Pregnancy: There are no or limited amount of data from the use of SIMBRINZA in pregnant women. Brinzolamide was not teratogenic in rats and rabbits, following systemic administration (oral gavage). 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 foetal circulation to a limited extent (see Pharmacology: Toxicology: Preclinical safety data under Actions). SIMBRINZA is not recommended during pregnancy and in women of childbearing 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 who are breast-feeding.
Fertility: Non-clinical 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.