Loteprednol ophthalmic Pregnancy and Breastfeeding Warnings
Brand names: Alrex, Eysuvis, Inveltys, Lotemax, Lotemax SM
Medically reviewed by Drugs.com. Last updated on Dec 1, 2023.
Loteprednol ophthalmic Pregnancy Warnings
Animal studies have shown this drug to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures). 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.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Loteprednol ophthalmic Breastfeeding Warnings
UK: Use is contraindicated.
US: Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
See also
References for pregnancy information
- Product Information. Lotemax (loteprednol ophthalmic). Bausch and Lomb. 2001;PROD.
- Product Information. Alrex (loteprednol ophthalmic). Bausch and Lomb. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
References for breastfeeding information
- Product Information. Lotemax (loteprednol ophthalmic). Bausch and Lomb. 2001;PROD.
- Product Information. Alrex (loteprednol ophthalmic). Bausch and Lomb. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
