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Brimonidine ophthalmic Pregnancy and Breastfeeding Warnings

Brimonidine ophthalmic is also known as: Alphagan, Alphagan P, Qoliana

Brimonidine ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: B

Animal studies have revealed maternotoxicity and increased early resorptions/post-implantation losses and decreased pup viability and bodyweights at exposures. Additional animal studies have shown that this drug crossed the placenta and entered 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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Brimonidine ophthalmic Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown.

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References for pregnancy information

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

References for breastfeeding information

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

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