Dorzolamide / timolol ophthalmic Pregnancy and Breastfeeding Warnings
Dorzolamide / timolol ophthalmic Pregnancy Warnings
One case in which timolol was administered during human pregnancy has been reported. A woman who was taking timolol ophthalmic drops, acetazolamide, and pilocarpine for glaucoma delivered at 36 weeks' gestation. The neonate suffered hyperbilirubinemia, metabolic acidosis, hypocalcemia, and hypomagnesemia. These complications were believed to be secondary to acetazolamide therapy, and were reversible after treatment. The use of some beta-blockers during human pregnancy has resulted in persistent bradycardia and other signs of beta-blockade. Close observation for signs and symptoms of beta-blockade for at least 48 hours of newborns whose mothers were taking timolol is recommended.
Dorzolamide-timolol has been assigned to pregnancy category C by the FDA. Animal studies conducted with dorzolamide revealed evidence of malformations of the vertebral bodies in rabbits in oral doses of approximately 31 times the maximum recommended human ophthalmic dose. These malformations occurred at doses that caused metabolic acidosis with decreased maternal body weight and decreased fetal weight. Dorzolamide caused no malformations in rats given 125 times the recommended human ophthalmic dose. Animal studies conducted using timolol have failed to reveal evidence of fetal malformations at doses approximately 7000 times the systemic exposure following the maximum recommended human ophthalmic dose. Delayed fetal ossification occurred in rats following these doses, however, there were no adverse effects on postnatal development of offspring. Maternotoxicity and increased fetal resorption occurred in mice after doses 142,000 times systemic exposure following the maximum recommended human ophthalmic dose (on a per kg basis). Increased fetal resorptions, but no maternotoxicty were observed in rabbits given 14,000 times the maximum recommended human ophthalmic dose (on a per kg basis). There are no controlled data in human pregnancy. Dorzolamide-timolol is only recommended for use during pregnancy when benefit outweighs risk.
Dorzolamide / timolol ophthalmic Breastfeeding Warnings
There are no data on the excretion of dorzolamide into human milk. Timolol is excreted into human milk following oral and ophthalmic administration. No adverse reactions in nursing infants have been reported, but close observation for bradycardia and other signs of beta-blockade in infants exposed to timolol via breast milk is recommended. Because of the potential for adverse effects 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.
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