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Loteprednol ophthalmic Pregnancy and Breastfeeding Warnings

Loteprednol ophthalmic is also known as: Alrex, Lotemax

Medically reviewed on January 18, 2018

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

See references

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 references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Alrex (loteprednol ophthalmic)." Bausch and Lomb, Tampa, FL.
  3. "Product Information. Lotemax (loteprednol ophthalmic)." Bausch and Lomb, Tampa, FL.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Lotemax (loteprednol ophthalmic)." Bausch and Lomb, Tampa, FL.
  3. "Product Information. Alrex (loteprednol ophthalmic)." Bausch and Lomb, Tampa, FL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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