Pilocarpine ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Adsorbocarpine, Akarpine, Isopto Carpine, Ocu-Carpine, Ocusert, Pilagan with C Cap, Pilocar, Pilopine HS, Piloptic-1, Piloptic-1/2, Piloptic-2, Piloptic-3, Piloptic-4, Piloptic-6, Pilostat, Qlosi, Vuity

Medically reviewed by Drugs.com. Last updated on Apr 20, 2023.

Pilocarpine ophthalmic Pregnancy Warnings

Animal studies have showed reproductive toxicity. 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.

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

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

Comments:
-This drug may be systemically absorbed and mothers using this drug may give birth to infants with signs mimicking neonatal meningitis such as restlessness, convulsions, diaphoresis, and hypothermia.

See references

Pilocarpine ophthalmic Breastfeeding Warnings

AU/UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

US: Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

See references

Further information

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