ETHIONAMIDE Dispersible tablet Ref.[9602] Active ingredients: Ethionamide

Oral use.

Ethionamide 125 mg Dispersible Tablets must always been given in combination with other antituberculosis agents.

The required number of Ethionamide 125 mg Dispersible Tablets should be dispersed in approximately 50 ml water and the entire mixture should be swallowed. The mixture (tablets dispersed in water) should be used within 10 minutes. An additional volume of water should then be consumed immediately.

The optimum daily adult dose is 15-20 mg/kg. The usual dose is 500 mg to 1 g daily, depending on body weight and tolerance. This daily dose can be taken either at a single occasion or split up in two doses over the day to improve tolerability. Ethionamide 125 mg Dispersible Tablets may be taken with food or between meals. Intake with food may improve gastrointestinal tolerability.

In order to assess and improve tolerability, therapy may be initiated at a dose of 250 mg daily with gradual titration to optimal doses as tolerated by the patient. Doses should be increased by 250 mg increments over a few days until the full dose is reached.

Children

Optimum doses for children have not been established. This, however, does not preclude use of the drug when crucial to therapy, i.e. when the organisms are definitely resistant to primary therapy and there is systemic dissemination of the disease, or other life-threatening complications of tuberculosis. A total daily paediatric dose of 15-20 mg/kg is recommended, and can be taken either at a single occasion or split up in two doses over the day to improve tolerability (see also section 5.2).

Hepatic and renal impairment

Ethionamide is almost completely metabolised in the liver. Its use should be avoided in patients with severe hepatic impairment. No data are available for patients with mild to moderate hepatic impairment. Very little ethionamide is excreted renally, and dose adjustments are not expected to be necessary in patients with renal impairment.

Duration of therapy

The duration of antituberculous therapy depends on the regimen chosen, the patient’s clinical and radiographical responses, smear and culture results, and susceptibility studies of Mycobacterium tuberculosis isolates from the patient or the suspected source case.

If therapy is interrupted, the treatment schedule should be extended to a later completion date depending, e.g. on the length of the interruption, the time during therapy (early or late) and the patient’s status.

When a dose is missed and this is noticed within 6 hours, the missed dose should be taken as soon as possible. The next regular dose should be taken as scheduled. If noticed later, then the normal dose should be taken when it is due. No double dose should be taken to make up for forgotten individual doses.

Cases of severe overdosage have not been described in the literature. In case of overdose, treatment should be symptomatic. Ethionamide is not dialyzable.

Shelf life: 24 months.

Store below 30°C in dry place. Protect from light. Store in original container.

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.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.