Cosopt/Cosopt-S Use In Pregnancy & Lactation

Cosopt: There are no adequate and well-controlled studies in pregnant women. DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether dorzolamide hydrochloride is excreted in human milk. Timolol maleate does appear in human milk. Because of the potential for serious adverse reactions on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pregnancy: Cosopt-S: Dorzolamide HCl/Timolol Maleate (Cosopt-S) should not be used during pregnancy.
Dorzolamide: No adequate clinical data in exposed pregnancies are available. In rabbits, dorzolamide produced teratogenic effect at maternotoxic doses.
Timolol: There are no adequate data for the use of timolol in pregnant women. Timolol 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 intra uterine 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 this medicinal product is administered until delivery, the neonate should be carefully monitored during the first days of life.
Breast-feeding: It is not known whether dorzolamide is excreted in human milk. In lactating rats receiving dorzolamide, decreases in the body weight gain of offspring were observed.
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 systemic absorption, see Dosage & Administration. If treatment with Dorzolamide HCl/Timolol Maleate (Cosopt-S) is required, then lactation is not recommended.