Biaxin

[clarithromycin]

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:

Text Continues Below

---

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 for life if clinical and mycobacterial improvements are observed.

Constituting Instructions

The table below indicates the volume of water to be added when constituting:
Clarithromycin Amount of Total volume concentration after water to after constitution constitution 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 at 15° to 30°C (59° to 86°F) and use within 14 days.

HOW SUPPLIED

BIAXIN ® Filmtab ® (clarithromycin tablets, USP) are supplied as yellow oval film-coated tablets in the following packaging sizes:

250 mg tablets: (imprinted in blue with the Abbott logo and Abbo-Code KT)
Bottles of 60 (NDC0074-3368-60) and ABBO-PAC unit dose strip packages of 100 (NDC0074-3368-11).

Store BIAXIN 250 mg tablets at controlled room temperature 15° to 30°C (59° to 86°F) in a well-closed container. Protect from light. 500 mg tablets: (debossed with the Abbott logo on one side and Abbo-Code KL on the opposite side)Bottles of 60 (NDC0074-2586-60) and ABBO-PAC unit dose strip packages of 100 (NDC0074-2586-11).

Store BIAXIN 500 mg tablets at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container. BIAXIN® XL Filmtab ® (clarithromycin extended-release tablets) are supplied as yellow oval film-coated 500 mg tablets debossed (on one side) with the Abbott logo and a two-letter Abbo-Code designation, KJ in the following packaging sizes:

500 mg tablets:

Bottles of 60 ( NDC 0074-3165-60), ABBO-PAC unit dose strip packages of 100 ( NDC 0074-3165-11), and BIAXIN® XL PAC carton of 4 blister packages 14 tablets each (NDC0074-3165-41).
Store BIAXIN XL tablets at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Con-
trolled Room Temperature.]
BIAXIN® Granules (clarithromycin for oral suspension, USP) is supplied in the following strengths and sizes:
Clarithromycin Clarithromycin
Total volume concentration after contents per
after constitution constitution bottle NDC
50 mL 125 mg/5 mL 1250 mg 0074-3163-50
100 mL 125 mg/5 mL 2500 mg 0074-3163-13
50 mL 250 mg/5 mL 2500 mg 0074-3188-50
100 mL 250 mg/5 mL 5000 mg 0074-3188-13
Store BIAXIN granules for oral suspension at controlled room temperature 15° to 30°C (59° to 86°F) in a well-closed container. Do not refrigerate BIAXIN suspension.

Page:  << Prev | 1 | 2 | 3 | 4 | 5