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Tropicamide ophthalmic Pregnancy and Breastfeeding Warnings

Tropicamide ophthalmic is also known as: Mydral, Mydriacyl, Ocu-Tropic, Opticyl, Tropicacyl

Tropicamide ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

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

No animal reproduction studies have been performed. 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

Tropicamide ophthalmic Breastfeeding Warnings

A single use of this drug is not likely to interfere with breastfeeding. Long-term use may inhibit lactation, producing signs in the nursing infant (e.g., slow weight gain, insatiety).

Caution is recommended.

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

Comments: Placing pressure over the tear duct for at least 1 minute after instillation can substantially decrease the amount of drug excreted in breast milk.

See references

References for pregnancy information

  1. "Product Information. Tropicamide (tropicamide ophthalmic)." Bausch and Lomb, Rochester, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. "Product Information. Tropicamide (tropicamide ophthalmic)." Bausch and Lomb, Rochester, NY.

Further information

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

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