Coartem

Generic Name: artemether and lumefantrine (ar TEM e ther and LOO me FAN treen)

What is Coartem?

Coartem (artemether and lumefantrine) is used to treat malaria, a disease caused by parasites. It works by interfering with the growth of parasites in the red blood cells of the human body.

Parasites that cause malaria typically 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.

This medication is used only to treat malaria. Do not use Coartem to prevent malaria.

Coartem may also be used for other purposes not listed in this medication guide.

Important information about Coartem

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

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

Before using Coartem, tell your doctor if you have a history of heart disease or “Long QT syndrome,” liver or kidney disease, or low levels of potassium or magnesium in your blood.

Take Coartem with food, milk, oatmeal, or broth. The tablet may be crushed and mixed with water for easier swallowing. If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues or you cannot eat, call your doctor.

In addition to taking Coartem, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

Before taking Coartem

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Coartem:

a history of heart disease; or

a personal or family history of “Long QT syndrome”;

low levels of potassium or magnesium in your blood;

liver disease; or

kidney disease.

FDA pregnancy category C. It is not known whether Coartem is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Coartem. It is not known whether artemether and lumefantrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Coartem should not be given to a child who weighs less than 11 pounds.

How should I take Coartem?

Take Coartem exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Coartem with food, milk, 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 pudding 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 to 2 hours after taking Coartem, 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.

In addition to taking Coartem, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

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

Store Coartem at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an Coartem overdose are not known.

What should I avoid while taking Coartem?

Do not take halofantrine (Halfan) while you are taking Coartem or just after you stop taking it. Serious, life-threatening side effects on your heart can occur if you take these medications within 30 days of each other.

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

Grapefruit and grapefruit juice may interact with Coartem and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Coartem side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Coartem: hives; difficulty 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;

dizziness, fainting, fast or pounding heartbeat;

severe or uncontrolled vomiting or diarrhea; or

stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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.

Less serious Coartem side effects may include:

weakness, mild headache;

nausea, vomiting, loss of appetite;

cough;

joint or muscle pain; or

sleep problems (insomnia).

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.

What other drugs will affect Coartem?

Many drugs can interact with Coartem. Below is just a partial list. Tell your doctor if you are using:

ketoconazole (Nizoral);

cold or allergy medicines;

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);

an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), or desipramine (Norpramin);

a heart rhythm medication such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), flecainide (Tambocor), procainamide (Procan, Pronestyl), propafenone (Rythmol), or quinidine (Quinaglute, Quinidex, Quin-Release);

HIV or AIDS medicine such as delavirdine (Rescriptor) or ritonavir (Norvir);

medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);

medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);

migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or

narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose).

This list is not complete and there may be other drugs that can interact with Coartem. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.