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Brimonidine / brinzolamide ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Simbrinza

Medically reviewed by Drugs.com. Last updated on Aug 3, 2023.

Brimonidine / brinzolamide ophthalmic Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-This drug is not recommended in women of child bearing potential not using contraception.

Animal studies have shown that this drug crosses the placenta and enters into the fetal circulation to a limited extent. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Brimonidine / brinzolamide ophthalmic Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown (brimonidine, brinzolamide)
Excreted into animal milk: Yes (brimonidine, brinzolamide)

Comments: The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Simbrinza (brimonidine-brinzolamide ophthalmic)." Alcon Laboratories Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Simbrinza (brimonidine-brinzolamide ophthalmic)." Alcon Laboratories Inc

Further information

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

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