Coartem® (as a combination product containing Artemether, Lumefantrine)
WHY is this medicine prescribed?
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.
HOW should this medicine be used?
The combination of artemether and lumefantrine comes as a tablet to take by mouth. It is usually taken twice a day for 3 days as instructed by your doctor. Always take artemether and lumefantrine with food. If you are not able to eat, contact your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take artemether and lumefantrine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you have trouble swallowing the tablets, they may be crushed and mixed with 1 or 2 teaspoons of water in a clean container. Drink the mixture right away. Rinse the glass with more water and swallow the entire contents.
You may vomit soon after you take the medication. If you vomit within 1 to 2 hours after you take artemether and lumefantrine, you should take another full dose of artemether and lumefantrine. If you vomit again after taking the extra dose, call your doctor.
You should begin to feel better during the first few days of treatment with artemether and lumefantrine. If your symptoms do not improve or get worse, call your doctor. Also call your doctor if you have a fever, chills, muscle pain, or headache soon after you finish your treatment. This could be a sign that you still are infected with malaria.
Take artemether and lumefantrine until you finish the prescription, even if you feel better. If you stop taking artemether and lumefantrine too soon or skip doses, your infection may not be completely treated and the organisms may become resistant to antimalarials.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking artemether and lumefantrine,
tell your doctor and pharmacist if you are allergic to artemether and lumefantrine, any other medications, or any of the ingredients in artemether and lumefantrine tablets. Ask your pharmacist for a list of the ingredients.
tell your doctor if you are taking carbamazepine (Carbatrol, Epitol, Tegretol); phenytoin (Dilantin, Phenytek); rifampin (Rifadin, in Rifamate, in Rifater, Rimactane); or St. John's wort. Your doctor will probably tell you not to take artemether and lumefantrine if you are taking one or more of these medications.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants including amitriptyline (Elavil), clomipramine (Anafranil), and imipramine (Tofranil); certain antifungals such as fluconazole (Diflucan); itraconazole (Sporanox) and ketoconazole (Nizoral); antimalarials such as mefloquine (Lariam) and quinine (Qualaquin); cisapride (Propulsid) (not available in the U.S.); fluoroquinolone antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin) (not available in the U.S.), gemifloxacin (Factive), levofloxacin (Levaquin), lomefloxacin (Maxaquin) (not available in the U.S.), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam) (not available in the U.S.); macrolide antibiotics such as clarithromycin (Biaxin, in PrevPac), erythromycin (E.E.S., Ery-tab, Eryc), and telithromycin (Ketek); certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant, in Complera), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus); medications for irregular heartbeat including amiodarone (Cordarone), disopyramide (Norpace), flecainide (Tambocor), procainamide (Procanbid), quinidine, and sotalol (Betapace, Betapace AF, Sorine); and certain medications for mental illness such as pimozide (Orap) and ziprasidone (Geodon). Also tell your doctor or pharmacist if you are taking or have stopped taking halofantrine (Halfan) (not available in the U.S.) within the past month. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with artemether and lumefantrine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
tell your doctor if you or anyone in your family has had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); or if you have or have ever had a slow, fast, or irregular heartbeat; a recent heart attack; a low level of magnesium or potassium in your blood; kidney, heart, or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking artemether and lumefantrine, call your doctor.
you should know that artemether and lumefantrine may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, and injections). Talk to your doctor about methods of birth control that will work for you while you are taking artemether and lumefantrine.
What SPECIAL DIETARY instructions should I follow?
Do not drink grapefruit juice while taking this medication.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Artemether and lumefantrine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
muscle or joint pain
difficulty falling asleep or staying asleep
loss of appetite
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
abnormal or fast heartbeat
difficulty breathing or swallowing
swelling of the lips, tongue, face, or throat
Artemether and lumefantrine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the artemether and lumefantrine, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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