Finasteride Tablets USP, 1 mg | Finasteride

16:57 EDT 1st September 2014 | BioPortfolio
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Mean (SD) Pharmacokinetic Parameters in Healthy Men (ages 18 to 26)
Mean (± SD)
n=15
Bioavailability
65% (26 to 170%)Range
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 to 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)First-dose values; all other parameters are last-dose values
4.5 (1.6)
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TABLE 1 Drug-Related Adverse Experiences for Finasteride Tablets 1 mg in Year 1 (%) MALE PATTERN HAIR LOSS
  Finasteride Tablets 1 mg
N=945
Placebo
N=934
Decreased Libido
1.8
1.3
Erectile Dysfunction
1.3
0.7
Ejaculation Disorder
(Decreased Volume of Ejaculate)
1.2
(0.8)
0.7
(0.4)
Discontinuation due to drug-related sexual adverse experiences
1.2
0.9
TABLE 2 Drug-Related Adverse Experiences for Finasteride Tablets 5 mg BENIGN PROSTATIC HYPERPLASIA
Year 1
(%)
Years 2, 3 and 4Combined Years 2 to 4
(%)
Finasteride, 5 mg Placebo Finasteride, 5 mg Placebo
N = 1524 and 1516, finasteride vs placebo, respectively
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
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Manufacturer

Sun Pharma Global FZE

Active Ingredients

Source

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Finasteride [Sun Pharma Global FZE]

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Finasteride [NorthStar Rx LLC]

FINASTERIDE TABLETS, USP 5 mg Rx Only

Finasteride [Accord Healthcare Inc.]

FINASTERIDE TABLETS USP, 5 mg

Clinical Trials [21 Associated Clinical Trials listed on BioPortfolio]

A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fed Conditions

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Kinetics of the Finasteride Prostate Induced Apoptosis

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Finasteride in Treating Patients Undergoing Surgery for Stage II Prostate Cancer

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Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition

The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®) 1 mg finasteride tablets under fed condi...

Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition

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PubMed Articles [14 Associated PubMed Articles listed on BioPortfolio]

Efficacy of Finasteride for Treating Patients with Androgenetic Alopecia who are Pileous in other Areas: A Pilot Study in Japan.

Androgenetic alopecia (AGA) involves androgen-dependent hair loss and finasteride is an established treatment for the disease. However, reports of the influence of finasteride on hair growth in other ...

Persistent Sexual, Emotional, and Cognitive Impairment Post-Finasteride: A Survey of Men Reporting Symptoms.

Finasteride is a synthetic 5-α reductase inhibitor, which prevents the conversion of testosterone to dihydrotestosterone and has been used for more than 20 years in the treatment of male pattern hair...

Antibody-capped mesoporous nanoscopic materials: design of a probe for the selective chromo-fluorogenic detection of finasteride.

The synthesis of capped mesoporous silica nanoparticles (MSN) conjugated with an antibody (AB) as a gatekeeper has been carried out in order to obtain a delivery system able to release an entrapped ca...

Finasteride associated melasma in a caucasian male.

Melasma is an acquired hypermelanosis that typically affects sun-exposed areas on the face and presents as symmetric brownish macules and patches. It is most commonly reported in women and thought to ...

Finasteride Inhibits Human Prostate Cancer Cell Invasion through MMP2 and MMP9 Downregulation.

The use of the 5-alpha reductase inhibitors (5-ARIs) finasteride and dutasteride for prostate cancer prevention is still under debate. The FDA recently concluded that the increased prevalence of high-...

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