Coartem

(Artemether/Lumefantrine)

The active ingredients in Coartem are artemether and lumefantrine. Artemether is rapidly converted in the body to its active metabolite, dihydroartemisinin (DHA), which acts quickly to reduce the number of malaria parasites in the blood. Lumefantrine has a longer duration of action and helps eliminate remaining parasites, reducing the risk of recrudescence (infection coming back). This combination targets different stages of the malaria parasite life cycle and improves treatment effectiveness against Plasmodium falciparum.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Coartem. However, the following is a synopsis of the general guidelines for the use of Coartem:

Coartem is taken by mouth as tablets.

It is taken as a six-dose regimen over three days.

Doses are taken at specific time intervals as prescribed.

Coartem should be taken with food or a milk-containing drink to improve absorption.

For patients who cannot swallow tablets, Coartem tablets may be crushed and mixed with 1 to 2 teaspoons of water and administered immediately.

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.

If vomiting occurs within one hour of a dose, the dose should be repeated.

Some mild or common side effects of Coartem seen in clinical trials include:

Headache.

Dizziness.

Nausea, vomiting, or abdominal pain.

Loss of appetite (anorexia).

Muscle pain.

Joint pain.

Weakness or fatigue.

Some individuals may experience serious side effects while using Coartem. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

Serious allergic reaction, including hives, swelling of the face or throat, or trouble breathing.

Heart rhythm problems, including QT prolongation or palpitations.

Fainting or sudden dizziness.

Seizures.

Severe skin reactions.

These are not all of the possible side effects of Coartem. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Coartem, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

Heart rhythm disorders or a prolonged QT interval.

A history of sudden death in the family.

Low levels of potassium or magnesium.

Liver problems.

Use of other antimalarial drugs.

Pregnancy or plans to become pregnant.

Breastfeeding or plans to breastfeed.

Coartem should not be used for the prevention of malaria or for the treatment of severe malaria.

Coartem is contraindicated in patients with known hypersensitivity to artemether, lumefantrine, or any component of the formulation. It is also contraindicated in patients taking medications that may significantly prolong the QT interval.

Coartem begins working quickly after the first dose by reducing the number of malaria parasites in the blood. Fever and other symptoms often improve within one to two days. It is essential to complete the full six-dose regimen to ensure complete clearance of the infection.

When Coartem is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Strong CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John’s wort may reduce lumefantrine levels and decrease effectiveness.

Strong CYP3A4 inhibitors such as ketoconazole may increase lumefantrine exposure and side effects.

Medications that prolong the QT interval, including amiodarone, quinidine, quinine, disopyramide, clomipramine, flecainide, certain antidepressants such as amitriptyline, antipsychotics such as pimozide, moxifloxacin, and ziprasidone, may increase the risk of serious heart rhythm problems.

Hormonal contraceptives (birth control pills), which may be less effective when taken with Coartem.

If you recently took mefloquine, you may have a lower absorption of lumefantrine and reduced efficacy due to reduced bile production.

Grapefruit juice, which may alter lumefantrine levels and should be avoided.

It is available in tablets containing 20mg of artemether and 120mg of lumefantrine.

It should be stored at room temperature, away from the reach of children or pets.

Coartem is manufactured by Novartis.

No, there are no generic versions of Coartem.

Do not stop taking Coartem early unless instructed by your healthcare provider. Stopping treatment too soon may result in treatment failure or recurrence of malaria infection.

Coartem should be used during pregnancy only if clearly needed. Your healthcare provider will weigh the potential benefits and risks.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Small amounts of artemether and lumefantrine may pass into breast milk.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.