Clarithromycin

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Side Effects & Adverse Reactions

Ask a doctor before use if you have

high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

When using this product: do not use more than directed

Do not use for more than 3 days. Use only as directed.

Ask a doctor before use if you have

high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

When using this product: do not use more than directed

Do not use for more than 3 days. Use only as directed.

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Uses

Uses
Temporarily relieves nasal congestion due to:

common cold
hay fever
upper respiratory allergies
sinusitis
shrinks swollen nasal membrances so you can breathe more freely.

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Sources

Clarithromycin Manufacturers

Teva Pharmaceuticals Usa Inc

Clarithromycin | Purinepharma Llc

Directions: Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostrill not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
Children under six years of age: ask a doctor.

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

No Recall
Genpharm

Clarithromycin | Genpharm

Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES
Clarithromycin Tablets, USP Infection Dosage Duration (q12h) (days) Pharyngitis/Tonsilitis due to S. pyogenes 250 mg 10 Acute maxillary sinusitis due to 500 mg 14 H. influenza M. catarrhalis S. pneumoniae Acute exacerbation of chronic bronchitis due to H. influenzae 500 mg 7-14 H. parainfluenzae 500 mg 7 M. catarrhalis 250 mg 7-14 S. pneumoniae 250 mg 7-14 Community-Acquired Pneumonia due to H. influenzae 250 mg 7 H. parainfluenzae - - M. catarrhalis - - S. pneumoniae 250 mg 7-14 C. pneumoniae 250 mg 7-14 M. pneumoniae 250 mg 7-14 Uncomplicated skin and skin structure 250 mg 7-14 S. aureus S. pyogenes
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: Clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (ql2h) for 10 or 14 days. (See INDICATIONS ANDUSAGE and CLINICAL STUDIES sections.)

Triple therapy: Clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (ql2h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: Clarithromycin/ omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS ANDUSAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: Clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (ql2h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (ql2h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

Children - The usual recommended daily dosage is 15 mg/kg/day divided ql2h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight Dose (q12h) 125 mg/5 mL 250 mg/ 5 mL kg lb 9 20 62.5 mg 2.5 mL q12h 1.25 mL q12h 17 37 125 mg 5 mL q12h 2.5 mL q12h 25 55 187.5 mg 7.5 mL q12h 3.75 mL q12h 33 73 250 mg 10 mL q12h 5 mL q12h
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL < 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial infections: Prophylaxis: The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment: Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Kaiser Foundation Hospitals

Clarithromycin | Kaiser Foundation Hospitals

Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP may be given with or
without food. BIAXIN XL Filmtab (clarithromycin extended-release tablets) should be taken with food.
BIAXIN XL tablets should be swallowed whole and not chewed, broken or crushed.
ADULT DOSAGE GUIDELINES
BIAXIN Tablets BIAXIN XL Tablets Infection Dosage
(q12h) Duration
(days) Dosage
(q24h) Duration
(days) Pharyngitis/Tonsillitis due to

     S. pyogenes 250 mg 10 - - Acute maxillary sinusitis due to 500 mg 14 2 x 500 mg 14      H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae 500 mg 7-14 2 x 500 mg 7      H. parainfluenzae 500 mg 7 2 x 500 mg 7      M. catarrhalis 250 mg 7-14 2 x 500 mg 7      S. pneumoniae 250 mg 7-14 2 x 500 mg 7 Community-Acquired Pneumonia due to

     H. influenzae 250 mg 7 2 x 500 mg 7      H. parainfluenzae - - 2 x 500 mg 7      M. catarrhalis - - 2 x 500 mg 7      S. pneumoniae 250 mg 7-14 2 x 500 mg 7      C. pneumoniae 250 mg 7-14 2 x 500 mg 7      M. pneumoniae 250 mg 7-14 2 x 500 mg 7 Uncomplicated skin and skin structure 250 mg 7-14 - -      S. aureus

     S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin,
all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

Triple Therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin,
all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES
sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of
omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg
omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL
STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer
healing and symptom relief.

Dual Therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily
(q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14
days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and
ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine
clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES
sections.)

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight Dose Kg lbs (q12h) 125 mg/5 mL 250 mg/5 mL 9
17
25
33 20
37
55
73 62.5 mg
125 mg
187.5 mg
250 mg 2.5 mL q12h
5 mL q12h
7.5 mL q12h
10 mL q12h 1.25 mL q12h
2.5 mL q12h
3.75 mL q12h
5 mL q12h
Clarithromycin may be administered without dosage adjustment in the presence of hepatic
impairment if there is normal renal function. However, in the presence of severe renal impairment
(CRCL less than 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial Infections

Prophylaxis

The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium
disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No
studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the
doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing
recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due
to Mycobacterium avium complex. Clarithromycin should be used in combination with other
antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC
treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults
is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing
recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are
observed.

No Recall
Kaiser Foundation Hospitals

Clarithromycin | Kaiser Foundation Hospitals

Clarithromycin tablets may be given with or without food.
ADULT DOSAGE GUIDELINES Clarithromycin Tablets Infection
Dosage

(q12h)

Duration

(days)
Pharyngitis/Tonsillitis due to S. pyogenes 250 mg 10 Acute maxillary sinusitis due to 500 mg 14 H. influenzae M. catarrhalis S. pneumoniae Acute exacerbation of chronic bronchitis due to H. influenzae 500 mg 7 to 14 H. parainfluenzae 500 mg 7 M. catarrhalis 250 mg 7 to 14 S. pneumoniae 250 mg 7 to 14 Community Acquired Pneumonia due to H. influenzae 250 mg 7 H. parainfluenzae M. catarrhalis S. pneumoniae 250 mg 7 to 14 C. pneumoniae 250 mg 7 to 14 M. pneumoniae 250 mg 7 to 14 Uncomplicated skin and skin structure 250 mg 7 to 14 S. aureus S. pyogenes H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES).
Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES).
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight Dose Kg lbs (q12h) 125 mg/5 mL 250 mg/5 mL 9 20 62.5 mg 2.5 mL q12h 1.25 mL q12h 17 37 125 mg 5 mL q12h 2.5 mL q12h 25 55 187.5 mg 7.5 mL q12h 3.75 mL q12h 33 73 250 mg 10 mL q12h 5 mL q12h
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL < 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.
Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Remedyrepack Inc.

Clarithromycin | Remedyrepack Inc.

Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES
ClarithromycinTabletsDosageDuration Infection(q12h)(days)Pharyngitis/Tonsillitis due toS. pyogenes250 mg10Acute maxillary sinusitis due to500 mg14H. influenzaeM. catarrhalisS. pneumoniaeAcute exacerbation of chronic bronchitis due toH. influenzae500 mg7 to 14H. parainfluenzae500 mg7M. catarrhalis250 mg7 to 14S. pneumoniae250 mg7 to 14Community Acquired Pneumonia due toH. influenzae250 mg7H. parainfluenzaeM. catarrhalisS. pneumoniae250 mg7 to 14C. pneumoniae250 mg7 to 14M. pneumoniae250 mg7 to 14Uncomplicated skin and skin structure250 mg7 to 14S. aureusS. pyogenes
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES).

Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES).

Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINES
Based on Body WeightDosing Calculated on 7.5 mg/kg q12hWeightDoseKglbs(q12h)125 mg/5 mL250 mg/5 mL92062.5 mg2.5 mL q12h1.25 mL q12h1737125 mg5 mL q12h2.5 mL q12h2555187.5 mg7.5 mL q12h3.75 mL q12h3373250 mg10 mL q12h5 mL q12hClarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL < 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial Infections

Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.
Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Remedyrepack Inc.

Clarithromycin | Remedyrepack Inc.

DOSAGE AND ADMINISTRATION
Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES
Clarithromycin Tablets, USPInfectionDosage (q12h)Duration (days)Pharyngitis/Tonsilitis due toS. pyogenes250 mg10Acute maxillary sinusitis due to500 mg14H. influenzaM. catarrhalisS. pneumoniaeAcute exacerbation of chronic bronchitis due toH. influenzae500 mg7 to 14H. parainfluenzae500 mg7M. catarrhalis250 mg7 to 14S. pneumoniae250 mg7 to 14Community-Acquired Pneumonia due toH. influenzae250 mg7H. parainfluenzae--M. catarrhalis--S. pneumoniae250 mg7 to 14C. pneumoniae250 mg7 to 14M. pneumoniae250 mg7 to 14Uncomplicated skin and skin structure250 mg7 to 14S. aureusS. pyogenesH. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:
Triple therapy: Clarithromycin/lansoprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (ql2h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)
Triple therapy: Clarithromycin/omeprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (ql2h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual therapy: Clarithromycin/omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual therapy: Clarithromycin/ranitidine bismuth citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (ql2h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (ql2h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight Dosing Calculated on 7.5 mg/kg q12hWeightDosekglb(q12h)125 mg/5 mL250 mg/5mL92062.5 mg2.5 mL q12h1.25 mL q12h1737125 mg5 mL q12h2.5 mL q12h2555187.5 mg7.5 mL q12h3.75 mL q12h3373250 mg10 mL q12h5 mL q12hClarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL < 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial infections

Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above. Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Remedyrepack Inc.

Clarithromycin | Remedyrepack Inc.

Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES
Clarithromycin TabletsInfectionDosageDuration(q12h)(days)Pharyngitis/Tonsillitis due toS. pyogenes250 mg10Acute maxillary sinusitis due to500 mg14H. influenzaeM. catarrhalisS. pneumoniaeAcute exacerbation of chronic bronchitis due toH. influenzae500 mg7 to 14H. parainfluenzae500 mg7M. catarrhalis250 mg7 to 14S. pneumoniae250 mg7 to 14Community Acquired Pneumonia due toH. influenzae250 mg7H. parainfluenzaeM. catarrhalisS. pneumoniae250 mg7 to 14C. pneumoniae250 mg7 to 14M. pneumoniae250 mg7 to 14Uncomplicated skin and skin structure250 mg7 to 14S. aureusS. pyogenes
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES).

Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES).

Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINES
Based on Body WeightDosing Calculated on 7.5 mg/kg q12hWeightDoseKglbs(q12h)125 mg/5 mL250 mg/5 mL92062.5 mg2.5 mL q12h1.25 mL q12h1737125 mg5 mL q12h2.5 mL q12h2555187.5 mg7.5 mL q12h3.75 mL q12h3373250 mg10 mL q12h5 mL q12hClarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL < 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial Infections

Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.
Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Remedyrepack Inc.

Clarithromycin | Remedyrepack Inc.

Clarithromycin immediate-release tablets and clarithromycin for oral suspension may be given with or without food.

ADULT DOSAGE GUIDELINESClarithromycin Immediate-Release TabletsInfectionDosage (q12h)Duration (days)Pharyngitis/Tonsillitis due toS. pyogenes250mg10Acute maxillary sinusitis due toH. influenzae500 mg14M. catarrhalisS. pneumoniaeAcute exacerbation of chronic bronchitis due toH. influenzae500 mg7 to 14H. parainfluenzae500 mg7M. catarrhalis250 mg7 to 14S. pneumoniae250 mg7 to 14Community-Acquired Pneumonia due toH. influenzae250 mg7H. parainfluenzae--M. catarrhalis--S. pneumoniae250 mg7 to 14C. pneumoniae250 mg7 to 14M. pneumoniae250 mg7 to 14Uncomplicated skin and skin structure250 mg7 to14S. aureusS. pyogenesH. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceTriple therapy: clarithromycin/lansoprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Triple therapy: clarithromycin/omeprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual therapy: clarithromycin/omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual therapy: clarithromycin/ranitidine bismuth citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Children - The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINESBased on Body WeightDosing Calculated on 7.5 mg/kg q12hWeightDosekglbs(q12h)125 mg/5 mL250 mg/5 mL92062.5 mg2.5 mL q12h1.25 mL q12h1737125 mg5 mL q12h2.5 mL q12h2555187.5 mg7.5 mL q12h3.75 mL q12h3373250 mg10 mL q12h5 mL q12hClarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL < 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.
Mycobacterial infections:
Prophylaxis: The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment: Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.
Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.
Constituting Instructions
The table below indicates the volume of water to be added when constituting.

Total volumeafter constitutionClarithromycin concentration after constitutionAmount of water to be added*50 mL125 mg/5 mL32 mL100 mL125 mg/5 mL64 mL50 mL250 mg/5 mL32 mL100 mL250 mg/5 mL64 mL*see instructions below.Add half the volume of water to the bottle and shake vigorously. Add the remainder of water to the bottle and shake.
Shake well before using. Oversize bottle provides shake space. Keep tightly closed. Do not refrigerate. After mixing, store at 20 - 25C (68 - 77F) (see USP Controlled Room Temperature) and use within 14 days.

No Recall
Remedyrepack Inc.

Clarithromycin | Remedyrepack Inc.

Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES
InfectionClarithromycin TabletsDosage (q12h)Duration (days)Pharyngitis/Tonsillitis due to S. pyogenes250 mg10Acute maxillary sinusitis due to H. influenzae M. catarrhalis S. pneumoniae500 mg14Acute exacerbation of chronic bronchitis due to H. influenzae H. parainfluenzae M. catarrhalis S. pneumoniae500 mg 500 mg 250 mg 250 mg7-14 7 7-14 7-14Community-Acquired Pneumonia due to H. influenzae H. parainfluenza M. catarrhalis S. pneumoniae C. pneumoniae M. pneumoniae250mg -- -- 250 mg 250 mg 250 mg7 -- -- 7-14 7-14 7-14Uncomplicated skin and skin structure S. aureus S. pyogenes250 mg7-14
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight Dosing Calculated on 7.5 mg/kg q12hWeightDose (q12h)kglbs92062.5 mg1737125 mg2555187.5 mg3373250 mgClarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL <30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial Infections

Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.
Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Remedyrepack Inc.

Clarithromycin | Remedyrepack Inc.

Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES
InfectionClarithromycin TabletsDosage (q12h)Duration (days)Pharyngitis/Tonsillitis due to S. pyogenes250 mg10Acute maxillary sinusitis due to H. influenzae M. catarrhalis S. pneumoniae500 mg14Acute exacerbation of chronic bronchitis due to H. influenzae H. parainfluenzae M. catarrhalis S. pneumoniae500 mg 500 mg 250 mg 250 mg7-14 7 7-14 7-14Community-Acquired Pneumonia due to H. influenzae H. parainfluenza M. catarrhalis S. pneumoniae C. pneumoniae M. pneumoniae250mg -- -- 250 mg 250 mg 250 mg7 -- -- 7-14 7-14 7-14Uncomplicated skin and skin structure S. aureus S. pyogenes250 mg7-14
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight Dosing Calculated on 7.5 mg/kg q12hWeightDose (q12h)kglbs92062.5 mg1737125 mg2555187.5 mg3373250 mgClarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL <30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial Infections

Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.
Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Clarithromycin | Lake Erie Medical Dba Quality Care Products Llc

DOSAGE AND ADMINISTRATION. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceTriple Therapy: Clarithromycin/Lansoprazole/Amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL less than 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial InfectionsProphylaxis

The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Physicians Total Care, Inc.

Clarithromycin | Physicians Total Care, Inc.

Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES Infection
Clarithromycin
Tablets
Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to
S. pyogenes 250 mg 10
Acute maxillary sinusitis due to

H. influenzae

M. catarrhalis
S. pneumoniae 500 mg 14
Acute exacerbation of chronic bronchitis due to

H. influenzae

H. parainfluenzae

M. catarrhalis
S. pneumoniae
500 mg

500 mg

250 mg
250 mg
7-14

7

7-14
7-14
Community-Acquired Pneumonia due to

H. influenzae

H. parainfluenza

M. catarrhalis

S. pneumoniae

C. pneumoniae
M. pneumoniae
250mg

--

--

250 mg

250 mg
250 mg
7

--

--

7-14

7-14
7-14
Uncomplicated skin and skin structure

S. aureus
S. pyogenes 250 mg 7-14 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h Weight Dose (q12h) kg lbs 9 20 62.5 mg 17 37 125 mg 25 55 187.5 mg 33 73 250 mg
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL <30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.
Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Life Line Home Care Services, Inc.

Clarithromycin | Life Line Home Care Services, Inc.

Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES Infection
Clarithromycin
Tablets
Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to
S. pyogenes 250 mg 10
Acute maxillary sinusitis due to

H. influenzae

M. catarrhalis
S. pneumoniae 500 mg 14
Acute exacerbation of chronic bronchitis due to

H. influenzae

H. parainfluenzae

M. catarrhalis
S. pneumoniae
500 mg

500 mg

250 mg
250 mg
7-14

7

7-14
7-14
Community-Acquired Pneumonia due to

H. influenzae

H. parainfluenza

M. catarrhalis

S. pneumoniae

C. pneumoniae
M. pneumoniae
250mg

--

--

250 mg

250 mg
250 mg
7

--

--

7-14

7-14
7-14
Uncomplicated skin and skin structure

S. aureus
S. pyogenes 250 mg 7-14 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h Weight Dose (q12h) kg lbs 9 20 62.5 mg 17 37 125 mg 25 55 187.5 mg 33 73 250 mg
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL <30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.
Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Dispensing Solutions, Inc.

Clarithromycin | Dispensing Solutions, Inc.

Clarithromycin extended-release tablets, USP should be taken with food. Clarithromycin extended-release tablets, USP should be swallowed whole and not chewed, broken or crushed.
ADULT DOSAGE GUIDELINES Clarithromycin Extended-Release Tablets, USP Infection Dosage
(q24h) Duration
(days)

Acute maxillary sinusitis
due to: 2 x 500 mg 14 H. influenzae M. catarrahalis S. pneumoniae Acute exacerbation of chronic bronchitis due to: H. influenzae 2 x 500 mg 7 H. parainfluenzae 2 x 500 mg 7 M. catarrhalis 2 x 500 mg 7 S. pneumoniae 2 x 500 mg 7 Community-Acquired
Pneumonia due to: H. influenzae 2 x 500 mg 7 H. parainfluenzae 2 x 500 mg 7 M. catarrhalis 2 x 500 mg 7 S. pneumoniae 2 x 500 mg 7 C. pneumoniae 2 x 500 mg 7 M. pneumoniae 2 x 500 mg 7
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL< 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

No Recall
Rebel Distributors Corp

Clarithromycin | Rebel Distributors Corp

Clarithromycin tablet may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES
Clarithromycin tablet
Infection
Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to

     S. pyogenes
250 mg
10
Acute maxillary sinusitis due to
500 mg
14
     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae
500 mg
7-14
     H. parainfluenzae
500 mg
7
     M. catarrhalis
250 mg
7-14
     S. pneumoniae
250 mg
7-14
Community-Acquired Pneumonia due to

     H. influenzae
250 mg
7
     H. parainfluenzae
-
-
     M. catarrhalis
-
-
     S. pneumoniae
250 mg
7-14
     C. pneumoniae
250 mg
7-14
     M. pneumoniae
250 mg
7-14
Uncomplicated skin and skin structure
250 mg
7-14
     S. aureus

     S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h
Weight
Dose

Kg
lbs
(q12h)
125 mg/5 mL
250 mg/5 mL
9
20
62.5 mg
2.5 mL q12h
1.25 mL q12h
17
37
125 mg
5 mL q12h
2.5 mL q12h
25
55
187.5 mg
7.5 mL q12h
3.75 mL q12h
33
73
250 mg
10 mL q12h
5 mL q12h

Mycobacterial infections

Prophylaxis

The recommended dose of clarithromycin tablet for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Pd-rx Pharmaceuticals, Inc.

Clarithromycin | Pd-rx Pharmaceuticals, Inc.

Clarithromycin tablet may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES
Clarithromycin tablet
Infection
Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to

     S. pyogenes
250 mg
10
Acute maxillary sinusitis due to
500 mg
14
     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae
500 mg
7-14
     H. parainfluenzae
500 mg
7
     M. catarrhalis
250 mg
7-14
     S. pneumoniae
250 mg
7-14
Community-Acquired Pneumonia due to

     H. influenzae
250 mg
7
     H. parainfluenzae
-
-
     M. catarrhalis
-
-
     S. pneumoniae
250 mg
7-14
     C. pneumoniae
250 mg
7-14
     M. pneumoniae
250 mg
7-14
Uncomplicated skin and skin structure
250 mg
7-14
     S. aureus

     S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h
Weight
Dose

Kg
lbs
(q12h)
125 mg/5 mL
250 mg/5 mL
9
20
62.5 mg
2.5 mL q12h
1.25 mL q12h
17
37
125 mg
5 mL q12h
2.5 mL q12h
25
55
187.5 mg
7.5 mL q12h
3.75 mL q12h
33
73
250 mg
10 mL q12h
5 mL q12h

Mycobacterial infections

Prophylaxis

The recommended dose of clarithromycin tablet for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

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Bryant Ranch Prepack

Clarithromycin | Bryant Ranch Prepack

Clarithromycin extended-release tablets should be taken with food. Clarithromycin extended-release tablets should be swallowed whole and not chewed, broken, or crushed.
ADULT DOSAGE GUIDELINES
Clarithromycin Extended-Release Tablets Infection Dosage(q24h) Duration(days) Acute maxillary sinusitis due to

H. influenzae 2 x 500 mg 14 M. catarrhalis

S. pneumoniae

Acute exacerbation of chronic bronchitis due to

H. influenzae 2 x 500 mg 7 H. parainfluenzae 2 x 500 mg 7 M. catarrhalis 2 x 500 mg 7 S. pneumoniae 2 x 500 mg 7 Community-Acquired Pneumonia due to

H. influenzae 2 x 500 mg 7 H. parainfluenzae 2 x 500 mg 7 M. catarrhalis 2 x 500 mg 7 S. pneumoniae 2 x 500 mg 7 C. pneumoniae 2 x 500 mg 7 M. pneumoniae 2 x 500 mg 7
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL GT 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

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Bryant Ranch Prepack

Clarithromycin | Bryant Ranch Prepack

Clarithromycin tablets may be given with or without food.

ADULT DOSAGE GUIDELINES Infection
Clarithromycin
Tablets
Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to
S. pyogenes 250 mg 10
Acute maxillary sinusitis due to

H. influenzae

M. catarrhalis
S. pneumoniae 500 mg 14
Acute exacerbation of chronic bronchitis due to

H. influenzae

H. parainfluenzae

M. catarrhalis
S. pneumoniae 250 mg
500 mg

500 mg

250 mg
7-14
7-14

7

7-14

Community-Acquired Pneumonia due to

H. influenzae

H. parainfluenza

M. catarrhalis

S. pneumoniae

C. pneumoniae
M. pneumoniae 250 mg
250mg

--

--

250 mg

250 mg
7-14
7

--

--

7-14

7-14

Uncomplicated skin and skin structure

S. aureus
S. pyogenes 250 mg 7-14 Eradication to Reduce the Risk of Duodenal Ulcer Recurrence H. pylori Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See and sections.) INDICATIONS AND USAGECLINICAL STUDIES
Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See and sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief. INDICATIONS AND USAGECLINICAL STUDIES
Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See and sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief. INDICATIONS AND USAGECLINICAL STUDIES
Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See and sections.) INDICATIONS AND USAGECLINICAL STUDIES
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h Weight Dose (q12h) kg lbs 9 20 62.5 mg 17 37 125 mg 25 55 187.5 mg 33 73 250 mg
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CR <30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled. CL
Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above. Mycobacterium avium

Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown activity against MAC or clinical benefit in MAC treatment. (See .) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above. Mycobacterium aviumin vitroCLINICAL STUDIES

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

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Bryant Ranch Prepack

Clarithromycin | Bryant Ranch Prepack

Clarithromycin Tablets may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin Tablets
Infection

Dosage

(q12h)
Duration

(days)
Pharyngitis/Tonsillitis due to S.pyogenes 250 mg 10 Acute maxillary sinusitis due to H. influenzae 500 mg 14 M. catarrhalis S. pneumoniae Acute exacerbation of chronic bronchitis due to H. influenzae 500 mg 7-14 H. parainfluenzae 500 mg 7 M. catarrhalis 250 mg 7-14 S. pneumoniae 250 mg 7-14 Community-Acquired Pneumonia due to H. influenzae 250 mg 7 H. parainfluenzae - - M. catarrhalis - - S. pneumoniae 250 mg 7-14 C. pneumoniae 250 mg 7-14 M. pneumoniae 250 mg 7-14 Uncomplicated skin and skin structure 250 mg 7-14 S. aureus S. pyogenes
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: clarithromycin/Iansoprazole/amoxicillin: The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

Triple Therapy: clarithromycin/omeprazole/amoxicillin: The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: clarithromycin/omeprazole: The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: clarithromycin/ranitidine bismuth citrate: The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

Children - The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight
kg Dose
lbs
(q12h) 9 20 62.5 mg 17 37 125 mg 25 55 187.5 mg 33 73 250 mg Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

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Remedyrepack Inc.

Clarithromycin | Remedyrepack Inc.

Clarithromycin tablets may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin Tablets, USP
Infection

Dosage

(q12h)

Duration

(days)

Pharyngitis/Tonsillitis due to

     S. pyogenes

250 mg

10

Acute maxillary sinusitis due to

500 mg

14

     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae

500 mg

7 to 14

     H. parainfluenzae

500 mg

7

     M. catarrhalis

250 mg

7 to 14

     S. pneumoniae

250 mg

7 to 14

Community-Acquired Pneumonia due to

     H. influenzae

250 mg

7

     H. parainfluenzae

-

-

     M. catarrhalis

-

-

     S. pneumoniae

250 mg

7 to 14

     C. pneumoniae

250 mg

7 to 14

     M. pneumoniae

250 mg

7 to 14

Uncomplicated skin and skin structure

250 mg

7 to 14

     S. aureus

    S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:

Triple Therapy: Clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (ql2h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES.)

Triple Therapy: Clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (ql2h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (ql2h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (ql2h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES.)

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h
Weight

Dose

kg

lbs

(q12h)

125 mg/5 mL

250 mg/5mL

9

20

62.5 mg

2.5 mL q12h

1.25 mL q12h

17

37

125 mg

5 mL q12h

2.5 mL q12h

25

55

187.5 mg

7.5 mL q12h

3.75 mL q12h

33

73

250 mg

10 mL q12h

5 mL q12h

The recommended dose of clarithromycin tablets for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin tablets should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above. Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Remedyrepack Inc.

Clarithromycin | Remedyrepack Inc.

Clarithromycin tablets may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin Tablets, USP
Infection

Dosage

(q12h)

Duration

(days)

Pharyngitis/Tonsillitis due to

     S. pyogenes

250 mg

10

Acute maxillary sinusitis due to

500 mg

14

     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae

500 mg

7 to 14

     H. parainfluenzae

500 mg

7

     M. catarrhalis

250 mg

7 to 14

     S. pneumoniae

250 mg

7 to 14

Community-Acquired Pneumonia due to

     H. influenzae

250 mg

7

     H. parainfluenzae

-

-

     M. catarrhalis

-

-

     S. pneumoniae

250 mg

7 to 14

     C. pneumoniae

250 mg

7 to 14

     M. pneumoniae

250 mg

7 to 14

Uncomplicated skin and skin structure

250 mg

7 to 14

     S. aureus

    S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:

Triple Therapy: Clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (ql2h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES.)

Triple Therapy: Clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (ql2h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: Clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (ql2h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (ql2h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES.)

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h
Weight

Dose

kg

lbs

(q12h)

125 mg/5 mL

250 mg/5mL

9

20

62.5 mg

2.5 mL q12h

1.25 mL q12h

17

37

125 mg

5 mL q12h

2.5 mL q12h

25

55

187.5 mg

7.5 mL q12h

3.75 mL q12h

33

73

250 mg

10 mL q12h

5 mL q12h

The recommended dose of clarithromycin tablets for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin tablets should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above. Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
American Health Packaging

Clarithromycin | American Health Packaging

Clarithromycin tablet may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES
Clarithromycin tablet

Infection

Dosage
(q12h)

Duration
(days)

Pharyngitis/Tonsillitis due to

     S. pyogenes

250 mg

10

Acute maxillary sinusitis due to

500 mg

14

     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae

500 mg

7-14

     H. parainfluenzae

500 mg

7

     M. catarrhalis

250 mg

7-14

     S. pneumoniae

250 mg

7-14

Community-Acquired Pneumonia due to

     H. influenzae

250 mg

7

     H. parainfluenzae

-

-

     M. catarrhalis

-

-

     S. pneumoniae

250 mg

7-14

     C. pneumoniae

250 mg

7-14

     M. pneumoniae

250 mg

7-14

Uncomplicated skin and skin structure

250 mg

7-14

     S. aureus

     S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight

Dosing Calculated on 7.5 mg/kg q12h

Weight

Dose

Kg

lbs

(q12h)

125 mg/5 mL

250 mg/5 mL

9

20

62.5 mg

2.5 mL q12h

1.25 mL q12h

17

37

125 mg

5 mL q12h

2.5 mL q12h

25

55

187.5 mg

7.5 mL q12h

3.75 mL q12h

33

73

250 mg

10 mL q12h

5 mL q12h

Mycobacterial infections

Prophylaxis

The recommended dose of clarithromycin tablet for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Wockhardt Limited

Clarithromycin | Wockhardt Limited

Clarithromycin tablet may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES
Clarithromycin tablet
Infection
Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to

     S. pyogenes
250 mg
10
Acute maxillary sinusitis due to
500 mg
14
     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae
500 mg
7-14
     H. parainfluenzae
500 mg
7
     M. catarrhalis
250 mg
7-14
     S. pneumoniae
250 mg
7-14
Community-Acquired Pneumonia due to

     H. influenzae
250 mg
7
     H. parainfluenzae
-
-
     M. catarrhalis
-
-
     S. pneumoniae
250 mg
7-14
     C. pneumoniae
250 mg
7-14
     M. pneumoniae
250 mg
7-14
Uncomplicated skin and skin structure
250 mg
7-14
     S. aureus

     S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h
Weight
Dose

Kg
lbs
(q12h)
125 mg/5 mL
250 mg/5 mL
9
20
62.5 mg
2.5 mL q12h
1.25 mL q12h
17
37
125 mg
5 mL q12h
2.5 mL q12h
25
55
187.5 mg
7.5 mL q12h
3.75 mL q12h
33
73
250 mg
10 mL q12h
5 mL q12h

Mycobacterial infections

Prophylaxis

The recommended dose of clarithromycin tablet for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Clinical Solutions Wholesale

Clarithromycin | Clinical Solutions Wholesale

Clarithromycin tablets may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin
Tablets
Infection Dosage
(q12h) Duration
(days)
Pharyngitis/Tonsillitis due to
S. pyogenes

250 mg

10

Acute maxillary sinusitis due to
H. influenzae
M. catarrhalis
S. pneumoniae

500 mg

14

Acute exacerbation of chronic bronchitis due to

H. influenzae

500 mg

7-14

H. parainfluenzae

500 mg

7

M. catarrhalis

250 mg

7-14

S. pneumoniae

250 mg

7-14

Community-Acquired Pneumonia due to

H. influenzae

250 mg

7

H. parainfluenzae

--

--

M. catarrhalis

--

--

S. pneumoniae

250 mg

7-14

C. pneumoniae

250 mg

7-14

M. pneumoniae

250 mg

7-14

Uncomplicated skin and skin structure
S. aureus
S. pyogenes

250 mg

7-14
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h

Weight

Dose (q12h)

kg

lbs

9

20

62.5 mg

17

37

125 mg

25

55

187.5 mg

33

73

250 mg
Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium aviumcomplex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Wockhardt Usa Llc.

Clarithromycin | Wockhardt Usa Llc.

Clarithromycin tablet may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES
Clarithromycin tablet
Infection
Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to

     S. pyogenes
250 mg
10
Acute maxillary sinusitis due to
500 mg
14
     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae
500 mg
7-14
     H. parainfluenzae
500 mg
7
     M. catarrhalis
250 mg
7-14
     S. pneumoniae
250 mg
7-14
Community-Acquired Pneumonia due to

     H. influenzae
250 mg
7
     H. parainfluenzae
-
-
     M. catarrhalis
-
-
     S. pneumoniae
250 mg
7-14
     C. pneumoniae
250 mg
7-14
     M. pneumoniae
250 mg
7-14
Uncomplicated skin and skin structure
250 mg
7-14
     S. aureus

     S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h
Weight
Dose

Kg
lbs
(q12h)
125 mg/5 mL
250 mg/5 mL
9
20
62.5 mg
2.5 mL q12h
1.25 mL q12h
17
37
125 mg
5 mL q12h
2.5 mL q12h
25
55
187.5 mg
7.5 mL q12h
3.75 mL q12h
33
73
250 mg
10 mL q12h
5 mL q12h

Mycobacterial infections

Prophylaxis

The recommended dose of clarithromycin tablet for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Ranbaxy Pharmaceuticals Inc.

Clarithromycin | Ranbaxy Pharmaceuticals Inc.

Clarithromycin immediate-release tablets and clarithromycin for oral suspension may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin Immediate-Release Tablets Infection Dosage (q12h) Duration (days) Pharyngitis/Tonsillitis due to S. pyogenes 250 mg 10 Acute maxillary sinusitis due to H. influenzae 500 mg 14 M. catarrhalis S. pneumoniae Acute exacerbation of chronic bronchitis due to H. influenzae 500 mg 7 to 14 H. parainfluenzae 500 mg 7 M. catarrhalis 250 mg 7 to 14 S. pneumoniae 250 mg 7 to 14 Community-Acquired Pneumonia due to H. influenzae 250 mg 7 H. parainfluenzae - - M. catarrhalis - - S. pneumoniae 250 mg 7 to 14 C. pneumoniae 250 mg 7 to 14 M. pneumoniae 250 mg 7 to 14 Uncomplicated skin and skin structure 250 mg 7 to14 S. aureus S. pyogenes
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight Dose kg lbs (q12h) 125 mg/5 mL 250 mg/5 mL 9 20 62.5 mg 2.5 mL q12h 1.25 mL q12h 17 37 125 mg 5 mL q12h 2.5 mL q12h 25 55 187.5 mg 7.5 mL q12h 3.75 mL q12h 33 73 250 mg 10 mL q12h 5 mL q12h
Mycobacterial Infections

Prophylaxis

The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

Constituting Instructions

The table below indicates the volume of water to be added when constituting:
Total volume After Constitution Clarithromycin Concentration After Constitution Amount of water to be Added* 50 mL 125 mg/5 mL 32 mL 100 mL 125 mg/5 mL 64 mL 50 mL 250 mg/5 mL 32 mL 100 mL 250 mg/5 mL 64 mL *see instructions below.
Add half the volume of water to the bottle and shake vigorously. Add the remainder of water to the bottle and shake.

Shake well before each use. Oversize bottle provides shake space. Keep tightly closed. Do not refrigerate. After mixing, store at 20 - 25° C (68 - 77° F) (see USP Controlled Room Temperature) and use within 14 days.

No Recall
Citron Pharma Llc

Clarithromycin | Seroyal Usa

Directions
Adults: At the first sign of symptoms, take one tablet
allowing it to dissolve under the tongue. Continue every half hour
to one hour. When symptoms subside, decrease frequency
to every four hours. Once the symptoms are gone, continue
taking one tablet daily for three more days.

If symptoms persist more than four days, discontinue
use and seek advice from a health care practitioner.

Children: Divide tablet in half and follow adult directions.

No Recall
Aidarex Pharmaceuticals Llc

Clarithromycin | Aidarex Pharmaceuticals Llc

Clarithromycin tablet may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES
Clarithromycin tablet
Infection
Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to

      S. pyogenes
250 mg
10
Acute maxillary sinusitis due to
500 mg
14
      H. influenzae

      M. catarrhalis

      S. pneumoniae

Acute exacerbation of chronic bronchitis due to

      H. influenzae
500 mg
7-14
      H. parainfluenzae
500 mg
7
      M. catarrhalis
250 mg
7-14
      S. pneumoniae
250 mg
7-14
Community-Acquired Pneumonia due to

      H. influenzae
250 mg
7
      H. parainfluenzae
-
-
      M. catarrhalis
-
-
      S. pneumoniae
250 mg
7-14
      C. pneumoniae
250 mg
7-14
      M. pneumoniae
250 mg
7-14
Uncomplicated skin and skin structure
250 mg
7-14
      S. aureus

      S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGEand CLINICAL STUDIESsections.)

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h
Weight
Dose

Kg
lbs
(q12h)
125 mg/5 mL
250 mg/5 mL
9
20
62.5 mg
2.5 mL q12h
1.25 mL q12h
17
37
125 mg
5 mL q12h
2.5 mL q12h
25
55
187.5 mg
7.5 mL q12h
3.75 mL q12h
33
73
250 mg
10 mL q12h
5 mL q12h

Mycobacterial infections

Prophylaxis

The recommended dose of clarithromycin tablet for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements are observed.

No Recall
Roxane Laboratories, Inc

Clarithromycin | Roxane Laboratories, Inc

Clarithromycin Tablets, USP, may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.

ADULT DOSAGE GUIDELINES

Clarithromycin Tablets

Infection

Dosage
(q12h)

Duration
(days)

Pharyngitis/Tonsillitis due to

S. pyogenes

250 mg

10

Acute Maxillary Sinusitis due to

500 mg

14

H. influenzae

M. catarrhalis

S. pneumoniae

Acute Exacerbation of Chronic Bronchitis due to

H. influenzae

500 mg

7 to 14

H. parainfluenzae

500 mg

7

M. catarrhalis

250 mg

7 to 14

S. pneumoniae

250 mg

7 to 14

Community-Acquired Pneumonia due to

H. influenzae

250 mg

7

H. parainfluenzae

-

-

M. catarrhalis

-

-

S. pneumoniae

250 mg

7 to 14

C. pneumoniae

250 mg

7 to 14

M. pneumoniae

250 mg

7 to 14

Uncomplicated Skin and Skin Structure

250 mg

7 to 14

S. aureus

S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days (see INDICATIONS AND USAGEand CLINICAL STUDIESsections).

Triple Therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days (see INDICATIONS AND USAGEand CLINICAL STUDIESsections). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGEand CLINICAL STUDIESsections). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGEand CLINICAL STUDIESsections).

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINES

Based on Body Weight

Dosing Calculated on 7.5 mg/kg q12h

Weight

Dose

kg

lbs

(q12h)

9

20

62.5 mg

17

37

125 mg

25

55

187.5 mg

33

73

250 mg

Mycobacterial Infections

Prophylaxis

The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

No Recall
Watson Laboratories, Inc.

Clarithromycin | Henan Lingrui Pharmaceutical Co Ltd

Adults and children 12 years of age and older: Apply to affected area three times a day, 2 - 5ml each time, a course of 15 days.

Children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor.
Children under 2 years of age: Do not use, consult a doctor.
Refer to the above warnings: use otherwise than as directed may be dangerous.

No Recall
Watson Pharma, Inc.

Clarithromycin | Watson Pharma, Inc.

Clarithromycin extended-release tablets should be taken with food. Clarithromycin extended-release tablets should be swallowed whole and not chewed, broken or crushed.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin Extended-release Tablets Infection Dosage
(q24h) Duration
(days) Acute maxillary sinusitis due to: 2 x 500 mg 14 H. influenzae M. catarrahalis S. pneumoniae Acute exacerbation of chronic bronchitis due to: H. influenzae 2 x 500 mg 7 H. parainfluenzae 2 x 500 mg 7 M. catarrhalis 2 x 500 mg 7 S. pneumoniae 2 x 500 mg 7 Community-Acquired Pneumonia due to: H. influenzae 2 x 500 mg 7 H. parainfluenzae 2 x 500 mg 7 M. catarrhalis 2 x 500 mg 7 S. pneumoniae 2 x 500 mg 7 C. pneumoniae 2 x 500 mg 7 M. pneumoniae 2 x 500 mg 7

No Recall
Sandoz Inc

Clarithromycin | Sandoz Inc

Clarithromycin tablets, USP may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin
Tablets
Infection Dosage
(q12h) Duration
(days)
Pharyngitis/Tonsillitis due to
S. pyogenes

250 mg

10

Acute maxillary sinusitis due to
H. influenzae
M. catarrhalis
S. pneumoniae

500 mg

14

Acute exacerbation of chronic bronchitis due to

H. influenzae

500 mg

7-14

H. parainfluenzae

500 mg

7

M. catarrhalis

250 mg

7-14

S. pneumoniae

250 mg

7-14

Community-Acquired Pneumonia due to

H. influenzae

250 mg

7

H. parainfluenzae

--

--

M. catarrhalis

--

--

S. pneumoniae

250 mg

7-14

C. pneumoniae

250 mg

7-14

M. pneumoniae

250 mg

7-14

Uncomplicated skin and skin structure
S. aureus
S. pyogenes

250 mg

7-14
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h

Weight

Dose (q12h)

kg

lbs

9

20

62.5 mg

17

37

125 mg

25

55

187.5 mg

33

73

250 mg
Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium aviumcomplex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

No Recall
Pd-rx Pharmaceuticals, Inc.

Clarithromycin | Pd-rx Pharmaceuticals, Inc.

Clarithromycin extended-release tablets should be taken with food. Clarithromycin extended-release tablets should be swallowed whole and not chewed, broken or crushed.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin Extended-release Tablets Infection Dosage
(q24h) Duration
(days) Acute maxillary sinusitis due to 2 x 500 mg 14 H. influenzae M. catarrhalis S. pneumoniae Acute exacerbation of chronic bronchitis due to: H. influenzae 2 x 500 mg 7 H. parainfluenzae 2 x 500 mg 7 M. catarrhalis 2 x 500 mg 7 S. pneumoniae 2 x 500 mg 7 Community-Acquired Pneumonia due to: H. influenzae 2 x 500 mg 7 H. parainfluenzae 2 x 500 mg 7 M. catarrhalis 2 x 500 mg 7 S. pneumoniae 2 x 500 mg 7 C. pneumoniae 2 x 500 mg 7 M. pneumoniae 2 x 500 mg 7

No Recall
Allied Pharma Inc

Clarithromycin | Allied Pharma Inc

Clarithromycin tablets, USP may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR <30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min, respectively.

ADULT DOSAGE GUIDELINES
Infection
Clarithromycin tablets

Dosage
(q12h)
Duration
(days)
Pharyngitis/Tonsillitis due to

S. pyogenes
250 mg
10
Acute maxillary sinusitis due to
500 mg
14
H. influenzae

M. catarrhalis

S. pneumoniae

Acute exacerbation of chronic bronchitis due to

H. influenzae
500 mg
7-14
H. parainfluenzae
500 mg
7
M. catarrhalis
250 mg
7-14
S. pneumoniae
250 mg
7-14
Community-Acquired Pneumonia due to

H. influenzae
250 mg
7
H. parainfluenzae
-
-
M. catarrhalis
-
-
S. pneumoniae
250 mg
7-14
C. pneumoniae
250 mg
7-14
M. pneumoniae
250 mg
7-14
Uncomplicated skin and skin structure
250 mg
7-14
S. aureus

S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

Triple therapy: clarithromycin/omeprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin tablets, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin /omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin /ranitidine bismuth citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

PEDIATRIC DOSAGE GUIDELINES

Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h
Weight
Dose

Kg
lbs
(q12h)
125 mg/5 mL
250 mg/5 mL
9
17
25
33
20
37
55
73
62.5 mg
125 mg
187.5 mg
250 mg
2.5 mL q12h
5 mL q12h
7.5 mL q12h
10 mL q12h
1.25 mL q12h
2.5 mL q12h
3.75 mL q12h
5 mL q12h

Mycobacterial Infections
Prophylaxis:
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment:
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

No Recall
Pd-rx Pharmaceuticals, Inc.

Clarithromycin | Pd-rx Pharmaceuticals, Inc.

Clarithromycin tablets, USP may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin
Tablets
Infection Dosage
(q12h) Duration
(days)
Pharyngitis/Tonsillitis due to
S. pyogenes

250 mg

10

Acute maxillary sinusitis due to
H. influenzae
M. catarrhalis
S. pneumoniae

500 mg

14

Acute exacerbation of chronic bronchitis due to

H. influenzae

500 mg

7-14

H. parainfluenzae

500 mg

7

M. catarrhalis

250 mg

7-14

S. pneumoniae

250 mg

7-14

Community-Acquired Pneumonia due to

H. influenzae

250 mg

7

H. parainfluenzae

--

--

M. catarrhalis

--

--

S. pneumoniae

250 mg

7-14

C. pneumoniae

250 mg

7-14

M. pneumoniae

250 mg

7-14

Uncomplicated skin and skin structure
S. aureus
S. pyogenes

250 mg

7-14
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight
Dosing Calculated on 7.5 mg/kg q12h

Weight

Dose (q12h)

kg

lbs

9

20

62.5 mg

17

37

125 mg

25

55

187.5 mg

33

73

250 mg
Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium aviumcomplex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection

No Recall
American Health Packaging

Clarithromycin | Nash-finch Company

adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

children under 12 years: do not use this product in children under 12 years of age

No Recall
Zydus Pharmaceuticals Usa Inc

Clarithromycin | Zydus Pharmaceuticals Usa Inc

Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP may be given with or without food. Clarithromycin Extended-Release Tablets should be taken with food. Clarithromycin Extended-Release Tablets should be swallowed whole and not chewed, broken or crushed.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin Tablets, USP Clarithromycin Extended-Release Tablets Infection Dosage
(q12h) Duration
(days) Dosage
(q24h) Duration
(days) Pharyngitis/Tonsillitis due to S. pyogenes 250 mg 10 - - Acute maxillary sinusitis due to 500 mg 14 2 x 500 mg 14 H. influenzae M. catarrhalis S. pneumoniae Acute exacerbation of chronic bronchitis due to H. influenzae 500 mg 7-14 2 x 500 mg 7 H. parainfluenzae 500 mg 7 2 x 500 mg 7 M. catarrhalis 250 mg 7-14 2 x 500 mg 7 S. pneumoniae 250 mg 7-14 2 x 500 mg 7 Community-Acquired Pneumonia due to H. influenzae 250 mg 7 2 x 500 mg 7 H. parainfluenzae - - 2 x 500 mg 7 M. catarrhalis - - 2 x 500 mg 7 S. pneumoniae 250 mg 7-14 2 x 500 mg 7 C. pneumoniae 250 mg 7-14 2 x 500 mg 7 M. pneumoniae 250 mg 7-14 2 x 500 mg 7 Uncomplicated skin and skin structure 250 mg 7-14 - - S. aureus S. pyogenes H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple therapy: clarithromycin/lansoprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).
Triple therapy: clarithromycin/omeprazole/amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual therapy: clarithromycin/omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual therapy: clarithromycin/ranitidine bismuth citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight Dose Kg lbs (q12h) 125 mg/5 mL 250 mg/5 mL 9
17
25
33 20
37
55
73 62.5 mg
125 mg
187.5 mg
250 mg 2.5 mL q12h
5 mL q12h
7.5 mL q12h
10 mL q12h 1.25 mL q12h
2.5 mL q12h
3.75 mL q12h
5 mL q12h Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.
Constituting Instructions
The table below indicates the volume of water to be added when constituting:
Total Volume After Constitution Clarithromycin Concentration After Constitution Amount of Water to be Added* 50 mL 125 mg/5 mL 27 mL 100 mL 125 mg/5 mL 55 mL 50 mL 250 mg/5 mL 27 mL 100 mL 250 mg/5 mL 55 mL * see instructions below.
Add half the volume of water to the bottle and shake vigorously. Add the remainder of water to the bottle and shake.

Shake well before each use. Oversize bottle provides shake space. Keep tightly closed. Do not refrigerate. After mixing, store below 25ºC (77ºF) and use within 14 days.

No Recall
Aurobindo Pharma Limited

Clarithromycin | Aurobindo Pharma Limited

Clarithromycin tablets may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.

ADULT DOSAGE GUIDELINES Clarithromycin Tablets Infection Dosage
(q 12 h) Duration
(Days) Pharyngitis/Tonsillitis due to

     S. pyogenes 250 mg
10
Acute maxillary sinusitis due to
500 mg
14
     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae 500 mg
7 to 14
     H. parainfluenzae
500 mg
7
     M. catarrhalis
250 mg
7 to 14
     S. pneumoniae
250 mg
7 to 14
Community-Acquired Pneumonia due to

     H. influenzae 250 mg
7
     H. parainfluenzae
-
-
     M. catarrhalis
-
-
     S. pneumoniae
250 mg
7 to 14
     C. pneumoniae
250 mg
7 to 14
     M. pneumoniae
250 mg
7 to 14
Uncomplicated skin and skin structure
250 mg
7 to 14
     S. aureus

     S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q 12 h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q 12 h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q 8 h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q 12 h) or three times daily (q 8 h) and 400 mg ranitidine bismuth citrate given twice daily (q 12 h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).

Children

The usual recommended daily dosage is 15 mg/kg/day divided q 12 h for 10 days.

PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q 12 h Weight Dose Kg lbs (q 12 h) 9
20
62.5 mg
17
37
125 mg
25
55
187.5 mg
33
73
250 mg
Mycobacterial Infections

Prophylaxis

The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

No Recall
Teva Pharmaceuticals Usa Inc

Clarithromycin | Teva Pharmaceuticals Usa Inc

Clarithromycin tablets USP may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES
Clarithromycin Tablets

Infection

Dosage

(q12h)

Duration

(days)

Pharyngitis/Tonsillitis due to

S. pyogenes

250 mg

10

Acute maxillary sinusitis due to

500 mg

14

H. influenzae

M. catarrhalis

S. pneumoniae

Acute exacerbation of chronic bronchitis due to

H. influenzae

500 mg

7 to 14

H. parainfluenzae

500 mg

7

M. catarrhalis

250 mg

7 to 14

S. pneumoniae

250 mg

7 to 14

Community-Acquired Pneumonia due to

H. influenzae

250 mg

7

S. pneumoniae

250 mg

7 to 14

C. pneumoniae

250 mg

7 to 14

M. pneumoniae

250 mg

7 to 14

Uncomplicated skin and skin structure

250 mg

7 to 14

S. aureus

S. pyogenes
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES).
Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin
The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Omeprazole
The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate
The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES).
Children
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
PEDIATRIC DOSAGE GUIDELINES
Based on Body Weight

Dosing Calculated on 7.5 mg/kg q12h

Weight

Dose

Kg

lbs

(q12h)

125 mg/5 mL

250 mg/5 mL

9

20

62.5 mg

2.5 mL q12h

1.25 mL q12h

17

37

125 mg

5 mL q12h

2.5 mL q12h

25

55

187.5 mg

7.5 mL q12h

3.75 mL q12h

33

73

250 mg

10 mL q12h

5 mL q12h
Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

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Teva Pharmaceuticals Usa Inc

Clarithromycin | Teva Pharmaceuticals Usa Inc

Clarithromycin extended-release tablets USP should be taken with food. Clarithromycin extended-release tablets USP should be swallowed whole and not chewed, broken or crushed.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES
Clarithromycin Extended-Release Tablets USP

Infection

Dosage (q24h)

Duration (days)

Acute maxillary sinusitis due to

2 x 500 mg

14

H. influenzae

M. catarrhalis

S. pneumoniae

Acute exacerbation of chronic bronchitis due to

H. influenzae

2 x 500 mg

7

H. parainfluenzae

2 x 500 mg

7

M. catarrhalis

2 x 500 mg

7

S. pneumoniae

2 x 500 mg

7

Community-Acquired Pneumonia due to

H. influenzae

2 x 500 mg

7

H. parainfluenzae

2 x 500 mg

7

M. catarrhalis

2 x 500 mg

7

S. pneumoniae

2 x 500 mg

7

C. pneumoniae

2 x 500 mg

7

M. pneumoniae

2 x 500 mg

7

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Apotex Corp

Clarithromycin | Apotex Corp

Clarithromycin tablets may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.
ADULT DOSAGE GUIDELINES Clarithromycin Tablets Infection Dosage (q12h) Duration (days) Pharyngitis/Tonsillitis due to S. pyogenes 250 mg 10 Acute maxillary sinusitis due to 500 mg 14 H. influenzae M. catarrhalis S. pneumoniae Acute exacerbation of chronic bronchitis due to H. influenzae 500 mg 7 to14 H. parainfluenzae 500 mg 7 M. catarrhalis 250 mg 7 to14 S. pneumoniae 250 mg 7 to14 Community-Acquired Pneumonia due to H. influenzae 250 mg 7 H. parainfluenzae - - M. catarrhalis - - S. pneumoniae 250 mg 7 to14 C. pneumoniae 250 mg 7 to14 M. pneumoniae 250 mg 7 to14 Uncomplicated skin and skin structure 250 mg 7 to14 S. aureus S. pyogenes
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).

Triple therapy: clarithromycin /omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin /omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin /ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).

Children

The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

Note: The tablet dosage form might not be suitable for certain pediatric dosages.
PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight Dose(q12h) Kg Lbs 9 20 62.5 mg 17 37 125 mg 25 55 187.5 mg 33 73 250 mg Mycobacterial Infections Prophylaxis
The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.
Treatment
Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

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