Artemether and Lumefantrine

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.

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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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.
• Some medications should not be taken with artemether and lumefantrine. Other medications may cause dosing changes or extra monitoring when taken with artemether and lumefantrine. Make sure you have discussed any medications you are currently taking or plan to take before starting artemether and lumefantrine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking artemether and lumefantrine, please get the advice of your doctor or pharmacist.
• You should know that artemether and lumefantrine may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking artemether and lumefantrine. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
• The following nonprescription and herbal products may interact with artemether and lumefantrine: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking artemether and lumefantrine. Do not start any of these medications while taking artemether and lumefantrine without discussing with your healthcare provider.
• 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.

Do not drink grapefruit juice while taking this medication.

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.

Artemether and lumefantrine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• weakness
• muscle or joint pain
• tiredness
• difficulty falling asleep or staying asleep
• vomiting
• loss of appetite
• fever
• chills

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
• fainting
• rash
• hives
• difficulty breathing or swallowing
• swelling of the lips, tongue, face, or throat
• hoarseness
• difficulty speaking

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 (http://goo.gl/c4Rm4p) 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. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

• Coartem^® (containing Artemether, Lumefantrine)