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Dorzolamide ophthalmic Pregnancy and Breastfeeding Warnings

Dorzolamide ophthalmic is also known as: Trusopt

Medically reviewed on Jul 16, 2018

Dorzolamide ophthalmic Pregnancy Warnings

Animal studies have shown teratogenic effects at maternotoxic doses. 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

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.

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

UK: Use is not recommended.

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

See references

Dorzolamide 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: Yes

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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Trusopt (dorzolamide ophthalmic)." Merck & Co, Inc, West Point, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Trusopt (dorzolamide ophthalmic)." Merck & Co, Inc, West Point, PA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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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