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Tafluprost ophthalmic Pregnancy and Breastfeeding Warnings

Tafluprost ophthalmic is also known as: Zioptan

Medically reviewed on Apr 30, 2018

Tafluprost 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: C

Comments:
-Women of childbearing potential should use effective contraception methods.

Animal studies have revealed reproductive toxicity. Additionally, studies have shown increased incidence of vertebral skeletal abnormalities, malformations of the skull, brain, and spine. There are no adequate 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

Tafluprost ophthalmic Breastfeeding Warnings

AU, US: Caution is recommended.

UK: Use is not recommended.

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. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Zioptan (tafluprost ophthalmic)." Merck & Company Inc, Whitehouse Station, NJ.

References for breastfeeding information

  1. "Product Information. Zioptan (tafluprost ophthalmic)." Merck & Company Inc, Whitehouse Station, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  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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