Loteprednol ophthalmic Pregnancy and Breastfeeding Warnings
Loteprednol ophthalmic Pregnancy Warnings
Embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) was observed during organogenesis when administered orally to animals at doses (35 times the maximum daily clinical dose) which caused no maternal toxicity. Maternal toxicity (significantly reduced body weight gain) was seen when administered to animals during organogenesis at doses greater than or equal to 5 mg/kg/day. The no-observed-effect-level (NOEL) for embryotoxicity, teratogenicity, maternal toxicity (resulting in decreased growth, survival and retarded development in offspring during lactation) was 5 mg/kg/day. There are no controlled data in human pregnancy. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA pregnancy category: C Potential benefit should outweigh the potential risk.
Loteprednol ophthalmic Breastfeeding Warnings
Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown It is not known if sufficient systemic absorption following ophthalmic administration can result in detectible quantities in human milk. Topically applied steroids have been reported to be absorbed systemically and could suppress infant growth and endogenous corticosteroid production. A bioavailability study showed limited (less than 1 ng/mL) systemic absorption of ophthalmic administration. The effects in the nursing infant are unknown.
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