artemether-lumefantrine 20 mg-120 mg tablet

Generic name:
Artemether/lumefantrine - oral

Pronunciation
(ar-TEM-e-ther/LOO-me-FAN-treen)

Brand name(s)
Coartem

This medication is used to treat malaria in adults and children. The two ingredients in this medication belong to a class of drugs known as antimalarials. Malaria is an infection caused by mosquito bites received while traveling or living in regions of the world where malaria is common. Malaria parasites enter the body, and live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in the liver. Both treatments may be needed for a complete cure and to avoid the return of infection (relapse). This product is not used to prevent malaria.

The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before starting treatment with this medication.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a meal as directed by your doctor, usually twice a day for 3 days (6 doses). On your first day of treatment, take your first dose with food, followed by your second dose 8 hours later. Then each day for the next 2 days, take one dose in the morning and one dose in the evening.

It is important to take every dose of this medication with food or milk, infant formula, pudding, porridge, or broth. Food helps this medication work better. Tell your doctor if you are unable to eat.

If you or your child cannot swallow tablets, the artemether/lumefantrine tablets may be crushed and mixed with one or two teaspoons (5 to 10 milliliters) of water in a clean container at the time your dose is due. Do not crush tablets or mix with water in advance. Follow the dose of medication with food or drink (such as whole milk, formula, pudding, broth, or porridge).

If you or your child vomits within 1 to 2 hours of taking this drug, repeat this dose and contact your doctor right away. You will need to make sure you have enough tablets to complete your full course of treatment. If you vomit 2 doses, you may need to be treated with a different medication.

The dosage is based on your medical condition, weight, and response to treatment.

It is very important to keep taking this medication exactly as prescribed by your doctor. Do not take more or less of this drug than prescribed. Do not skip any doses. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few doses. Skipping doses or stopping the medication too early may make the infection more difficult to treat and result in a return of the infection.

This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Get medical help right away if your symptoms of malaria (such as fever, chills, headache, other flu-like symptoms) last or get worse after 1 to 2 days of taking this medication. If your fever returns after completing this prescription, contact your doctor so that he/she can determine whether the malaria has returned. Quick treatment of malaria is needed to prevent serious, possibly fatal, outcomes.

Headache, dizziness, loss of appetite, weakness, fever, chills, tiredness, muscle/joint pain, nausea, vomiting, abdominal pain, cough, and trouble sleeping may occur. If any of these effects last after stopping the medication or if these effects get worse while taking this medication, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if you have any very serious side effects, including:

• chest pain
• severe dizziness
• fainting
• fast/irregular/pounding heartbeat

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking artemether/lumefantrine, tell your doctor or pharmacist if you are allergic to artemether or lumefantrine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• recent use (within the past month) of any medication to prevent or treat malaria (such as halofantrine, quinine, or quinidine)
• kidney problems
• liver problems

Artemether/lumefantrine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using artemether/lumefantrine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using artemether/lumefantrine safely.

This drug may make you feel dizzy or tired or weak. Alcohol or marijuana (cannabis) can make you more dizzy or tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Be sure to tell your doctor about all medications you take for malaria within the 4 weeks before, during, and after treatment with artemether/lumefantrine. Some antimalarial drugs (such as halofantrine) should not be used within one month of treatment with artemether/lumefantrine. In some cases a serious (possibly fatal) drug interaction may occur.

Many drugs besides artemether/lumefantrine may affect the heart rhythm (QT prolongation), including other antimalarial drugs (such as quinine, quinidine), antiarrhythmic drugs (such as amiodarone, sotalol, procainamide, disopyramide), antipsychotics (such as pimozide, ziprasidone), macrolide antibiotics (such as erythromycin), quinolone antibiotics (such as ciprofloxacin, moxifloxacin), among others.

Other medications can affect the removal of artemether/lumefantrine from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole, itraconazole), mefloquine, HIV NNRTIs (such as efavirenz), HIV protease inhibitors (such as nelfinavir), rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, some anti-seizure drugs (such as carbamazepine, phenobarbital, phenytoin), among others.

This medication can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include clomipramine, flecainide, certain beta blockers such as metoprolol, certain tricyclic antidepressants (such as amitriptyline and imipramine), among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, fainting, slow/irregular heartbeat.

Do not share this medication with others.

Lab and/or medical tests (such as EKG) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.