Combigan Use In Pregnancy & Lactation

Pregnancy: There are no adequate data for the use of COMBIGAN in pregnant women. Because animal reproduction studies are not always predictive of human response, COMBIGAN should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Brimonidine tartrate: In animal studies, brimonidine tartrate did not cause any teratogenic effects. Brimonidine tartrate has been shown to cause abortion in rabbits and postnatal growth reduction in rats at systemic exposures approximately 37-times and 134-times those obtained during therapy in humans, respectively.
Timolol: Teratogenicity studies in mice, rats and rabbits, at oral doses up to 4200 times the human daily dose of COMBIGAN, shown no evidence of foetal malformation.
However, epidermiological studies suggest that a risk of intra uterine growth retardation may exist following exposure to systemic beta-blockers. In addition, some signs and symptoms of beta-blockade (e.g. bradycardia) have been observed in both the foetus and the neonate.
Consequently, COMBIGAN should not be used during pregnancy unless clearly necessary.
Lactation: Timolol has been detected in human milk following oral and ophthalmic drug administration. It is not known if brimonidine is excreted in human milk but is excreted in the milk of the lactating rat. Because of the potential for serious adverse reactions from timolol or brimonidine tartrate in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Therefore, COMBIGAN should not be used by women breast-feeding infants.