Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
RIFAMPIN
SANOFI-AVENTIS CANADA INC
J04AB02
RIFAMPICIN
300MG
CAPSULE
RIFAMPIN 300MG
ORAL
100
Prescription
ANTITUBERCULOSIS AGENTS
Active ingredient group (AIG) number: 0105824001; AHFS:
CANCELLED POST MARKET
2021-01-28
_Pr_ _RIFADIN_ _®_ _ _ _Page 1 of 38 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR RIFADIN ® RIFAMPIN CAPSULES USP 150 MG & 300 MG ANTIBIOTIC sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud Laval, Quebec H7V 0A3 Date of Revision: December 9, 2020 Submission Control No.: 241843 _Pr_ _RIFADIN_ _®_ _ _ _Page 2 of 38 _ PRODUCT MONOGRAPH Pr RIFADIN ® (rifampin) Capsules 150 mg & 300 mg Antibiotic CLINICAL PHARMACOLOGY RIFADIN (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. This is the probable mechanism of action by which rifampin exerts its therapeutic effects. Absorption is more rapid when rifampin is administered one hour before meals. Peak blood levels in normal adults vary widely from individual to individual. Peak levels occur between 2 and 4 hours following the oral administration of a 600 mg dose with average peak values of 7- 10 mcg/mL. Rifampin is distributed throughout the body and is detectable in many organs and body fluids, including the cerebrospinal fluid. The highest concentrations are present in the liver and bile. In normal subjects, the biological half-life of rifampin in serum averages about 3 hours after a 600 mg oral dose, with increases up to 5.1 hours reported after 900 mg dose. Rifampin is eliminated from the blood equally in the urine and feces as unchanged drug and metabolites. The principal metabolite in man is the biologically active desacetylrifampin. Desacetylation of rifampin in the body does not substantially modify its anti-mycobacterial activity. In Kirschner's medium, the MIC against M. tuberculosis varied from 0.1 to 2 mcg/mL. INDICATIONS AND CLINICAL USE RIFADIN (rifampin) is indicated as a treatment of tuberculosis. To achieve a complete kill of the bacillary population and to avoid selection of drug-resistant mutants, RIFADIN must be used concomitan Đọc toàn bộ tài liệu