Pyrazinamide tablets BP 400mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pyrazinamide

Available from:

Cadila Pharmaceuticals Ltd.

ATC code:

J04AK01

INN (International Name):

pyrazinamide

Dosage:

400mg

Pharmaceutical form:

tablets

Units in package:

(1000) in plastic container, (672/24x28/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-06-05

Patient Information leaflet

MODULE 1
1.3.2 LABELING AND PACKAGE INSERT PYRAZINAMIDE TABLETS BP 400 MG
PACK INSERT:-
1389, DHOLKA – 382 225 DISTRICT: AHMEDABAD, GUJARAT STATE, INDIA.
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MODULE 1
1.3.2 LABELING AND PACKAGE INSERT PYRAZINAMIDE TABLETS BP 400 MG
1389, DHOLKA – 382 225 DISTRICT: AHMEDABAD, GUJARAT STATE, INDIA.
2 OF 4
MODULE 1
1.3.2 LABELING AND PACKAGE INSERT PYRAZINAMIDE TABLETS BP 400 MG
1389, DHOLKA – 382 225 DISTRICT: AHMEDABAD, GUJARAT STATE, INDIA.
3 OF 4
MODULE 1
1.3.2 LABELING AND PACKAGE INSERT PYRAZINAMIDE TABLETS BP 400 MG
1389, DHOLKA – 382 225 DISTRICT: AHMEDABAD, GUJARAT STATE, INDIA.
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Summary of Product characteristics

PYRAZINAMIDE TABLETS BP 400 MG
1.3.1 SUMMARY PRODUCT CHARACTERISTICS
1389, DHOLKA – 382 225, DISTRICT: AHMEDABAD, GUJARAT STATE, INDIA
MODULE 1
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS PYRAZINAMIDE TABLETS BP 400 MG
1. NAME OF THE MEDICINAL PRODUCT
Pyrazinamide 400 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
Pyrazinamide………………400 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets
White, smooth, round, biconvex, uncoated tablets plain on both sides
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pyrazinamide 400 mg Tablets is indicated in combination with other
antituberculosis
agents
for
the
treatment
of
all
forms
of
tuberculosis
caused
by
_Mycobacterium _
_tuberculosis. _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
Pyrazinamide
400
mg
Tablets
must
always
been
given
in
combination
with
other
antituberculosis agents.
DAILY REGIMEN
25 mg/kg (20-30 mg/kg) body weight as a single daily dose.
INTERMITTENT REGIMEN
35 mg/kg (30-40 mg/kg) body weight 3 times a week as a single dose or
50 mg/kg (40-60
mg/kg) body weight 2 times a week as a single dose (The latter
regimen, however, is not
recommended by WHO).
_ _
_NUMBER OF PYRAZINAMIDE 400 MG TABLETS FOR TREATMENT ACCORDING TO
WEIGHT BANDS _
Daily regimen (adults and children)
Weight in kg
11-20
21-39
40-54
55-70
>70
Number of
tablets per day
1
2
3
4
5
Pyrazinamide 400 mg Tablets should preferably be taken without food
_(1)_
. Tablets should
be swallowed whole with drinking water. Tablets should neither be
crushed nor chewed.
1389, DHOLKA – 382 225, DISTRICT: AHMEDABAD, GUJARAT STATE, INDIA
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MODULE 1
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS PYRAZINAMIDE TABLETS BP 400 MG
In
patients
requiring
less
than
400
mg
pyrazinamide
per
dose,
another
formulation
containing less pyrazinamide should be used.
_ _
_Renal impairment_
:
Dose adjustment is necessary in patients with CrCL <30 ml/min. It is
recommended to
administer 20-30 mg/kg per dose three times per week (not daily).
Patients o