Artemether 80 mg + Lumefantrine 480 mg Tablet (quadruple-strength)
- Product Name: Artemether 80 mg + Lumefantrine 480 mg Tablet (quadruple-strength)
- Packing: 10x1x6 Alu-Alu Blister
- Pack Insert/Leaflet: Yes
- Dosage Form: swallow whole; not dispersible
- Packaging: Typically supplied in blister strips (6, 12, or 18 tablets depending on market presentation)
- Storage: Store below 30 °C in a dry place, protect from light and moisture
- Therapeutic Category: Artemisinin-based Combination Therapy (ACT) for uncomplicated malaria (Plasmodium falciparum)
This is a high-strength ACT formulation intended to reduce pill burden even further compared to 20/120 mg and 40/240 mg tablets. Each tablet provides four times the base strength of the pediatric dispersible version. Primarily used in adolescents and adults, especially in weight categories requiring higher per-dose amounts.
Active Ingredients:
Artemether (80 mg) – rapid parasite clearance, fast reduction in parasitemia.
Lumefantrine (480 mg) – sustained activity, prevents recrudescence.
Mechanism:
Artemether (via DHA) generates reactive intermediates that kill parasites quickly.
Lumefantrine disrupts parasite heme detoxification, extending protection.
Onset of Action: Parasite and fever clearance generally within 24–48 hours.
Artemether (80 mg) – rapid parasite clearance, fast reduction in parasitemia.
Lumefantrine (480 mg) – sustained activity, prevents recrudescence.
Mechanism:
Artemether (via DHA) generates reactive intermediates that kill parasites quickly.
Lumefantrine disrupts parasite heme detoxification, extending protection.
Onset of Action: Parasite and fever clearance generally within 24–48 hours.
First-line treatment of acute uncomplicated malaria caused by Plasmodium falciparum.
May be used for mixed infections where P. falciparum is present.
Reserved for adolescents and adults needing higher doses, minimizing tablet count.
Not suitable for severe/complicated malaria (IV artesunate recommended).
May be used for mixed infections where P. falciparum is present.
Reserved for adolescents and adults needing higher doses, minimizing tablet count.
Not suitable for severe/complicated malaria (IV artesunate recommended).
Total regimen: 6 doses over 3 days (at 0, 8, 24, 36, 48, 60 hours).
Administration: Swallow whole with water. Must be taken with fatty food (milk, porridge, or meal) to ensure lumefantrine absorption. If vomiting occurs within 1 hour, repeat the dose.
Weight-Based Dosing with 80/480 mg Tablets
≥35 kg (adolescents/adults): 1 tablet per dose × 6 doses (total 6 tablets).
Equivalent to 4 × 20/120 mg tablets or 2 × 40/240 mg tablets per dose.
<35 kg patients: Lower-strength formulations (20/120 or 40/240) are recommended instead.
Administration: Swallow whole with water. Must be taken with fatty food (milk, porridge, or meal) to ensure lumefantrine absorption. If vomiting occurs within 1 hour, repeat the dose.
Weight-Based Dosing with 80/480 mg Tablets
≥35 kg (adolescents/adults): 1 tablet per dose × 6 doses (total 6 tablets).
Equivalent to 4 × 20/120 mg tablets or 2 × 40/240 mg tablets per dose.
<35 kg patients: Lower-strength formulations (20/120 or 40/240) are recommended instead.
Cardiac Risk: May prolong QT interval. Avoid concomitant use with other QT-prolonging agents (antiarrhythmics, macrolides, some antifungals/antidepressants).
Drug Interactions:
Avoid grapefruit/grapefruit juice.
Caution with CYP3A4/CYP2D6 inhibitors/inducers.
May reduce effectiveness of hormonal contraceptives → advise additional contraception.
Special Populations:
Use with caution in severe hepatic disease.
Not recommended in infants/children due to high strength.
Pregnancy: Generally safe in 2nd/3rd trimester; avoid in 1st trimester unless benefits outweigh risks.
Drug Interactions:
Avoid grapefruit/grapefruit juice.
Caution with CYP3A4/CYP2D6 inhibitors/inducers.
May reduce effectiveness of hormonal contraceptives → advise additional contraception.
Special Populations:
Use with caution in severe hepatic disease.
Not recommended in infants/children due to high strength.
Pregnancy: Generally safe in 2nd/3rd trimester; avoid in 1st trimester unless benefits outweigh risks.
Common: Headache, dizziness, nausea, abdominal pain, vomiting, loss of appetite, muscle/joint pain, fatigue, fever.
Less Common in Adults: Palpitations, insomnia, skin rash.
Serious (rare): QT prolongation, arrhythmias, hypersensitivity reactions.
Less Common in Adults: Palpitations, insomnia, skin rash.
Serious (rare): QT prolongation, arrhythmias, hypersensitivity reactions.
Marketed in some regions as quadruple-strength AL tablets.
May appear as adult-dose brands of established AL products.
May appear as adult-dose brands of established AL products.
Provides adult patients with simplified dosing (only 1 tablet per dose).
Must be taken with fatty food for optimal lumefantrine absorption.
Maintains high cure rates when six-dose regimen is completed.
Reserved for ≥35 kg patients; lower strengths should be used for children.
Always avoid in severe malaria cases — parenteral therapy required.
Must be taken with fatty food for optimal lumefantrine absorption.
Maintains high cure rates when six-dose regimen is completed.
Reserved for ≥35 kg patients; lower strengths should be used for children.
Always avoid in severe malaria cases — parenteral therapy required.