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Cyclopentolate ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Ak-Pentolate, Cyclogyl, Cylate, Ocu-Pentolate, Pentolair

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Cyclopentolate ophthalmic Pregnancy Warnings

Use is recommended only if clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Animal studies have not been reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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

Cyclopentolate ophthalmic Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Placing pressure over the tear duct by the corner of the eye for at least 1 minute and removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches breast milk after using eye drops.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Cyclopentolate Hydrochloride (cyclopentolate ophthalmic). Falcon Ophthalmics. 2006.
  3. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Cyclopentolate Hydrochloride (cyclopentolate ophthalmic). Falcon Ophthalmics. 2006.
  3. Cerner Multum, Inc. Australian Product Information.
  4. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.

Further information

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