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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

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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 (%)*
 
 
 
Event

Placebo
N=1503

  Finasteride N=1513

Relative
Risk

95% CI
 PValue
All Treatment Failures
37.1
26.2
0.68
(0.57 to 0.79)
<0.001
Surgical Interventions for BPH
10.1
 
4.6
 
0.45
 
(0.32 to 0.63)
 
<0.001
 
Two consecutive symptom score > 20
9.2
 
6.7
 
 
Bladder Stone
0.4
0.5
Incontinence
2.1
1.7
Renal Failure
0.5
0.6
UTI
5.7
4.9
Discontinuation due to worsening of BPH, lack of improvement, or to receive other medical treatment
21.8
 
13.3
 
 

Manufacturer

Hetero Drugs Limited

Active Ingredients

Source

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