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
Precautions & Warning:
Some antimalarials (e.g., halofantrine, quinine, quinidine)
including Coartem Tablets have been associated with prolongation of
the QT interval on the electrocardiogram.
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
with a family history of congenital prolongation of the QT interval
or sudden death.
with known disturbances of electrolyte balance, e.g., hypokalemia
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.