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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-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.
Mean (SD) Pharmacokinetic Parameters in Healthy Men (ages 18-26) | Mean (± SD)
n=15 |
| Bioavailability | 65% (26-170%)
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| Clearance (mL/min) | 165 (55) |
| Volume of Distribution (L) | 76 (14) |
Mean (SD) Noncompartmental Pharmacokinetic Parameters After Multiple Doses of 1 mg/day in Healthy Men (ages 19-42) | Mean (± SD)
(n=12) |
| AUC (ng•hr/mL) | 53 (33.8) |
| Peak Concentration (ng/mL) | 9.2 (2.6) |
| Time to Peak (hours) | 1.3 (0.5) |
| Half-Life (hours)
| 4.5 (1.6) |
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OVERDOSAGE
In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with finasteride 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
PROPECIA is contraindicated in the following:
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.
Hypersensitivity to any component of this medication.
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Page last updated: 2008-02-15
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