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Betaxolol ophthalmic Pregnancy and Breastfeeding Warnings

Betaxolol ophthalmic is also known as: Betoptic, Betoptic S

Medically reviewed on Feb 17, 2017

Betaxolol ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-There is a risk for intrauterine growth retardation when beta-blockers are administered orally.
-Signs and symptoms of beta-blockade (e.g., bradycardia, hypotension, respiratory distress, hypoglycemia) have been observed in neonates when beta-blockers have been administered until delivery.
-If this drug is administered until delivery, neonates should be carefully monitored during the first days of life.

Animal studies have shown reproductive toxicity. There are no adequate and well controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Betaxolol 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. "Product Information. Betoptic (betaxolol ophthalmic)." Alcon Laboratories Inc, Fort Worth, TX.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Betoptic (betaxolol ophthalmic)." Alcon Laboratories Inc, Fort Worth, TX.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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