Coartem (artemether/lumefantrine) Tablets
20 mg/120 mg Tablets — yellow, round flat tablets with beveled edges and scored on one side. Tablets are imprinted with “N/C” on one side and “CG” on the other.
Bottle of 24 NDC 0078-0568-45
Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature ].
Dispense in tight container (USP).
Advise patients to read the FDA-Approved Patient Labeling (Patient Information).
Instruct patients to take Coartem Tablets with food. Patients who do not have an adequate intake of food are at risk for recrudescence of malaria [see Dosage and Administration (2.1)].
Patients with known hypersensitivity to artemether, lumefantrine, or to any of the excipients should not receive Coartem Tablets [see Contraindications (4)].
Prolongation of the QT Interval
- Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia [see Warnings and Precautions (5.1)].
- Instruct patients to inform their physician if they are taking any 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) [see Warnings and Precautions (5.1)].
- Instruct patients to notify their physicians if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness [see Warnings and Precautions (5.1)].
Drug Interactions With CYP2D6
Instruct patients to avoid medications that are metabolized by the cytochrome enzyme CYP2D6 while receiving Coartem Tablets since these drugs also have cardiac effects (e.g., flecainide, imipramine, amitriptyline, clomipramine) [see Warnings and Precautions (5.4)].
Advise patients that use of Coartem may reduce the efficacy of hormonal contraceptives. Advise patients using hormonal contraceptive to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with Coartem [see Drug Interactions (7.5) and Use in Specific Populations (8.3)].
Use of QT Prolonging Drugs and Other Antimalarials
Halofantrine and Coartem Tablets should not be administered within 1 month of each other due to potential additive effects on the QT interval. Antimalarials should not be given concomitantly with Coartem Tablets, unless there is no other treatment option, due to limited safety data [see Warnings and Precautions (5.2)].
Sequential Use of Quinine
QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets due to the long elimination half-life of lumefantrine 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 [see Drug Interactions (7.7)].
Prior Use of Mefloquine
Closely monitor food intake in patients who received mefloquine immediately prior to treatment with Coartem Tablets [see Drug Interactions (7.4)].
Drug Interactions With CYP3A4
Use Coartem Tablets cautiously in patients receiving other drugs that are substrates, inhibitors or inducers of CYP3A4, including grapefruit juice, especially those that prolong the QT interval or are antiretroviral drugs. Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort is contraindicated with Coartem Tablets [see Warnings and Precautions (5.3)].
Inform patients that Coartem Tablets can 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 swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction [see Contraindications (4)].
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Revised: August 2019|
|Patient Information Coartem® (co-AR-tem) (artemether and lumefantrine)tablets, for oral use|
Read this Patient Information leaflet before you start taking Coartem. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
|What is Coartem? Coartem is a prescription medicine used to treat uncomplicated malaria caused by the parasite Plasmodium falciparum (P. falciparum) in people 2 months of age and older who weigh at least 11 pounds (5 kg).
Coartem is not approved to:
It is not known if Coartem is safe and effective in children who weigh less than 11 pounds (5 kg).
|Who should not take Coartem? Do not take Coartem if you:
| What should I tell my healthcare provider before taking Coartem?
Before taking Coartem, tell your healthcare provider about all of your medical conditions, including if you: |
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Coartem and other medicines may affect each other causing side effects. Coartem may affect the way other medicines work and other medicines may affect how Coartem works.
Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take Coartem?
Tell your healthcare provider right away if:
|What are the possible side effects of Coartem? Coartem can cause serious side effects, including:|
|The most common side effects of Coartem in adults include:|
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|The most common side effects of Coartem in children include:|
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These are not all the possible side effects of Coartem. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
| How should I store Coartem? |
|General information about the safe and effective use of Coartem. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Coartem for a condition for which it was not prescribed. Do not give Coartem to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information leaflet summarizes the most important information about Coartem. If you would like more information about Coartem talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Coartem that is written for health professionals.|
|What are the ingredients in Coartem? Active ingredients: artemether, lumefantrine Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and polysorbate 80Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2019-89 For more information about Coartem, call 1-855-262-7836 or go to http://www.coartem.us.com|
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