Butoconazole topical Pregnancy and Breast Feeding Warnings

Butoconazole topical is also known as: Femstat 3, Gynazole 1, Gynazole-1, Mycelex-3

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Butoconazole Cream while you are pregnant. It is not known if Butoconazole Cream is found in breast milk. If you are or will be breast-feeding while you use Butoconazole Cream, check with your doctor. Discuss any possible risks to your baby.

Butoconazole topical Pregnancy Warnings

Butoconazole has been assigned to pregnancy category C by the FDA. Animals studies utilizing high oral (up to 50 mg/kg) and topical doses have not revealed evidence of teratogenicity. Daily administration of doses greater than 100 mg/kg/day have resulted in fetal malformations in rats. Use of butoconazole in women during the second and third trimester has been documented in clinical trials and has not been associated with adverse fetal outcome. Butoconazole is only recommended for use during pregnancy when benefit outweighs risk. Butoconazole is indicated for the treatment of vaginal candidiasis during the second and third trimester.

In a review of 229,101 deliveries to Michigan Medicaid patients, 444 first-trimester exposures to butoconazole and 2450 exposures any time during pregnancy were recorded. A total of 16 birth defects were reported with first trimester exposure (17 expected) and included (observed/expected) 4/4 cardiovascular defects and one spina bifida. These data do not support an association between butoconazole use and birth defects (written communication, Franz Rosa, MD, Food and Drug Administration, 1994).

Butoconazole topical Lactation Warnings

There are no data on the excretion of butoconazole into human milk. The manufacturer recommends that caution be used when administering butoconazole to nursing women.

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.