Pregnancy: Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Non-Clinical Information under Actions). Because there is vaginal absorption, GYNO-PEVARYL should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient. GYNO-PEVARYL may be used during the second and third trimester if the potential benefit to the mother outweighs the possible risks to the fetus.
Breast-feeding: Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. It is not known whether econazole nitrate is excreted in human milk.
Caution should be exercised when using GYNO-PEVARYL if the patient is breast-feeding.
Fertility: Results of econazole animal reproduction studies showed no effects on fertility (see Pharmacology: Toxicology: Non-Clinical Information under Actions).