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Levobunolol ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: AK-Beta, Betagan, Betagan C-Cap

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Levobunolol 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

Comments:
-Signs and symptoms of beta-blockade (e.g., bradycardia, hypotension, respiratory distress, and hypoglycemia) have been observed neonates when beta-blockers have been administered until delivery.
-Neonates should be carefully monitored during the first days of life, if this drug is administered until delivery.

Animal studies have shown reproductive toxicity at doses significantly higher than would be used in clinical practice. 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.

See references

Levobunolol ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. (2022) "Product Information. Betagan (levobunolol ophthalmic)." Allergan Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

References for breastfeeding information

  1. (2022) "Product Information. Betagan (levobunolol ophthalmic)." Allergan Inc
  2. 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.