Artemether-lumefantrine

Pregnancy Category: C

Lactation: not known if either component enters breast milk, use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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.

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.

Tell your doctor about all other medicines you use.

Some medicines can interact with artemether and lumefantrine and should not be used at the same time, especially: dexamethasone, nefazodone, rifampin, St. John's wort; certain antibiotics or antifungal medicines--clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, rifampin, telithromycin, voriconazole; hepatitis C medication--boceprevir, telaprevir; HIV/AIDS medication--atazanavir, cobicistat, darunavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir; or seizure medication--carbamazepine, fosphenytoin, phenobarbital, phenytoin.

You should not use this medication 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:

• dexamethasone, nefazodone, rifampin, St. John's wort; or
• certain antibiotics or antifungal medicines--clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, rifampin, telithromycin, voriconazole; hepatitis C medication--boceprevir, telaprevir; HIV/AIDS medication--atazanavir, cobicistat, darunavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir; or seizure medication--carbamazepine, fosphenytoin, phenobarbital, phenytoin.

To make sure artemether and lumefantrine is safe for you, tell your doctor if you have:

• a history of heart disease or a recent heart attack;
• heart rhythm disorder, or a personal or family history of Long QT syndrome;
• liver or kidney disease;
• low levels of potassium or magnesium in your blood.

Tell your doctor about all other anti-malaria medications you have used recently.

FDA pregnancy category C. 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 while using this medication.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as 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 harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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.

If you vomit within 1 to 2 hours after taking this medication, take another dose. If your vomiting continues or you cannot eat, call your doctor.

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.

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

Store at room temperature away from moisture and heat.

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

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.

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.

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.