Timolol ophthalmic Pregnancy and Breastfeeding Warnings

Timolol ophthalmic is also known as: Betimol, Istalol, Timoptic, Timoptic Ocudose, Timoptic-XE

Timolol ophthalmic Pregnancy Warnings

One case report described the use of timolol ophthalmic drops, acetazolamide, and pilocarpine during pregnancy. The neonate was delivered at 36 weeks' gestation and 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. Another case report described the use of latanoprost and timolol gel-forming solution during an entire pregnancy. Placental insufficiency occurred, but the infant was normal.

Timolol ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity at doses approximately 7000 times the systemic exposure following the maximum recommended human ophthalmic dose; while some maternotoxicity and/or fetotoxicity was observed with even higher doses. There are no controlled data from human pregnancy studies. Timolol ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.

Timolol ophthalmic Breastfeeding Warnings

Timolol has been measured in human milk after use of timolol eyedrops. In one case the milk timolol concentration averaged 5.6 ng/mL 1.5 hours after dosing in a woman who was receiving timolol 0.5% eye drops to one eye twice a day. In this case, even if the infant nursed 4 times daily, receiving 75 mL each time, the daily dose to the nursing infant would be below that expected to produce beta-blockade. Following oral administration data reveal average milk to maternal plasma drug level ratios of approximately 0.80. In one series of nine patients, dosages of timolol 5 mg three times a day were associated with an average milk timolol level of 15.9 ng/mL. After the dosage was increased to 10 mg three times a day in four of the nine patients, the average milk timolol level rose to 41 ng/mL.

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. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Timolol is considered compatible with breast-feeding by the American Academy of Pediatrics.

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