Brimonidine / timolol ophthalmic Pregnancy and Breastfeeding Warnings

Brimonidine / timolol ophthalmic is also known as: Combigan

Brimonidine / timolol ophthalmic Pregnancy Warnings

Brimonidine-timolol ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies of brimonidine have failed to reveal evidence of teratogenicity associated with oral brimonidine. Brimonidine crosses the placenta and enters the fetal circulation. Maternotoxic doses caused increased preimplantation losses, early absorptions/post-implantation losses, decreased viability, and/or postnatal growth reduction in rats and rabbits. Animal studies of timolol have failed to reveal evidence of teratogenicity at doses approximately 7000 times the systemic exposure following the maximum recommended human ophthalmic dose; while some maternotoxicity and/or fetotoxicity was observed with even higher doses. There are no controlled data in human pregnancy. Brimonidine-timolol ophthalmic is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Brimonidine / timolol ophthalmic Breastfeeding Warnings

There are no data on the excretion of brimonidine ophthalmic into human milk. Timolol is excreted into human milk following oral and ophthalmic administration. No adverse reactions in nursing infants have been reported, but close observation for bradycardia and other signs of beta-blockade in infants exposed to timolol via breast milk is recommended. Timolol is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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