Dusorac Use In Pregnancy & Lactation

Dutasteride + Tamsulosin HCl (Dusorac) is contraindicated for use by women. There have been no studies to investigate the effect of Dutasteride + Tamsulosin HCl (Dusorac) on pregnancy, lactation, and fertility.
Pregnancy: As with the other 5 alpha-reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male fetus, inhibit the development of the external genitalia of the fetus. Small amounts of Dutasteride have been recovered from the semen of subjects receiving Dutasteride. It is not known whether a male fetus will be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride (the risk of which is greatest during the first 16 weeks of pregnancy).
As with all 5 alpha reductase inhibitors, when the patient's partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom.
Administration of Tamsulosin hydrochloride to pregnant female rats and rabbits showed no evidence of fetal harm.
Breastfeeding: It is not known whether Dutasteride or Tamsulosin are excreted in human milk.
Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men.
Effects of Tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated.