Clarithromycin dosage and administration

Clarithromycin
BIAXIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Dosage And Administration

BIAXIN Filmtab (clarithromycin tablets, USP) and BIAXIN Granules (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.

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.

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

Triple therapy: BIAXIN/lansoprazole/amoxicillin

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

Triple therapy: BIAXIN/omeprazole/amoxicillin

The recommended adult dose is 500 mg BIAXIN, 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: BIAXIN/omeprazole

The recommended adult dose is 500 mg BIAXIN 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: BIAXIN/ranitidine bismuth citrate

The recommended adult dose is 500 mg BIAXIN 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. BIAXIN 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.

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Mycobacterial Infections

=Prophylaxis

The recommended dose of BIAXIN 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:

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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 15° to 30°C (59° to 86°F) and use within 14 days.

References

Adapted from the FDA Package Insert.