Artemether / Lumefantrine

What it is and how it works

Mechanism of Action Coartem Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent .

Indications

Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported . Limitations of Use : Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria. Coartem Tablets are not approved for the prevention of malaria. Coartem Tablets are a combination of artemether and lumefantrine, both antimalarials, indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported. Limitations of Use: Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria . Coartem Tablets are not approved for the prevention of malaria.

Dosage and administration (summary)

Coartem Tablets should be taken with food. ( 2.1 , 5.2 ) Tablets may be crushed and mixed with 1 to 2 teaspoons of water immediately prior to administration to patients, including children. Coartem Tablets should be administered over 3 days for a total of 6 doses: an initial dose, second dose after 8 hours, and then twice-daily (morning and evening) for the following 2 days. ( 2.2 , 2.3 ) The adult dosage for patients with bodyweight of 35 kg and above is 4 tablets per dose for a total of 6 doses. The number of tablets per dose for children is determined by bodyweight, as shown in the chart below. Tablets per dose by bodyweight.

Contraindications

Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets . Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy . Known hypersensitivity to artemether, lumefantrine, or to any of the excipients.

Warnings and precautions

Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval. ( 5.1 , 12.6 ) Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval. ( 5.1 , 5.2 , 12.3 ) Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data. QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets.

Pregnancy

Pregnancy Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) .

Storage and supply

Coartem (artemether/lumefantrine) Tablets 20 mg/120 mg Tablets - yellow, round flat tablets with beveled edges and scored on one side. Tablets are imprinted with “N/C” on one side and “CG” on the other. Bottle of 24 NDC 0078-0568-45 Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) .

Source: Artemether And Lumefantrine (Coartem) — US FDA prescribing information, 2026-03-26, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.