artemether + lumefantrine: clinical use

Prescribing considerations

• Confirm uncomplicated P. falciparum malaria and assess promptly for severe features or organ dysfunction.
• Review previous antimalarial exposure, oral intake, pregnancy or breastfeeding, cardiac history and the complete medicines list.
• Poor food intake may reduce lumefantrine absorption and increase recrudescence risk.
• Safety and efficacy are not established below 5 kg body weight.

Contraindications and cautions

• Severe malaria.
• Hypersensitivity to either active ingredient or an excipient.
• Congenital or acquired QT prolongation, relevant arrhythmia, clinically significant bradycardia, reduced-ejection-fraction heart failure, family history of sudden death or congenital QT prolongation.
• Hypokalaemia or hypomagnesaemia.
• Concomitant QT-prolonging medicines, relevant CYP2D6 substrates or strong CYP3A4 inducers.

Monitoring

• Reassess urgently if the patient deteriorates, cannot maintain oral intake or continues vomiting.
• Consider ECG and electrolyte assessment where cardiac risk exists; monitor ECG and potassium in severe renal or hepatic impairment.
• If fever returns, arrange urgent same-day reassessment and malaria films because recrudescence is possible.
• Remain alert to delayed haemolytic anaemia during the following weeks.

Clinical pharmacology

Artemether is rapidly converted partly to active dihydroartemisinin and clears parasites quickly. Lumefantrine is lipophilic, absorbed much better with food and eliminated more slowly. Both principally undergo CYP3A4 metabolism; lumefantrine inhibits CYP2D6 and can prolong QT.

Formulation and product differences

• The selected product is a conventional oral tablet that may be crushed for small children or infants.
• No separate paediatric pack is supplied; unused tablets from a child's pack should be returned to a pharmacist or discarded appropriately.
• The product is essentially sodium-free.

Tablet

Route: Oral

Strengths: 20 mg + 120 mg