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 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
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 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 25°C (41° to 77°F) and use within 10 days. Discard after full dosing is completed.
