Each tablet contains 20mg of Artemether and 120mg of Lumefantrine, along with excipients.
Treatment of acute, uncomplicated malaria infections caused by Plasmodium falciparum.
Orally with food or a milky drink. Repeat dose if vomiting occurs within 1 hour. If food cannot be tolerated, take with water, but absorption may be reduced.
Refer to Figure 1 (not provided).
Hypersensitivity to ingredients, family history of sudden death or congenital QT prolongation, history of QT prolongation, concurrent use of QT-prolonging drugs, cardiac arrhythmias, bradycardia, reduced left ventricle ejection fraction, electrolyte imbalances, use of strong CYP3A4 inducers, severe malaria complications, use of drugs metabolized by CYP2D6, and first trimester of pregnancy (when other options are available).
Avoid in first trimester if possible; caution in second and third. Not for severe malaria. Monitor for deterioration. ECG and electrolyte monitoring if deterioration occurs. Consider lumefantrine's half-life. Caution with quinine, mefloquine, halofantrine, ARTs, renal/hepatic impairment. Monitor food intake if aversion persists. Potential for QT prolongation.
Decreased appetite, psychiatric and sleep disorders, headache, dizziness, paraesthesia, clonus, palpitations, prolonged QT interval, cough, vomiting, abdominal pain, nausea, diarrhea, increased liver function tests, rash, pruritus, arthralgia, myalgia, asthenia, fatigue, and gait disturbance.
Symptomatic and supportive therapy, including ECG and blood potassium monitoring.
Caution with CYP3A4 inhibitors; contraindicated with QT prolonging drugs. May interact with ARTs, CYP2D6 substrates, hormonal contraceptives, and grapefruit juice. Avoid strong CYP3A4 inducers. Monitor with mefloquine and quinine.
Dry place below 30°C, out of reach of children.