Adult Dosing
Acute, uncomplicated malaria
- >16 yrs,
35 kg: A 3-day treatment schedule as follows - Day 1: 4 tablets PO as a single initial dose; 4 tablets PO 8 hrs after the first dose
- Day 2 & 3: 4 tablets PO bid
- MAX: 24 tablets for a 3-day course
Notes:- Give with food
- Tablets may be crushed and mixed with 1-2 teaspoons of water
Pediatric Dosing
Acute, uncomplicated malaria
- 5 to <15 kg: A 3-day treatment schedule as follows
- Day 1: 1 tablet PO as a single initial dose; 1 tablet PO 8 hrs after first dose
- Day 2 & 3: 1 tablet PO bid
- MAX: 6 tablets for a 3-day course
- 15 to <25 kg: A 3-day treatment schedule as follows
- Day 1: 2 tablets PO as a single initial dose; 2 tablets PO 8 hrs after first dose
- Day 2 & 3: 2 tablets PO bid
- MAX: 12 tablets for a 3-day course
- 25 to <35 kg: A 3-day treatment schedule as follows
- Day 1: 3 tablets PO as a single initial dose; 3 tablets PO 8 hrs after first dose
- Day 2 & 3: 3 tablets PO bid
- MAX: 18 tablets for a 3-day course
- 35 kg: Use adult dosing
Notes:- Give with food
- Tablets may be crushed and mixed with 1-2 teaspoons of water
[Outline]
See Supplemental Patient Information
- Artemether/lumefantrine may cause prolongation of the QT interval on the electrocardiogram
- Avoid use in patients with congenital prolongation of the QT interval or a family history of congenital prolongation of the QT interval, known disturbances of electrolyte balance such as hypokalemia or hypomagnesemia, history of symptomatic cardiac arrhythmias with clinically relevant bradycardia or with severe cardiac disease, or in those receiving other medications that prolong the QT interval
- Do not administer halofantrine and artemether/lumefantrine within one month of each other due to the long elimination half-life of lumefantrine (3-6 days) and potential additive effects on the QT interval
- Avoid coadministration with other drugs that prolong QT interval including ; class IA antiarrhythmics (quinidine, procainamide, disopyramide), or class III antiarrhythmics (amiodarone, sotalol) antiarrhythmic agents, antipsychotics (pimozide, ziprasidone), antidepressants; and certain antibiotics (macrolide, fluoroquinolones)
- Do not administer artemether/lumefantrine with other antimalarials, unless there is no other treatment option
- When artemether/lumefantrine therapy is co-administered with substrates of CYP3A4, it may result in decreased concentrations of the substrate and potential loss of substrate efficacy. When artemether/lumefantrine therapy is co-administered with an inhibitor of CYP3A4, including grapefruit juice, it may result in increased concentrations of artemether and/or lumefantrine and potentiate QT prolongation. When co-administered with inducers of CYP3A4, it may result in decreased concentrations of artemether and/or lumefantrine and loss of anti-malarial efficacy
- Advise patients using hormonal contraceptives to use an additional non-hormonal method of birth control as it may reduce the effectiveness of hormonal contraceptives
- Do not co-administer with drugs that are metabolized by the cytochrome enzyme CYP2D6 as it may significantly increase plasma concentrations of the co-administered drug and increase the risk of adverse effects
- Food enhances absorption of artemether and lumefantrine following administration of therapy; closely monitor the patients who remain averse to food during treatment as they are at greater risk for recrudescence of malaria
Cautions: Use cautiously in
- Severe hepatic impairment
- Severe renal impairment
- Administration of drugs that prolong QT interval such as quinine and quinidine
- Use of substrates, inhibitors, or inducers of CYP3A4
- Anti-retroviral use
Supplemental Patient Information
- Instruct patients to promptly report their physicians if they have any symptoms of prolongation of the QT interval such as prolonged heart palpitations or a loss of consciousness
- Inform patients that the therapy may cause hypersensitivity reactions; instruct patients to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in breathing or swallowing, any swelling suggesting angioedema, or other symptoms of an allergic reaction
Pregnancy Category:C
Breastfeeding: Safety unknown. No data available regarding artemether and lumefantrine use during breastfeeding. However, a dosage has been established for infants weighing as little as 5 kg, so it is unlikely to adversely affect breastfed infants weighing 5 kg or more. Very low amounts of antimalarial drugs are usually excreted in the breastmilk of lactating mothers. Because the amount of antimalarial drugs excreted in breastmilk is insufficient to provide adequate protection against malaria, administer recommended dosages of antimalarial drugs crushed and mixed in breastmilk to the infants who require chemoprophylaxis. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 December 2010). As per manufacturer's data, animal studies suggest that both artemether and lumefantrine are excreted into breastmilk. Manufacturer advises caution and suggests that a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
US Trade Name(s)
US Availability
Coartem (artemether/lumefantrine)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Riamet (artemether/lumefantrine)
Australian Trade Name(s)
Australian Availability
Riamet (artemether/lumefantrine)
[Outline]
Drug Name: Coartem (artemether 20 MG / lumefantrine 120 MG) Oral Tablet
Ingredient(s): Artemether mixture with lumefantrine
Imprint: N;C;CG
Color(s): Yellow
Shape: Round
Size (mm): 9.00
Score: 2
Inactive Ingredient(s): silicon dioxide / croscarmellose sodium / hypromellose / magnesium stearate / cellulose, microcrystalline / polysorbate 80
Drug Label Author:
Novartis Pharmaceuticals Corporation
DEA Schedule:
Non-Scheduled
