Combodart

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Combodart on Prescriptsy

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Combodart is a dual-action medicine containing dutasteride 0.5 mg (a 5-alpha reductase inhibitor) and tamsulosin hydrochloride 0.4 mg (an alpha-1A adrenoceptor blocker) in a single capsule.

It is 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 one of the most common urological conditions affecting older men, with prevalence increasing from approximately 50% at age 50 to over 80% at age 70.

Combodart offers a single-capsule alternative to taking dutasteride and tamsulosin separately, simplifying treatment and supporting medication adherence.

The combination delivers both rapid symptom relief through alpha-blockade and long-term disease modification through hormonal prostate volume reduction.

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

Important safety information about Combodart

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

• Women who are or may become pregnant must not handle damaged or opened Combodart capsules. Dutasteride is absorbed through the skin and may cause birth defects in male foetuses.
• Men taking Combodart should use a condom if their partner is or may become pregnant. Dutasteride is present in semen.
• Combodart reduces serum PSA by approximately 50%. Any PSA result during treatment must be doubled before comparison with standard reference ranges. A confirmed rise from the lowest value warrants investigation.
• Inform your ophthalmologist before cataract or glaucoma surgery that you take or have taken tamsulosin, due to the risk of intraoperative floppy iris syndrome.
• Do not donate blood during treatment or for 6 months after stopping Combodart.

Understanding benign prostatic hyperplasia (BPH)

BPH is the non-malignant growth of prostate tissue that progressively narrows the prostatic urethra, causing lower urinary tract symptoms (LUTS).

The prostate surrounds the upper portion of the urethra just below the bladder, and as it enlarges, it creates mechanical obstruction to urinary flow (the static component) and increased smooth muscle tone in the prostate and bladder neck adds dynamic obstruction.

LUTS associated with BPH are classified into voiding (obstructive) and storage (irritative) symptoms.

Voiding symptoms include hesitancy, a weak or intermittent stream, straining, prolonged micturition time, 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.

These symptoms can significantly impair quality of life, disrupt sleep, and restrict social activities.

The two principal hormonal and mechanical drivers of BPH symptoms provide the rationale for combination therapy.

DHT, formed from testosterone by 5-alpha reductase in prostate cells, is the primary androgen driving prostatic growth.

Alpha-1 adrenergic receptors in prostatic smooth muscle and the bladder neck mediate dynamic obstruction.

Targeting both mechanisms simultaneously provides more comprehensive symptom control and disease modification than addressing either alone.

How Combodart works: mechanism of action

Dutasteride: 5-alpha reductase inhibition

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

By blocking both isoforms, it 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, progressively reducing prostate volume by approximately 25% over 6 to 12 months.

This reduces the static component of urethral obstruction and lowers the long-term risk of acute urinary retention (AUR) and BPH-related surgical intervention.

Tamsulosin: alpha-1A adrenoceptor blockade

Tamsulosin selectively blocks alpha-1A adrenoceptors, which are predominantly found in prostatic smooth muscle, the bladder neck, and the prostatic urethra.

By relaxing this smooth muscle, tamsulosin reduces dynamic urethral obstruction and improves urinary flow rate.

The selectivity for alpha-1A over alpha-1B receptors (found in blood vessel walls) means tamsulosin causes less systemic vasodilation and fewer blood pressure-related side effects than non-selective alpha-blockers such as doxazosin.

Symptom improvement typically begins within 1 to 2 weeks of starting treatment.

Rationale for combination therapy

Alpha-blockers provide rapid symptomatic relief but do not alter the natural history of BPH. 5-alpha reductase inhibitors modify disease progression but have a slow onset of clinical effect.

Combination therapy delivers the best of both approaches: early symptom relief from the alpha-blocker and sustained, progressive improvement from prostate volume reduction.

The CombAT study demonstrated that this strategy is superior to either monotherapy for long-term outcomes.

Clinical evidence: the CombAT study

The Combination of Avodart and Tamsulosin (CombAT) study was a landmark 4-year, randomised, double-blind trial involving over 4,800 men with moderate to severe BPH symptoms (IPSS 12 or above) and prostate volumes of 30 mL or greater.

Patients were randomised to dutasteride 0.5 mg alone, tamsulosin 0.4 mg alone, or the combination of both.

At 4 years, combination therapy was statistically superior to either monotherapy for the primary endpoints of symptom improvement (change in IPSS) and maximum urinary flow rate (Qmax).

Combination therapy reduced the relative risk of AUR by 67.6% compared with tamsulosin and by 19.6% compared with dutasteride.

The relative risk of BPH-related surgery was reduced by 70.6% compared with tamsulosin and by 31.1% compared with dutasteride.

Importantly, combination therapy provided clinically meaningful symptom improvement from month 3 onward (driven initially by tamsulosin) and continued to separate from both monotherapies through year 4 (driven by the progressive effect of dutasteride).

These results established combination therapy as the standard of care for men with moderate to severe BPH at risk of disease progression.

NICE guidance on BPH management

NICE Clinical Guideline NG45 (Lower urinary tract symptoms in men: management) recommends offering an alpha-blocker to men with moderate to severe LUTS as first-line pharmacotherapy.

A 5-alpha reductase inhibitor should be offered 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 surrogate marker of prostate volume).

Combination therapy with an alpha-blocker and a 5-alpha reductase inhibitor is recommended for men with bothersome moderate to severe LUTS and a prostate estimated to be larger than 30 g, particularly those at risk of disease progression.

Combodart provides this combination in a single capsule, supporting the NICE recommendation while simplifying the treatment regimen.

NICE also recommends that men considering pharmacotherapy should be counselled about the expected timeline of benefit, potential side effects (particularly sexual adverse effects), and the need for long-term treatment.

Dosage and administration

Take one Combodart capsule once daily, approximately 30 minutes after the same meal each day. The capsule must be swallowed whole with water.

Do not chew, crush, or open the capsule, as this may damage the modified-release tamsulosin pellets and cause oropharyngeal irritation from dutasteride.

Treatment is intended to be long-term. The tamsulosin component provides perceptible symptom improvement within 1 to 2 weeks.

The dutasteride component requires 3 to 6 months before additional clinical benefit becomes apparent, with maximum prostate volume reduction at 12 to 24 months.

If Combodart is discontinued, prostate regrowth and symptom recurrence are expected. Patients should not stop treatment without consulting their prescriber.

No dose adjustment is required for elderly patients or for those with mild to moderate renal impairment.

Combodart has not been studied in severe renal impairment or in patients with severe hepatic impairment and should be used with caution or avoided in these groups.

CYP3A4 inhibitors may increase dutasteride exposure; concurrent use should be discussed with the prescriber.

Missed doses

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

Due to the long half-life of dutasteride (approximately 5 weeks at steady state), occasional missed doses do not materially affect DHT suppression.

However, missing tamsulosin doses may result in a transient return of urinary symptoms.

Side effects of Combodart

Common side effects

The most frequently reported adverse effects relate to sexual function.

In the CombAT study, combination therapy was associated with higher rates of erectile dysfunction (approximately 9%), decreased libido (approximately 5%), ejaculation disorders including retrograde ejaculation and reduced semen volume (approximately 4%), and gynaecomastia and breast tenderness (approximately 2%) compared with either monotherapy.

Dizziness occurred in approximately 2% of patients, primarily related to the tamsulosin component.

Most sexual side effects resolve during continued treatment, though a small proportion of men report symptoms that persist after discontinuation. Dizziness is most common when starting treatment and tends to diminish with continued use.

Uncommon and rare side effects

Uncommon effects include postural hypotension, nasal congestion, headache, palpitations, and nausea. Allergic reactions including rash, pruritus, urticaria, angioedema, and localised oedema are rare.

Post-marketing reports have identified depressed mood, testicular pain and swelling, priapism (tamsulosin component), and, very rarely, Stevens-Johnson syndrome (tamsulosin component).

Intraoperative floppy iris syndrome (IFIS) has been reported during cataract surgery in patients taking or who have previously taken tamsulosin.

This condition causes the iris to billow and prolapse during surgery and can complicate the procedure.

Ophthalmologists must be informed of current or past tamsulosin use before eye surgery.

In the CombAT study, cardiac failure was reported at a slightly higher rate in the combination group than in either monotherapy group. A direct causal relationship was not established, but patients with pre-existing cardiac conditions should be monitored.

When to seek medical advice

Contact your GP or NHS 111 if you experience persistent erectile dysfunction, significant mood changes, breast lumps, or troublesome dizziness.

Seek emergency care (call 999 or attend A&E) if you develop signs of a severe allergic reaction (swelling of face, lips, tongue, or throat, difficulty breathing), a painful erection lasting more than 4 hours (priapism), or are unable to pass urine at all (acute urinary retention).

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

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 Combodart capsules.

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

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

PSA and prostate cancer screening

Combodart 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 lowest recorded value, even within the "normal" range, should prompt referral for urological assessment.

NICE NG12 (Suspected cancer: recognition and referral) two-week wait referral criteria apply where prostate cancer is suspected.

Postural hypotension

Tamsulosin may cause a reduction in blood pressure on standing, particularly after the first dose, during dose escalation, or when restarting after an interruption.

Patients should be advised to sit or lie down if they feel dizzy or lightheaded.

Caution is required when Combodart is used alongside antihypertensives, particularly other alpha-blockers (which must not be co-prescribed) and PDE5 inhibitors.

Blood donation

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

Drug interactions

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

Concurrent use of other alpha-blockers with Combodart may cause additive hypotension and is not recommended.

There are no clinically significant interactions with warfarin, digoxin, or cholestyramine based on in-vivo data.

How to get a Combodart prescription in the UK

Combodart is a prescription-only medicine available on the NHS.

Your GP can prescribe it following a clinical assessment that includes symptom evaluation using the IPSS questionnaire, a digital rectal examination, PSA testing, renal function tests, and urinalysis.

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

Referral to a urologist may be appropriate for patients with complex symptoms, suspected prostate cancer, or who are being considered for surgical intervention.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) may also prescribe Combodart following a structured online consultation that includes a comprehensive clinical assessment.

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

While Combodart addresses both the hormonal and mechanical drivers of BPH symptoms, lifestyle modifications can complement pharmacological treatment. Reducing evening fluid intake may improve nocturia.

Limiting caffeine and alcohol, which are bladder irritants, can improve storage symptoms.

Double voiding (waiting a few seconds after finishing urination, then trying again) may help with incomplete emptying. Pelvic floor exercises can improve 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 adjusted PSA levels, 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. Call 999 or attend A&E immediately.

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

Sources

• Combodart 0.5 mg/0.4 mg Hard Capsules, Summary of Product Characteristics (EMC)
• Dutasteride with tamsulosin hydrochloride, British National Formulary (BNF)
• NICE NG45: Lower urinary tract symptoms in men: management
• Benign prostate enlargement, NHS
• MHRA Yellow Card Scheme