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Proscar: Clinically Proven 5-Alpha Reductase Inhibitor for BPH
Proscar (finasteride) is a prescription medication specifically formulated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men. As a competitive and specific inhibitor of Type II 5-alpha reductase, an intracellular enzyme that converts testosterone to the potent androgen dihydrotestosterone (DHT), Proscar directly targets the hormonal pathway implicated in prostate enlargement. By significantly reducing serum and intraprostatic DHT levels, this oral therapy addresses the underlying cause of BPH, leading to a measurable reduction in prostate volume, improvement in urinary flow rate, and a decrease in symptoms associated with urinary obstruction. Its mechanism offers a well-tolerated, long-term medical management option for appropriate patients, reducing the need for surgical intervention.
Features
- Active Pharmaceutical Ingredient: Finasteride 5 mg.
- Pharmacological Class: 4-azasteroid compound, competitive inhibitor of Type II 5-alpha reductase.
- Standard Tablet Formulation: For oral administration.
- Proven Bioavailability: Not significantly affected by food.
- Extensive Clinical Data: Supported by the landmark PLESS (Proscar Long-Term Efficacy and Safety Study) and subsequent trials.
- Half-Life: Approximately 6 hours in men 18-60 years of age and 8 hours in men over 70 years of age.
Benefits
- Reduces Prostate Volume: Achieves a median reduction in prostate volume of approximately 20% after 24 months of therapy, directly alleviating physical obstruction.
- Improves Urinary Symptoms: Leads to a significant and sustained improvement in symptom scores, as measured by standardized tools like the American Urological Association (AUA) Symptom Index.
- Increases Urinary Flow Rate: Results in a measurable increase in maximum urinary flow rate (Qmax), reducing voiding difficulty and improving bladder emptying.
- Lowers Risk of Acute Urinary Retention (AUR): Demonstrated to reduce the risk of AUR and the need for BPH-related surgery by over 50% compared to placebo in long-term studies.
- Provides Long-Term Management: Offers a non-surgical, pharmacological approach for the chronic management of BPH, with effects maintained over years of treatment.
- Well-Characterized Safety Profile: Benefits are achieved with a generally favorable and predictable long-term tolerability profile for the majority of patients.
Common use
Proscar is indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate to achieve the following clinical endpoints: improve urinary flow, reduce the incidence of acute urinary retention, and reduce the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. It is intended for use in men who are experiencing moderate to severe symptoms of BPH, such as hesitancy, straining, weak stream, incomplete emptying, frequency, urgency, and nocturia. Treatment is considered a long-term therapeutic strategy, with maximum effects on prostate size typically observed after 6-12 months of continuous therapy.
Dosage and direction
The recommended dosage of Proscar is one 5 mg tablet administered orally once a day, with or without food. The tablet should be swallowed whole. Clinical response, particularly improvement in urinary flow and symptom scores, is not immediate. A minimum of six months of treatment may be necessary to adequately assess whether a therapeutic response has been achieved. Treatment is intended to be continuous; cessation of therapy leads to a gradual return of DHT levels to baseline and a subsequent reversal of the therapeutic benefit over a similar timeframe. Regular monitoring by a healthcare provider is essential to evaluate efficacy and tolerability.
Precautions
Prior to initiating treatment with Proscar, a proper diagnostic evaluation should be conducted to confirm BPH and to rule out other urological conditions, including prostate cancer, which may cause similar symptoms. A digital rectal examination (DRE) and, as appropriate, determination of prostate-specific antigen (PSA) are recommended before and periodically during treatment. Patients should be informed that Proscar is not indicated for use in women or children and that pregnant women or women who may become pregnant must not handle crushed or broken tablets due to the potential risk of absorption and subsequent risk to a male fetus. As with any chronic therapy, adherence to the prescribed regimen and scheduled follow-up appointments is crucial for optimal outcomes.
Contraindications
Proscar is contraindicated in the following patient populations:
- Patients with hypersensitivity to finasteride, any other 5-alpha-reductase inhibitors, or any of the tablet’s excipients.
- Women who are or may potentially be pregnant.
- Pediatric patients.
Possible side effect
While generally well-tolerated, Proscar is associated with a specific profile of adverse reactions related to its anti-androgenic mechanism. The most frequently reported events are sexual in nature. In controlled clinical studies, the incidence of these events decreased with continued therapy.
- Common (>1%): Erectile dysfunction, decreased libido (loss of sexual desire), ejaculation disorder (including decreased ejaculate volume).
- Less Common: Breast enlargement (gynecomastia) and/or breast tenderness.
- Rare: Allergic reactions, including rash, itching, hives, and swelling of the lips and face.
- Post-Marketing Reports: Testicular pain, depression, male breast cancer. A causal relationship with finasteride has not been established.
Drug interaction
Formal drug interaction studies have been conducted with Proscar. No clinically significant interactions have been identified with specific agents; however, theoretical and pharmacological considerations are important.
- No clinically significant interactions were observed with antipyrine, digoxin, propranolol, theophylline, or warfarin.
- Although specific interaction studies were not performed, concomitant use of other 5-alpha-reductase inhibitors (e.g., dutasteride) is not recommended due to the redundancy of mechanism and lack of additive benefit.
- Caution is advised with potent CYP3A4 inhibitors, though the clinical relevance is likely low due to multiple metabolic pathways for finasteride.
Missed dose
If a dose of Proscar is missed, the patient should take it as soon as remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. The patient should not take a double dose to make up for a missed one. Maintaining a consistent daily schedule is important for stable suppression of DHT levels.
Overdose
In reported cases of overdose with finasteride, no specific adverse events were identified. Single doses of up to 400 mg and multiple doses of up to 80 mg/day for three months have been administered without significant clinical effects. As there is no specific antidote for finasteride overdose, treatment should consist of general supportive measures and symptomatic management. Due to the extensive protein binding of finasteride, hemodialysis is not likely to be of significant benefit.
Storage
Proscar tablets should be stored at room temperature, between 15Β°C and 30Β°C (59Β°F and 86Β°F). The medication must be kept in its original container to protect it from light and moisture. It should be stored in a secure location out of the reach of children and pets to prevent accidental ingestion. Do not use the medication beyond the expiration date printed on the bottle.
Disclaimer
This information is intended for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content provided is based on the manufacturer’s prescribing information but may not be exhaustive.
Reviews
“After six months on Proscar, my AUA symptom score dropped from 18 to 8. The change in urinary flow is undeniable. The initial side effect of decreased libido was noticeable but has largely subsided after the first few months. For me, the trade-off for significantly improved quality of life is well worth it.” β M.B., 68
“As a urologist, I have prescribed finasteride for two decades. It remains a cornerstone of BPH medical management. Its efficacy in reducing prostate volume and the long-term risks of AUR and surgery is well-documented in the literature. I always ensure patients are fully informed about the potential for sexual side effects during the consent process.” β Dr. A. Reynolds, MD
“The reduction in prostate size confirmed by my follow-up ultrasound was impressive. However, I did experience persistent breast tenderness which was bothersome. My doctor and I decided the benefits still outweighed this side effect, but it’s something patients should be aware can occur.” β R.L., 72
“From a clinical trial perspective, the data for finasteride 5 mg is robust. The PLESS study was a landmark that clearly showed its disease-modifying capabilities, not just symptomatic relief. It fundamentally alters the natural history of BPH for many men.” β Clinical Research Coordinator



