Atovaquone with Proguanil Hydrochloride

eMC §4.2 (Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets). PROPHYLAXIS WEIGHT LIMIT: this 250 mg/100 mg strength is for adults and children weighing at least 40 kg; it is NOT recommended for malaria prophylaxis in persons under 40 kg — atovaquone/proguanil hydrochloride paediatric tablets are recommended for prophylaxis in persons weighing under 40 kg. DURATION OF PROPHYLAXIS EXPOSURE: in residents (semi-immune subjects) of endemic areas, safety and effectiveness have been established in studies of up to 12 weeks; in non-immune subjects the average duration of exposure in clinical studies was 27 days. TREATMENT DOSES IN CHILDREN WEIGHING 11 kg OR MORE (whole-tablet weight bands of the 250 mg/100 mg tablet, not a per-kg dose): 11–20 kg — one tablet daily for three consecutive days; 21–30 kg — two tablets as a single dose for three consecutive days; 31–40 kg — three tablets as a single dose for three consecutive days; over 40 kg — dose as for adults. Safety and effectiveness of the 250 mg/100 mg tablet have not been established for treatment of malaria in paediatric patients weighing less than 11 kg (§4.4). Verify all under-18 dosing against a children's formulary. ELDERLY: a pharmacokinetic study indicates no dosage adjustment is needed. HEPATIC IMPAIRMENT: no dosage adjustment needed in mild to moderate impairment; no studies in severe hepatic impairment, but no special precautions or dosage adjustment are anticipated. OTHER §4.4 WARNINGS: take a repeat dose if vomiting occurs within 1 hour; continue normal dosing in the event of diarrhoea, but consider alternative therapy in patients with acute malaria who present with diarrhoea or vomiting, and if used in such patients monitor parasitaemia and clinical condition closely. Not evaluated for cerebral malaria or other severe manifestations of complicated malaria (hyperparasitaemia, pulmonary oedema, renal failure). No efficacy against hypnozoites of P. vivax — travellers with intense exposure to P. vivax or P. ovale, and those who develop malaria caused by either parasite, require additional treatment with a drug active against hypnozoites. Recrudescent P. falciparum infection after treatment, or prophylaxis failure, should be treated with a different blood schizonticide as this can reflect parasite resistance. Severe allergic reactions including anaphylaxis have occasionally been reported — discontinue promptly and treat. SOURCE NOTE: the eMC §4.5 interactions section was not captured in this bundle; the interactions listed below are those stated within §4.4, and the full §4.5 should be reviewed in the SPC. The openFDA record fetched for this id is ATOVAQUONE ORAL SUSPENSION ALONE (a single-component product for P. jirovecii pneumonia, dosed 1,500 mg once daily for prevention and 750 mg twice daily for 21 days for treatment) — that is a different medicine and a different indication and must NOT be used for this combination product.