FINASTERIDE - finasteride tablet, film coated
Sun Pharma Global FZE
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 USP, 5 mg Initial U.S. Approval: 1992 RECENT MAJOR CHANGESINDICATIONS AND USAGEFinasteride tablets 5 mg are 5α-reductase inhibitors, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1):
Limitations of Use: Finasteride tablets 5 mg are not approved for the prevention of prostate cancer (1.3). DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHS5 mg film-coated tablets (3). CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe drug-related adverse reactions, reported in ≥1% in patients treated with finasteride tablets 5 mg and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash (6.1). To report SUSPECTED ADVERSE REACTIONS, contact CARACO Pharmaceutical Laboratories Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 8/2011 |
Year 1 (%) | Years 2, 3 and 4*
(%) |
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Finasteride | Placebo | Finasteride | Placebo | |
N = 1524 and 1516, finasteride vs placebo, respectively |
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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 |
Adverse Experience | Placebo (N=737) (%) | Doxazosin 4 mg or 8 mg* (N=756) (%) | Finasteride (N=768) (%) | Combination (N=786) (%) |
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Body as a whole | | | | |
Asthenia | 7.1 | 15.7 | 5.3 | 16.8 |
Headache | 2.3 | 4.1 | 2 | 2.3 |
Cardiovascular | ||||
Hypotension | 0.7 | 3.4 | 1.2 | 1.5 |
Postural Hypotension | 8 | 16.7 | 9.1 | 17.8 |
Metabolic and Nutritional | ||||
Peripheral Edema | 0.9 | 2.6 | 1.3 | 3.3 |
Nervous | ||||
Dizziness | 8.1 | 17.7 | 7.4 | 23.2 |
Libido Decreased | 5.7 | 7 | 10 | 11.6 |
Somnolence | 1.5 | 3.7 | 1.7 | 3.1 |
Respiratory | ||||
Dyspnea | 0.7 | 2.1 | 0.7 | 1.9 |
Rhinitis | 0.5 | 1.3 | 1 | 2.4 |
Urogenital | ||||
Abnormal Ejaculation | 2.3 | 4.5 | 7.2 | 14.1 |
Gynecomastia | 0.7 | 1.1 | 2.2 | 1.5 |
Impotence | 12.2 | 14.4 | 18.5 | 22.6 |
Sexual Function Abnormal | 0.9 | 2 | 2.5 | 3.1 |
Mean (± SD) | |
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Bioavailability | 63% (34 to 108%)*
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Clearance (mL/min) | 165 (55) |
Volume of Distribution (L) | 76 (14) |
Half-Life (hours) | 6.2 (2.1) |
Mean (± SD) | ||
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45 to 60 years old (n=12) | ≥70 years old (n=12) | |
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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 (1.5) | 8.2 (2.5) |
Patients (%)* | |||||
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Event | Placebo N=1503 | Finasteride N=1513 | Relative Risk† | 95% CI | P Value† |
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 scores ≥20 | 9.2 | 6.7 | |
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Bladder Stone | 0.4 | 0.5 | |
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Incontinence | 2.1 | 1.7 | |
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Renal Failure | 0.5 | 0.6 | |
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UTI | 5.7 | 4.9 | |
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Discontinuation due to worsening of BPH, lack of improvement, or to receive other medical treatment | 21.8 | 13.3 | |
Event | Treatment Group | ||||
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Placebo N=737 N (%) | Doxazosin N=756 N (%) | Finasteride N=768 N (%) | Combination N=786 N (%) | Total N=3047 N (%) |
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AUA 4-point rise | 100 (13.6) | 59 (7.8) | 74 (9.6) | 41 (5.2) | 274 (9) |
Incontinence | 8 (1.1) | 11 (1.5) | 9 (1.2) | 3 (0.4) | 31 (1) |
Recurrent UTI/urosepsis | 2 (0.3) | 2 (0.3) | 0 (0) | 1 (0.1) | 5 (0.2) |
Creatinine rise | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Total Events | 128 (17.4) | 85 (11.2) | 89 (11.6) | 49 (6.2) | 351 (11.5) |
Placebo N=534 | Doxazosin N=582 | Finasteride N=565 | Combination N=598 |
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Baseline Mean (SD) | 16.8 (6) | 17 (5.9) | 17.1 (6) | 16.8 (5.8) |
Mean Change AUA Symptom Score (SD) | -4.9 (5.8) | -6.6 (6.1) | -5.6 (5.9) | -7.4 (6.3) |
Comparison to Placebo (95% CI) | -1.8 (-2.5, -1.1) | -0.7 (-1.4, 0) | -2.5 (-3.2, -1.8) |
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Comparison to Doxazosin alone (95% CI) | -0.7 (-1.4, 0) |
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Comparison to Finasteride alone (95% CI) | -1.8 (-2.5, -1.1) |
FINASTERIDE
finasteride tablet, film coated |
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Labeler - Sun Pharma Global FZE (864347344) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Sun Pharmaceutical Industries | 650445203 | MANUFACTURE, ANALYSIS |