Finasteride Tablets USP, 1 mg | Finasteride

03:55 EDT 3rd July 2015 | 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

Drugs and Medications [27 Associated Drugs and Medications listed on BioPortfolio]

Finasteride [Sun Pharma Global FZE]

These highlights do not include all the information needed to use finasteride tablets 5 mg safely and effectively. See full prescribing information for finasteride tablets 5 mg. Finasteride Tablets US...

Finasteride [Greenstone LLC]

These highlights do not include all the information needed to use finasteride safely and effectively. See full prescribing information for finasteride tablets, USP. finasteride tablets, USPInitial U.S...

Finasteride [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use finasteride safely and effectively. See full prescribing information for finasteride tablets, USP. Finasteride Tablets, USPInitial U.S...

Finasteride [NorthStar Rx LLC]

FINASTERIDE TABLETS, USP 5 mg Rx Only

Finasteride [Accord Healthcare Inc.]

FINASTERIDE TABLETS USP, 5 mg

Clinical Trials [24 Associated Clinical Trials listed on BioPortfolio]

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

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...

Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

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...

Kinetics of the Finasteride Prostate Induced Apoptosis

The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need a s...

Finasteride in Treating Patients Undergoing Surgery for Stage II Prostate Cancer

RATIONALE: Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Gi...

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...

PubMed Articles [12 Associated PubMed Articles listed on BioPortfolio]

Finasteride Concentrations and Prostate Cancer Risk: Results from the Prostate Cancer Prevention Trial.

In the Prostate Cancer Prevention Trial (PCPT), finasteride reduced the risk of prostate cancer by 25%, even though high-grade prostate cancer was more common in the finasteride group. However, it rem...

Finasteride Quantification in Human Plasma by High-Performance Liquid Chromatography Coupled to Electrospray Ionization Tandem Mass Spectrometry. Application to a Comparative Pharmacokinetics Study.

A specific, fast and sensitive LC-MS/MS assay was developed for the determination of finasteride in human plasma using betamethsone dipropionate as the internal standard (IS). The limit of quantificat...

Finasteride Reduces Microvessel Density and Expression of Vascular Endothelial Growth Factor in Renal Tissue of Diabetic Rats.

Vascular endothelial growth factor (VEGF) plays a critical role in the pathogenesis of diabetic microvascular complications. Finasteride has been confirmed to decrease VEGF expression in prostate and ...

Simultaneous pharmacokinetic and pharmacodynamic analysis of 5α-reductase inhibitors and androgens by liquid chromatography tandem mass spectrometry.

Benign prostatic hyperplasia and prostate cancer can be treated with the 5α-reductase inhibitors, finasteride and dutasteride, when pharmacodynamic biomarkers are useful in assessing response. A nove...

Anti-Androgenic Therapy with Finasteride Attenuates Cardiac Hypertrophy and Left Ventricular Dysfunction.

-Compared to men, women have a better prognosis when suffering from aortic valve stenosis, hypertrophic cardiomyopathy or heart failure. Recent data suggest that androgens like testosterone or the mor...


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