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Finasteride

Hetero Drugs Limited
Hetero Labs Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONHIGHLIGHTS 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. Approval: 1992RX only RECENT MAJOR CHANGES1.35.2INDICATIONS AND USAGE1.11.3DOSAGE AND ADMINISTRATION22.1DOSAGE FORMS AND STRENGTHS3CONTRAINDICATIONS445.58.116WARNINGS AND PRECAUTIONS5.15.26.15.312.35.48.1165.58.18.38.412.3Side Effects6.1www.fda.gov/madwatch


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

1 INDICATIONS & USAGE

1.1 Monotherapy





1.3 Limitations of Use


Finasteride tablets USP are not approved for the prevention of prostate cancer.

2 DOSAGE & ADMINISTRATION


2.1 Monotherapy


[see Clinical Studies (14.1)].

3 DOSAGE FORMS & STRENGTHS


4 CONTRAINDICATIONS




Pregnancy[See also Warnings and Precautions (5.4), Use in Specific Populations (8.1), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2).]

5 WARNINGS AND PRECAUTIONS

5.1 Effects on Prostate Specific Antigen (PSA)and the Use of PSA in Prostate Cancer Detection









5.2 Increased Risk of High-Grade Prostate Cancer


[See Indications and Usage (1.3) and Adverse Reactions (6.1).]

5.3 Evaluation for Other Urological Conditions





5.4 Exposure of Women — Risk to Male Fetus


[See Contraindications (4), Use in Specific Populations (8.1) , Clinical Pharmacology (12.3), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2).]

5.5 Pediatric Patients and Women


[see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)][see also Warnings and Precautions (5.4), Use in Specific Populations (8.1), Clinical Pharmacology (12.3), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2)].

5.6 Effect on Semen Characteristics


6 ADVERSE REACTIONS

6.1 Clinical Trials Experience




4-Year Placebo-Controlled Study (A Long-Term Efficacy and Safety Study)



  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

*


Phase III Studies and 5-Year Open Extensions


Long-Term Data
High-Grade Prostate Cancer
[see Indications and Usage (1.3) and Warnings and Precautions (5.2)]

Breast Cancer

Sexual Function

6.2 Postmarketing Experience






7 DRUG INTERACTIONS

7.1 Cytochrome P450-Linked Drug Metabolizing Enzyme System


7.2 Other Concomitant Therapy


2

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy


[See Contraindications (4).]


[see Clinical Pharmacology (12.3)]








8.3 Nursing Mothers




8.4 Pediatric Use




8.5 Geriatric Use


[see Clinical Pharmacology (12.3) and Clinical Studies (14)].

8.6 Hepatic Impairment


[see Clinical Pharmacology (12.3)].

8.7 Renal Impairment


[see Clinical Pharmacology (12.3)].

10 OVERDOSAGE



222

11 DESCRIPTION



233622

Finasteride





12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action




½ in vivoin vitro

12.2 Pharmacodynamics








12.3 Pharmacokinetics


Absorption 


Distribution 


[see also Use in Specific Populations (8.1)].Metabolism


Excretion
14
(0 to 24 hr)


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)



Pediatric

[see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]. Gender
[see Contraindications (4), Warnings and Precautions (5.4 and 5.5) , Use in Specific Populations (8.1), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2)].


[See Clinical Pharmacology (12.3) , Use in Specific Population (8.5)]


 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)


Race


Hepatic Impairment


Renal Impairment
14

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility


(0 to 24 hr)(0 to 24 hr)

in vitroin vitroin vitroin vivo

14 CLINICAL STUDIES

14.1 Monotherapy





Effect on Symptom Score




Figure 1Symptom Score in A Long-Term Efficacy and Safety Study


Finasteride




Effect on the Need for Surgery



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
 
 







Finasteride

Effect on Maximum Urinary Flow Rate




Effect on Prostate Volume




                                                 Figure 3
        Prostate Volume in A Long-Term Efficacy and Safety Study

Finasteride

Prostate Volume as a Predictor of Therapeutic Response





14.3 Summary of Clinical Studies


16 HOW SUPPLIED/STORAGE AND HANDLING



NDC
NDC
NDC
NDC
NDC

Storage and Handling



see Warnings and Precautions (5.4), Use in Specific Populations (8.1) and Patient Counseling Information (17.2)].

17 PATIENT COUNSELING INFORMATION


[See FDA-Approved Patient Labeling.]

17.1 Increased Risk of High-Grade Prostate Cancer


[see Indications and Usage (1.3), Warnings and Precautions (5.2), and Adverse Reactions (6.1)].

17.2 Exposure of Women — Risk to Male Fetus


[see Contraindications (4), Warnings and Precautions (5.4), Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].

17.3 Additional Instructions


[see Adverse Reactions (6.1)].
[see Adverse Reactions (6.1)].


Finasteride

Patient Information


Finasteride Tablets USP are for use by men only.


What are finasteride tablets USP?


Who should NOT take finasteride tablets USP?


Do Not Take finasteride tablets USP if you are:
“A warning about finasteride tablets USP and pregnancy”.


A warning about finasteride tablets USP and pregnancy:



How should I take finasteride tablets USP?






What are the possible side effects of finasteride tablets USP?

















What you need to know while taking finasteride tablets USP:
 
 You should see your doctor regularly while taking finasteride tablets USP.
Checking for prostate cancer.
About Prostate-Specific Antigen (PSA).

How should I store finasteride tablets USP?


Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.




 
What are the ingredients in finasteride tablets USP?
 
Active ingredients

Inactive ingredients:

What is BPH?









What finasteride tablets USP does:






Finasteride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL




Finasteride

Finasteride

Finasteride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65977-5025
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FINASTERIDE FINASTERIDE 5 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
DOCUSATE SODIUM
MAGNESIUM STEARATE
FD&C BLUE NO. 2
HYPROMELLOSES
talc
titanium dioxide
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
BLUE 6 mm H;37 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 100 in 1 BOTTLE
3 1000 in 1 BOTTLE
4 90 in 1 BOTTLE
5 500 in 1 BOTTLE
6 NDC:65977-5025-4 48 in 1 CONTAINER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090061 2010-06-07


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