Difluprednate ophthalmic Pregnancy and Breastfeeding Warnings
Brand names: Durezol
Medically reviewed by Drugs.com. Last updated on Nov 4, 2024.
Difluprednate ophthalmic Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Animal studies have shown this drug to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies). There are no adequate and well-controlled studies in pregnant women.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Difluprednate ophthalmic Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
See also
References for pregnancy information
- (2008) "Product Information. Durezol (difluprednate ophthalmic)." Sirion Therapeutics
References for breastfeeding information
- (2008) "Product Information. Durezol (difluprednate ophthalmic)." Sirion Therapeutics
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.