Generic Trecator-sc

ETHIONAMIDE
Tablets: 250 mg (Rx) Trecator-SC (Wyeth-Ayerst)

Indications
Recommended for any form of active tuberculosis when treatment with first-line drugs (isoniazid, rifampin) has failed. Use only with other effective anti-tuberculosis agents.

Administration and Dosage
Administer with > 1 other effective anti-tuberculosis drug(s).
Average adult dose: 15 to 20 mg/kg/day taken once daily up to a maximum of 1 g/day.
Children: A dose of 10 to 20 mg/kg/day in 2 to 3 divided doses given after meals or 15 mg/kg/24 hours as a single daily dose has been recommended. Concomitant administration of pyridoxine is recommended.

Actions
Pharmacology: Ethionamide may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. The exact mechanism of action of ethionamide has not been fully elucidated, but the drug appears to inhibit peptide synthesis in susceptible organisms.
Pharmacokinetics:
Absorption/Distribution - Ethionamide is essentially completely absorbed following oral administration and is not subjected to any appreciable first pass metabolism.
The drug is about 30% bound to plasma proteins. Ethionamide is rapidly and widely distributed into body tissues and fluids, with concentrations in plasma and various organs being approximately equal. Significant concentrations also ate present in cerebrospinal fluid.
Metabolism/Excretion - Ethionamide is extensively metabolized to active and inactive metabolites with Monitoring - Normal serum concentrations of 1 to 5 mcg/mL are usually seen 2 hours following doses of 250 to 500 mg and approximate the therapeutic range for this drug.

Contraindications
Severe hypersensitivity to ethionamide; severe hepatic damage.

Warnings
Resistance: The use of ethionamide alone in the treatment of tuberculosis results in rapid development of resistance.
Compliance: It is recommended that directly observed therapy be practiced when patients are receiving anti-tuberculosis medication.
Pregnancy: Category C.
Lactation: Because no information is available on the excretion of ethionamide in breast milk, administer to nursing mothers only if the benefits outweigh the risks.
Children: Investigations have been limited; do not use in pediatric patients

Precautions
Monitoring: Make determinations of serum transaminase (AST, ALT) prior to and monthly during therapy. Monitor blood glucose and thyroid function tests periodically.

Drug Interactions
Ethionamide may interact with isoniazid and cycloserine.

Adverse Reactions
Adverse reactions may include the following: Depression; drowsiness and asthenia; convulsions; peripheral neuritis and neuropathy; olfactory disturbances; blurred vision; diplopia; optic neuritis; dizziness; headache; restlessness; tremors; psychosis; anorexia; nausea and vomiting; diarrhea; metallic taste; hepatitis; jaundice; stomatitis; postural hypotension; skin rash; acne; alopecia; thrombocytopenia; pellagra-like syndrome; gynecomastia; impotence; menorrhagia; and increased difficulty managing diabetes mellitus.
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