Brimonidine / brinzolamide ophthalmic Pregnancy and Breastfeeding Warnings

Brimonidine / brinzolamide ophthalmic is also known as: Simbrinza

Brimonidine / brinzolamide ophthalmic Pregnancy Warnings

Maternal and developmental toxicity was observed in animals with brinzolamide at oral doses of 20 to 120 times the recommended human ophthalmic dose. No fetal harm was seen in animal studies with oral doses of brimonidine reaching plasma concentrations 100 times higher than that seen in humans at recommended human ophthalmic dose. Brimonidine crossed the placenta and a small amount entered the fetal circulation in animals. There are no controlled data in human pregnancy. 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.

FDA pregnancy category: C Potential benefit should outweigh the potential risk.

Brimonidine / brinzolamide ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown (brinzolamide/brimonidine) Excreted into animal milk: Yes (brinzolamide/brimonidine) The effects in the nursing infant are unknown.

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