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Alpha-1 Adrenoceptor Antagonist Pregnancy: Not applicable to this indication - alfuzosin is used in men. eMC §4.6: 'This section is not applicable given the therapeutic indications.' US label §8.1: 'Alfuzosin hydrochloride extended-release tablets are not indicated for use in women. There are no adequate data on the developmental risk associated with the use of alfuzosin hydrochloride extended-release tablets in pregnant women.' Animal data showed no teratogenic, embryotoxic or fetotoxic effect at up to 1200 times the maximum recommended human dose of 10 mg via AUC in rats and 3 times in rabbits by body surface area.

Alfuzosin Hydrochloride

Brand names: Xatral XL

Alfuzosin is an alpha-1 adrenoceptor antagonist used to relieve the lower urinary tract symptoms of benign prostatic hyperplasia and is also used as medical expulsive therapy and to facilitate trial without catheter.

Adult dose

Dose: 10 mg once daily
Route: Oral - extended-release (modified-release) tablet, swallowed whole; must not be chewed or crushed
Frequency: Once daily, taken with food and with the same meal each day
Max: Maximum 10 mg per day
SCOPE: covers alfuzosin for this page's primary use - lower urinary tract symptoms of benign prostatic hyperplasia in men - by the oral modified-release route only. The 10 mg once-daily figure is verbatim from the US label in this bundle: 'The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.' US labelling may differ from UK - confirm against the UK SPC for the specific modified-release product prescribed (e.g. Xatral XL). DIFFERENT UK PRODUCT IN THIS BUNDLE - DO NOT APPLY TO A MODIFIED-RELEASE TABLET: the eMC SPC fetched is for the immediate-release 'Alfuzosin HCl 2.5 mg film-coated tablets', whose regimen is 'The usual dose is one tablet three times daily. The dose may be increased to a maximum of 4 tablets (10 mg) per day depending on the clinical response'; those tablets 'should be swallowed whole. The first dose should be given just before bedtime.' ELDERLY AND TREATED HYPERTENSIVE PATIENTS (2.5 mg immediate-release product): 'As a routine precaution when prescribing alfuzosin to elderly patients (aged over 65 years) and the treated hypertensive patient, the initial dose should be 1 tablet in the morning and 1 tablet in the evening.' MAXIMUM: the 10 mg/day ceiling is the eMC SPC's explicit maximum total daily dose ('a maximum of 4 tablets (10 mg) per day'); the US extended-release label states no separate maximum, and the ceiling is identical to the once-daily dose shown. PAEDIATRIC: not indicated, so paedDose is null - eMC 'Efficacy of alfuzosin has not been demonstrated in children aged 2 to 16 years... Therefore, alfuzosin is not indicated for use in paediatric population'; US label 'Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.' Some sections of the product information we used were incomplete — check the full SPC.

Dose adjustments

Renal

eMC (2.5 mg immediate-release tablets): 'In patients with renal insufficiency, as a precaution, it is recommended that the dosing be started at Alfuzosin HCl 2.5mg twice daily adjusted according to clinical response.' US extended-release label: 'Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min).' No modified-release-specific renal dose reduction appears anywhere in this bundle.

Hepatic

eMC (2.5 mg immediate-release tablets): 'In patients with mild to moderate hepatic insufficiency, it is recommended that therapy should commence with a single dose of Alfuzosin HCl 2.5 mg Tablets/day to be increased to Alfuzosin HCl 2.5 mg Tablets twice daily according to clinical response. Alfuzosin HCl 2.5 mg tablets are contraindicated in patients with severe hepatic insufficiency.' US extended-release label: contraindicated in moderate or severe hepatic impairment (Child-Pugh B and C); use with caution in mild hepatic impairment. No modified-release hepatic dose reduction is given.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to alfuzosin, to another quinazoline (e.g. terazosin, doxazosin) or to any of the excipients (eMC §4.3); known hypersensitivity such as urticaria or angioedema (US label §4)
  • History of orthostatic hypotension (eMC §4.3)
  • Combination with other alpha-1-blockers and/or dopamine receptor agonists (eMC §4.3); should not be used in combination with other alpha adrenergic antagonists (US label §5.4, §7.2)
  • Severe hepatic insufficiency (eMC §4.3); moderate or severe hepatic impairment, Child-Pugh categories B and C (US label §4)
  • Co-administration with potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir (US label §4); eMC §4.4 advises avoiding potent CYP3A4 inhibitors including protease inhibitors, clarithromycin, telithromycin and nefazodone

Side effects

  • Common: faintness/dizziness, headache, vertigo; asthenia, malaise (eMC §4.8)
  • Common: nausea, abdominal pain, diarrhoea, dry mouth (eMC §4.8)
  • Common: tachycardia, palpitations; angina pectoris in patients with pre-existing coronary artery disease (eMC §4.8)
  • Uncommon: postural hypotension, syncope, drowsiness, flushing, rhinitis, oedema, chest pain, rash, vomiting, abnormal vision (eMC §4.8)
  • Very rare or not known: neutropenia, thrombocytopenia, atrial fibrillation, hepatotoxicity with hepatocellular injury and cholestatic liver disease, priapism, pruritus, urticaria, angioedema (eMC §4.8)
  • Intraoperative floppy iris syndrome (a variant of small pupil syndrome) during cataract surgery in patients on or previously treated with an alpha-1 blocker (eMC §4.4 and §4.8; US label §5.6)
  • Most common in US trials, incidence 2% or more and higher than placebo: dizziness, upper respiratory tract infection, headache, fatigue (US label §6.1)

Monitoring

  • Blood pressure at the start of treatment - 'Blood pressure should be monitored at the start of treatment. A reduction in blood pressure may arise in individual cases' (eMC §4.4)
  • Postural hypotension and syncope, which may develop within a few hours of a dose; greater risk in elderly patients and those on antihypertensive medication or nitrates (eMC §4.4; US label §5.1)
  • Digital rectal examination before treatment and regularly during treatment, with a PSA test also carried out if required (eMC §4.4)
  • Exclude other conditions that may cause the same symptoms as benign prostatic hyperplasia before starting, and rule out prostate carcinoma prior to treatment (eMC §4.4; US label §5.5)
  • Evaluate patients with congenital QTc prolongation, a known history of acquired QTc prolongation, or taking drugs known to increase the QTc interval, before and during administration (eMC §4.4; US label §5.9)
  • Discontinue if angina pectoris reappears or worsens (eMC §4.4; US label §5.8)
  • Cataract surgery: intraoperative floppy iris syndrome may require modifications to the surgical technique in patients on or previously treated with an alpha-1 blocker (eMC §4.4; US label §5.6)

Clinical monograph

How it works

It selectively blocks alpha-1 adrenoceptors in the smooth muscle of the prostate, bladder neck and prostatic urethra, reducing outflow resistance and improving urinary flow.

Prescribing in practice

  • It can cause postural hypotension, dizziness and syncope, especially with the first dose, in the elderly and when combined with antihypertensives or PDE5 inhibitors, so advise caution on standing.
  • Stop before cataract surgery is planned and inform the ophthalmologist, as it is associated with intraoperative floppy iris syndrome even after discontinuation.
  • Avoid co-administration with potent CYP3A4 inhibitors, which raise its plasma levels, and use cautiously in hepatic impairment.

Monitoring

Monitor blood pressure, particularly after initiation and dose changes, and review symptom relief.

Counselling the patient

  • Stand up slowly, especially when starting treatment, as you may feel faint or dizzy.
  • Tell your eye surgeon you take or have taken this medicine before any cataract operation.
  • Take it consistently after the same meal each day as advised.

Evidence & guidelines

Alfuzosin is an established treatment for benign prostatic hyperplasia symptoms, supported by the SPC and NICE guidance on lower urinary tract symptoms.

Reference: NICE NG104 (Lower urinary tract symptoms in men, 2022); EAU Guidelines on Non-neurogenic Male LUTS (2024); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Pathways