Artemether+Lumefantrine

DRUG INFORMATION

  ADULT
    - 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. ( 2.1 ) 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.
      Source: US FDA label for artemether (COARTEM), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of Coartem Tablets have been established in pediatric
      patients aged 2 months and older with a bodyweight of 5 kg and above for the
      treatment of acute, uncomplicated malaria [see Clinical Studies (14.1)] . The
      safety and effectiveness of Coartem Tablets have not been established in pediatric
      patients younger than 2 months old or who weigh less than 5 kg.
      Source: US FDA label for artemether (COARTEM), section 'pediatric use', retrieved
      2026-08-29
    - 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. ( 2.1 ) 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.
      Source: US FDA label for artemether (COARTEM), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - For patients weighing less than 35 kg, [see Dosage and Administration (2.3)] . 2.3
      Dosage in Pediatric Patients A 3-day treatment schedule with a total of 6 doses is
      recommended as below: 5 kg to less than 15 kg bodyweight : One tablet as an
      initial dose, 1 tablet again after 8 hours, and then 1 tablet twice daily (morning
      and evening) for the following 2 days (total course of 6 tablets).
      Source: US FDA label for artemether (COARTEM), section 'dosage and
      administration', retrieved 2026-08-29
    - Most patients with acute malaria present with some degree of related hepatic
      and/or renal impairment.
      Source: US FDA label for artemether (COARTEM), section 'dosage and
      administration', retrieved 2026-08-29
    - In clinical studies, the adverse event profile did not differ in patients with
      mild or moderate renal impairment compared to patients with normal renal function.
      Source: US FDA label for artemether (COARTEM), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - In clinical studies, the adverse event profile did not differ in patients with
      mild or moderate hepatic impairment compared to patients with normal hepatic
      function.
      Source: US FDA label for artemether (COARTEM), section 'dosage and
      administration', retrieved 2026-08-29
    - No specific dose adjustments are needed for patients with mild or moderate hepatic
      impairment.
      Source: US FDA label for artemether (COARTEM), section 'dosage and
      administration', retrieved 2026-08-29
    - No dosage adjustment is necessary in patients with mild-to-moderate hepatic
      impairment [see Dosage and Administration (2.4) and Warnings and Precautions
      (5.6)] .
      Source: US FDA label for artemether (COARTEM), section 'use in specific
      populations', retrieved 2026-08-29

  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) .
      Source: US FDA label for artemether (COARTEM), section 'pregnancy', retrieved
      2026-08-29
    - The estimated background risk of major birth defects and miscarriage for the
      indicated population is unknown.
      Source: US FDA label for artemether (COARTEM), section 'pregnancy', retrieved
      2026-08-29
    - All pregnancies have a background risk of birth defect, loss, or other adverse
      outcomes.
      Source: US FDA label for artemether (COARTEM), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - The relevance of the findings from the animal reproductive studies to human risk
      is unclear. 8.2 Lactation Risk Summary There are no data on the presence of
      artemether or lumefantrine in human milk, the effects on the breastfed infant or
      the effects on milk production.
      Source: US FDA label for artemether (COARTEM), section 'use in specific
      populations', retrieved 2026-08-29
    - When a drug is transferred into animal milk, it is likely that the drug will also
      be transferred into human milk.
      Source: US FDA label for artemether (COARTEM), section 'use in specific
      populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother’s clinical need for Coartem and any potential adverse effects on
      the breastfed infant from Coartem or from the underlying maternal condition. 8.3
      Females and Males of Reproductive Potential Contraception Use of Coartem may
      reduce the efficacy of hormonal contraceptives.
      Source: US FDA label for artemether (COARTEM), section 'use in specific
      populations', retrieved 2026-08-29