Coartem contains a combination of artemether and lumefantrine. Artemether and lumefantrine are anti-malaria medicines 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.

Coartem is used to treat non-severe malaria.

Coartem is used only to treat malaria. Do not use this medicine to prevent malaria.

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.

Before taking this medicine

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

Some medicines can interact with artemether and lumefantrine and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• 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.

To make sure Coartem is safe for you, tell your doctor if you have ever had:

• heart disease;

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

• liver or kidney disease;

• low levels of potassium or magnesium in your blood.

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

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether artemether and lumefantrine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Coartem should not be given to a child who weighs less than 11 pounds.

Take Coartem exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Coartem 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.

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

Coartem 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. Coartem 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.

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

Usual Adult Dose of Coartem for Malaria:

Less than 35 kg: Usual pediatric dose

35 kg or more: 4 tablets as 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)

Usual Pediatric Dose of Coartem for Malaria:

5 kg to less than 15 kg: 1 tablet as 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)

15 kg to less than 25 kg: 2 tablets as 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)

25 kg to less than 35 kg: 3 tablets as 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)

35 kg or more: 4 tablets as 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)

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

Some medicines can interact with artemether and lumefantrine and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• 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.

To make sure Coartem is safe for you, tell your doctor if you have ever had:

• heart disease;

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

• liver or kidney disease;

• low levels of potassium or magnesium in your blood.

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

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether artemether and lumefantrine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Coartem should not be given to a child 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 and grapefruit juice may interact with artemether and lumefantrine and lead to unwanted side effects. Avoid the use of grapefruit products while taking Coartem.

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

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.

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

Common Coartem side effects may include:

• headache, dizziness;

• fever, chills, cough, feeling weak or tired;

• stiffness or pain in your muscles and joints;

• 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.

Many drugs can interact with artemether and lumefantrine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• other anti-malaria medications;

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

• an antidepressant;

• antipsychotic medication;

• antiviral medicine to treat HIV or AIDS;

• an asthma inhaler;

• birth control pills or hormone replacement therapy;

• cancer medicine;

• heart or blood pressure medication;

• medicine to prevent vomiting; or

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

This list is not complete and many other drugs can interact with artemether and lumefantrine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.