Product Details

Product Information of Malanil Tablets

Contraindications
MALANIL is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil hydrochloride or any component of the formulation.
MALANIL is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance less than 30 mL/min).

Warnings and Precautions
MALANIL 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 MALANIL 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 MALANIL 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 MALANIL 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 MALANIL 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 MALANIL 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 MALANIL and rifampicin or rifabutin is not
recommended (see Interactions)

Interactions
Proguanil may potentiate the anticoagulant effect of warfarin and other coumarin based anticoagulants. The mechanism of this potential drug interaction has not been established.
Caution is advised when initiating or withdrawing malaria prophylaxis or treatment with atovaquone-proguanil in patients on continuous treatment with coumarin based anticoagulants.
Concomitant treatment with tetracycline, metoclopramide, rifampicin and rifabutin have been associated with significant decreases in plasma concentrations of atovaquone (see Warnings and Precautions).
Concomitant administration of atovaquone and indinavir results in a decrease in the Cmin of indinavir (23% decrease; 90% CI: 8 to 35%). Caution should be exercised when prescribing atovaquone with indinavir due to the decrease in trough levels of indinavir.
Atovaquone is highly protein bound (greater than 99%) but does not displace other highly protein bound drugs in vitro, indicating significant drug interactions arising from displacement are unlikely.

Pregnancy and Lactation
Pregnancy:-
The safety of atovaquone and proguanil hydrochloride when administered concurrently for use in human pregnancy has not been established.
Reproductive toxicity studies in animals did not indicate any teratogenic potential at dosages of atovaquone:proguanil hydrochloride of up to 50:20 mg/kg/day in the rat or 100:40 mg/kg/day in the rabbit. In rabbits given atovaquone alone at dosages up to 1200 mg/kg/day, an increased incidence of resorptions and decreased length and weight of foetuses was noted. These effects were likely to be secondary to toxicity of atovaquone in maternal animals.
However, as animal studies are not always predictive of human response the use of
MALANIL in pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus.
The proguanil component of MALANIL acts by inhibiting parasitic dihydrofolate
reductase. There are no clinical data indicating that folate supplementation diminishes drug efficacy. For women of childbearing age receiving folate supplements to prevent neural tube birth defects, such supplements may be continued while taking MALANIL.

Lactation:-
The atovaquone concentrations in milk, in a rat study, were 30% of the concurrent
atovaquone concentrations in maternal plasma. It is not known whether atovaquone is excreted in human milk.
Proguanil is excreted in human milk in small quantities.
It is not recommended that mothers receiving MALANIL breast feed their babies.