Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
MINOCYCLINE HYDROCHLORIDE
Surtech International Ltd
50 Milligram
Capsule
1994-06-14
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aknemin 50 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minocycline base 50 mg (as the hydrochloride Ph. Eur.) per capsule. 3 PHARMACEUTICAL FORM Capsule, hard. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Minocycline is an antibiotic with a spectrum of activity similar to other tetracyclines but more active against _Staphylococcus aureus _and _Nocardia spp._ It is indicated for the treatment of diseases associated with organisms sensitive to tetracyclines such as acne, respiratory infections. gonorrhoea, nocardiosis, staphylococcal infections; the chemoprophylaxis of meningococcal infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration _Adults_ 1. Routine antibiotic use: 200 mg daily in divided doses. 2. Acne: 50 mg twice daily or 100 mg once daily 3. Gonorrhoea: In adult males, 200 mg initially followed by 100 mg every l2 hours for a minimum of 4 days with post-therapy cultures within 2-3 days. Adult females may require more prolonged therapy. 4. Prophylaxis of meningococcal infections: 100 mg twice daily for 5 days, usually followed by a course of rifampicin. _Children_ Aknemin 50 is not recommended for children under 12 years old. For children above 12 years old the recommended dose is 50 mg every 12 hours. _The Elderly_ Aknemin 50 may be used at the normal recommended dosage in elderly patients but caution is advised in patients with renal impairment. The treatment of acne should be continued for a minimum of 6 weeks. 4.3 CONTRAINDICATIONS Hypersensitivity to tetracyclines, systemic lupus erythematosus, complete renal failure, children under 12 years old, pregnancy, lactation. IRISH MEDICINES BOARD ________________________________________________________________________________________________ Leggi il documento completo