COMPOSITION :
Each tablet contains : Sulfadoxine USP 500 mg
Pyrimethamine USP 25 mg.
DESCRIPTION :
Malarim is a combined antimalarial product which is active against all human pathogenic species of Plasmodia (P.falciparum, P.vivax,P.ovale
and P. malariae). It is also effective against chloroquine and other 4-aminoquinoline derivatives or to pyrimethamine resistant strains. It acts
by inhibition of two enzymes involved in the biosynthesis of folinic acid in the parasites. After administration of 1 tablet of the product , peak
plasma levels for both components are achieved after about 4 hours. Pyrimethamine binds to plasma proteins by 84.9% while sulfadoxine is
bound to plasma proteins by 91.4 %. Both components pass to the breast milk. Both components have long elimination half lives. The mean
values are 96 hours for pyrimethamine and 184 hours for sulfadoxine. Elimination of both components is mainly via the kidneys.
INDICATIONS :
Malarim is indicated for the treatment and prophylaxis of malaria. In addition it is effective in infections caused by Toxoplasma gondii and
in the prophylaxis of pneumonia due to pneumocystis carinii.
DOSAGE & ADMINISTRATION :
A) Prophylaxis of malaria : The amount indicated below is to be taken as a single dose.
B) Curative treatment of malaria : with a single dose .
N.B. For malaria prophylaxis : the first dose of Malarim should be administered about one week before departure for an endemic area ,
administration should be continued at the above dosage during the stay and also for the first 6 weeks after returning.
C) Treatment of toxoplasmosis : Two Malarim tablets once a week for 6 - 8 weeks. If CNS is involved it should be combined with
spiramycin in a dose of 3g daily for 3 - 4 weeks.
D) For Prophylaxis against pneumocystis carinii infections :
Infants and young children : 40 mg per kg (based on the sulfadoxine content) every two weeks.
Proposed dosage for adults : 1 - 2 tablets weekly.
RESTRICTIONS ON USE :
Contraindications
- Hypersensitivity to sulfadoxine (or other sulfonamides) or pyrimethamine. Discontinue the medicine if allergy occurs.
- Malarim should not be given to infants during the first two months of life.
Use in pregnancy and lactation
Avoid during pregnancy particularly in the first trimester or where there is a possibility of conception. It should be used only if deemed
imperative. It must be avoided during nursing otherwise breast feeding should be avoided during its usage.
DRUG INTERACTIONS :
Concomitant administration of Malarim with trimethoprim or trimethoprim - sulphonamides combinations potentiate the impairment of folic
acid metabolism with consequent haematological side effects and thus it should be avoided.
ADVERSE EFFECTS :
Malarim is usually well tolerated. Side effects include skin reactions; usually drug rash, pruritus and mild hair loss. Rarely erythema
multiforme, Steven's Johnson Syndrome and Lyell's Syndrome. Gastrointestinal reactions include nausea, rarely vomiting, stomatitis and
isolated reports of hepatitis. Haematological changes : in rare cases leukopenia, thrombocytopenia and megaloblastic anaemia have been
observed. Other side effects like fatigue, headache, fever and polyneuritis may occasionally occur. These side effects are usually mild and
disappear after discontinuation of the drug.
STORAGE INSTRUCTIONS :
Tablets : Store below 30oC , in a dry place.
PRESENTATIONS :
Malarim Tablets : Pack of 3 tablets and hospital packs of different sizes.