Klacid/Klacid MR

Klacid/Klacid MR Dosage/Direction for Use

clarithromycin

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Klacid FC Tablet: For oral use.
Adults: The usual recommended dosage of clarithromycin in adults and children 12 years of age or older, is one 250mg tablet twice daily. In more severe infections, the dosage can be increased to 500mg twice daily. The usual duration of therapy is 5 to 14 days, excluding treatment of community acquired pneumonia and sinusitis which require 6 to 14 days of therapy.
Eradication of H.pylori in patients with duodenal ulcers: Adults: The usual dose of Clarithromycin is 500 mg three times daily for 14 days.
Dual therapy: Klacid should be administered with oral omeprazole 40 mg once daily. The pivotal study was conducted with omeprazole 40 mg once daily for 28 days. Supportive studies have been conducted with omeprazole 40 mg once daily for 14 days.
Triple Therapy: Klacid 500 mg twice daily should be given with amoxycillin 1000mg twice daily and omeprazole 20 mg daily for 10 days.
Elderly: As for adults.
Renal impairment: In patients with renal impairment with creatinine clearance less than 30 mL/min, the dosage of clarithromycin should be reduced by one-half, i.e., 250 mg once daily, or 250 mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients.
Pediatric Population: The use of clarithromycin IR has not been studied in children less than 12 years of age.
Klacid granules for oral susp: 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 (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 table is a suggested guide for determining dosage based on the weight of the child and the concentration of the suspension: (See Tables 2 and 3.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Dosage in Patients with Mycobacterial Infections: Klacid granules for oral susp 125 mg/5 mL: 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/g clarithromycin b.i.d, not exceeding a maximum dose of 500mg 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. (See Table 4.)

Click on icon to see table/diagram/image

Klacid granules for oral susp 250 mg/5 mL: In children with disseminated or localized mycobacterial infections (M. avium, M. intracellulare, M. chelonae, M. fortuitum, M. kansasii), the recommended dose is 15 to 30 mg/kg clarithromycin per day in two divided doses.
Treatment with clarithromycin should continue as long as clinical benefit is demonstrated. The addition of other antimycobacterial agents may be of benefit. (See Table 5.)

Click on icon to see table/diagram/image

Renal Impairment: In children with creatinine clearance less than 30 ml/min, 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 your 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 250mg per 5 ml.
Administration: Several devices can be used to dose and administer Clarithromycin Pediatric Suspension.
Conservation: After reconstitution, store at room temperature (15°C to 30°C) and use within 14 days. Do not refrigerate.
Swirl well before each use.
Klacid MR Tablet:
For oral use.
Adults: The usual recommended dosage of clarithromycin MR tablets in adults and children 12 years of age or older is 500 mg once-daily with food. In more severe infections, the dosage may be increased to 1000 mg once- daily (2 x 500 mg). The usual duration of therapy is 5 to 14 days, excluding treatment of community acquired pneumonia and sinusitis which require 6 to 14 days therapy.
Do not crush or chew clarithromycin modified release tablets.
Renal Impairment: In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the usual recommended dose is 250 mg once daily. Because the modified-release tablet cannot be split, instead immediate-release tablets should be used. In more severe infections, the recommended dose is one 500mg modified-release tablet once daily. No dose adjustment is required for patients with moderate renal impairment (creatinine clearance 30 to 60 ml/min).
Pediatric Population: The use of clarithromycin MR has not been studied in children less than 12 years of age.
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