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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.

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