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Artemether + Lumefantrine

Generic Medicine
Indications

Artemether + Lumefantrine is indicated for: Treatment and standby emergency treatment of acute, uncomplicated malaria caused by Plasmodium falciparum or mixed infections including P. falciparum in adults, children, and infants Effective against both drug-sensitive and drug-resistant strains of P. falciparum Recommended for malaria acquired in regions where resistance to other antimalarial drugs is common

Standby emergency treatment: In situations where immediate medical care is not accessible (e.g., remote locations), travelers may carry this medication for self-administration if malaria symptoms develop. This is particularly useful when treatment cannot be obtained within 24 hours. Use should follow official medical guidelines for antimalarial therapy.

Pharmacology

This combination contains Artemether and Lumefantrine in a fixed ratio of 1:6. Artemether is derived from artemisinin, a natural compound, while Lumefantrine is a synthetic antimalarial belonging to the aryl amino alcohol group.

Both drugs act within the food vacuoles of malaria parasites, where they interfere with the detoxification of heme into non-toxic hemozoin. Artemether produces reactive metabolites through interaction with heme iron, while Lumefantrine inhibits the polymerization of heme.
Additionally, both components inhibit nucleic acid and protein synthesis in the parasite, contributing to parasite death.

This combination is effective against the blood stages of Plasmodium vivax but does not eliminate liver-stage hypnozoites; therefore, additional treatment (e.g., primaquine) is required for complete eradication.

Dosage Administration

Patients with acute malaria are frequently averse to food. The dose should be taken with high fat food or drinks such as milk. In the event of vomiting within 1 hour of administration a repeat dose should be taken.

Adults and children weighing 35 kg and above: A standard 3 days treatment schedule with a total of 6 doses is recommended dosage is 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after eight hours, and then 4 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 24 tablets).

5 to <15 kg body weight: 1 tablet at the time of initial diagnosis, 1 tablet again after 8 hours and then 1 tablet twice
daily (morning and evening) on each of the following two days (Total course comprises of 6 tablets).

15 to <25 kg body weight: 2 tablets as a single dose at the time of initial diagnosis , 2 tablets again after 8 hours and then 2 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 12 tablets).

25 to <35 kg body weight: 3 tablets as a single dose at the time of initial diagnosis, 3 tablets again after 8 hours and then 3 tablets twice daily (morning and evening) on each of the following two days (Total courses comprises 18 tablets).

Interactions

Artemether + Lumefantrine has no well-established or clinically significant drug interaction data available.

Contraindications

Artemether + Lumefantrine is contraindicated in patients with known hypersensitivity to any of its active ingredients or excipients; in patients with severe malaria as defined by WHO; during the first trimester of pregnancy; in patients with a history of congenital QT interval prolongation, sudden cardiac death, or any condition associated with prolonged QT interval such as symptomatic cardiac arrhythmias, clinically significant bradycardia, or severe cardiac disease; in patients with electrolyte imbalance including hypokalemia or hypomagnesemia; and in patients receiving medications metabolized by CYP2D6 such as flecainide, metoprolol, imipramine, amitriptyline, and clomipramine.

Side Effects

This medication is generally well tolerated in both adults and children. Most adverse effects are mild to moderate and temporary. Reported side effects include hypersensitivity reactions, headache, dizziness, sleep disturbances, drowsiness, muscle spasms, paresthesia, hypoesthesia, abnormal gait, ataxia, palpitations, cough, abdominal pain, loss of appetite, diarrhea, vomiting, nausea, itching, rash, joint pain, muscle pain, weakness, and fatigue.

Pregnancy & Lactation

Use during pregnancy, particularly in the first trimester, is contraindicated. Breastfeeding mothers should avoid this medication. Due to the long half-life of lumefantrine, breastfeeding should not be resumed until at least 28 days after treatment unless the benefits outweigh the risks.

Precautions & Warnings

This medication is not indicated for malaria prophylaxis. It has not been evaluated for severe malaria, including cerebral malaria, pulmonary edema, or renal failure, and should not be used in these conditions.

Overdose Effects

In case of overdose, supportive and symptomatic treatment should be provided. ECG monitoring and blood potassium level assessment are recommended.

Therapeutic Class

Antimalarial combination therapy.

Storage Conditions

Store below 30°C, protected from light and moisture. Keep out of reach of children.

Common Questions

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