Finasteride is the generic equivalent of the brand-name drug Finasteride. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Finasteride through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS & USAGE Finasteride tablets, are 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 acute urinary retention • 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 is 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 pros…
Adverse Reactions
6 ADVERSE REACTIONS The drug-related adverse reactions, reported in ≥1% in patients treated with finasteride 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 Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducte…
Drug Interactions
7 DRUG INTERACTIONS 7.1 Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. 7.2 Other Concomitant Therapy Although specific interaction studies were not performed, f…
Dosage & Administration
2 DOSAGE & 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 tablet is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)]. 2.2 Combination with Alpha-Blocker The reco…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). 17.1 Increased Risk of High-Grade Prostate Cancer Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, including finasteride tablets, compared to those treated with placebo in studies looking at the use of these drugs to prevent 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…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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