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Brimonidine / timolol ophthalmic Pregnancy and Breastfeeding Warnings

Brimonidine / timolol ophthalmic is also known as: Combigan

Medically reviewed on May 23, 2018

Brimonidine / timolol ophthalmic Pregnancy Warnings

Animal studies have shown reproductive toxicity at high doses. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

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

See references

Brimonidine / timolol ophthalmic Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Brimonidine: Unknown; Timolol: Yes
Excreted into animal milk: Brimonidine: Unknown

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Combigan (brimonidine-timolol ophthalmic)." Allergan Inc, Irvine, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Combigan (brimonidine-timolol ophthalmic)." Allergan Inc, Irvine, CA.
  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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