Posology : מינונים

4.2.   Posology and method of administration

Pediatric Patients under 12 years of age
Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin pediatric suspension (granules for oral suspension).

The recommended daily dosage of Clarithromycin Pediatric Suspension in children is 7.5 mg/kg b.i.d. up to a maximum dose of 500 mg b.i.d. for non-mycobacterial infections. The usual duration of treatment is for 5 to 10 days depending on the pathogen involved and the severity of the condition. The prepared suspension can be taken with or without meals, and can be taken with milk.
The following table is a suggested guide for determining dosage, based on the weight of the child and the concentration of the suspension.

DOSAGE GUIDELINES FOR PEDIATRIC PATIENTS
Based on Body Weight
Weight*          7.5 mg/kg b.i.d. dosage in ml given twice daily
Kg                              125 mg/5 ml
8-11                                 2.5ml
12-19                                  5 ml
20-29                                7.5 ml
30-40                                 10 ml
* Children < 8 kg should be dosed on a per kg. basis (approx. 7.5 mg/kg b.i.d.)

Dosage in Patients with Mycobacterial Infections
In children with disseminated or localized mycobacterial infections (M. avium, M.
intracellulare, M. chelonae, M. fortuitum, M. kansasii), the recommended dose is 7.5 to 15 mg/kg clarithromycin b.i.d.
Treatment with clarithromycin should continue as long as clinical benefit is demonstrated.
The addition of other antimycobacterial agents may be of benefit.

Renal Impairment
In children with creatinine clearance less than 30 ml/min/, 1.73 m2 the dosage of clarithromycin should be reduced by one-half, i.e., up to 250 mg once daily, or 250 mg twice daily in more severe infections. Dosage should not be continued beyond 14 days in these patients.

Instructions for use and handling
See section 6.6.