Proscar

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Proscar on Prescriptsy

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Proscar is a branded prescription medicine containing finasteride 5 mg, a selective type II 5-alpha reductase inhibitor licensed in the United Kingdom for the treatment and control of benign prostatic hyperplasia (BPH).

BPH is one of the most common conditions affecting men over 50 years of age, with histological evidence of prostatic enlargement present in approximately 50% of men by age 60 and up to 90% by age 85.

It causes lower urinary tract symptoms (LUTS) including urinary hesitancy, weak stream, frequency, nocturia, urgency, and incomplete bladder emptying, significantly affecting quality of life.

This page provides a comprehensive clinical overview of Proscar, including how finasteride works in BPH, clinical evidence, dosing guidance, side effects, safety warnings, and how to obtain a prescription in the UK.

It is written for patients who have been prescribed Proscar or who are considering treatment for BPH-related urinary symptoms.

Important safety information about Proscar

Before reading further, note the following key safety points about Proscar.

• Proscar is for men only. It must not be taken by women or children.
• Pregnant women or women who may become pregnant must not handle crushed or broken Proscar tablets, as finasteride can be absorbed through the skin and may harm a developing male foetus.
• Proscar reduces serum PSA levels by approximately 50%. Inform any clinician performing a PSA test that you take finasteride.
• If you experience persistent sexual side effects, mood changes, breast lumps, or breast pain, stop Proscar and consult your GP.

What is benign prostatic hyperplasia

Benign prostatic hyperplasia is a non-cancerous enlargement of the prostate gland caused by proliferation of both stromal and epithelial cells within the transitional zone of the prostate.

The prostate surrounds the urethra just below the bladder, and as it enlarges, it can compress the urethra and obstruct the flow of urine.

This obstruction produces the characteristic lower urinary tract symptoms (LUTS) associated with BPH.

LUTS are broadly categorised into storage symptoms (urinary frequency, urgency, nocturia, urge incontinence), voiding symptoms (hesitancy, weak stream, straining, intermittency, terminal dribbling, incomplete emptying), and post-micturition symptoms (post-void dribbling, sensation of incomplete emptying).

The severity of symptoms does not always correlate with prostate size, as the degree of urethral compression depends on the anatomical relationship between the enlarging tissue and the urethra.

BPH in the UK

BPH is extremely common. It is estimated that approximately 3 million men in the UK are affected by bothersome LUTS related to prostatic enlargement.

The condition becomes increasingly prevalent with age.

NICE Guideline NG79 (Lower urinary tract symptoms in men) provides comprehensive guidance on the assessment, management, and treatment of LUTS in men, including the role of 5-alpha reductase inhibitors such as finasteride.

How Proscar works: mechanism of action

The growth and maintenance of the prostate gland is androgen-dependent.

Testosterone, the primary circulating androgen in men, is converted to dihydrotestosterone (DHT) within prostatic cells by the enzyme 5-alpha reductase.

DHT has approximately five times the binding affinity for the androgen receptor compared with testosterone and is the principal androgen responsible for prostate growth.

There are two isoenzymes of 5-alpha reductase: type I (predominant in the skin and liver) and type II (predominant in the prostate and hair follicle).

Finasteride 5 mg selectively inhibits the type II isoenzyme, reducing intraprostatic DHT concentrations by approximately 80 to 90%.

This leads to gradual involution of the hyperplastic prostatic tissue, with a reduction in prostate volume of approximately 20 to 30% over 6 to 12 months.

The resulting decrease in mechanical obstruction improves urinary flow rates, reduces the International Prostate Symptom Score (IPSS), and lowers the risk of acute urinary retention and the need for BPH-related surgery.

Unlike alpha-adrenergic blockers (tamsulosin, doxazosin, alfuzosin), which provide rapid symptomatic relief by relaxing prostatic smooth muscle and bladder neck tone, finasteride works gradually by addressing the hormonal mechanism underlying prostate enlargement.

For this reason, the two classes are often used in combination for men with moderate to severe symptoms and a significantly enlarged prostate.

Clinical evidence for Proscar

The PLESS study

The Proscar Long-Term Efficacy and Safety Study (PLESS) was a landmark 4-year, randomised, double-blind, placebo-controlled trial involving over 3,000 men with moderate to severe LUTS and enlarged prostates.

Finasteride 5 mg reduced prostate volume by a mean of 18% compared with a 14% increase with placebo.

Maximum urinary flow rate improved by a mean of 1.9 mL/s compared with 0.2 mL/s with placebo.

The risk of acute urinary retention was reduced by 57%, and the risk of BPH-related surgery was reduced by 55%.

The MTOPS study

The Medical Therapy of Prostatic Symptoms (MTOPS) study compared finasteride alone, doxazosin alone, and the combination in over 3,000 men with symptomatic BPH.

Combination therapy reduced the risk of overall clinical progression by 66%, compared with 34% for doxazosin alone and 34% for finasteride alone.

The combination was significantly more effective than either monotherapy in reducing the risk of acute urinary retention, the need for invasive therapy, and symptom deterioration.

The CombAT study

The Combination of Avodart and Tamsulosin (CombAT) study, although using dutasteride (a dual 5-alpha reductase inhibitor) rather than finasteride, provided further evidence supporting the rationale for combination therapy of 5-alpha reductase inhibitors with alpha-blockers in men with larger prostates and moderate to severe symptoms.

Dosage and administration

The recommended dose of Proscar is one 5 mg tablet taken once daily, with or without food.

Treatment should be continued indefinitely, as discontinuation leads to gradual regrowth of the prostate and return of symptoms over approximately 6 months.

Clinical benefit in symptom improvement and flow rate typically becomes apparent after 3 to 6 months, with maximum effect at 6 to 12 months.

Proscar may be prescribed alone or in combination with an alpha-blocker.

Combination therapy is particularly appropriate for men with a prostate volume greater than 30 to 40 mL and an IPSS of 8 or above.

Your prescriber will determine whether monotherapy or combination therapy is most appropriate based on your symptoms, prostate size, PSA level, and flow rate measurements.

If a dose is missed, take the next dose at the usual time. Do not take a double dose. No dose adjustment is required for renal impairment. Caution is advised in hepatic impairment as finasteride undergoes hepatic metabolism.

Side effects of Proscar

Sexual side effects

The most commonly reported adverse effects are sexual in nature and include decreased libido, erectile dysfunction, and reduced ejaculate volume.

In the PLESS trial, these effects were more frequent in the first year (approximately 6 to 8% of men) and declined with continued treatment (to approximately 0.3 to 0.6% by year 4).

Most sexual side effects resolved upon discontinuation. Post-marketing reports have described persistent sexual dysfunction in some men after stopping finasteride, and patients should be informed of this possibility.

Other side effects

Gynaecomastia (breast tenderness or enlargement) has been reported in approximately 0.4% of men. Depressed mood and anxiety have been reported. Testicular pain occurs rarely.

Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema are uncommon.

An increased incidence of high-grade prostate cancer (Gleason 7 to 10) was observed in the PCPT, although interpretation of this finding remains debated due to potential detection bias.

When to seek medical advice

Consult your GP if you experience persistent sexual dysfunction, mood changes, breast lumps, breast tenderness, or nipple discharge.

Seek immediate medical advice if you are unable to pass urine (acute urinary retention) or if you notice blood in your urine.

Contact NHS 111 for non-urgent medical queries. Report any suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Women and children

Proscar is indicated for men only. Finasteride is a teratogen that can cause hypospadias and other abnormalities of the external genitalia in a male foetus.

Pregnant women must not handle crushed or broken tablets. Men whose partners are pregnant or planning pregnancy should use a condom to prevent semen exposure.

PSA testing

Finasteride 5 mg reduces serum PSA by approximately 50%. The PSA value should be doubled to estimate the true level for comparison with age-appropriate reference ranges.

Any sustained or confirmed rise in PSA from the lowest level (nadir) during finasteride treatment should prompt further urological investigation, as it may indicate prostate cancer despite remaining within the normal absolute range.

Prostate cancer

BPH and prostate cancer can coexist. Proscar does not treat or prevent prostate cancer.

A digital rectal examination and PSA assessment should be performed before starting treatment and at regular intervals thereafter.

Any suspicion of prostate cancer should be investigated with appropriate specialist referral.

Mood changes

Post-marketing reports have described depressed mood and, rarely, suicidal ideation in men taking finasteride. Patients should be counselled about this possibility and advised to seek prompt medical attention if they develop new or worsening psychological symptoms.

Blood donation

Do not donate blood while taking Proscar and for at least one month after stopping treatment, to prevent finasteride-containing blood from being administered to a pregnant woman.

How to get a Proscar prescription in the UK

Proscar is a prescription-only medicine (POM) in the UK.

Your GP or urologist can prescribe it following clinical assessment, which typically includes a symptom questionnaire (IPSS), digital rectal examination, PSA blood test, urinary flow rate measurement, and post-void residual volume assessment.

Generic finasteride 5 mg tablets are widely available and are bioequivalent to Proscar. Your prescriber or pharmacist may offer a generic alternative, which is typically less expensive.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Repeat prescriptions for ongoing treatment can be arranged through your GP surgery. Regular review appointments are recommended to assess treatment response and monitor for side effects.

Living with BPH: practical advice

In addition to medical treatment with Proscar, the following lifestyle measures can help manage urinary symptoms associated with BPH.

Avoid excessive fluid intake in the evening to reduce nocturia. Limit caffeine and alcohol, which can irritate the bladder and increase urinary frequency.

Practice double voiding by waiting a few moments after finishing urination and then trying again to ensure complete bladder emptying.

Maintain a healthy weight, as obesity is associated with worsening LUTS. Stay physically active, as regular exercise is associated with improved urinary health.

When to seek urgent medical advice

Seek immediate medical attention if you are unable to pass urine (acute urinary retention), which presents as a painful, distended lower abdomen with an inability to void.

This is a medical emergency requiring catheterisation. Call 999 or attend A&E.

Also seek urgent advice if you notice visible blood in your urine (haematuria), severe flank or lower abdominal pain, fever with urinary symptoms (suggesting urinary tract infection), or symptoms of a severe allergic reaction.

Report any suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Proscar 5 mg film-coated tablets, Summary of Product Characteristics (EMC)
• Finasteride, British National Formulary (BNF)
• NICE NG79: Lower urinary tract symptoms in men
• NICE CKS: LUTS in men
• Prostate enlargement, NHS
• MHRA Yellow Card Scheme