Artemether & Lumefantrine

Artemether/lumefantrine is a prescription medication used to treat malaria, a blood infection caused by Plasmodium parasites. Artemether/lumefantrine belongs to a group of drugs called antimalarial agents. These medications work by inhibiting nucleic acid and protein synthesis to interfere with the growth of Plasmodium organisms that cause malaria.

Artemether/lumefantrine is a prescription medicine used to treat uncomplicated malaria in adults and children who weigh at least 11 pounds (5 kg).

Artemether & Lumefantrine may be found in some form under the following brand names:

• Coartem

The most common side effects in adults are: 

• headache 
• feeling dizzy 
• feeling weak 
• loss of appetite 
• muscle and joint pain or stiffness 
• feeling tired 
• chills 
• fever

The most common side effects in children are:

• fever 
• cough 
• vomiting
• headache
• loss of appetite

These are not all the possible side effects of artemether/lumefantrine. For more information, ask your doctor or pharmacist. \

Artemether/lumefantrine can cause serious side effects. See "Drug Precautions" section.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Artemether/lumefantrine and other medicines may affect each other causing side effects. Artemether/lumefantrine may affect the way other medicines work and other medicines may affect how artemether/lumefantrine works.

Especially tell your doctor if you take:

• any other medicines to treat or prevent malaria
• medicines for your heart
• antipsychotic medicines 
• antidepressants
• medicines for seizures or trigeminal neuralgia (facial nerve pain)
• antibiotics (including medicines to treat tuberculosis)
• antihistamines
• Cisapride (Propulsid) 
• medicines to treat HIV-infection
• hormonal methods of birth control (for example, birth control pills or patch)

Ask your healthcare provider if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

Artemether/lumefantrine can cause serious side effects including:

• A heart problem called QT prolongation that can cause an abnormal heartbeat can happen in people who take artemether/lumefantrine. The chance of this happening is higher in people with a family history of prolonged QT interval, low potassium (hypokalemia), and in people who take medicines to control heartbeats. 
• Allergic reactions. Symptoms of an allergic reaction include: rash, hives, fast heartbeat, trouble swallowing or breathing, swelling of lips, tongue, face, tightness of the throat, or trouble speaking. If you have a serious allergic reaction, stop taking artemether/lumefantrine and get emergency medical help right away.

Do not take artemether/lumefantrine if you are allergic to any of the ingredients.

Do not take artemether/lumefantrine if you are taking rifampin (medicine to treat leprosy or tuberculosis), certain medicines used to treat epilepsy (such as carbamazepine, phenytoin), or St. John’s wort (Hypericum perforatum, a medicinal plant or extract of this medicinal plant).

Do not drink grapefruit juice while you take artemether/lumefantrine. Drinking grapefruit juice during treatment with artemether/lumefantrine can cause you to have too much medicine in your blood.

Before you take artemether/lumefantrine, tell your healthcare provider about all your medical conditions including if you have:

• heart disease or a family history of heart problems or heart disease
• liver or kidney problems
• recently taken other medicines used to treat malaria 
• if you are pregnant or are planning to become pregnant. Artemether/lumefantrine may increase your risk for loss of pregnancy. Fetal defects have been reported when artemisinins are administered to animals. Talk to your healthcare provider before taking artemether/lumefantrine. 
• if you are breastfeeding. It is not known if artemether/lumefantrine passes into your breast milk. You and your doctor will decide the best way to feed your baby if you take this medication.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. Artemether/lumefantrine may increase your risk for loss of pregnancy. Fetal defects have been reported when artemisinins are administered to animals. Talk to your healthcare provider before taking this medication. 

Tell your healthcare provider if you are breastfeeding. It is not known if artemether/lumefantrine passes into your breast milk. You and your doctor will decide the best way to feed your baby if you take artemether/lumefantrine.

• Take artemether/lumefantrine exactly as prescribed.
• If you weigh 77 pounds (35 kg) or more, one dose of artemether/lumefantrine is 4 tablets.
• If you weigh less than 77 pounds (35 kg), your healthcare provider will tell you how many tablets to take for each dose.
• A full course of treatment is 6 doses of artemether/lumefantrine taken over 3 days: 
  Day 1: take 1 dose; 8 hours later take 1 dose
  Day 2: take 1 dose in the morning, 1 dose in the evening
  Day 3: take 1 dose in the morning, 1 dose in the evening

Take artemether/lumefantrine for 3 days even if you are feeling better.

• Every dose of artemether/lumefantrine should be taken with food, such as milk, infant formula, pudding, porridge, or broth. It is important for you to eat as soon as you can so that your malaria will go away and not get worse. 
• Do not drink grapefruit juice while you take artemether/lumefantrine. Drinking grapefruit juice during treatment with artemether/lumefantrine can cause you to have too much medicine in your blood. 
• Artemether/lumefantrine may be crushed and mixed with one to two teaspoons of water in a clean container. 
• If you vomit within 1 hour of taking artemether/lumefantrine you should take another dose of artemether/lumefantrine. If you vomit the second dose, tell your healthcare provider. A different medicine may need to be prescribed for you.

Tell your healthcare provider right away if:

• your malaria does not get better 
• you vomited any of your doses of artemether/lumefantrine
• you are not able to eat
• you get flu-like symptoms (chills, fever, muscle pains, or headaches) again after you have finished your treatment with artemether/lumefantrine.
• you have any change in the way your heart beats or a loss of consciousness (fainting). 

If you take too much artemether/lumefantrine call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If artemether/lumefantrine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

• Store artemether/lumefantrine between 59ºF to 86ºF (15ºC to 30ºC). 
• Keep artemether/lumefantrine and all medicines out of the reach of children.