Terconazole topical Pregnancy and Breastfeeding Warnings

Terconazole topical is also known as: Terazol, Terazol 3, Terazol 7, Terazole 3, Zazole

Terconazole topical Pregnancy Warnings

In a review of 229,101 deliveries to Michigan Medicaid patients, 1167 first-trimester exposures to terconazole and 7551 exposures any time during pregnancy were recorded. A total of 34 birth defects were reported with first trimester exposure (48 expected) and included (observed/expected) 14/12 cardiovascular defects, 3/2 polydactyly, 1 limb reduction, and 1 hypospadias. These data do not support an association between terconazole use and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

Terconazole topical has been assigned to pregnancy category C by the FDA. Animal studies utilizing high oral and subcutaneous doses have not revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Since it is absorbed from the human vagina, terconazole topical should not be used during the first trimester of pregnancy unless the benefit to the mother outweighs the risk to the fetus. Terconazole topical is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Terconazole topical Breastfeeding Warnings

There are no data on the excretion of terconazole topical into human milk. At least one manufacturer recommends that caution be used when administering terconazole topical to nursing women. Other manufacturers recommend that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See Also...

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.

Hide
(web3)