Pregnancy: There are no or limited amount of data from the use of SIMBRINZA in pregnant women. Brinzolamide was teratogenic in rats, but not rabbits, following systemic administration. Animal studies with oral brimonidine do not indicate direct harmful effects with respect to reproductive toxicity. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. SIMBRINZA is not recommended during pregnancy and in women of child bearing potential not using contraception.
Breast-feeding: It is unknown whether topical SIMBRINZA is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown that following oral administration, minimal levels of brinzolamide are excreted in breast milk. Brimonidine administered orally is excreted in breast milk. SIMBRINZA should not be used by women nursing infants.
Fertility: Nonclinical data do not show any effects of brinzolamide or brimonidine on fertility. There are no data on the effect of topical ocular administration of SIMBRINZA on human fertility.