RIFADIN CAPSULE

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

RIFAMPIN

Fáanlegur frá:

SANOFI-AVENTIS CANADA INC

ATC númer:

J04AB02

INN (Alþjóðlegt nafn):

RIFAMPICIN

Skammtar:

300MG

Lyfjaform:

CAPSULE

Samsetning:

RIFAMPIN 300MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTITUBERCULOSIS AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0105824001; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2021-01-28

Vara einkenni

_Pr_
_RIFADIN_
_®_
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_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