Artesunate Amodiaquine Tablets

● Treatment of uncomplicated malaria due to Plasmodium falciparum strains susceptible to both amodiaquine and artesunate [1] ● Therapy should follow the latest official malaria treatment guidelines and local information on drug resistance [1] ● Not for severe or complicated malaria, no

● Oral use: swallow the tablet whole with water; do not take with a meal containing a high amount of fat [1] ● If swallowing is difficult, the tablet may be crushed and mixed with water (per the approved prescribing information) [1] ● If the patient vomits within half an hour of dosing, give another dose; if vomiting continues, management for severe malaria should be considered [1] ● Take once daily for 3 consecutive days

The regimen is based on the WHO-recommended target doses of artesunate 4 mg/kg/day (range 2–10) and amodiaquine 10 mg/kg/day (range 7.5–15), once daily for 3 days [1].

● Contraindicated in hypersensitivity to the active substances or excipients, in a history of liver injury or haematological events during treatment with amodiaquine, and in retinopathy (with frequent treatment). Not for malaria prophylaxis [1] ● Monitor for signs of hepatitis (jaundice) and agranulocytosis (fever, tonsillitis, mouth ulcers); if suspected, check liver function and/or blood counts immediately and discontinue treatment if required [1] ● QT interval caution: use with care in cardiac disease, history of ventricular arrhythmias, uncorrected hypokalaemia or hypomagnesaemia, bradycardia, or with medicines that prolong the QT interval [1] ● Avoid concomitant use with efavirenz (marked hepatotoxicity) and with CYP2A6 or CYP2C8 inhibitors; caution with beta-blockers, antidepressants and antipsychotics [1] ● Pregnancy: avoid in the first trimester unless clearly necessary; use with caution in later trimesters if no alternative. Breastfeeding is acceptable as amounts in milk are small [1] ● Common side effects: anorexia, abdominal pain, nausea, asthenia, somnolence, insomnia, cough; QT prolongation. May cause drowsiness or dizziness — do not drive or use machines if affected [1] ● Store below 30 °C (product label: below 25 °C, in a dry place, protected from light and moisture); keep out of the reach of children; dispose of unused medicine per local requirements [1][2] ● Prescription-only medicine [1] For full prescribing information, refer to t