Azarga Use In Pregnancy & Lactation

Pregnancy: There are no adequate data regarding the use of ophthalmic brinzolamide and timolol in pregnant women. Studies in animals with brinzolamide have shown reproductive toxicity following systemic administration, see Pharmacology: Toxicology: Preclinical safety data under Actions. AZARGA should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see Dosage & Administration.
Epidemiological studies have not revealed malformative effects but show a risk for intrauterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If AZARGA is administered until delivery, the neonate should be carefully monitored during the first days of life.
Breast-feeding: It is not known whether ophthalmic brinzolamide is excreted in human breast milk. Studies in animals have shown that following oral administration brinzolamide is excreted in breast milk, see Pharmacology: Toxicology: Preclinical safety data under Actions.
Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. To reduce the systemic absorption, see Dosage & Administration.
However, a risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from AZARGA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Studies have not been performed to evaluate the effect of topical ocular administration of AZARGA on human fertility.
Non-clinical data do not show any effects of either brinzolamide or timolol on male or female fertility following oral dosing. No effects on male or female fertility are anticipated from the use of AZARGA.