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DRUG INTERACTIONS Drug Interactions
(also see PRECAUTIONS, Drug Interactions)
No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolism enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin, and no clinically meaningful interactions were found.
Mean (SD) Pharmacokinetic Parameters in Healthy Young Subjects (n=15)
| Mean (±SD) |
| Bioavailability | 63% (34-108%)
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| Clearance (mL/min) | 165 (55) |
| Volume of Distribution (L) | 76 (14) |
| Half-Life (hours) | 6.2 (2.1) |
Mean (SD) Noncompartmental Pharmacokinetic Parameters After Multiple Doses of 5 mg/day in Older Men
| Mean (± SD) |
| 45-60 years old (n=12) | ≥70 years old (n=12) |
| AUC (ng · hr/mL) | 389 (98) | 463 (186) |
| Peak Concentration (ng/mL) | 46.2 (8.7) | 48.4 (14.7) |
| Time to Peak (hours) | 1.8 (0.7) | 1.8 (0.6) |
| Half-Life (hours)
| 6.0 (1.5) | 8.2 (2.5) |
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OVERDOSAGE
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.
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CONTRAINDICATIONS
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 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, EXPOSURE OF WOMEN — RISK TO MALE FETUS and PRECAUTIONS, Information for Patients and Pregnancy.) In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.
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