ROFACT CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

RIFAMPIN

Предлага се от:

BAUSCH HEALTH, CANADA INC.

АТС код:

J04AB02

INN (Международно Name):

RIFAMPICIN

дозиране:

150MG

Лекарствена форма:

CAPSULE

Композиция:

RIFAMPIN 150MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

ANTITUBERCULOSIS AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0105824002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2019-07-02

Данни за продукта

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