Ketotifen ophthalmic Pregnancy and Breastfeeding Warnings
Ketotifen ophthalmic Pregnancy Warnings
Ketotifen ophthalmic has been assigned to pregnancy category C by the FDA. Animal data have revealed evidence of an increased incidence of retarded ossification of the sternebrae and increased postnatal mortality and slightly decreased body weight among offspring associated with doses at least 30,000 times the maximum recommended human daily dose (MRHDD, on a per kg basis). Other animal data have failed to reveal evidence of embryofetal toxicity after maternal doses of 10,000 times the MRHDD. There are no controlled data in human pregnancy. It is not significantly absorbed after ocular administration (less than 20 pg/mL). Ketotifen ophthalmic should only be given during pregnancy when benefit outweighs risk.
Ketotifen ophthalmic Breastfeeding Warnings
There are no data on the excretion of ketotifen ophthalmic into human milk. It is excreted into rat milk after oral administration. Ketotifen is not significantly absorbed after ocular administration (< 20 pg/mL). The manufacturer recommends caution when administering ketotifen ophthalmic to nursing women.
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