Artemether/Lumefantrine Oral Suspension (Artemether 180 mg + Lumefantrine 1080 mg per 60 mL)

● Treatment of acute, uncomplicated Plasmodium falciparum malaria in adults, children and infants weighing 5 kg and above [1][2] ● Shown to be effective in geographical regions where resistance to chloroquine has been reported [2] ● Recommended as first-line therapy for acute malaria in adults and children in malaria-endemic regions [3] ● Not approved for severe or complicated P. falciparum malaria, and not approved for the prevention of malaria [1][2]

● For oral administration; take with food or a milky drink to increase absorption of both artemether and lumefantrine [1][2][3] ● A full course comprises 6 doses given over 3 days: an initial dose, a second dose 8 hours later, then twice daily (morning and evening) for the following 2 days [1][2] ● If the patient vomits within 1–2 hours of taking a dose, repeat the dose; if the repeat dose is also vomited, seek medical attention [1][2] ● Do not drink grapefruit juice during treatment [2] ● Encourage normal eating as soon as tolerated to improve absorption and reduce the risk of recrudescence [1][2] ● Complete the full course of treatment even if symptoms improve [3] ● Storage: UK reference — do not store above 30 °C [1]; US reference — store at controlled room temperature 20–25 °C in a tightly closed container [2]; suspension reference — store below 30 °C in a dry place, protected from light [3]; keep out of the reach of children [2][3]

The regimens below refer to registered artemether/lumefantrine products; the dose of the oral suspension should be given according to the weight-based schedule on the approved label of the product concerned [1][2][3].

● Contraindicated in patients with known hypersensitivity to artemether, lumefantrine or any excipient [1][2] ● Contraindicated in severe malaria according to the WHO definition [1] ● Contraindicated with strong CYP3A4 inducers such as rifampin, carbamazepine, phenytoin and St. John’s wort, which markedly reduce exposure and antimalarial efficacy [1][2] ● Avoid use in patients with known QT prolongation, hypokalaemia or hypomagnesaemia, a family history of QT prolongation or sudden death, or in patients taking other QT-prolonging drugs; halofantrine should not be used within one month [1][2] ● Lumefantrine inhibits CYP2D6: concomitant use with CYP2D6-metabolised drugs with cardiac effects (e.g. flecainide, imipramine, amitriptyline, clomipramine) is contraindicated [1][2] ● Pregnancy: not recommended in the first trimester when suitable alternatives are available, but should not be withheld in life-threatening situations; use in later pregnancy if the benefit to the mother outweighs the risk to the fetus [1][2] ● Breast-feeding: do not breast-feed during treatment; resume no earlier than one week after the last dose because of the long half-life of lumefantrine [1] ● Hormonal contraceptives: effectiveness may be reduced; use an additional non-hormonal or barrier method during treatment and for about one month afterwards [1][2] ● Do not give concurrently with other antimalarials unless there is no other option; quinine and other QT-prolonging drugs should be used cautiously after treatment, with ECG monitoring if medically required [1][2] ● Monitor patients who remain averse to food, as the risk of recrudescence may be greater; treat recrudescent infection with a different antimalarial [1][2] ● Use with caution in patients with severe hepatic or renal impairment, with ECG and blood potassium monitoring [1][2] ● Adverse reactions: in adults the most common are headache, decreased appetite, dizziness, asthenia, arthralgia and myalgia; in children pyrexia, cough, vomiting, decreased appetite and headache; delayed haemolytic anaemia and hypersensitivity reactions have been reported [1][2] ● Overdose: symptomatic and supportive therapy, including ECG and blood electrolyte monitoring [1][2] ● Dizziness or fatigue may occur; patients should not drive or use machines if affected [1] ● This is a prescription medicine (POM in the UK [1]; Rx only in the US [2]) For full prescribing information, refer to the approved product label of the product concerned [1][2][3].