Claritrox Dosage/Direction for Use

Film-coated tablet: Clarithromycin tablets may be given with or without food.
Adults: 250 mg every 12 hours for 7 days, increased in severe infections to 500 mg every 12 hours for up to 14 days. In patients with renal impairment with creatinine clearance <30 ml/min, the dosage should be reduced by half. Dosage should not be continued beyond 14 days in these patients.
Granules for oral suspension: 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 Claritrox Granules for Oral Suspension 125 mg/5 mL or 250 mg/5 mL 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 tables are suggested guides for determining dosage based on the weight of the child and the concentration of the suspension.
125 mg/5mL: (See Table 2.)

Click on icon to see table/diagram/image

250 mg/5 mL: (See Table 3.)

Click on icon to see table/diagram/image

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 15mg/Kg clarithromycin b.i.d, not exceeding a maximum dose of 500mg b.i.d. (125 mg/5mL) or 15 to 30mg/Kg clarithromycin per day in two divided doses (250 mg/5 mL).
Treatment with clarithromycin should continue as long as clinical benefit is demonstrated. The addition of other antimycobacterial agents may be of benefit.
125 mg/5mL: (See Table 4.)

Click on icon to see table/diagram/image

250 mg/5 mL: (See Table 5.)

Click on icon to see table/diagram/image

Renal Impairment: In children with creatinine clearance less than 30 ml/min/1.73m², 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.
Preparation for Use: An appropriate amount of water, consult approved International Manufacturing Formula, should be added to the granules in the bottle and shaken until all of the particles are suspended. Avoid vigorous and/or lengthy shaking. Shake prior to each subsequent use to ensure resuspension. The concentration of clarithromycin in the reconstituted suspension is 125 mg/5 mL or 250 mg/5 mL.
125 mg/5mL: Administration: Several devices can be used to dose and administer Claritrox Granules for Oral Suspension. Conservation: After reconstitution, store at room temperature (below 30°C) and use within 14 days. Do not refrigerate. Swirl well before each use.
250 mg/5 mL: The reconstituted suspension can be used for up to 14 days when stored at room temperature (15°C to 30°C). Shake well before each use.