Suprofen ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Profenal

Suprofen ophthalmic Pregnancy Warnings

Suprofen has been assigned to pregnancy category C by the FDA. Animal studies have revealed an increased incidence of fetal resorption associated with maternal toxicity from suprofen (2.5 mg/kg per day). There are no data from controlled human pregnancy trials. Suprofen should only be given during pregnancy when benefit outweighs risk.

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Suprofen ophthalmic Breastfeeding Warnings

Suprofen is excreted into human breast milk in small amounts. There are no reports of adverse effects on nursing infants.

In one study of six healthy nursing women who received a single dose of suprofen 200 mg orally, the maximum concentrations of suprofen in breast milk (per HPLC, with protein binding correction per equilibrium dialysis) ranged from 0.118 to 0.232 mcg/mL between 1 to 2 hours after ingestion. The maximum concentrations of suprofen in maternal plasma ranged from 13.8 to 28.3 mcg/mL between 0.5 to 2.0 hours after dosing. Within any subject, the maximum suprofen concentration in milk was 0.5% to 0.9% of the maximum maternal plasma concentration. The plasma and milk protein binding values averaged 99.4% and 10.0%, respectively. These data indicate that there would be minimal suprofen exposure to a nursing infant after administration of recommended doses to the nursing mother.

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Further information

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