RIFAFOUR e-275 Film-coated tablet Ref.[115257] Active ingredients: Ethambutol Isoniazid Pyrazinamide Rifampicin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2018  Publisher: sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand, South Africa, 1685

Product name and form

RIFAFOUR e-275 (tablets).

Pharmaceutical Form

Purple, round, film coated tablets.

Qualitative and quantitative composition

Each tablet contains:

Rifampicin 150 mg
Isoniazid 75 mg
Pyrazinamide 400 mg
Ethambutol HCl 275 mg

Contains sodium ascorbate as anti-oxidant.

Contains sugar (54,66 mg lactose monohydrate per tablet).

Active Ingredient

Ethambutol is bacteriostatic. It is effective against Mycobacterium tuberculosi and M.bovis with an MIC of 0.5–8µg per ml. The exact mechanism of action is unknown. While it has activity against some atypical mycobacteria including M.Kansasii, activity against other micro-organisms has not yet been reported.

Isoniazid is used mainly in the treatment of pulmonary tuberculosis but it appears to be effective also in the treatment of extrapulmonary lesions, including meningitis and genito-urinary disease.

Pyrazinamide exhibits tuberculostatic activity. Pyrazinamide is active only at an acid pH, and it is therefore active mainly on the tubercle bacilli located within the cell.

Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and also has bactericidial activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

List of Excipients

Core tablet:

Croscarmellose sodium
Glyceryl behenate
Lactose monohydrate
Magnesium stearate
Maize starch
Polyvinylpyrrolidone
Sodium lauryl sulphate
Sodium ascorbate as anti-oxidant

Film coating:

Carmine
FD&C blue indigo carmine aluminium lake
Iron oxide black
Macrogol 3350
Polyvinyl alcohol
Talc
Titanium dioxide

Pack sizes and marketing

Packs of 20, 28, 40, 56, 60, 80, 84, 100, 112 and 500 tablets in foil-foil blisters or white polypropylene securitainers.

Marketing authorization holder

sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand, South Africa, 1685

Marketing authorization dates and numbers

34/20.2.3/0187

Drugs

Drug Countries
RIFAFOUR E-275 South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.