Alphascar Use In Pregnancy & Lactation

Pregnancy: Finasteride is contraindicated for use in women when they are or may potentially be pregnant (see Contraindications).
Because of the ability of Type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone, these medicinal products, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.
In animal developmental studies, dose-dependent development of hypospadias were observed in the male offspring of pregnant rats given finasteride at doses ranging from 100 μg/kg/day to 100 mg/kg/day, at an incidence of 3.6% to 100%. Additionally, pregnant rats produced male offspring with decreased prostatic and seminal vesicular weights, delayed preputial separation, transient nipple development and decreased anogenital distance, when given finasteride at doses below the recommended human dose. The critical period during which these effects can be induced has been defined in rats as days 16-17 of gestation.
The changes previously described are expected pharmacological effects of Type II 5α-reductase inhibitors. Many of the changes, such as hypospadias, observed in male rats exposed in utero to finasteride are similar to those reported in male infants with a genetic deficiency of Type II 5α-reductase. It is for these reasons that finasteride is contraindicated in women who are or may potentially be pregnant.
No effects were seen in female offspring exposed in utero to any dose of finasteride.
Exposure to finasteride - risk to male foetus: Women should not handle crushed or broken tablets of finasteride when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus (see Pregnancy as previously mentioned). Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
Small amounts of finasteride have been recovered from the semen in subjects receiving finasteride 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 finasteride. When the patient's sexual partner is or may potentially be pregnant, the patient is recommended to minimise exposure of his partner to semen.
Breast-feeding: Finasteride is not indicated for use in women. It is not known whether finasteride is excreted in human milk.