Nepafenac ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Ilevro, Nevanac

Medically reviewed by Drugs.com. Last updated on May 29, 2023.

Nepafenac ophthalmic Pregnancy Warnings

Use is not recommended.

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

Comments:
-This drug should not be used by women of child bearing potential not using contraception.
-Use of this drug during late pregnancy should be avoided because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (e.g., premature closure of ductus arteriosus).

Animal studies have revealed evidence of malformations, postimplantation losses, decreased fetal weight/growth, and lower fetal survival at maternotoxic doses. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Nepafenac ophthalmic Breastfeeding Warnings

Caution is recommended.
-Some experts recommend: Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comment: The effects in the nursing infant are unknown.

See references

Further information

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

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