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Finasteride tablets USP are not approved for the prevention of prostate cancer.
| Table 1
Drug-Related Adverse Experiences
|Year 1 (%)||Years 2, 3 and 4* (%)|
|Decreased Volume of Ejaculate||3.7||0.8||1.5||0.5|
Mean (SD) Pharmacokinetic Parameters in Healthy Young Subjects (n=15)
Mean (± SD)
|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)|
All Treatment Failures in A Long-Term Efficacy and Safety Study
|All Treatment Failures
||(0.57 to 0.79)
|Surgical Interventions for BPH
||(0.32 to 0.63)
|Two consecutive symptom score > 20
|Discontinuation due to worsening of BPH, lack of improvement, or to receive other medical treatment
Hetero Drugs Limited
Finasteride Tablets USP, 5 mg RX Only
FINASTERIDE TABLETS, USP
These highlights do not include all the information needed to use finasteride safely and effectively. See full prescribing information for finasteride. Finasteride Tablets, USP for oral use Init...
The purpose of this study is to compare the rate and extent of absorption of Actavis Group hf, Iceland, finasteride and Merck & Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1...
This study is designed to compare safety and efficacy of monotherapy finasteride to combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic hyperplasia (BPH) wh...
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Double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of once weekly, high dose oral finasteride compared to placebo for the treatment of sev...
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