Maa: Kanada
Kieli: englanti
Lähde: Health Canada
RIFAMPIN
BAUSCH HEALTH, CANADA INC.
J04AB02
RIFAMPICIN
150MG
CAPSULE
RIFAMPIN 150MG
ORAL
100
Prescription
ANTITUBERCULOSIS AGENTS
Active ingredient group (AIG) number: 0105824002; AHFS:
APPROVED
2019-07-02
PRESCRIBING INFORMATION INCLUDING PATIENT MEDICATION INFORMATION Pr ROFACT ® Rifampin Capsules, USP 150 mg & 300 mg Antituberculosis Agent Date of Preparation: June 28, 2019 Bausch Health, Canada Inc. 2150 St-Elzear Blvd.West Laval, Quebec H7L 4A8 Control #: 228050 ROFACT ® Prescribing Information Page 2 of 27 PRESCRIBING INFORMATION Pr ROFACT ® Rifampin Capsules, USP 150 & 300 mg Antituberculosis Agent ACTION AND CLINICAL PHARMACOLOGY Rifampin may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. Rifampin usually is rapidly bactericidal against Mycobacterium leprae in vivo. Rifampin suppresses initiation of chain formation for RNA synthesis in susceptible bacteria by inhibiting DNA-depending RNA polymerase. The ß subunit of the enzyme appears to be the site of action. Rifampin is most active against susceptible bacteria when they are undergoing cell division; however, the drug also has some effect when bacteria are in the metabolic resting state. Pharmacokinetics Absorption Rifampin is well absorbed from the gastrointestinal tract. Distribution Rifampin diffuses well to most body tissues and fluids, including the cerebrospinal fluid, where concentrations are increased if the meninges are inflamed; concentrations in the liver, gallbladder, bile, and urine are higher than those found in the blood; therapeutic concentrations are achieved in the saliva, reaching 20% of serum concentrations; crosses the placenta, with fetal serum concentrations at birth found to be approximately 33% of the maternal serum concentration; penetrates into aqueous humor; and is distributed into breast milk. Being lipid-soluble, rifampin may reach and kill susceptible intracellular, as well as extracellular, bacteria and Mycobacteria species. Volume of Distribution: 1.6 L per kg Protein binding: high to very high (89%) Biotransformation: hepatic ROFACT ® Prescribing Information Page 3 of 27 Metabolism Rifampin is e Lue koko asiakirja