Finished product reference

Prothionamide

Tablet · Oral · 250 mg

List code
1657
Pharmacologic class
Antituberculosis agent (thioamide; second-line)

What it is and how it works

Prothionamide is a thioamide prodrug activated by the mycobacterial enzyme EthA; the active form inhibits InhA, blocking mycolic acid synthesis in the cell wall of Mycobacterium tuberculosis. It is closely related to ethionamide, with complete cross-resistance.

Indications

Treatment of multidrug-resistant and rifampicin-resistant tuberculosis as part of a combination regimen; also used in some leprosy regimens.

Dosage and administration (summary)

Taken orally, usually 15–20 mg/kg daily (commonly 500–750 mg daily in adults, maximum 1 g), often in divided doses or at bedtime to improve tolerance, always in combination with other antituberculosis drugs.

Contraindications

Severe hepatic impairment and hypersensitivity to prothionamide or ethionamide.

Warnings and precautions

Gastrointestinal intolerance is common; hepatotoxicity, hypothyroidism, peripheral and optic neuropathy, psychiatric effects and hypoglycaemia in diabetics may occur. Monitor liver and thyroid function; pyridoxine supplementation is recommended.

Pregnancy

Generally avoided in pregnancy because of teratogenicity in animal studies; use only if essential in drug-resistant tuberculosis.

Storage and supply

Store below 25 °C, protected from light and moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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