Classes
DEA Class; Rx
Common Brand Names; Coartem
- Antimalarials
Description
Fixed artemisinin-based combination tablet
For the treatment of acute, uncomplicated malaria infections in patients 2 months and older with a bodyweight of at least 5 kg
Artemisinin-based therapies are potent with rapid onset of anti-parasitic activity
Indications
Indicated for the treatment of malaria.
Contraindications
Hypersensitivity
Coadministration with strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John’s wort) can result in decreased artemether and/or lumefantrine serum concentrations and loss of antimalarial efficacy
Adverse Effects
- Abdominal pain (17%)
- Anorexia (40%)
- Arthralgia (34%)
- Asthenia (38%)
- Chills (23%)
- Dizziness (39%)
- Fatigue (17%)
- Headache (56%)
- Myalgia (32%)
- Nausea (26%)
- Palpitations (18%)
- Pyrexia (25%)
- Sleep disorder (22%)
- Vomiting (17%)
Warnings
Not approved for severe/complicated P. falciparum infections
Not approved for prophylaxis
If patient vomits out drug repeatedly, use alternative treatment
Food enhances absorption of artemether and lumefantrine following administration of this medication; patients who remain averse to food during treatment should be closely monitored as risk of recrudescence may be greater; in event of recrudescent P. falciparum infection after treatment with this medication, patients should be treated with a different antimalarial drug
Pregnancy and Lactation
Published data from clinical studies and pharmacovigilance data have not established an association between drug use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes
There are no data on presence of drug in human milk, effects on breastfed infant or on milk production
Maximum Dosage
35 kg or more: 8 tablets/day PO.
25 kg to 34 kg: 6 tablets/day PO.
35 kg or more: 8 tablets/day PO.
25 kg to 34 kg: 6 tablets/day PO.
35 kg or more: 8 tablets/day PO.
25 kg to 34 kg: 6 tablets/day PO.
35 kg or more: 8 tablets/day PO.
25 kg to 34 kg: 6 tablets/day PO.
15 kg to 24 kg: 4 tablets/day PO.
5 kg to 14 kg: 2 tablets/day PO.
at least 2 months old and 15 kg to 24 kg: 4 tablets/day PO.
at least 2 months old and 5 kg to 14 kg: 2 tablets/day PO.
younger than 2 months old or less than 5 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Artemether/lumefantrine
tablet
- 20mg/120mg
