MALARONE has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria including hyperparasitaemia, pulmonary oedema or renal failure.
Safety and effectiveness of MALARONE for the treatment and prophylaxis of malaria in paediatric patients who weigh less than 11 kg has not been established.
In the event of recrudescent infections due to P. falciparum or failure of chemoprophylaxis, patients should be treated with a different blood schizonticide.
Parasite relapse occurred commonly when P. vivax malaria was treated with MALARONE alone. Travellers with intense exposure to P. vivax or P. ovale, and those who develop malaria caused by either of these parasites, will require additional treatment with a drug such as primaquine, that is active against hypnozoites.
Persons taking MALARONE for prophylaxis or treatment of malaria should take a repeat dose if they vomit within 1 hour of dosing. In the event of diarrhoea, normal dosing should be continued. Absorption of atovaquone may be reduced in patients with diarrhoea or vomiting, but diarrhoea or vomiting was not associated with reduced efficacy in clinical trials of MALARONE for malaria prophylaxis. However, as with other antimalarial agents, patients with diarrhoea or vomiting should be advised to continue to comply with personal protection measures (repellants, bednets).
In patients with acute malaria who present with diarrhoea or vomiting, alternative therapy should be considered. If MALARONE is used to treat malaria in these patients, parasitaemia should be closely monitored.
Parasitaemia should be closely monitored in patients receiving concurrent metoclopramide or tetracycline (see Interactions).
The concomitant administration of MALARONE and rifampicin or rifabutin is not recommended (see Interactions).
In patients with severe renal impairment (creatinine clearance less than 30 mL/min) alternatives to MALARONE should be recommended for treatment of acute P. falciparum malaria whenever possible (see Pharmacology: Pharmacokinetics under Actions, Dosage & Administration and Contraindications).
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of MALARONE on driving performance or the ability to operate machinery but a detrimental effect on such activities is not predicted from the pharmacology of the component drugs.