Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: SUPPLIER: Macleods Pharmaceuticals Limited, 304, Atlanta Arcade, Marol Church road, Andheri (East), Mumbai – 400 059, India, Tel: +91-22-66762800, Fax: +91-22-28216599
Ethionamide 125 mg Dispersible Tablets1.
1 Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s (NMRA) responsibility. Throughout this WHOPAR the proprietary name is given as an example only.
| Pharmaceutical Form |
|---|
|
Dispersible tablet. Ethionamide 125 mg Dispersible Tablets are yellow coloured, circular, biconvex, uncoated tablets having angular break line on one side and plain surface on the other side. The tablet can be divided into equal doses. |
Each tablet contains 125 mg ethionamide.
Excipient with known effects: Each tablet contains 4 mg aspartame.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ethionamide |
Ethionamide is bacteriostatic against M. tuberculosis at therapeutic concentrations, but may be bactericidal at higher concentrations. The exact mechanism of action of ethionamide has not been fully elucidated, but the drug appears to inhibit peptide synthesis in susceptible organisms. Drug resistance develops rapidly when ethionamide is given as monotherapy. |
| List of Excipients |
|---|
|
Aspartame |
The primary packs are strips of 6 tablets (comprised of Alu/Alu foil). Such 5 strips are kept packed in a carton.
Pack size: 6 × 5 tablets.
SUPPLIER: Macleods Pharmaceuticals Limited, 304, Atlanta Arcade, Marol Church road, Andheri (East), Mumbai – 400 059, India, Tel: +91-22-66762800, Fax: +91-22-28216599
WHO REFERENCE NUMBER (PREQUALIFICATION PROGRAMME): TB333
30 May 2017
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