Isoniazid Dispersible Tablets 100mg

Land: Tanzania

Taal: Engels

Bron: Tanzania Medicinces & Medical Devices Authority

Werkstoffen:

Isoniazid

Beschikbaar vanaf:

Macleods Pharmaceuticals Limited, INDIA

ATC-code:

Drugs for treatment of tuberculosis

INN (Algemene Internationale Benaming):

Isoniazid

Dosering:

100

farmaceutische vorm:

Dispersible Tablets

Geproduceerd door:

Oxalis Labs, INDIA

Product samenvatting:

Physical description: White to off-white, circular, flat faced bevelled edge uncoated tablets with break line on one side and plain surface on the other side; Local technical representative: Barnabas Maganga Shija (3292)

Autorisatie-status:

Registered/Compliant

Autorisatie datum:

2022-08-04

Productkenmerken

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1
SUMMARY OF PRODUCT CHARACTERISTIC
NAME OF THE MEDICINAL PRODUCT
1.
Isoniazid Dispersible Tablets 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains:
Isoniazid BP ………….. 100 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White to off-white, circular, flat faced, bevelled edge uncoated
tablet with a break line on one side
and plain on other side.
The break line is intended for subdivision of tablets when half a
tablet dose is to be administered.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Isoniazid Dispersible Tablets 100 mg is indicated in combination with
other anti-tuberculosis
agents for the treatment of multi-drug resistant tuberculosis caused
by Mycobacterium
tuberculosis.
Isoniazid Dispersible Tablets 100 mg is also indicated either alone or
in combination with other
anti-tuberculosis agents for the prevention of tuberculosis caused by
Mycobacterium
tuberculosis.
Consideration should be given to official guidelines for prevention
and treatment of tuberculosis,
e.g., those of WHO.
This product is intended for use in children. Safety information on
use in adults is also provided.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Multi-Drug Resistant Tuberculosis
Isoniazid Dispersible Tablets 100 mg is always given in combination
with other anti-tuberculosis
medicines for treatment of MDR-TB.
Adults and adolescents 15 years and older:
The dose is taken once daily, as follows:
Weight-based daily dose
Weight bands of patients
30-35
kg
36-45
kg
46-55
kg
56-70
kg
> 70 kg
4-6 mg/kg body weight
(standard dose)
Number of tablets of Isoniazid
Dispersible Tablets 100 mg
200 mg
300 mg*
300 mg*
300 mg*
300 mg*
2
--*
--
--
--
10-15 mg/kg body weight
(high-dose)
450 mg*
450 mg*
600 mg*
600 mg*
600 mg*
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2
SUMMARY OF PRODUCT CHARACTERISTIC
*For these patients, other formulations containing more isoniazid
should be used.
The higher dose may be used except when there is risk of toxicity.
Levels are expected to be
lowered because o