Artemether 20 mg + Lumefantrine 120 mg Oral Suspension
- Product Name: Artemether 20 mg + Lumefantrine 120 mg Oral Suspension
- Available Strength: Artemether 20 mg + Lumefantrine 120 mg Oral Suspension
- Pack Insert/Leaflet: Yes
- Formulation: Oral suspension (liquid ACT formulation)
- Packaging: Amber glass or PET bottle (commonly 60 mL or 100 mL), with measuring cup/spoon or oral syringe
- Self Life Storage: Shelf life 24 months; store below 30 °C; shake well before use; protect from light and moisture
- Therapeutic Category: Artemisinin-based Combination Therapy (ACT) for uncomplicated malaria (Plasmodium falciparum)
This oral suspension is a child-friendly ACT formulation designed for infants and small children who cannot swallow tablets. It delivers the proven combination of artemether (fast parasite clearance) and lumefantrine (long-acting partner that prevents recrudescence). The suspension ensures accurate dosing for pediatric patients by weight, with good palatability to improve compliance.
Active Ingredients:
Artemether – an artemisinin derivative; rapidly metabolized to dihydroartemisinin (DHA); provides fast parasite killing.
Lumefantrine – a lipophilic antimalarial with a long half-life; ensures sustained antimalarial activity and prevents relapse.
Mechanism of Action:
Artemether/DHA generates reactive oxygen species and free radicals inside the parasite, damaging essential proteins and leading to parasite death.
Lumefantrine inhibits heme polymerization in the parasite’s digestive vacuole, causing accumulation of toxic heme, which kills residual parasites.
Together, they provide rapid parasite clearance and durable protection.
Artemether – an artemisinin derivative; rapidly metabolized to dihydroartemisinin (DHA); provides fast parasite killing.
Lumefantrine – a lipophilic antimalarial with a long half-life; ensures sustained antimalarial activity and prevents relapse.
Mechanism of Action:
Artemether/DHA generates reactive oxygen species and free radicals inside the parasite, damaging essential proteins and leading to parasite death.
Lumefantrine inhibits heme polymerization in the parasite’s digestive vacuole, causing accumulation of toxic heme, which kills residual parasites.
Together, they provide rapid parasite clearance and durable protection.
Treatment of acute uncomplicated Plasmodium falciparum malaria in infants and children.
Can also be used in mixed malaria infections where P. falciparum is suspected.
Especially valuable where pediatric dosing precision is required.
Can also be used in mixed malaria infections where P. falciparum is suspected.
Especially valuable where pediatric dosing precision is required.
Regimen: 6 doses over 3 days (0, 8, 24, 36, 48, 60 hours).
Administration: Shake bottle well before each use; measure dose accurately using the provided cup/syringe. Always administer with milk or a small fatty meal to enhance lumefantrine absorption. If vomiting occurs within 1 hour, repeat the dose.
Typical Weight-Based Pediatric Dosing (using suspension)
5 to <15 kg: Equivalent of 20 mg/120 mg per dose (5 mL) × 6 doses.
15 to <25 kg: Equivalent of 40 mg/240 mg per dose (10 mL) × 6 doses.
25 to <35 kg: Equivalent of 60 mg/360 mg per dose (15 mL) × 6 doses.
≥35 kg (adolescents/adults): Higher-dose tablets (40/240 or 80/480 mg) preferred.
Administration: Shake bottle well before each use; measure dose accurately using the provided cup/syringe. Always administer with milk or a small fatty meal to enhance lumefantrine absorption. If vomiting occurs within 1 hour, repeat the dose.
Typical Weight-Based Pediatric Dosing (using suspension)
5 to <15 kg: Equivalent of 20 mg/120 mg per dose (5 mL) × 6 doses.
15 to <25 kg: Equivalent of 40 mg/240 mg per dose (10 mL) × 6 doses.
25 to <35 kg: Equivalent of 60 mg/360 mg per dose (15 mL) × 6 doses.
≥35 kg (adolescents/adults): Higher-dose tablets (40/240 or 80/480 mg) preferred.
Precautions & Warnings
Cardiac: Risk of QT prolongation → avoid with other QT-prolonging drugs.
Drug Interactions: Avoid use with CYP3A4/CYP2D6 inducers/inhibitors and grapefruit juice; may reduce hormonal contraceptive effectiveness.
Special Populations:
Use cautiously in severe hepatic impairment.
Not recommended for infants <5 kg or <3 months old unless specifically indicated.
Pregnancy: Generally avoided in 1st trimester; considered safe in 2nd and 3rd trimesters.
Cardiac: Risk of QT prolongation → avoid with other QT-prolonging drugs.
Drug Interactions: Avoid use with CYP3A4/CYP2D6 inducers/inhibitors and grapefruit juice; may reduce hormonal contraceptive effectiveness.
Special Populations:
Use cautiously in severe hepatic impairment.
Not recommended for infants <5 kg or <3 months old unless specifically indicated.
Pregnancy: Generally avoided in 1st trimester; considered safe in 2nd and 3rd trimesters.
Common: Loss of appetite, nausea, vomiting, abdominal discomfort, headache, dizziness, fever, cough.
In Children: Irritability, tiredness, rash, itching.
Serious (rare): QT prolongation, arrhythmias, allergic reactions, delayed hemolysis.
In Children: Irritability, tiredness, rash, itching.
Serious (rare): QT prolongation, arrhythmias, allergic reactions, delayed hemolysis.
Coartem Oral Suspension
Other pediatric ACT suspensions (varies by manufacturer/country)
Other pediatric ACT suspensions (varies by manufacturer/country)
Designed specifically for infants and young children with uncomplicated malaria.
Ensures accurate dosing and improved compliance compared to crushed tablets.
Must be given with fatty food or milk to ensure lumefantrine absorption.
Highly effective, with cure rates above 95% when given in the full 6-dose regimen.
Essential pediatric formulation in malaria-endemic regions.
Ensures accurate dosing and improved compliance compared to crushed tablets.
Must be given with fatty food or milk to ensure lumefantrine absorption.
Highly effective, with cure rates above 95% when given in the full 6-dose regimen.
Essential pediatric formulation in malaria-endemic regions.