Generic Name and Formulations:
Artemether 20mg, lumefantrine 120mg; scored tabs.
Novartis Pharmaceuticals Corp
Indications for COARTEM:
Acute, uncomplicated malaria infections due to Plasmodium falciparum. Limitations of use: not approved for severe or complicated P. falciparum malaria, or for the prevention of malaria.
Take with food. May be crushed and mixed with water (1–2tsp). Repeat dose if vomiting occurs within 1–2hrs of administration; if repeat dose vomited, give alternative treatment. >16yrs (≥35kg): 4 tabs as a single initial dose, 4 tabs again after 8hrs, then 4 tabs twice daily (AM & PM) for the following two days (total course of 24 tabs).
Take with food. May be crushed and mixed with water (1–2tsp). Repeat dose if vomiting occurs within 1–2hrs of administration; if repeat dose vomited, give alternative treatment. <2mos & <5kg: not established. ≥2mos: 5–<15kg: 1 tab as initial dose, 1 tab again after 8hrs, then 1 tab twice daily (AM & PM) for the following two days (total course of 6 tabs). 15–<25kg: 2 tabs as initial dose, 2 tabs again after 8hrs; then 2 tabs twice daily for the following two days (total course of 12 tabs). 25–<35kg: 3 tabs as initial dose, 3 tabs again after 8hrs, then 3 tabs twice daily for the following two days (total course of 18 tabs). ≥35kg: give adult dose.
Concomitant strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John's wort).
Avoid in congenital QT prolongation, history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease, family history of congenital prolongation of the QT interval or sudden death, disturbances of electrolyte balance (eg, hypokalemia, hypomagnesemia). Recrudescence in those averse to food; monitor; if occurs, treat with different antimalarial. Plasmodium vivax infection. Severe hepatic or renal impairment. Pregnancy (Cat.C). Nursing mothers.
See Contraindications. Avoid with concomitant drugs that prolong the QT interval (eg, Class IA [quinidine, procainamide, disopyramide] or Class III [amiodarone, sotalol] antiarrhythmics, antipsychotics [pimozide, ziprasidone], antidepressants, certain antibiotics [macrolides, fluoroquinolones, imidazole and triazole antifungals], drugs metabolized by CYP2D6 which also have cardiac effects (eg, flecainide, imipramine, amitriptyline, clomipramine). Caution with quinine (monitor). Concomitant other antimalarials: not recommended; if necessary, use cautiously and monitor. Do not administer within one month of halofantrine. May be antagonized by mefloquine. May potentiate CYP2D6 substrates. May antagonize CYP3A4 substrates. May be potentiated by CYP3A4 inhibitors. May be antagonized by CYP3A4 inducers. Caution with drugs that have mixed effect of CYP3A4 (eg, anti-retrovirals). May reduce effectiveness of hormonal contraception; use additional non-hormonal method.
Headache, anorexia, dizziness, asthenia, arthralgia, myalgia; also children: pyrexia, cough, vomiting; QT prolongation.
Hepatic (artemether: CYP3A4/5, also CYP2B6, CYP2C9, CYP2C19; lumefantrine: CYP3A4, CYP2D6).