Artemether/lumefantrine

What is Artemether/lumefantrine?

• Artemether/lumefantrine (Coartem) is a combination of artemether and lumefantrine, both antimalarials, used to treat malaria caused by Plasmodium falciparum that is not treatable with chloroquine.
• Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported.

Artemether

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Artemether 3D balls

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Lumefantrine

What are the uses of this medicine?

• Artemether/lumefantrine (Coartem) is a prescription medicine used to treat uncomplicated malaria caused by the parasite Plasmodium falciparum (P. falciparum) in people 2 months of age and older who weigh at least 11 pounds (5 kg).

Limitations of Use: Coartem is not approved to:

• Treat severe or complicated P. falciparum malaria
• Prevent malaria
• It is not known if Coartem is safe and effective in children who weigh less than 11 pounds (5 kg).

How does this medicine work?

• Coartem Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent.
• Artemether is rapidly metabolized into an active metabolite DHA.
• The antimalarial activity of artemether and DHA has been attributed to endoperoxide moiety.
• The exact mechanism by which lumefantrine exerts its antimalarial effect is not well defined.
• Available data suggest lumefantrine inhibits the formation of β-hematin by forming a complex with hemin.
• Both artemether and lumefantrine were shown to inhibit nucleic acid and protein synthesis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets.
• use strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort.

What drug interactions can this medicine cause?

• Coartem and other medicines may affect each other causing side effects. Coartem may affect the way other medicines work and other medicines may affect how Coartem works.

Especially tell your healthcare provider 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)
• antifungal medicines (such as itraconazole, ketoconazole, and fluconazole)
• medicines to treat HIV-infection
• hormonal methods of birth control.

• Concomitant use of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort is contraindicated with Coartem Tablets.
• Coartem Tablets should be used cautiously with drugs that inhibit CYP3A4.
• Coartem Tablets should be used cautiously in patients on antiretroviral drugs.
• Mefloquine, if used immediately before treatment, monitor for decreased efficacy of Coartem Tablets and encourage food consumption.
• Coartem Tablets may potentially reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method.
• Monitor for adverse reactions and potential QT prolongation when used with CYP2D6 Substrates.

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage:

• If you weigh 77 pounds (35 kg) or more, 1 dose of Coartem is 4 tablets. A full course of treatment is 6 doses (24 tablets) of Coartem taken over 3 days:
• Day 1: take 1 dose, then 8 hours later take 1 dose
• Day 2: take 1 dose in the morning, 1 dose in the evening
• Day 3: take 1 dose in the morning, 1 dose in the evening
• If you weigh less than 77 pounds (35 kg), your healthcare provider will tell you how many tablets to take for each dose.

The number of tablets per dose for children is determined by bodyweight, as shown in below:

• 5 to < 15 kg: 1 tablet
• 15 to < 25 kg: 2 tablets
• 25 to < 35 kg: 3 tablets
• 35 kg and over: 4 tablets

Administration:

• Each dose of Coartem should be taken with food or drink, such as milk, infant formula, pudding, porridge, or broth. It is important for you to eat as soon as you can so that your malaria will go away and not get worse.
• Do not drink grapefruit juice while you take Coartem. Drinking grapefruit juice during treatment with Coartem can cause you to have too much medicine in your blood.
• If you are not able to swallow Coartem tablets, Coartem may be crushed and mixed with 1 to 2 teaspoons of water in a clean container. If any medicine remains, you can add more water to the container and drink right away.
• If you vomit within 1 to 2 hours after taking Coartem, you should take another dose of Coartem. If you vomit the second dose, tell your healthcare provider. A different medicine may need to be prescribed for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets are scored and contain 20 mg artemether and 120 mg lumefantrine

This medicine is available in fallowing brand namesː

• Coartem

What side effects can this medication cause?

The most common side effects of Coartem in adults include:

• headache
• not wanting to eat
• dizziness
• fever
• weakness or lack of energy
• joint pain
• muscle pain, tenderness and weakness

The most common side effects of Coartem in children include:

• fever
• cough
• vomiting
• not wanting to eat
• headache

Coartem can cause serious side effects, including:

• A heart problem called QT prolongation

What special precautions should I follow?

• Some antimalarials (e.g., halofantrine, quinine, quinidine) including Coartem Tablets have been associated with prolongation of the QT interval on the electrocardiogram (ECG). Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval.
• Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval. Antimalarials should not be given concomitantly with Coartem Tablets, unless there is no other treatment option, due to limited safety data.
• QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets.
• Substrates, inhibitors, or inducers of CYP3A4, including antiretroviral medications, should be used cautiously with Coartem Tablets, due to a potential loss of efficacy of the concomitant drug or additive QT prolongation.
• Coartem Tablets may reduce the effectiveness of hormonal contraceptives. Therefore, patients using hormonal contraceptives should be advised to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with Coartem.
• Food enhances absorption of artemether and lumefantrine following administration of Coartem Tablets. Patients who remain averse to food during treatment should be closely monitored as the risk of recrudescence may be greater.
• Coartem Tablets have been shown in limited data (43 patients) to be effective in treating the erythrocytic stage of P. vivax infection.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no information on overdoses of Coartem Tablets higher than the doses recommended for treatment.

Management of overdosage:

• In cases of suspected overdosage, symptomatic and supportive therapy, which would include ECG and blood electrolyte monitoring, should be given as appropriate.

Can this medicine be used in pregnancy?

• Treatment of malaria is important because it can be a serious disease for a pregnant woman and her unborn baby.
• While available studies have not demonstrated an increase in major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• It is not known if Coartem is safe and effective in children who weigh less than 11 pounds (5 kg).

What are the active and inactive ingredients in this medicine?

• Active ingredients: artemether, lumefantrine
• Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and polysorbate 80

Who manufactures and distributes this medicine?

• Distributed by:

Novartis Pharmaceuticals Corporation East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store Coartem at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Coartem in the original container and keep the container tightly closed.

• Dailymed label info on Artemether/lumefantrine
• FDA Artemether/lumefantrine

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