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Finasteride Tablets USP, 1 mg | Finasteride

04:58 EDT 27th August 2014 | 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.
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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 [29 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...

Finasteride Treatment of Severe Nodulocystic Acne

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...

PubMed Articles [19 Associated PubMed Articles listed on BioPortfolio]

Tissue Effects in a Randomized Controlled Trial of Short-term Finasteride in Early Prostate Cancer.

In the Prostate Cancer Prevention Trial, finasteride selectively suppressed low-grade prostate cancer and significantly reduced the incidence of prostate cancer in men treated with finasteride compare...

Finasteride in Hidradenitis Suppurativa: A "Male" Therapy for a Predominantly "Female" Disease.

Hidradenitis suppurativa is associated with obesity and metabolic syndrome, and a hormonal component has been implicated. Finasteride is an anti-androgenic agent used for benign prostatic hypertrophy,...

Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia.

The effects on scalp and serum dihydrotestosterone (DHT) of different doses of a novel topical solution of 0.25% finasteride (P-3074), a type 2 5α-reductase, were investigated in men with androgeneti...

Grade-dependent Response to Finasteride in Early Prostate Cancer.

The neurosteroidogenic enzyme 5α-reductase modulates the role of D1 dopamine receptors in rat sensorimotor gating.

Neurosteroids exert diverse modulatory actions on dopamine neurotransmission and signaling. We previously documented that the enzyme 5α-reductase, which catalyzes the main rate-limiting step in neuro...

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