"April 13, 2012 -- The baldness drug Propecia and the BPH drug Proscar may cause infertility and more sexual problems than previously thought, the FDA warns.
The main ingredient of both drugs is finasteride. Finasteride reduces male ho"...
Patients have received single doses of PROSCAR up to 400 mg and multiple doses of PROSCAR up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with PROSCAR can be recommended.
Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m² (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m² (400 mg/kg) and 5900 mg/m² (1000 mg/kg), respectively.
PROSCAR is contraindicated in the following:
- Hypersensitivity to any component of this medication.
- Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. [See also WARNINGS AND PRECAUTIONS, Use in Specific Populations, HOW SUPPLIED/Storage and Handling and PATIENT INFORMATION.] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.
Last reviewed on RxList: 5/2/2012
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