Generic Name: artemether/lumefantrine (ar-TEM-e-ther/LOO-me-FAN-treen)
Brand Name: Coartem
Coartem is used for:
Treating certain types of malaria in adults and children who weigh at least 11 pounds (5 kg). It may also be used for other conditions as determined by your doctor.
Coartem is an antimalarial agent. Exactly how it works is not known.
Do NOT use Coartem if:
- you are allergic to any ingredient in Coartem
- you have low blood potassium or magnesium levels, a very slow heartbeat, or severe heart problems
- you have a history of a certain type of irregular heartbeat (eg, QT prolongation) or you take any medicine that may increase the risk of this type of irregular heartbeat. Check with your doctor if you are not sure if any of your medicines may increase this risk
- a family member has a history of QT prolongation or sudden death
- you are taking carbamazepine, efavirenz, enzalutamide, hydantoins (eg, phenytoin), nevirapine, phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort
- you are taking amitriptyline, certain antiarrhythmics (eg, amiodarone, disopyramide, flecainide, procainamide, quinidine, sotalol), azole antifungals (eg, fluconazole, ketoconazole), clomipramine, fluoroquinolone antibiotics (eg, ciprofloxacin), imipramine, macrolide antibiotics (eg, clarithromycin), pimozide, or ziprasidone
- you have taken or will be taking halofantrine within 30 days before or after using Coartem
Contact your doctor or health care provider right away if any of these apply to you.
Before using Coartem:
Some medical conditions may interact with Coartem. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have heart problems (eg, slow or irregular heartbeat), have had a recent heart attack, or have a family history of heart problems
- if you have a history of electrolyte problems (eg, low blood potassium or magnesium levels)
- if you have liver or kidney problems
- if you have an infection or a history of mental or mood problems (eg, depression)
- if you are unable to eat food while taking Coartem
- if you are taking medicine to treat depression or HIV infection
- if you are taking or have recently taken other medicines used to treat malaria
Some MEDICINES MAY INTERACT with Coartem. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amitriptyline, antiarrhythmics (eg, amiodarone, disopyramide, flecainide, procainamide, quinidine, sotalol), other antimalaria medicines (eg, halofantrine, quinine), antipsychotics (eg, pimozide, ziprasidone), azole antifungals (eg, fluconazole, ketoconazole), clomipramine, fluoroquinolone antibiotics (eg, ciprofloxacin), imipramine, or macrolide antibiotics (eg, clarithromycin) because the risk of severe irregular heartbeat (QT prolongation) may be increased
- Carbamazepine, efavirenz, enzalutamide, hydantoins (eg, phenytoin), mefloquine, nevirapine, phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Coartem's effectiveness
- Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Coartem
This may not be a complete list of all interactions that may occur. Ask your health care provider if Coartem may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Coartem:
Use Coartem as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Coartem. Talk to your pharmacist if you have questions about this information.
- Take Coartem by mouth with food.
- If you are unable to swallow the tablet, Coartem may be crushed and mixed with a small amount of water (1 or 2 teaspoons) in a clean container. Swallow the mixture immediately; then rinse the container with more water and swallow to be sure you receive the entire dose. Follow with food or drink (eg, milk, formula, pudding, broth, porridge). Do not store the mixture for future use.
- Do not eat grapefruit or drink grapefruit juice while you use Coartem.
- If you vomit within 1 hour after taking Coartem, take another dose. If you vomit the repeat dose, contact your doctor.
- Continue to take Coartem even if you feel well. Do not miss any doses.
- If you miss a dose of Coartem, contact your doctor.
Ask your health care provider any questions you may have about how to use Coartem.
Important safety information:
- Coartem may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Coartem with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Coartem works better if you take it with food, but malaria may cause you to lose your appetite. If you cannot eat while you take Coartem, your doctor will closely monitor you because the risk of your malaria getting worse may be greater if you cannot eat with Coartem.
- If your symptoms do not get better or if they get worse, check with your doctor.
- Tell your doctor if you notice flu-like symptoms (eg, fever, muscle pains, headache, chills) again after you have finished treatment with Coartem.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Coartem. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Coartem should be used with extreme caution in CHILDREN who weigh less than 11 pounds (5 kg); safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Coartem, contact your doctor. You will need to discuss the benefits and risks of using Coartem while you are pregnant. It is not known if Coartem is excreted in breast milk. If you are or will be breast-feeding while you use Coartem, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Coartem:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Cough; diarrhea; dizziness; headache; joint and muscle pain and stiffness; loss of appetite; mild stomach pain; nausea; runny or stuffy nose; tiredness; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest or throat; trouble speaking; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; dark urine; decreased coordination; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mood swings; pale skin; pale stools; severe or persistent headache, muscle pain, stomach pain, tiredness, or weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Coartem:
Store Coartem at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Coartem out of the reach of children and away from pets.
- If you have any questions about Coartem, please talk with your doctor, pharmacist, or other health care provider.
- Coartem is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Coartem or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Coartem. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Coartem. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Coartem.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.