Proscar: Clinically Proven BPH Symptom Relief and Hair Regrowth
Proscar
| Product dosage: 1mg | |||
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| Product dosage: 5mg | |||
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Proscar (finasteride) is a prescription medication specifically formulated to address two distinct yet common medical conditions: benign prostatic hyperplasia (BPH) in men and male pattern hair loss (androgenetic alopecia). As a 5-alpha-reductase inhibitor, it represents a cornerstone of long-term, non-surgical management strategies. This product card provides a comprehensive, expert-level overview of its pharmacology, clinical applications, and essential safety information for healthcare professionals and informed patients. Its targeted mechanism offers a well-tolerated approach to improving urinary flow and promoting hair retention and growth in eligible individuals.
Features
- Active Ingredient: Finasteride 5 mg (for BPH) / 1 mg (for hair loss, marketed as Propecia®).
- Drug Class: Specific, competitive inhibitor of Type II 5-alpha-reductase, an intracellular enzyme.
- Presentation: Film-coated, pentagonal-shaped tablets for oral administration.
- Mechanism: Converts testosterone to the more potent androgen dihydrotestosterone (DHT) in target tissues.
- Bioavailability: Approximately 63% following oral administration, unaffected by food.
- Half-life: Terminal elimination half-life is approximately 6-8 hours in men aged 18-60.
- Excretion: Primarily metabolized in the liver via the CYP3A4 enzyme system; excreted in feces and urine.
Benefits
- Significant Reduction in Prostate Volume: Leads to a measurable decrease in the size of the enlarged prostate gland over 6-12 months of treatment.
- Improved Urinary Flow and Symptom Score: Clinically and statistically significant improvements in maximum urinary flow rate (Qmax) and symptom scores (e.g., IPSS) compared to placebo.
- Reduced Risk of Acute Urinary Retention (AUR) and Surgery: Long-term use (≥4 years) is associated with a >50% reduction in the risk of developing AUR and the need for surgical intervention related to BPH.
- Hair Follicle Stimulation: For male pattern hair loss, it halts the progression of hair loss and stimulates regrowth in the vertex and anterior mid-scalp areas in a majority of men.
- Convenient Dosing: A single, once-daily oral tablet supports high adherence rates for chronic management.
- Well-Established Safety Profile: Decades of clinical use and post-marketing surveillance have confirmed its general tolerability for long-term therapy.
Common use
Proscar is primarily indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve urinary flow, reduce the incidence of acute urinary retention, and reduce the need for prostate-related surgery. While the 1mg dose (Propecia®) is formally indicated for male pattern hair loss, the 5mg Proscar tablet is sometimes used off-label and compounded for this purpose, though this is not recommended without direct physician oversight due to dosage inaccuracy risks.
Dosage and direction
- For BPH: The recommended dosage is one 5 mg tablet administered orally once a day, with or without food.
- For Male Pattern Hair Loss (using Propecia®): The recommended dosage is one 1 mg tablet administered orally once a day, with or without food.
- Administration: The tablet should be swallowed whole. It should not be crushed or broken due to the potential for absorption of the active ingredient through the skin, which is a serious precaution for women who are or may become pregnant.
- Duration: Treatment is long-term. A minimum of 6 months of therapy is usually required to assess the initial response for BPH and 12 months for hair growth. Continued administration is recommended to sustain benefit.
Precautions
- Pregnancy Warning (Category X): Finasteride is contraindicated in women who are or may become pregnant. Tablets must not be handled by women who are pregnant or could become pregnant due to the risk of absorption through the skin and the potential for causing abnormalities of the external genitalia in a male fetus.
- Prostate Cancer Evaluation: Prior to initiating therapy for BPH, patients should be evaluated to rule out other urological conditions, including carcinoma of the prostate. Proscar causes a decrease in serum PSA levels by approximately 50% in men with BPH. Any confirmed increase in PSA while on Proscar should be evaluated, as it may signal the presence of prostate cancer. Physicians should adjust the PSA value for accurate interpretation (e.g., double the PSA value for a patient on finasteride for ≥6 months).
- Blood Donation: Men being treated with Proscar should not donate blood until at least one month has passed after their final dose to prevent potential administration to a pregnant female recipient.
- Hepatic Impairment: Caution should be exercised in patients with liver function abnormalities, as finasteride is extensively metabolized in the liver.
Contraindications
- Hypersensitivity to finasteride or any component of the formulation.
- Use in women, particularly those who are pregnant, trying to conceive, or of childbearing potential.
- Use in pediatric patients.
Possible side effect
The majority of adverse reactions are mild and transient. The most common side effects are related to the sexual dysfunction associated with its endocrine effects.
- Common (>1%): Decreased libido, erectile dysfunction, ejaculation disorder (e.g., decreased ejaculate volume).
- Less Common (0.1% - 1%): Breast tenderness and enlargement (gynecomastia).
- Rare (<0.1%): Allergic reactions including rash, itching, hives, and swelling of the lips and face; testicular pain; depression.
- Post-Marketing Reports: Persistent sexual dysfunction (e.g., erectile dysfunction, diminished libido, ejaculatory disorders) that continued after discontinuation of the drug has been reported; however, the incidence and mechanism are not well understood.
Drug interaction
Formal drug interaction studies have not shown clinically significant interactions with several common medications. However, theoretical interactions exist.
- Theophylline: A small increase in theophylline clearance was observed, but this is not considered clinically relevant.
- Warfarin: No clinically meaningful effect on prothrombin time was observed in controlled clinical studies.
- Other 5-alpha-reductase inhibitors: Concomitant use with dutasteride is not recommended due to overlapping mechanisms and lack of additive benefit.
- Potent CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, ritonavir): May increase finasteride plasma concentrations, though the clinical impact is likely minimal.
Missed dose
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule resumed. Do not take a double dose to make up for a missed one.
Overdose
- Symptoms: No specific symptoms of overdose have been reported. Based on the drug’s safety profile, any overdose would be expected to be manageable.
- Management: In case of suspected overdose, supportive care and symptomatic treatment are indicated. Since finasteride is highly protein-bound, it is not expected to be dialyzable.
Storage
- Store at room temperature between 20°C to 25°C (68°F to 77°F).
- Excursions are permitted between 15°C and 30°C (59°F and 86°F).
- Keep the bottle tightly closed and stored in a dry place.
- Keep out of reach of children and women of childbearing potential.
Disclaimer
This information is 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.
Reviews
- Clinical Studies (BPH): The PLESS (Proscar Long-Term Efficacy and Safety Study), a 4-year, placebo-controlled trial involving over 3,000 men, demonstrated that Proscar 5 mg daily reduced the risk of acute urinary retention by 57% and the need for BPH-related surgery by 55% compared to placebo. It also significantly improved symptom scores and urinary flow rates.
- Clinical Studies (Hair Loss): A 5-year, placebo-controlled study of men with male pattern hair loss found that 90% of men taking finasteride 1 mg experienced visible hair regrowth or no further hair loss, compared to 25% in the placebo group. Vertex studies showed a 10% increase in hair count at 1 year and sustained benefit at 5 years.
- Patient Reports: Patient reviews often highlight the effectiveness in improving urinary symptoms and slowing/stopping hair loss. Common themes in negative reviews center on the experience of sexual side effects, which for a minority of users can be a reason for discontinuation. Satisfaction is generally high among those who respond to treatment without significant adverse effects.