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Drug Catalog - Product Detail

FINASTERIDE TB 5MG 90

NDC Mfr Size Str Form
00378-5036-77 MYLAN 90 5MG TABLET
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Description
11 DESCRIPTION Finasteride, USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N -(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The molecular formula of finasteride is C 23 H 36 N 2 O 2 and its molecular weight is 372.55. Its structural formula is: Finasteride is a white to off-white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, docusate sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (corn), titanium dioxide and triacetin. Finasteride Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Finasteride Tablets, USP are available containing 5 mg of finasteride, USP. The 5 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 151 on the other side. They are available as follows: NDC 0378-5036-93 bottles of 30 tablets NDC 0378-5036-77 bottles of 90 tablets NDC 0378-5036-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus [see Warnings and Precautions (5.3) , Use in Specific Populations (8.1) and Patient Counseling Information (17.2) ].
Indications & Usage
1 INDICATIONS AND USAGE Finasteride is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): • Improve symptoms • Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use: Finasteride tablets are not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: • Improve symptoms • Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 1.2 Combination with Alpha-Blocker Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score). 1.3 Limitations of Use Finasteride tablets are not approved for the prevention of prostate cancer.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Finasteride tablets may be administered with or without meals. Finasteride tablets may be administered with or without meals ( 2 ). Monotherapy: One tablet (5 mg) taken once a day ( 2.1 ). Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin ( 2.2 ). 2.1 Monotherapy The recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1) ]. 2.2 Combination with Alpha-Blocker The recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2) ].