Label Changes for:
Coartem (Artemether/Lumefantrine) Tablets
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –
WARNINGS AND PRECAUTIONS
Prolongation of the QT Interval
- 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)
Use of QT Prolonging Drugs and Other Antimalarials
- Drugs that prolong the QT interval, including antimalarials such as quinine and quinidine, should be used cautiously following Coartem Tablets, due to the long elimination half-life of lumefantrine (3-6 days) and the potential for additive effects on the QT interval; ECG monitoring is advised if use of drugs that prolong the QT interval is medically required
Strong CYP3A4 Inducers
- Co-administration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin and St. John’s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of anti-malarial efficacy.