Indication:The combination of artemether and lumefantrine is used to treat certain kinds of malaria infections (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death). Artemether and lumefantrine should not be used to prevent malaria. Artemether and lumefantrine is in a class of medications called antimalarials. It works by killing the organisms that cause malaria.
Precautions & Warning:
Some antimalarials (e.g., halofantrine, quinine, quinidine) including Coartem Tablets have been associated with prolongation of the QT interval on theelectrocardiogram.
Coartem Tablets should be avoided in patients:
with congenital prolongation of the QT interval (e.g., long QT syndrome) or any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
with a family history of congenital prolongation of the QT interval or sudden death.
with known disturbances of electrolyte balance, e.g., hypokalemia or hypomagnesemia.
receiving other medications that prolong the QT interval, such as class IA (quinidine, procainamide, disopyramide), or class III (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; certain antibiotics (macrolide antibiotics, fluoroquinolone antibiotics, imidazole, and triazole antifungal agents); certain non-sedating antihistaminics (terfenadine, astemizole), or cisapride.
receiving medications that are metabolized by the cytochrome enzyme CYP2D6 which also have cardiac effects (e.g., flecainide, imipramine,amitriptyline, clomipramine)
Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets
There is no information on overdoses of Coartem Tablets higher than the doses recommended for treatment.
In cases of suspected overdosage, symptomatic and supportive therapy, which would include ECG and blood electrolyte monitoring, should be given as appropriate.
Artemether-lumefantrine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryo-fetal loss and fetal defects. Safety data from an observational pregnancy study of approximately 500 pregnant women who were exposed to artemether-lumefantrine (including a third exposed during the first trimester), and published data of over 1000 pregnant patients who were exposed to artemisinin derivatives, did not show an increase in adverse pregnancy outcomes or teratogenic effects over background rate. Artemether-lumefantrine is only recommended for use during pregnancy when benefit outweighs risk.
for Export use only