Retapamulin topical Pregnancy and Breastfeeding Warnings
Retapamulin topical is also known as: Altabax
Retapamulin topical Pregnancy Warnings
Animal studies have shown evidence of maternal toxicity (decreased body weight gain and food consumption, and abortions) and developmental toxicity (decreased fetal body weight and delayed skeletal ossification) with oral doses of 150 mg/kg/day or greater, which corresponds to 3 or more times the human estimated exposure, and IV doses of 7.2 mg/kg/day or greater, which is 8-fold higher than the estimated human systemic exposure. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Benefit should outweigh risk AU TGA pregnancy category: B3 US FDA pregnancy category: B
Retapamulin topical Breastfeeding Warnings
Safety has not been established Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown, however, exposure to the breastfeeding infant is likely to be negligible since minimal systemic exposure is observed in adults.
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 material 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 combination thereof in no way should be construed to indicate that the drug or 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 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.