RIFATER TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RIFAMPIN; ISONIAZID; PYRAZINAMIDE

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

J04AM05

INN (International Name):

RIFAMPICIN, PYRAZINAMIDE AND ISONIAZID

Dosage:

120MG; 50MG; 300MG

Pharmaceutical form:

TABLET

Composition:

RIFAMPIN 120MG; ISONIAZID 50MG; PYRAZINAMIDE 300MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

ANTITUBERCULOSIS AGENTS

Product summary:

Active ingredient group (AIG) number: 0327238001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-03-29

Summary of Product characteristics

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