FANSIDAR^®

Sulfadoxine + pyrimethamine

Composition Properties Indications Contraindications Dosage and Administration Side Effects Skin Reactions Gastrointestinal reactions Interactions Stability Packs

1 tablet, 5ml syrup (1 teaspoonful) or 1 ampoule (2.5ml) of FANSIDAR^®  contains 500mg N-(5,6-dimethoxy – 4 – pyrimidinly) sulfanilamide (sulfadoxine) and 25mg 2, 4 – diamino – 5-(p-chlorophenyl) –6-ethylpyrimidine (pyrimethamine).

FANSIDAR^® by virtue of this marked synergistic action FANSIDAR^® is also effective against strains that are resistant to such antimalarial drugs as chloroquine and other 4-aminoquinoline derivatives or to pyrimethamine. With FANSIDAR^®, the risk of resistance emerging is reduced to a minimum.
One of the major advantages of FANSIDAR® is that it attacks the different stages of the life cycle of the malaria parasite. Effective concentrations are rapidly attained with a single dose and trophozoites and schizonts eliminated from the blood. The pre erythrocytic stages are also affected, not however, the secondary exoerythrocytic forms, which may cause recurrence of infection with plasmodium vivax. In such cases, therefore, consideration should be given to following up treatment with FANSIDAR^® with primaquine to prevent recurrence. FANSIDAR^® is compatible with other antimalarial drugs, particularly quinine, and with antibiotics. It has no hypoglycemic effect and does not influence the action of antidiabetic agents.

FANSIDAR^® (tablets) is now recommended by Federal Ministry of Health, Abuja for: Intermittent preventive treatment of malaria in pregnancy (IPT).
· Treatment of all forms of malaria due to Plasmodium Falciparum, Plasmodium Vivax, Plasmodium ovale and plasmodium malaria.
· Infections with Toxoplasma gondii and in the prophylaxis of pneumonia due to Pneumocystis carinii.

FANSIDAR^® (tablets) is contraindicated in patients with hypersensitivity to sulfonamides or to any of the ingredients of FANSIDAR^®. Fetal malformation has been observed in rats when FANSIDAR^® was administered in early pregnancy. This was due to pyrimethamine, the folic acid antagonist contained in FANSIDAR^® Although pyrimethamine is not known to cause fetal malformation in humans, FANSIDAR^® should not be administered prophylaxtically in the first trimester of pregnancy.In already existing malaria infections, the risk of fetal damage from the disease must be balanced against the possible implications of the above-mentioned animal experiements. FANSIDAR^® should not be employed in premature and newborn infants during the first weeks of life, in view of the immaturity of their enzyme systems. FANSIDAR^® should not be administered prophylactically in the last two weeks of pregnancy.It is also contraindicated in cases of intolerance to sulfonamides.

In the recommended dosage, FANSIDAR^® is generally well tolerated. As with other drugs containing sulfonamides and/or pyrimethamine, the following side effects and hypersensitivity reactions may occur

Drug rash, pruritus and slight hair loss have been observed. These reactions are usually mild and regress spontaneously on withdrawal of the drug. In rare cases, particularly in hypersensitive patients, severe possibly life-threatening skin reactions such as erythema multiforme, Stevens-Johnson syndrome and Lyell’s syndrome may occur.

If skin reactions are observed, the drug should be withdrawn.

There have been isolated reports of hepatitis occuring conjointly with administration of FANSIDAR^®. Hematological changes: In rare cases, leukopenia (usually asymptomatic), thrombocytopenia and megaloblastic anemia have been observed. In extremely rare cases, they take the form of agranulocytosis or purpura. As a rule, all these changes regress after withdrawal of the drug. Other side effects: Fatigue, haedache, fever and polyneuritis may occasionally occur. Pulmonary infiltrates such as occur in eosinophilic or allergic alveolitis have been reported in rare instances. If symptoms such as cough or shortness of breath should occur under FANSIDAR^® therapy, the drug should be discontinued.

Concurrent administration of FANSIDAR^® with trimethoprim or trimethoprim-sulfonamide combinations can result in increased impairment of folic acid metabolism and the consequent hematological side effects, and should therefore be avoided. There have been reports which may indicate an increase in incidence and severity of adverse reactions when chloroquine is used with FANSIDAR^® as compared with the use of FANSIDAR^® alone.