HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. Finasteride Tablets USP Initial U.S. Appr | Finasteride [Hetero Drugs Limited] | BioPortfolio

13:17 EST 27th January 2019 | BioPortfolio

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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* (%)
 Finasteride   Placebo   Finasteride   Placebo
Impotence      8.1    3.7       5.1    5.1
Decreased Libido      6.4    3.4       2.6    2.6
Decreased Volume of Ejaculate      3.7    0.8       1.5    0.5
Ejaculation Disorder      0.8    0.1       0.2    0.1
Breast Enlargement      0.5    0.1       1.8    1.1
Breast Tenderness      0.4    0.1       0.7    0.3
Rash      0.5    0.2       0.5    0.1

Table 2
Mean (SD) Pharmacokinetic Parameters in Healthy Young Subjects (n=15)
Mean (± SD)
Bioavailability     63% (34-108%)*
Clearance (mL/min)             165 (55)
Volume of Distribution (L)              76 (14)
Half-Life (hours)             6.2 (2.1)

 Table 3
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)

Table 4
               All Treatment Failures in A Long-Term Efficacy and   Safety Study
Patients (%)*


  Finasteride N=1513


95% CI
All Treatment Failures
(0.57 to 0.79)
Surgical Interventions for BPH
(0.32 to 0.63)
Two consecutive symptom score > 20
Bladder Stone
Renal Failure
Discontinuation due to worsening of BPH, lack of improvement, or to receive other medical treatment


Hetero Drugs Limited

Active Ingredients


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