NIKP-Dutasteride Use In Pregnancy & Lactation

Dutasteride NIKP soft cap 0.5 mg is contraindicated for use by women.
Pregnancy: As with other 5-alpha reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus (see Precautions). Small amounts of Dutasteride have been recovered from the semen in subjects receiving Dutasteride 0.5 mg/day. It is not known whether a male foetus may 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.
For information on preclinical data, see Pharmacology: Toxicology: Preclinical safety data under Actions.
Breast-feeding: It is not known whether Dutasteride is 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 (see Pharmacology: Pharmacodynamics under Actions). The possibility of reduced male fertility cannot be excluded.