Isoniazid Tablets 100 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Isoniazid

Available from:

Macleods Pharmaceuticals Limited, INDIA

ATC code:

Antimycobacterials, hydrazides

INN (International Name):

Isoniazid

Dosage:

100 mg

Pharmaceutical form:

Tablets

Manufactured by:

MACLEODS PHARMACEUTICALS LIMITED, INDIA

Product summary:

Physical description: White to off white, circular, biconvex, uncoated Tablets with break line on one side and plain on other side; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

Authorization status:

Registered/Compliant

Authorization date:

2020-07-09

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Isoniazid Tablets BP 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Isoniazid 100 mg
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Isoniazid 100 mg Tablets
White to off-white, circular, biconvex, uncoated tablets with break
line on one side and plain
surface on the other side.
Isoniazid 100 mg Tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Isoniazid
Tablets
BP
100
mg
is
indicated
for
the
treatment
of
tuberculosis
caused
by
Mycobacterium tuberculosis.
The most recent official guidelines on the treatment of tuberculosis
(e.g. WHO guideline: http://
whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf) should be
taken into consideration
for deciding on the appropriateness of therapy with Isoniazid Tablets
BP 100 mg.
4.2.
Posology and method of administration
Oral use.
Isoniazid Tablets BP 100 mg should be swallowed whole with water or
another drink.
The tablets should be taken on an empty stomach (at least one hour
before or two hours
after a meal).
Active tuberculosis
For the treatment of active tuberculosis isoniazid must always be used
in combination with
other antituberculosis drugs
_Adults _
In adults weighing 30–45 kg the daily dose is 200 mg isoniazid,
administered as a single
dose.
In patients weighing > 45 kg the daily dose is 300 mg isoniazid,
administered as a single
dose.
_Children _
The dose for children is 10 mg/kg daily (range 10–15 mg/kg
body-weight daily). The following
table can be used:
Number of Isoniazid Tablets BP 100 mg by weight band to be taken once
daily
Isoniazid Tablets BP 100 mg is not indicated for daily therapy of
children weighing < 3.5 kg, as
appropriate dose adjustments cannot be made. The duration of therapy
is dependent on the
diagnostic category, as well as the combination of drugs used together
with isoniazid.
Official national and/or international guidelines (e.g. WHO Guideline,
available at http://
whqlib