Artemether / Lumefantrine Dosage

This dosage information may not include all the information needed to use Artemether / Lumefantrine safely and effectively. See additional information for Artemether / Lumefantrine.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Malaria

Less than 35 kg: Usual pediatric dose

35 kg or more: 4 tablets as single initial dose, followed by 4 tablets after 8 hours, and then 4 tablets twice a day (morning and evening) for the following 2 days (total course: 24 tablets)

Usual Pediatric Dose for Malaria

5 kg to less than 15 kg: 1 tablet as single initial dose, followed by 1 tablet after 8 hours, and then 1 tablet twice a day (morning and evening) for the following 2 days (total course: 6 tablets)

15 kg to less than 25 kg: 2 tablets as single initial dose, followed by 2 tablets after 8 hours, and then 2 tablets twice a day (morning and evening) for the following 2 days (total course: 12 tablets)

25 kg to less than 35 kg: 3 tablets as single initial dose, followed by 3 tablets after 8 hours, and then 3 tablets twice a day (morning and evening) for the following 2 days (total course: 18 tablets)

35 kg or more: 4 tablets as single initial dose, followed by 4 tablets after 8 hours, and then 4 tablets twice a day (morning and evening) for the following 2 days (total course: 24 tablets)

Renal Dose Adjustments

No adjustment recommended. The manufacturer recommends caution when administering this drug to patients with severe renal dysfunction.

Liver Dose Adjustments

Mild to moderate hepatic impairment: No adjustment recommended.
Severe hepatic impairment: No data available; the manufacturer recommends caution when administering this drug to patients with severe liver dysfunction.

Precautions

Coadministration of artemether-lumefantrine is contraindicated with strong CYP450 3A4 inducers (such as rifampin, carbamazepine, phenytoin, and St. John's wort) where decreased levels of artemether and/or lumefantrine may lead to loss of antimalarial efficacy.

Coadministration of artemether-lumefantrine with CYP450 3A4 substrates may decrease substrate concentrations with potential loss of substrate efficacy. Coadministration with CYP450 3A4 inhibitors (including grapefruit juice) may increase artemether and/or lumefantrine levels and potentiate QT prolongation. Coadministration with CYP450 3A4 inducers may decrease artemether and/or lumefantrine levels and loss of antimalarial efficacy may occur. Drugs with a mixed effect on CYP450 3A4 (especially antiretroviral agents such as HIV protease inhibitors and nonnucleoside reverse transcriptase inhibitors) should be used with caution during artemether-lumefantrine use.

Prolongation of the QT interval on electrocardiogram has been associated with artemether-lumefantrine. Artemether-lumefantrine should be avoided in patients with congenital prolongation of the QT interval or any conditions known to prolong the QTc interval (e.g., history of symptomatic cardiac arrhythmias, clinically relevant bradycardia, severe cardiac disease), with family history of congenital prolongation of the QT interval or sudden death, with known electrolyte balance disturbances (such as hypokalemia or hypomagnesemia), receiving other drugs that prolong the QT interval (such as class IA or class III antiarrhythmics, antipsychotics, antidepressants, certain antibiotics [macrolides, fluoroquinolones, imidazole, and triazole antifungals], and cisapride), or receiving drugs metabolized by CYP450 2D6 which also have cardiac effects. Drugs that affect the QT interval should be used with caution in patients taking artemether-lumefantrine.

Due to the long elimination half-life of lumefantrine and potential additive effects on QT interval, artemether-lumefantrine and halofantrine should not be administered within 1 month of each other and drugs that prolong the QT interval (including antimalarials such as quinine and quinidine) should be used with caution following artemether-lumefantrine use.

Concomitant use of artemether-lumefantrine with other antimalarials is not recommended, unless no other treatment option is available, due to limited safety data.

Decreased exposure to lumefantrine may occur if mefloquine is administered immediately prior to artemether-lumefantrine, possibly due to a mefloquine-induced decrease in bile production. Patients should be monitored for decreased efficacy and encouraged to consume food while taking artemether-lumefantrine.

Food increases artemether and lumefantrine absorption. Patients who remain averse to food during treatment should be closely monitored due to a higher risk of recrudescence. In the event of recrudescent Plasmodium falciparum infection following artemether-lumefantrine therapy, treatment with a different antimalarial is recommended.

Hypersensitivity reactions have been associated with artemether-lumefantrine. The drug should be discontinued at the first sign of skin rash, urticaria or other skin reactions, tachycardia, difficulty in swallowing or breathing, any swelling suggestive of angioedema, or other symptoms of an allergic reaction.

Limited data have shown artemether-lumefantrine to be effective against the erythrocytic stage of P vivax infection. However, relapsing malaria caused by P vivax requires additional treatment with other antimalarial drugs to achieve radical cure (i.e., eradicate hypnozoites that may be dormant in the liver).

Efficacy of artemether-lumefantrine has not been established in the treatment of pregnant women with acute, uncomplicated malaria.

Safety and effectiveness have not been established in pediatric patients who weigh less than 5 kg.

Dialysis

Data not available

Other Comments

Artemether-lumefantrine should be taken with food.

Artemether-lumefantrine tablets may be crushed and mixed with 1 to 2 teaspoons of water in a clean container for administration immediately prior to use. The patient can then rinse the container with more water and swallow the contents. This crushed tablet preparation should be followed by food/drink.

A repeat dose should be taken if the patient vomits within 1 to 2 hours of administration. If the repeat dose is vomited, an alternative antimalarial treatment is recommended.

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