Rifampicin Isoniazid Pyrazinamide Ethambutol hydrochloride tablets film-coated

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

rifampicin, isoniazid, pyrazinamide, ethambutol (ethambutol hydrochloride)

Disponible desde:

Lupin Limited

Código ATC:

J04AM06

Designación común internacional (DCI):

rifampicin, isoniazid, pyrazinamide, ethambutol (ethambutol hydrochloride)

Dosis:

150mg+ 75mg+ 400mg+ 275mg

formulario farmacéutico:

tablets film-coated

Unidades en paquete:

(672/24x28/) in blister

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2016-12-08

Ficha técnica

LUPIN LIMITED
ANNEX 5
PRODUCT: AKURIT- 4 (RIFAMPIN, ISONIAZID, PYRAZINAMIDE AND ETHAMBUTOL HYDROCHLORIDE TABLETS USP)
PAGE 1 OF 22
TITLE: SUMMARY OF PRODUCT CHARACTERISTICS STRICTLY CONFIDENTIAL
1. NAME OF THE FINISHED PHARMACEUTICAL PRODUCT
AKuriT-4 (Rifampin, Isoniazid, Pyrazinamide and Ethambutol
Hydrochloride Tablets USP)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains ;
Rifampin USP
150mg
Isoniazid USP
75mg
Pyrazinamide USP
400 mg
Ethambutol Hydrochloride USP 275 mg
3. PHARMACEUTICAL FORM
Brown coloured, capsule shaped film -coated tablets with breakline on
one side & plain on
the other side.
The breakline is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses or the tablet should not be divided.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AKURIT-4
is
indicated
in
the
treatment
of
both
pulmonary
and
extra
pulmonary
tuberculosis, in the intensive initial phase of treatment.
ANTIBACTERIAL ACTIVITY
RIFAMPIN: Escherichia coli, Pseudomonas, Indole negative and indole
positive Proteus,
Klebsiella,
Staphylococcus
aureus,
Coagulase-negative
staphylococci,
Neisseria
meningitidis, Haemophilus influenzae, Legionella species, M
tuberculosis, M kansassi, M
scrofulaceum, M intracellulare & M avium.
LUPIN LIMITED
ANNEX 5
PRODUCT: AKURIT- 4 (RIFAMPIN, ISONIAZID, PYRAZINAMIDE AND ETHAMBUTOL HYDROCHLORIDE TABLETS USP)
PAGE 2 OF 22
TITLE: SUMMARY OF PRODUCT CHARACTERISTICS STRICTLY CONFIDENTIAL
ISONIAZID: It exerts an active bactericidal action on M tuberculosis
which it inhibits in
concentrations of 0.05-2 mg/l. Other mycobacteria are generally
resistant, although some
strains of M kansassi are susceptible.
ETHAMBUTOL:
M tuberculosis, M fortuitum, M kansassi, M intracellulare, M avium,
M ulcerans (some strains) & M marinum (some strains).
PYRAZINAMIDE:
Its activity against M. tuberculosis is highly pH dependent. It is
almost
inactive at neutral pH; at pH 5.5 the MIC is 16-32 mg/l.
Other Mycobacteria are resistant. Its action, which depends on
intracellular