Tablet Manufacturer/Distributor: Square Pharmaceuticals Ltd. Generic Name: Pyrimethamine 25 mg + Sulfadoxine 500 mg Tablet
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Indications
Treatment of all forms of malaria due to Plasmodium falciparum, Plasmodium vivax, and Plasmodium malariae. The drug is also indicated for suppressive or prophylactic management, particularly in areas where resistance to chloroquine is known to exist.
Pharmacology
Malacide® is an antimalarial agent embodying the concept of synergism. Individually the components of Malacide® exert inferior results with higher doses in comparison with that obtained with the combination. Moreover, Malacide® is effective against strains that are resistant to other antimalarial agents and the risk of resistance development is minimum with Malacide®. It is an extremely long-acting drug, attacks the different development stages of the parasite, and attains effective concentration with a single dose. The
protective effect of a single dose lasts for approximately four weeks and Malacide® is compatible with other antimalarial drugs and with antibiotics. It does not influence the action of antidiabetic agents.
Dosage & Administration
Curative treatment of malaria with a single dose-
Adults: 2-3 tablets
Children under 4 years: ½ tablets
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 tablets
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 to protect tolerance, the administration should be continued in the above dosage during the stay and also for four weeks after the return or as prescribed by the physician.
Interaction
Concurrent administration of other preparations containing folate antagonists (e.g. cotrimoxazole, methotrexate, anticonvulsants) can result in increased impairment of folic acid metabolism, which leads to hematological side effects.
Contraindications
Prophylactic (repeated) use of Malacide® is contraindicated in patients with severe renal insufficiency, marked liver parenchymal damage, or blood dyscrasias. Treatment must be immediately discontinued upon the appearance of any mucocutaneous signs or symptoms such as pruritus, erythema, rash, orogenital lesions, or pharyngitis.
Side Effects
Malacide® at the recommended dose is well tolerated. The main side effects are given below skin reactions: Drug rash, pruritus, and slight hair loss have been observed. Gastrointestinal reactions: Feeling of fullness, nausea, rarely vomiting, stomatitis. Hematological reactions: In rare cases, leukopenia, thrombocytopenia, and megaloblastic anemia have been observed. Other reactions: Fatigue, headache, fever, and polyneuritis may occasionally occur.
Pregnancy & Lactation
Malacide® is contraindicated during pregnancy, premature and newborn infants during the first weeks of life, and intolerance to sulfonamide. If pregnancy can not be excluded, possible risks should be balanced against the therapeutic effect. Both Pyrimethamine and Sulphadoxine are excreted in maternal breast milk. The nursing mother should not take Malacide®.
Storage Conditions
Store below 30° C and away from light and moisture. Keep out of children's reach.
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