מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
RIFAMPICIN ISONIAZID
Sandoz GmbH
300/150mg Milligram
Coated Tablets
1997-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rimactazid 300 tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of rifampicin is 3-[4-methyl-1-piperazinyl)-imino]-methyl]- Rifamycin SV (=rifampicin) 300 mg. The active ingredient for isoniazid is isonicotinic acid hydrazide (=isoniazid, INH) 150 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rimactane and isoniazid are both major drugs in the management of tuberculosis and in certain opportunist mycobacterial infections. Rifampicin is effective in cases resistant to other anti-tuberculous agents and shows no cross-resistance outside the rifamycin group of drugs. Rimactazid must always be used in combination with other anti-tuberculous agents, e.g. streptomycin, pyrazinamide, ethambutol and the majority of second-line drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rimactazid should be given as a single dose, preferably on an empty stomach, at least 30 minutes before breakfast to ensure a high peak serum concentration. Rimactazid has to be supplemented with 150mg isoniazid for every 10kg body weight above 20kg (i.e. body weight 60kg: 150 x 4 = 600mg additional isoniazid needed). The chemotherapeutic agents usually employed today as combined therapy for tuberculosis are rifampicin (Rimactane) (RMP), isoniazid (INH), pyrazinamide (PZA), ethambutol (EMB), streptomycin (STM). _ADULTS_: _Continuous therapy_ Body weight less than 50kg: 3 tablets Rimactazid 150 (= 450mg rifampicin + 300mg INH) once daily. Body weight 50kg or more: 2 tablets Rimactazid 300 (= 600mg rifampicin + 300mg INH) once daily. _Intermittent therapy_ Body weight less than 50kg: 3 tablets rimactazid 150 (= 450mg rifampicin + 300mg INH) twice or 3 times week קרא את המסמך השלם