Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
RIFAMPIN; ISONIAZID; PYRAZINAMIDE
SANOFI-AVENTIS CANADA INC
J04AM05
RIFAMPICIN, PYRAZINAMIDE AND ISONIAZID
120MG; 50MG; 300MG
TABLET
RIFAMPIN 120MG; ISONIAZID 50MG; PYRAZINAMIDE 300MG
ORAL
60
Prescription
ANTITUBERCULOSIS AGENTS
Active ingredient group (AIG) number: 0327238001; AHFS:
CANCELLED POST MARKET
2017-03-29
PRODUCT MONOGRAPH PR RIFATER ® _ _ (RIFAMPIN 120 MG, ISONIAZID 50 MG AND PYRAZINAMIDE 300 MG) MANUFACTURER STANDARD _ _ FIXED COMBINATION TABLET ANTITUBERCULOUS ANTIBIOTIC sanofi-aventis Canada Inc. Date of Revision: 2150 St. Elzear Blvd. West March 11, 2009 Laval, Quebec H7L 4A8 SUBMISSION CONTROL NUMBER: 126678 -2- PRODUCT MONOGRAPH PR RIFATER ® _ _ (RIFAMPIN 120 MG, ISONIAZID 50 MG AND PYRAZINAMIDE 300 MG) FIXED COMBINATION TABLET ANTITUBERCULOUS ANTIBIOTIC ACTION AND CLINICAL PHARMACOLOGY ACTION RIFATER (rifampin/isoniazid/pyrazinamide) is an anti-bacterial fixed combination product containing 120 mg rifampin, 50 mg isoniazid and 300 mg pyrazinamide used for the treatment of tuberculosis. Rifampin, isoniazid and pyrazinamide are bactericidal agents active against both intracellular and extracellular tuberculosis organisms. Rifampin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase, but does not inhibit the mammalian enzyme. Cross- resistance to rifampin has only been shown with other rifamycins. Isoniazid kills actively growing tubercle bacilli by inhibition of mycolic acid synthesis. The mechanism of action of pyrazinamide is unknown. _In vitro _ and _in vivo_ the drug is active only at a slightly acidic pH. _ _ PHARMACOKINETICS Pharmacokinetic studies in normal volunteers have shown that the three ingredients in RIFATER have comparable bioavailability whether they are given together as individual dose forms or as RIFATER. Once daily doses of 4-7 tablets in tubercolosis patients resulted in the following steady state pharmacokinetics. TABLE 1: STEADY STATE PHARMACOKINETIC PARAMETERS OF ISONIAZID, RIFAMPIN AND PYRAZINAMIDE Half-Life (h) Cmax (mg/L) Tmax (h) AUC (mg/L/h) Isoniazid 2.5 7.6 1.5 34.2 Rifampin 2.0 9.5 2.2 47.9 Pyrazinamide 7.7 41.7 1.8 509.4 -3- INDICATIONS AND CLINICAL USAGE RIFATER (rifampin/isoniazid/pyrazinamide) is indicated in the initial phase of the short-course treatment of pulmonary tuberculosis. During this ph Baca dokumen lengkapnya