Pregnancy: There are no or limited amount of data from the use of ophthalmic brinzolamide in pregnant women. Studies in animals with brinzolamide have shown reproductive toxicity following systemic administration (see also Pharmacology: Toxicology: Preclinical safety data under Actions). AZOPT is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether brinzolamide/metabolites are excreted in human milk following topical ocular administration. Animal studies have shown the excretion of minimal levels of brinzolamide in breast milk following oral administration.
A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from AZOPT therapy taking in to account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Animal studies with brinzolamide demonstrated no effect on fertility. Studies have not been performed to evaluate the effect of topical ocular administration of brinzolamide on human fertility.