This combination tablet is indicated for the treatment of all forms of malaria caused by Plasmodium falciparum, Plasmodium vivax, and Plasmodium malariae. It is also used for suppressive or prophylactic therapy, particularly in areas where chloroquine resistance is known to exist.

Sulphadoxine and Pyrimethamine is an antimalarial combination based on synergistic action. Individually, each component shows weaker efficacy and requires higher doses compared to the combination. Together, they produce a stronger therapeutic effect with reduced risk of resistance development. This preparation is effective against strains resistant to other antimalarial drugs. It is long-acting, targets different stages of the malaria parasite life cycle, and achieves effective plasma concentration after a single dose. The protective effect of a single dose lasts for approximately four weeks. It is compatible with other antimalarial drugs and antibiotics and does not affect the action of antidiabetic agents.

Curative treatment of malaria with a single dose

• Adults: 2–3 tablets
• Children under 4 years: ½ tablet
• 4–8 years: 1 tablet
• 9–14 years: 2 tablets

In severe cases, Sulphadoxine & Pyrimethamine can be beneficially combined with quinine.

Suppressive or prophylactic management
The dose given below should be taken at one time:

For semi-immune subjects (Dose: once every four weeks)

• Adults: 2–3 tablets
• Children under 4 years: ½ tablet
• 4–8 years: 1 tablet
• 9–14 years: 2 tablets

For non-immune subjects (Dose: once every two weeks)

• Adults: 2 tablets
• Children under 4 years: 1½ tablets
• 4–8 years: 1 tablet
• 9–14 years: 1½ tablets

For malaria prophylaxis: The first dose of Sulphadoxine & Pyrimethamine should be taken one or two days before departure for an endemic area in order to protect tolerance. Administration should be continued in the above dosage during the stay and also for four weeks after return or as prescribed by the physician.

Concurrent use of other folate antagonist drugs (e.g., cotrimoxazole, methotrexate, anticonvulsants) may further impair folic acid metabolism, increasing the risk of hematological adverse effects.

Prophylactic (repeated) use of Pyrimethamine + Sulphadoxine is contraindicated in patients with severe renal impairment, significant hepatic parenchymal damage, or blood dyscrasias. Treatment should be discontinued immediately if mucocutaneous reactions such as pruritus, erythema, rash, orogenital lesions, or pharyngitis occur.

At recommended doses, Sulphadoxine & Pyrimethamine is generally well tolerated.

• Skin reactions may include drug rash, pruritus, and mild hair loss.
• Gastrointestinal effects include fullness, nausea, and rarely vomiting or stomatitis.
• Hematological reactions (rare) include leukopenia, thrombocytopenia, and megaloblastic anemia.
• Other effects such as fatigue, headache, fever, and polyneuritis may occasionally occur.

Contraindicated in pregnancy, premature infants, and newborns during the first weeks of life. If pregnancy cannot be excluded, risks should be weighed against benefits. Both components are excreted in breast milk; therefore, use during breastfeeding is not recommended.

Use with caution in renal or hepatic impairment, folate deficiency, severe allergy or bronchial asthma, G6PD deficiency, and pregnancy. Take with plenty of water to prevent crystalluria. Avoid excessive sun exposure. Discontinue at the first sign of rash or folate deficiency. For prolonged use (>3 months), regular monitoring of CBC, liver function tests, and urine analysis is recommended. Taking with food may reduce gastrointestinal side effects such as nausea and anorexia.

Anti-malarial drugs

Store below 30°C, protect from light and moisture. Keep out of reach of children.