Medication Guide App

Suprofen ophthalmic Pregnancy and Breastfeeding Warnings

Suprofen ophthalmic is also known as: 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.

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.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web3)