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Atovaquone / proguanil Pregnancy and Breastfeeding Warnings

Atovaquone / proguanil is also known as: Malarone, Malarone Pediatric

Atovaquone / proguanil Pregnancy Warnings

Falciparum malaria carries a higher risk of morbidity and mortality in pregnant women causing both maternal death and fetal loss. Pregnant women who must travel to malaria-endemic areas should be instructed to use personal protection against mosquito bites in addition to antimalarials.

Atovaquone-proguanil has been assigned to pregnancy category C by the FDA. Animal studies conducted with the combination product have failed to reveal evidence of teratogenicity at plasma concentrations equal to the estimated human exposure during treatment of malaria. Animal studies using atovaquone alone have revealed evidence of increased resorption and fetal harm, however, it is unclear if these effects were due to direct embryotoxicity and fetotoxicity or secondary to maternal toxicity. There are no controlled data in human pregnancies. Atovaquone-proguanil should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Atovaquone / proguanil Breastfeeding Warnings

There are no data on the excretion of atovaquone into human milk. Proguanil is excreted into human milk in small quantities. There are no data on adverse effects from proguanil in the nursing infant. The manufacturer recommends that caution be used when administering atovaquone-proguanil to nursing women.

In a rat study, atovaquone milk concentration was 30% of maternal plasma concentration. However, assumptions on excretion of drugs into human breast milk cannot be drawn based on animal data due to the difference in composition of breast milk between species.

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