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*
- 1 INDICATIONS & USAGE
- 2 DOSAGE & ADMINISTRATION
- 3 DOSAGE FORMS & STRENGTHS
- 4 FINASTERIDE CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
- 6 FINASTERIDE ADVERSE REACTIONS
- 7 DRUG INTERACTIONS
- 8 USE IN SPECIFIC POPULATIONS
- 10 OVERDOSAGE
- 11 FINASTERIDE DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
- 13 NONCLINICAL TOXICOLOGY
- 14 CLINICAL STUDIES
- 16 HOW SUPPLIED/STORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Patient Information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
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
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 |
|
||
Effect on Maximum Urinary Flow Rate
Effect on Prostate Volume
Figure 3
Prostate Volume in A Long-Term Efficacy and Safety Study
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)].
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:
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FinasterideFinasteride TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
