Artemether and lumefantrine are anti-malaria medications that interfere with the growth of parasites in the red blood cells of the human body. Malaria is caused by parasites that enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Artemether and lumefantrine is a combination medicine used to treat non-severe malaria.

Artemether and lumefantrine is for use in adults and children at least 2 months old or who weigh at least 11 pounds (5 kilograms).

This medication is used only to treat malaria. Do not use artemether and lumefantrine to prevent malaria.

Artemether and lumefantrine may also be used for purposes not listed in this medication guide.

Serious drug interactions can occur when certain medicines are used together. Tell your doctor about all your current medicines and any you start or stop using, especially carbamazepine, phenytoin, rifampin, or St. John's wort.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take artemether and lumefantrine with food, milk, pudding, oatmeal, or broth. The tablet may be crushed and mixed with 1 or 2 teaspoons of water for easier swallowing. You may also mix a crushed tablet with infant formula when giving this medication to a child. Start eating normally as soon as possible to help your body better absorb the medication.

Artemether and lumefantrine is usually given as a total of 6 doses over a period of 3 days. Carefully follow your doctor's instructions about how many tablets to take per dose. Artemether and lumefantrine doses are based on weight and age. The usual doses are as follows, unless your doctor tells you otherwise.

For people over 16 years old who weigh at least 77 pounds:

• Take four (4) tablets as an initial dose.

• Take 4 more tablets 8 hours later.

• Take 4 tablets in the morning and 4 tablets in the evening for the next 2 days.

For children younger than 16 years old who weigh between 55 and 77 pounds:

• Take three (3) tablets as an initial dose.

• Take 3 more tablets 8 hours later.

• Take 3 tablets in the morning and 3 tablets in the evening for the next 2 days.

For children younger than 16 years old who weigh between 33 and 55 pounds:

• Take two (2) tablets as an initial dose.

• Take 2 more tablets 8 hours later.

• Take 2 tablets in the morning and 2 tablets in the evening for the next 2 days.

For children younger than 16 years old who weigh between 11 and 33 pounds:

• Take one (1) tablet as an initial dose.

• Take a second tablet 8 hours later.

• Take 1 tablet in the morning and 1 tablet in the evening for the next 2 days.

If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues or you cannot eat, call your doctor.

No medication is 100% effective in treating malaria. For best results, keep using the medication as directed.

Call your doctor if your symptoms do not improve, or if you have a fever, chills, headache, or muscle pain.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Malaria:

Less than 35 kg: Usual pediatric dose

At least 35 kg: 4 tablets orally as a single initial dose, followed by 4 tablets after 8 hours, and then 4 tablets twice a day (morning and evening) for the following 2 days
-Total course: 24 tablets

Comments:
-A 3-day treatment regimen, with a total of 6 doses

Use: For the treatment of acute uncomplicated malaria infections due to Plasmodium falciparum

Usual Pediatric Dose for Malaria:

2 months or older:
-Weight 5 to less than 15 kg: 1 tablet orally as a single initial dose, followed by 1 tablet after 8 hours, and then 1 tablet twice a day (morning and evening) for the following 2 days
---Total course: 6 tablets
-Weight 15 to less than 25 kg: 2 tablets orally as a single initial dose, followed by 2 tablets after 8 hours, and then 2 tablets twice a day (morning and evening) for the following 2 days
---Total course: 12 tablets
-Weight 25 to less than 35 kg: 3 tablets orally as a single initial dose, followed by 3 tablets after 8 hours, and then 3 tablets twice a day (morning and evening) for the following 2 days
---Total course: 18 tablets
-Weight At least 35 kg: 4 tablets orally as a single initial dose, followed by 4 tablets after 8 hours, and then 4 tablets twice a day (morning and evening) for the following 2 days
---Total course: 24 tablets

Comments:
-A 3-day treatment regimen, with a total of 6 doses

Use: For the treatment of acute uncomplicated malaria infections due to P falciparum

You should not use this medication if you are allergic to artemether or lumefantrine.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with artemether and lumefantrine. Your doctor may change your treatment plan if you also use:

• rifampin;

• St. John's wort; or

• seizure medicine--carbamazepine, phenytoin.

Tell your doctor about all other anti-malaria medications you have used within the past 30 days.

Tell your doctor if you have ever had:

• heart disease;

• long QT syndrome (in you or a family member);

• liver or kidney disease; or

• low levels of potassium or magnesium in your blood.

It is not known whether artemether and lumefantrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common.

Artemether and lumefantrine can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using artemether and lumefantrine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Artemether and lumefantrine should not be given to a child younger than 2 months or who weighs less than 11 pounds.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking other anti-malaria medications, unless your doctor has told you to.

Grapefruit may interact with artemether and lumefantrine and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; fast heart rate; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you develop fever, chills, body aches, severe headache, or flu symptoms after you have finished taking all your doses of artemether and lumefantrine.

Also call your doctor at once if you have a serious side effect such as:

• worsening malaria symptoms;

• severe vomiting, loss of appetite, or being unable to eat;

• fast or pounding heartbeats;

• a light-headed feeling, like you might pass out; or

• the first sign of any skin rash, no matter how mild.

Common side effects of artemether and lumefantrine may include:

• headache, dizziness;

• fever, cough, feeling weak or tired;

• muscle pain, tenderness, or weakness;

• joint pain;

• vomiting; or

• loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect artemether and lumefantrine, especially:

• other anti-malaria medications;

• heart or blood pressure medication;

• antipsychotic medication;

• an antidepressant;

• seizure medication or medicine for nerve pain in your face;

• antibiotics, antifungal medicine, or medicine to treat tuberculosis;

• antiviral medicine to treat HIV or AIDS; or

• birth control pills or hormone replacement therapy.

This list is not complete and many other drugs may affect artemether and lumefantrine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.