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ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS › ANTIPROTOZOALS › ANTIMALARIALS › Artemisinin and derivatives, combinations
artesunate and amodiaquine
P01BF03
Forms & Strengths
- Fixed-dose combination tablet: Artesunate 25 mg / Amodiaquine hydrochloride 67.5 mg
- Fixed-dose combination tablet: Artesunate 50 mg / Amodiaquine hydrochloride 135 mg
- Fixed-dose combination tablet: Artesunate 100 mg / Amodiaquine hydrochloride 270 mg
Adult Dosing
- Uncomplicated Plasmodium falciparum malaria: 1 tablet of Artesunate 100 mg / Amodiaquine 270 mg once daily for 3 consecutive days
- Dosing based on weight range (geq 9 kg): target dose 4 mg/kg/day artesunate and 10 mg/kg/day amodiaquine for 3 days
Pediatric Dosing
- Infants and children 2 to <11 months (4.5 to <9 kg): 1 tablet of Artesunate 25 mg / Amodiaquine 67.5 mg once daily for 3 days
- Children 1 to <6 years (9 to <18 kg): 1 tablet of Artesunate 50 mg / Amodiaquine 135 mg once daily for 3 days
- Children 6 to <14 years (18 to <36 kg): 1 tablet of Artesunate 100 mg / Amodiaquine 270 mg once daily for 3 days
Indications
- Treatment of acute uncomplicated malaria caused by Plasmodium falciparum
Mechanism of Action
- Artesunate: endoperoxide moiety is cleaved by intraparasitic iron, generating free radicals that alkylate and damage parasite macromolecules
- Amodiaquine: 4-aminoquinoline derivative that concentrates in parasite food vacuoles, inhibiting heme polymerase and preventing the detoxification of heme into hemozoin
Contraindications
- Known hypersensitivity to artesunate, amodiaquine, or any component of the formulation
- History of amodiaquine-induced agranulocytosis or severe neutropenia
- History of amodiaquine-induced hepatotoxicity
- Concomitant use of other drugs known to cause severe hepatotoxicity or blood dyscrasias
Adverse Reactions
- Common: asthenia, anorexia, cough, diarrhea, dizziness, fever, headache, insomnia, nausea, vomiting, weakness
- Hematologic: neutropenia, leukopenia, anemia
- Hepatic: transient transaminase elevations, hepatitis, jaundice
- Cardiac: QT prolongation (amodiaquine component)
Drug Interactions
- Avoid co-administration with other medications known to cause hepatotoxicity, agranulocytosis, or QT prolongation (e.g., efavirenz, protease inhibitors)
- Potential for altered plasma concentrations when co-administered with strong CYP2C8 or CYP3A4 inhibitors/inducers
- Antiretroviral drugs such as zidovudine should be used with caution due to overlapping hematologic toxicity
Curated Content: Needs Vetting Before Put to Clinical Use