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 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).

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.

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.