Zileuton Pregnancy and Breast Feeding Warnings

Zileuton is also known as: Zyflo, Zyflo CR

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zileuton while you are pregnant. It is not known if Zileuton is found in breast milk. Do not breast-feed while taking Zileuton .

Zileuton Pregnancy Warnings

Zileuton has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of fetotoxicity using doses equal to the maximum recommended daily human dose on a mg/m2 basis. There are no controlled data in human pregnancy. Zileuton is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Zileuton Lactation Warnings

There are no data on the excretion of zileuton into human milk. A potential for tumorigenicity has been demonstrated in animal studies. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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