Atovaquone/proguanil Pregnancy and Breast Feeding Warnings
Atovaquone/proguanil is also known as: Malarone, Malarone Pediatric
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Atovaquone/Proguanil while you are pregnant. Atovaquone/Proguanil is found in breast milk. If you are or will be breast-feeding while you use Atovaquone/Proguanil , check with your doctor. Discuss any possible risks to your baby.
Atovaquone/proguanil Pregnancy Warnings
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.
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 Lactation 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.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This drug information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information in contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
