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 MALARONE in pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus.
The proguanil component of MALARONE 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 MALARONE.
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 MALARONE breast feed their babies.