Avodart

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Avodart on Prescriptsy

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Avodart contains the active ingredient dutasteride, a dual 5-alpha reductase inhibitor licensed in the United Kingdom for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

BPH is a non-cancerous enlargement of the prostate gland that becomes increasingly common with age, affecting approximately half of men over 50 and up to 80% of men over 70 in the UK.

The growing prostate compresses the urethra and causes lower urinary tract symptoms (LUTS) including hesitancy, weak stream, incomplete bladder emptying, frequency, urgency, and nocturia.

By blocking the conversion of testosterone to dihydrotestosterone (DHT), Avodart reduces prostate volume by approximately 25% over 6 to 12 months, improving urinary flow and reducing the long-term risk of acute urinary retention and BPH-related surgery.

This page provides a comprehensive clinical overview of how Avodart works, correct dosing, expected treatment timelines, side effects, safety warnings, and how to obtain a prescription in the UK.

Important safety information about Avodart

Before reading further, note the following critical safety points. Avodart is a prescription-only medicine (POM) in the United Kingdom and must only be taken under medical supervision.

• Women who are or may become pregnant must not handle damaged or opened Avodart capsules. Dutasteride is absorbed through the skin and may cause abnormalities of the external genitalia in a developing male foetus.
• Men taking Avodart should use a condom if their partner is or may become pregnant. Dutasteride is present in semen.
• Avodart reduces PSA (prostate-specific antigen) by approximately 50%. Any PSA result obtained during treatment must be doubled before comparison with normal reference ranges. A confirmed rise from the nadir value warrants further investigation even if the reading appears normal.
• Do not donate blood during treatment or for 6 months after stopping dutasteride.

What is benign prostatic hyperplasia (BPH)

BPH is the non-malignant growth of prostate tissue that progressively narrows the prostatic urethra.

The prostate is a walnut-sized gland situated just below the bladder and in front of the rectum.

It surrounds the upper portion of the urethra, the tube through which urine passes from the bladder out of the body.

As the prostate enlarges, it compresses the urethra and creates resistance to urinary flow.

The condition develops gradually and is strongly associated with ageing and exposure to androgens, particularly dihydrotestosterone (DHT).

DHT is formed from testosterone by the enzyme 5-alpha reductase in prostate cells.

BPH is histologically present in approximately 50% of men by age 50, though not all will develop bothersome symptoms.

Risk factors include family history, obesity, lack of physical activity, and metabolic syndrome.

Symptoms of BPH

Symptoms are broadly categorised into storage (irritative) and voiding (obstructive) groups.

Voiding symptoms include urinary hesitancy, a weak or intermittent stream, straining to pass urine, prolonged micturition, a sensation of incomplete bladder emptying, and terminal dribbling.

Storage symptoms include increased daytime frequency, nocturia (waking at night to urinate), urgency, and urge incontinence.

NICE recommends that men presenting with LUTS should be assessed using validated symptom scoring tools such as the International Prostate Symptom Score (IPSS).

A digital rectal examination (DRE), PSA test, urinalysis, and renal function tests are typically performed during initial assessment to exclude prostate cancer, urinary tract infection, and other causes of obstruction.

How Avodart works: mechanism of action

Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 isoforms of the intracellular enzyme 5-alpha reductase.

This enzyme converts testosterone to DHT, the androgen primarily responsible for prostatic growth.

Type 2 5-alpha reductase is the predominant isoform in prostate tissue, while type 1 is found in the skin, liver, and sebaceous glands.

By inhibiting both isoforms, dutasteride achieves a serum DHT reduction of over 90%, compared with approximately 70% achieved by finasteride (which inhibits type 2 only).

The sustained suppression of DHT leads to apoptosis of prostatic epithelial cells and a progressive reduction in prostate volume.

In the pivotal phase III studies and the 4-year ARIA study, dutasteride reduced prostate volume by approximately 25% from baseline, with statistically significant improvements in urinary symptom scores, peak urinary flow rate (Qmax), and risk of acute urinary retention and surgical intervention.

Testosterone levels may rise modestly during treatment (typically by 10 to 20%) as a compensatory response to DHT suppression. This increase is not clinically significant in most patients but should be noted when interpreting hormone panels.

Clinical evidence and NICE guidance

NICE Clinical Guideline NG45 (Lower urinary tract symptoms in men) recommends offering a 5-alpha reductase inhibitor to men with LUTS who have a prostate estimated to be larger than 30 g (or a PSA greater than 1.4 ng/mL as a proxy marker of prostate volume).

The guideline notes that 5-alpha reductase inhibitors are particularly suitable for men at risk of disease progression, specifically those with larger prostates, higher PSA values, or more severe symptoms.

The CombAT (Combination of Avodart and Tamsulosin) study demonstrated that dual therapy with dutasteride 0.5 mg and tamsulosin 0.4 mg daily was superior to either monotherapy in reducing the relative risk of acute urinary retention (AUR) and BPH-related surgery over 4 years.

Combination therapy also provided faster symptom relief than dutasteride alone, with the alpha-blocker component offering benefit from the first weeks of treatment while the dutasteride component delivered progressive long-term prostate volume reduction.

The REDUCE (Reduction by Dutasteride of Prostate Cancer Events) trial evaluated dutasteride for chemoprevention and found a 23% relative risk reduction in biopsy-detectable prostate cancer over 4 years.

However, there was a numerically higher incidence of Gleason 8 to 10 tumours in the dutasteride group.

As a result, dutasteride is not licensed for prostate cancer prevention, and PSA monitoring during BPH treatment remains essential.

Dosage and administration

The standard dose is one 0.5 mg soft capsule taken orally once daily, swallowed whole with water.

The capsule must not be chewed, crushed, or opened because the contents may cause oropharyngeal irritation.

Avodart can be taken with or without food at any consistent time of day.

Treatment with Avodart is long-term.

Meaningful clinical improvement in symptoms and urinary flow rate typically requires 3 to 6 months of continuous treatment, and maximum prostate volume reduction occurs at 12 to 24 months.

Men who discontinue treatment prematurely may not achieve the full therapeutic benefit. If Avodart is stopped, prostate regrowth and symptom recurrence are expected within several months.

No dose adjustment is required for elderly patients or for those with renal impairment. Dutasteride is extensively metabolised by CYP3A4 in the liver.

Patients with severe hepatic impairment have not been adequately studied, and Avodart should be prescribed with caution in this group.

Concomitant use of potent CYP3A4 inhibitors (such as ritonavir, ketoconazole, verapamil, and diltiazem) may increase dutasteride exposure. Your prescriber will review potential drug interactions before issuing a prescription.

Missed doses

If a dose is missed, take the next capsule at the usual time the following day. Do not take two capsules to compensate.

Due to the long half-life of dutasteride (approximately 5 weeks at steady state), occasional missed doses are unlikely to materially affect DHT suppression.

Side effects of Avodart

Common side effects

The most frequently reported adverse effects in clinical trials were related to sexual function.

Impotence (erectile dysfunction) occurred in approximately 6% of patients, decreased libido in approximately 4%, and ejaculation disorders (including reduced semen volume and anejaculation) in approximately 2%.

Gynaecomastia (breast enlargement) and breast tenderness were reported in approximately 1 to 2% of patients.

These effects were generally mild and resolved during continued treatment in the majority of cases, though a small proportion of men reported symptoms that persisted after discontinuation.

Uncommon and rare side effects

Uncommon side effects include dizziness and hair changes (alopecia or, paradoxically, increased body hair growth). Allergic reactions including rash, pruritus, urticaria, angioedema, and localised skin reactions are rare.

Post-marketing surveillance has identified reports of depressed mood and, very rarely, testicular pain and swelling.

In the CombAT study, patients receiving combination therapy with tamsulosin reported higher rates of dizziness, orthostatic hypotension, and ejaculatory dysfunction compared with either monotherapy alone.

Cardiac failure was reported at a higher rate in the combination group, though causality was not established.

When to seek medical advice

Contact your GP or call NHS 111 if you experience persistent erectile dysfunction, mood changes, breast lumps, or testicular pain.

Seek emergency care (call 999 or attend A&E) if you develop signs of a severe allergic reaction such as swelling of the face, lips, tongue, or throat, or difficulty breathing.

Warnings and precautions

Pregnancy exposure risk

Dutasteride is classified as a teratogen. It is absorbed through the skin and is present in semen.

Women who are or may become pregnant must not handle broken or leaking capsules.

Men whose partners are or may become pregnant should use a condom to prevent semen exposure.

Because of the long half-life, these precautions should continue for at least 6 months after the last dose.

PSA and prostate cancer screening

Avodart reduces serum PSA by approximately 50% after 6 months of treatment. A new baseline PSA should be established at that point.

Any confirmed increase from the nadir, even within the "normal" range, should prompt referral for urological assessment.

The 2-week wait urgent cancer referral pathway should be used where appropriate in line with NICE NG12 guidance on suspected cancer.

Blood donation

Men taking Avodart must not donate blood during treatment or for 6 months after discontinuation. This measure prevents the possibility of a pregnant female recipient being exposed to dutasteride via transfusion.

Drug interactions

Dutasteride is metabolised primarily by CYP3A4. Potent CYP3A4 inhibitors such as ritonavir, ketoconazole, itraconazole, verapamil, and diltiazem may increase dutasteride plasma concentrations.

Your prescriber should review your full medication list before starting Avodart. There are no clinically significant interactions with tamsulosin, warfarin, digoxin, or cholestyramine based on in-vivo interaction studies.

Avodart versus finasteride

Both dutasteride and finasteride are 5-alpha reductase inhibitors used in the management of BPH, but they differ in isoform selectivity and potency.

Finasteride inhibits only the type 2 isoform, achieving approximately 70% suppression of serum DHT. Dutasteride inhibits both type 1 and type 2, achieving over 90% DHT suppression.

In the EPICS head-to-head trial, dutasteride demonstrated a slightly greater reduction in prostate volume at 12 months, though both drugs produced clinically meaningful improvements in IPSS scores.

Your prescriber will consider factors including prostate size, symptom severity, tolerability, and cost when choosing between the two.

How to get an Avodart prescription in the UK

Avodart is classified as a prescription-only medicine (POM) in the UK and cannot be purchased over the counter from pharmacies. The most common route to obtaining a prescription is via your GP or through a secondary care urologist following referral.

An initial assessment will typically involve a review of symptoms using the IPSS questionnaire, a digital rectal examination (DRE), blood tests including PSA and renal function, and urinalysis.

An abdominal ultrasound or post-void residual volume measurement may be performed if indicated.

Based on these findings, your clinician will determine whether Avodart, an alpha-blocker, combination therapy, or referral for surgical assessment is the most appropriate management strategy.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) may also prescribe Avodart following a structured online consultation, provided that an appropriate clinical assessment has been completed and documented.

All UK prescriptions for Avodart are dispensed by registered pharmacies.

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

Living with BPH: practical management

Whilst Avodart addresses the underlying hormonal driver of prostatic enlargement, lifestyle modifications can complement pharmacological treatment. Reducing evening fluid intake may help with nocturia.

Limiting caffeine and alcohol, which are bladder irritants, can improve storage symptoms. Pelvic floor exercises have evidence of benefit for post-void dribbling.

Regular physical activity and maintaining a healthy weight are associated with a reduced risk of BPH progression.

Follow-up with your GP or urologist is important to monitor treatment response, check PSA levels (adjusted for the dutasteride effect), and assess for disease progression.

NICE recommends reviewing patients annually once stable on treatment, with earlier review if symptoms change or new symptoms develop.

When to seek urgent medical advice

Contact your GP or NHS 111 if you experience a significant worsening of urinary symptoms, blood in the urine (haematuria), recurrent urinary tract infections, or persistent inability to pass urine.

Complete urinary retention (inability to pass any urine despite a full bladder) is a medical emergency requiring catheterisation. In that situation, call 999 or attend A&E immediately.

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

Sources

• Avodart 0.5 mg Soft Capsules, Summary of Product Characteristics (EMC)
• Dutasteride, British National Formulary (BNF)
• NICE NG45: Lower urinary tract symptoms in men: management
• Benign prostate enlargement, NHS
• MHRA Yellow Card Scheme