Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Clonmel Healthcare Ltd
50mg/ml
Granules for Oral Suspension
2005-04-15
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clonocid 250mg/5ml granules for oral suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml reconstituted oral suspension contains 50 mg clarithromycin. 5 ml reconstituted oral suspension contains 250 mg clarithromycin. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. White to off-white granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Streptococcal tonsillitis, otitis media, skin and soft tissue infections of mild to moderate severity in penicillin hypersensitive patients or in cases where penicillin is inappropriate for other reasons. Available data on epidemiological resistance to macrolide antibiotics should be considered. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _General:_ The dosage of Clarithromycin depends on the clinical condition of the patient and has to be defined in any case by the physician. The usual dose in children aged 6 months or older is 7.5 mg/kg twice daily. _Recommendations for dosage:_ “Children < 8 kg should be dosed on a per kg basis (approx. 7.5mg/kg twice daily) which is equal to 0.15 ml of ready to use suspension per kg body weight.” _Dosage in renal functional impairment:_ Dosage adjustment is not usually required except in patients with severe renal impairment (creatinine clearance < 30 ml/min). If adjustment is necessary, the total daily standard dosage should be reduced by half. Treatments should not be continued beyond 14 days in these patients. Weight Age Dosage 12-19 kg 2-4 years 2.5 ml twice daily 20-29 kg 4-8 years 3.75 ml twice daily 30-40 kg 8-12 years 5 ml twice daily IRISH MEDICINES BOARD __________________________________________ Read the complete document