SP is indicated in malaria-endemic areas in Africa, for intermittent preventive treatment of malaria in pregnancy for all women in their first or second pregnancy as part of antenatal care. In areas of moderate to high malaria transmission in Africa, for intermittent preventive treatment of malaria in infants (below 12 months of age) where SP is still effective.
Do not take SP
· In patients with renal or hepatic failure or with blood dyscrasias · Hypersensitivity to pyrimethamine, sulfonamides, or any other ingredient of SP · In patients with sulfonamide intolerance · In patients with documented megaloblastic anaemia due to folate deficiency
· In pregnant women during first trimester and lactating mothers · Premature or newborn infants in the first two months of life · HIV infected patients receiving cotrimoxazole prophylaxis against opportunistic infections
Take special care with SP
Fatalities associated with the administration of sulfonamides, although rare, have occurred due to severe reactions, including fulminant hepatic necrosis, agranulocytosis, aplastic anaemia and other blood dyscrasias. SP prophylaxis regimen has been reported to cause leukopenia during a treatment of 2 months or longer. This leukopenia is generally mild and reversible. As with some sulfonamides drugs, in glucose-6-phosphate dehydrogenase-deficient individuals, hemolysis may occur.
Taking other medicines
There have been reports which may indicate an increase in incidence and severity of adverse reactions when chloroquine is used with SP as compared to the use of SP alone. SP is compatible with quinine and with antibiotics. However, antifolic drugs such as sulfonamides, trimethoprim, or co-trimoxazole should not be used while the patient is receiving SP for IPTi or IPTp. SP has not been reported to interfere with diabetic agents. If signs of folic acid deficiency develop, SP should be discontinued. When recovery of depressed platelets or white blood cell counts in patients with drug-induced folic acid deficiency is too slow, folic acid (leucovorin) may be administered in doses of 5-15 mg intramuscularly daily for 3 days or longer
Pregnancy and breast-feeding
Teratogenic effects: Pregnancy category C. SP has been shown to be teratogenic in rats when given in weekly doses approximately 12 times the weekly human prophylactic dose. Teratology studies with pyrimethamine plus sulfadoxine (1:20) in rats showed the minimum oral teratogenic dose to be approximately 0.9 mg/kg pyrimethamine plus 18 mg/kg sulfadoxine. In rabbits, no teratogenic effects were noted at oral doses as high as 20mg/kg pyrimethamine plus 400mg/kg sulfadoxine Although there are no adequately large, well-controlled studies in pregnant women, the benefits of IPTp are considered to outweigh any potential risks of exposure of the developing fetus to SP.
Lactation: this drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore breast feeding is not recommended when using this drug.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Patients receiving SP should be warned that undesirable effects such as dizziness and visual disorders may occur in which case they should not drive or use machines.