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Artemether/​Lumefantrine

    Brands

    DEA Class; Rx

    Common Brand Names; Coartem

    • Antimalarials

    Fixed artemisinin-based combination tablet
    For the treatment of acute, uncomplicated malaria infections in patients 2 months and older with a bodyweight of at least 5 kg
    Artemisinin-based therapies are potent with rapid onset of anti-parasitic activity

    Indicated for the treatment of malaria.

    Hypersensitivity

    Coadministration with strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John’s wort) can result in decreased artemether and/or lumefantrine serum concentrations and loss of antimalarial efficacy

    • Abdominal pain (17%)
    • Anorexia (40%)
    • Arthralgia (34%)
    • Asthenia (38%)
    • Chills (23%)
    • Dizziness (39%)
    • Fatigue (17%)
    • Headache (56%)
    • Myalgia (32%)
    • Nausea (26%)
    • Palpitations (18%)
    • Pyrexia (25%)
    • Sleep disorder (22%)
    • Vomiting (17%)

    Not approved for severe/complicated P. falciparum infections

    Not approved for prophylaxis

    If patient vomits out drug repeatedly, use alternative treatment

    Food enhances absorption of artemether and lumefantrine following administration of this medication; patients who remain averse to food during treatment should be closely monitored as risk of recrudescence may be greater; in event of recrudescent P. falciparum infection after treatment with this medication, patients should be treated with a different antimalarial drug

    Published data from clinical studies and pharmacovigilance data have not established an association between drug use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes

    There are no data on presence of drug in human milk, effects on breastfed infant or on milk production

    Adults

    35 kg or more: 8 tablets/day PO.
    25 kg to 34 kg: 6 tablets/day PO.

    Geriatric

    35 kg or more: 8 tablets/day PO.
    25 kg to 34 kg: 6 tablets/day PO.

    Adolescents

    35 kg or more: 8 tablets/day PO.
    25 kg to 34 kg: 6 tablets/day PO.

    Children

    35 kg or more: 8 tablets/day PO.
    25 kg to 34 kg: 6 tablets/day PO.
    15 kg to 24 kg: 4 tablets/day PO.
    5 kg to 14 kg: 2 tablets/day PO.

    Infants

    at least 2 months old and 15 kg to 24 kg: 4 tablets/day PO.
    at least 2 months old and 5 kg to 14 kg: 2 tablets/day PO.
    younger than 2 months old or less than 5 kg: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Artemether/lumefantrine

    tablet

    • 20mg/120mg