Silodosin Pregnancy and Breastfeeding Warnings

Silodosin is also known as: Rapaflo

Silodosin Pregnancy Warnings

Treatment of male rats at 20 mg/kg/day (approximately twice the MRHE) for 15 days resulted in decreased fertility, which was reversible following a two-week recovery period. No effect was observed at 6 mg/kg/day. Sperm viability and count were significantly lower after administration of 600 mg/kg/day (approximately 65 times the MRHE) for one month. Histopathological examination of infertile males revealed changes in the testes and epididymides at 200 mg/kg/day (approximately 30 times the MRHE). The clinical relevance of these findings is unknown.

Silodosin has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity when silodosin was administered to pregnant rats during organogenesis at 1,000 mg/kg/day (approximately 20 times the maximum recommended human exposure, or MRHE). Administration to male rats at dosages above the MRHE has been associated with decreased fertility, sperm viability, and sperm count. Silodosin should only be given during pregnancy when need has been clearly established. There are no approved indications for use of this drug in females.

Silodosin Breastfeeding Warnings

There are no data on the excretion of silodosin into human milk. No effects on physical or behavioral development of offspring were observed when rats were treated during lactation with high dosages. There are no approved indications for use of this drug in females.

See Also...

• silodosin Consumer Information
• Pregnancy Support Group
• FDA Pregnancy Categories
• Medicine use during Pregnancy
• Medicine use while Breastfeeding
• Safe Medications during Breastfeeding

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 drug information 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 drug combination in no way should be construed to indicate that the drug of drug 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 in 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.