Rifampicin Isoniazid tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rifampicin, isoniazid

Available from:

Lupin Limited

ATC code:

J04AM02

INN (International Name):

rifampicin, isoniazid

Dosage:

150mg+ 75mg

Pharmaceutical form:

tablets film-coated

Units in package:

(672/24x28) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-12-08

Summary of Product characteristics

LUPIN LIMITED
ANNEX 5
PRODUCT: AKURIT (RIFAMPIN AND ISONIAZID TABLETS)
PAGE 1 OF 10
TITLE: SUMMARY OF PRODUCT CHARACTERISTICS
D:\regestration\FC registrac\Nist 368 25-11-16 24dex\Rifampicin
Isoniazid\Orig PIl mock 3 vida, SPC by mail Anaida gr\Rifampin
Isoniazid_SmPC.doc STRICTLY CONFIDENTIAL
1. NAME OF THE FINISHED PHARMACEUTICAL PRODUCT
Rifampin and Isoniazid Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains;
Rifampin USP 150mg
Isoniazid USP 75mg
3. PHARMACEUTICAL FORM
Tablets
Brick red coloured, capsule shaped, biconvex, film coated tablets with
breakline on one side
and 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
It
is
indicated
for
the
continuation
phase
of
short
course
treatment
of
patients
with
pulmonary or extra-pulmonary tuberculosis. During this phase, it
should be administered on
a daily continuous basis.
This fixed-dosage combination drug is not recommended for initial
therapy of tuberculosis
or for prevention therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Akurit is administered to patients on the basis of body weight.
Patient Body Weight Continuation Phase
(Kg)
Four Months Akurit Tablets Daily
30-37
2
LUPIN LIMITED
ANNEX 5
PRODUCT: AKURIT (RIFAMPIN AND ISONIAZID TABLETS)
PAGE 2 OF 10
TITLE: SUMMARY OF PRODUCT CHARACTERISTICS
D:\regestration\FC registrac\Nist 368 25-11-16 24dex\Rifampicin
Isoniazid\Orig PIl mock 3 vida, SPC by mail Anaida gr\Rifampin
Isoniazid_SmPC.doc STRICTLY CONFIDENTIAL
38-54
3
55-70
4
>70
5
4.3 CONTRAINDICATIONS
It is contraindicated in patients with a history of hypersensitivity
to Rifampin, Isoniazid or
the any of the excipients. Other contraindications include patients
with severe hepatic
damage, patients who develop severe adverse reactions to Isoniazid
like drug fever, chills
and arthritis. Patients with acute liver disease with any aetiology
and patients suffering
f