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.5
11
2.5 mL
(1/2 tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)15 mL
600 mg
30
66
7.5 mL
(1 ½ tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2 ½ tsp)37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 15
11
3.75 mL
(3/4 tsp)3.75 mL
150 mg
10
22
7.5 mL
(1 ½ tsp)7.5 mL
300 mg
20
44
15 mL
(3 tsp)15 mL
600 mg
30
66
22.5 mL
(4 ½ tsp)22.5 mL
900 mg
40
88
30 mL
(6 tsp)30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7 ½ tsp)37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–58
18
2.5 mL
(½ tsp)12.5 mL
500 mg
17
37
5 mL
(1 tsp)25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)37.5 mL
1500 mg
33
73
10 mL
(2 tsp)50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)62.5 mL
2500 mg
Constituting instructions for azithromycin Oral Suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
Clinical Solutions Wholesale
Azithromycin | Clinical Solutions Wholesale
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults * DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).Infection*
Recommended Dose/Duration of Therapy
Community-Acquired Pneumonia (Mild Severity) Pharyngitis/Tonsillitis (Second Line Therapy) Skin/Skin Structure (Uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease (Mild to Moderate)
500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute Bacterial Sinusitis
500 mg QD x 3 days
Genital Ulcer Disease (Chancroid)
One single 1 gram dose
Non-Gonococcal Urethritis and Cervicitis
One single 1 gram dose
Gonococcal Urethritis and Cervicitis
One single 2 gram dose
Azithromycin Tablets USP can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0 to 120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when Azithromycin Tablets are administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a Single Dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
Day 1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per TreatmentCourse
Total mg per TreatmentCourse
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2½ tsp)
62.5 mL
2500 mg
-
Clinical Solutions Wholesale
Azithromycin | Clinical Solutions Wholesale
(See INDICATIONS AND USAGE.)
Not for pediatric use.
Pediatric UseFor pediatric patients, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Prevention of Disseminated MAC InfectionsThe recommended dose of azithromycin tablets for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablets may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC InfectionsAzithromycin tablets should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin tablets plus ethambutol at the discretion of the physician or health care provider.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0 to 120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Hepatic Insufficiency).
-
Teva Pharmaceuticals Usa Inc
Azithromycin | Teva Pharmaceuticals Usa Inc
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
* DUE TO THE INDICATED ORGANISMS [ see Indications and Usage (1.1)]Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1 * DUE TO THE INDICATED ORGANISMS [ see Indications and Usage (1.2)]Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL;
(1 tsp)2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL; (½ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
15 mL
600 mg
30
66
7.5 mL; (1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2 ½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
1 Day Regimen
5
11
3.75 mL; (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL; (1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL; (3 tsp)
15 mL
600 mg
30
66
22.5 mL; (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL; (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL; (7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per TreatmentCourse
Total mg per TreatmentCourse
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
-
Pliva, Inc.
Azithromycin | Pliva, Inc.
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg-once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1 see dosing tables below for maximum doses evaluated by indication
Azithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL
(½ tsp)15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL
(¾ tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL
(½ tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
1 Day Regimen
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL
(½ tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)
62.5 mL
2500 mg
-
Teva Pharmaceuticals Usa Inc
Azithromycin | Teva Pharmaceuticals Usa Inc
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg-once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1 see dosing tables below for maximum doses evaluated by indication
Azithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL;
(½ tsp)15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL;
(¾ tsp)22.5 mL
900 mg
40
88
10 mL;
(2 tsp)5 mL;
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL;
(½ tsp)7.5 mL
150 mg
10
22
5 mL;
(1 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
1 Day Regimen
5
11
3.75 mL;
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;
(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;
(3 tsp)
15 mL
600 mg
30
66
22.5 mL;
(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;
(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per TreatmentCourse
Total mg per TreatmentCourse
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL;
(½ tsp)
12.5 mL
500 mg
17
37
5 mL;
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL;
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL;
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL;
(2½ tsp)
62.5 mL
2500 mg
Constituting instructions for azithromycin for oral suspension 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added
Total volume after constitution (azithromycin content)
Azithromycin concentration after constitution
9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
-
Teva Pharmaceuticals Usa Inc
Azithromycin | Teva Pharmaceuticals Usa Inc
[See Indications and Usage (1)]
Not for pediatric use.
Pediatric Use
For pediatric patients, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets USP may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
2.2 Mycobacterial InfectionsPrevention of Disseminated MAC Infections
The recommended dose of azithromycin tablets for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablets may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablets should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
-
Pd-rx Pharmaceuticals, Inc.
Azithromycin | Pd-rx Pharmaceuticals, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg Adults: Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1tsp)
30 mL
1200 mg
50 and above
12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-3 Day 1-3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp) 15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp )
37.5 mL
1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1
5
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp) 15 mL
600 mg
30
66
22.5 mL (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp) 37.5 mL
1500 mg
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
Dosing Calculated on 12 mg/kg/day for 5 days
Weight
200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg 40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg -
Teva Pharmaceuticals Usa Inc
Azithromycin | Teva Pharmaceuticals Usa Inc
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3).]
* DUE TO THE INDICATED ORGANISMS [ see Indications and Usage (1.1)]Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients* * DUE TO THE INDICATED ORGANISMS [ see Indications and Usage (1.2)]Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
* see dosing tables below for maximum doses evaluated by indicationAzithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL; (½ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
1 Day Regimen
5
11
3.75 mL; (¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL; (1½ tsp)
7.5 mL
300 mg
20
44
15 mL; (3 tsp)
15 mL
600 mg
30
66
22.5 mL; (4½ tsp)
22.5 mL
900 mg
40
88
30 mL; (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL; (7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
Constituting instructions for azithromycin for oral suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution.
Amount of water to be added
Total volume after constitution (azithromycin content)
Azithromycin concentration after constitution
9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
Proficient Rx Lp
Azithromycin | Topco Associates Llc
• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor -
Pd-rx Pharmaceuticals, Inc.
Azithromycin | Pd-rx Pharmaceuticals, Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Adults * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.5
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 15
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
-
Proficient Rx Lp
Azithromycin | Proficient Rx Lp
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults *DUE TO THE INDICATED ORGANISMS (seeINDICATIONS AND USAGE).Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets USP can be taken with or without food.
Renal InsufficiencyNo dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal insufficiency).
Hepatic InsufficiencyThe pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric PatientsAzithromycin for oral suspension can be taken with or without food.
Acute Otitis MediaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial SinusitisThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired PneumoniaThe recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.)
Based on Body WeightOTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mLTotal mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL
(½ tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2 ½ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
Day 1
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/TonsillitisThe recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.)
Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per TreatmentCourse
Total mg per TreatmentCourse
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL
(½ tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)
62.5 mL
2500 mg
-
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
12
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-55
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
13
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-35
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
14
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 15
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
12 (See 13 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 14 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY).
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia
(mild severity)
Pharyngitis/tonsillitis (second
line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on
Day 1, followed by 250 mg
once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
12
Azithromycin tablets can be taken with or without food.
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY: Special Populations: Renal Insufficiency).
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY: Special Populations: Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY: Special Populations).
Azithromycin for oral suspension can be taken with or without food.
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL
Per
Treatment
Course Total mg
Per
Treatment
Course
Kg
Lbs. Day
1 Days
2-5 Day
1 Days
2-55
11
2.5 mL
(1/2 tsp)
1.25 mL
(1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(1/2 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
3.75 mL
(3/4 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
6.25 mL
(1-1/4 tsp)
37.5 mL
1500 mg
13
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 1-3 Day 1-35
11
2.5 mL
(1/2 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1-1/2 tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50
and
above
110
and
above
12.5 mL
(2-1/2 tsp)
37.5 mL
1500 mg
14
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per
Treatment
Course Total mg per
Treatment
Course Kg Lbs. Day 15
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1-1/2 tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4-1/2 tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and
above
110 and
above
37.5 mL
(7-1/2 tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS: Pediatric Use.) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL
(1/2 tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1-1/2 tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2-1/2 tsp)
62.5 mL
2500 mg
12 (See 13 Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 14 Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. -
Remedyrepack Inc.
Azithromycin | Remedyrepack Inc.
•
Adult Patients
Infection Recommended Dose/Duration of TherapyCommunity-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic bronchitis (mild to moderate)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days.
Acute bacterial sinusitis
500 mg once daily for 3 days.
Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitis
One single 1 gram dose.
Gonococcal urethritis and cervicitis
One single 2 gram dose.
•
Pediatric Patients
Infection Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
Infection* Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indication
Azithromycin can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITYACQUIRED PNEUMONIA
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight5
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1-3 Days 1-35
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen5
11
3.75 mL;(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;(3 tsp)
15 mL
600 mg
30
66
22.5 mL;(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
-
Medsource Pharmaceuticals
Azithromycin | Medsource Pharmaceuticals
2.1 Adult Patients[See Indications and Usage ( 1.1) and Clinical Pharmacology ( 12.3)]
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg-once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage ( 1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients 1Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage ( 1.2)]
1 see dosing tables below for maximum doses evaluated by indication
Azithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations ( 8.4)] )
Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL
(½ tsp)15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL
(¾ tsp)22.5 mL
900 mg
40
88
10 mL
(2 tsp)5 mL
(1 tsp)30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL
(½ tsp)7.5 mL
150 mg
10
22
5 mL
(1 tsp)15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
1 Day Regimen
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations ( 8.4)] )
Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per TreatmentCourse
Total mg per TreatmentCourse
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL
(½ tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)
62.5 mL
2500 mg
-
Preferred Pharmaceuticals Inc.
Azithromycin | Preferred Pharmaceuticals Inc.
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1 Infection* Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indication
Azithromycin can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY‑ACQUIRED PNEUMONIA
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight5
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1-3 Days 1-35
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen5
11
3.75 mL;(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;(3 tsp)
15 mL
600 mg
30
66
22.5 mL;(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
-
Preferred Pharmaceuticals Inc.
Azithromycin | Preferred Pharmaceuticals Inc.
2.1 Adult Patients[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1 Infection* Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indication
Azithromycin can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY‑ACQUIRED PNEUMONIA
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight5
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1-3 Days 1-35
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen5
11
3.75 mL;(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;(3 tsp)
15 mL
600 mg
30
66
22.5 mL;(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
Treatment Course Total mg per
Treatment Course Kg Lbs. Day 1-58
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
-
American Health Packaging
Azithromycin | American Health Packaging
[See Indications and Usage (1)]
Not for pediatric use.
Pediatric Use
For pediatric patients, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets USP may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
2.2 Mycobacterial InfectionsPrevention of Disseminated MAC Infections
The recommended dose of azithromycin tablets for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablets may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin tablets should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
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