Biaxin - Indications & Dosage

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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.

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 (CR CL < 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 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.