INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ETHATYL tablets
SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form)

ETHATYL tablets

COMPOSITION
Per tablet:
Ethionamide 250 mg

PHARMACOLOGICAL CLASSIFICATION
A 20.2.3 Tuberculostatics

PHARMACOLOGICAL ACTION
ETHATYL is a tuberculostatic agent and is active against strains of M. tuberculosis which are resistant to other tuberculostatics, although there may be cross-resistance to thiosemicarbazones such as thiacetazone. Bacterial resistance to ethionamide develops rapidly if the drug is used alone but its incidence may be delayed by the concurrent administration of isoniazid, pyrazinamide or, to a lesser extent, streptomycin.
ETHATYL is used in conjunction with tuberculostatic drugs in the treatment of pulmonary and extrapulmonary tuberculosis.

INDICATIONS:
For the treatment of pulmonary and extrapulmonary tuberculosis.

CONTRAINDICATIONS:
Pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
Usual dosage:
Adults:
0,5 to 1 g daily in divided doses with meals.

Children:
12 to 15 mg per kg body mass per day (maximum 750 mg per day) in divided with meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effect of ethionamide therapy is gastro-intestinal upset which occurs in about one-third of the patients receiving an oral dosage of more than 500 mg daily. Patients may experience anorexia, a metallic taste, nausea, vomiting, excessive salivation, stomatitis or diarrhoea.
Other slide-effects which have been reported include slight deafness, diplopia, headache, hypotension, insomnia, drowsiness, peripheral neuropathy, convulsions, hepatoxicity, skin rash, alopecia, gynaecomastia, impotence and menstrual disturbances. Increased difficulty has been reported in controlling diabetes mellitus when diabetic patients are given ethionamide. Ethionamide may intensify the adverse effects of other tuberculostatic drugs administered concurrently.
Ethionamide should be administered with caution to patients with depression or other psychiatric disorders, chronic alcoholism or epilepsy.
Liver function, tests should be carried out before and during treatment. It is suggested that pyridoxine should be given to patients receiving ethionamide who have developed neuropathy on previous isoniazid therapy. Prochlorperazine or trimeprazine tartrate may be of value in the treatment of severe nausea and vomiting, and testosterone may be of value if gynaecomastia and impotence occur as side-effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Acute overdosage may lead to an accentuation of the symptoms listed under “Side-effects and special precautions”. Treatment is symptomatic and supportive.

IDENTIFICATION
Bright yellow, biconvex tablet scored on one side.

PRESENTATION
Tablets: 50’, 250’, 1 000’and 5 000’

STORAGE INSTRUCTIONS
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER
A98 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
11 October 1984

NORISTAN GENERICA
Division of
NORISTAN LIMITED, WALTLOO, PRETORIA

NPS 540/001

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