Finished product reference

Pyrimethamine / Sulfadoxine

Tablet · Oral · 500 mg/25 mg

List code
1682
Pharmacologic class
Antimalarial (antifolate combination)

What it is and how it works

Sulfadoxine inhibits dihydropteroate synthase and pyrimethamine inhibits dihydrofolate reductase, sequentially blocking folate synthesis in Plasmodium parasites. Both components have long half-lives, allowing single-dose treatment.

Indications

Intermittent preventive treatment of malaria in pregnancy and seasonal malaria chemoprevention (with amodiaquine) in endemic areas; treatment of uncomplicated falciparum malaria in combination with artesunate where effective.

Dosage and administration (summary)

Taken orally as a single dose; for adults, 3 tablets (each 25 mg pyrimethamine/500 mg sulfadoxine), according to national malaria programme guidance.

Contraindications

Hypersensitivity to sulfonamides or pyrimethamine, severe hepatic or renal impairment, megaloblastic anaemia due to folate deficiency, and infants under 2 months; concurrent co-trimoxazole prophylaxis.

Warnings and precautions

Severe cutaneous reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis, may occur and are a reason for its restricted use; stop at the first sign of rash. Blood dyscrasias and haemolysis in G6PD deficiency may occur, and high-dose folic acid may reduce efficacy.

Pregnancy

Used for intermittent preventive treatment in the second and third trimesters under WHO guidance; avoid in the first trimester and near term.

Storage and supply

Store below 25 °C, protected from light.

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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