📌 COMPOSITION

• Sulfadoxine USP 500 mg
• Pyrimethamine USP 25 mg

📌 DESCRIPTION

Malarim is a combined antimalarial product active against all human pathogenic species of Plasmodia (P. falciparum, P. vivax, P. ovale and P. malariae). It is also effective against chloroquine‑resistant strains and other 4‑aminoquinoline derivatives or pyrimethamine‑resistant strains. It acts by inhibiting two enzymes involved in the biosynthesis of folinic acid in the parasites. After administration of 1 tablet, peak plasma levels for both components are achieved after about 4 hours. Pyrimethamine binds to plasma proteins by 84.9%, while sulfadoxine is bound by 91.4%. Both components pass into breast milk. Both 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: The amount indicated below is to be taken as 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 the CNS is involved, it should be combined with spiramycin in a dose of 3 g daily for 3-4 weeks.

D) Prophylaxis against Pneumocystis carinii infections:

• Infants and young children: 40 mg/kg (based on the sulfadoxine content) every two weeks.
• Proposed dosage for adults: 1-2 tablets weekly.

Dosage by age group for prophylaxis (once every 4 weeks / once weekly):

Semi-immune / Non-immune subjects:

📌 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 use.

📌 DRUG INTERACTIONS

Concomitant administration of Malarim with trimethoprim or trimethoprim‑sulphonamide combinations potentiates the impairment of folic acid metabolism, with consequent haematological side effects, and thus 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, Stevens‑Johnson syndrome and Lyell's syndrome.
• Gastrointestinal reactions: 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 such as 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 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Malarim Tablets: Pack of 3 tablets and hospital packs of different sizes.