Alfuzosin for benign prostatic hyperplasia symptom relief

Alfuzosin hydrochloride extended-release tablets are used to treat the symptoms of benign prostatic hyperplasia (BPH), a condition involving enlargement of the prostate gland that causes urinary difficulties. This medication works by relaxing muscles in the prostate and bladder neck to improve urine flow.

This medicine is prescribed for adult men to relieve signs and symptoms of benign prostatic hyperplasia. It is not approved for the treatment of hypertension or for use in children.

Alfuzosin hydrochloride

Alfuzosin is an alpha-1 adrenergic antagonist which blocks alpha receptors in the smooth muscle of the prostate and bladder neck. This action relaxes these muscles, easing urine flow and reducing urinary symptoms caused by prostate enlargement.

The recommended dose is one 10 mg extended-release tablet taken once daily with food, always with the same meal each day. The tablet must not be chewed or crushed. It is important to follow this dosing schedule because absorption is significantly reduced without food.

• Moderate or severe hepatic impairment (Child-Pugh B or C).
• Concomitant use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir.
• Known hypersensitivity to alfuzosin or any tablet components.

• Postural hypotension/syncope: Alfuzosin can cause dizziness, low blood pressure, or fainting, especially within hours of the first dose or when combined with antihypertensive drugs or nitrates. Patients should avoid situations where fainting could result in injury.
• Severe renal impairment: Use caution in patients with creatinine clearance below 30 mL/min.
• Hepatic impairment: Contraindicated in moderate or severe liver impairment. Use cautiously in mild cases.
• Drug interactions: Contraindicated with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) due to increased drug levels. Not to be combined with other alpha-adrenergic blockers. Caution advised with PDE5 inhibitors due to risk of hypotension.
• Prostate cancer screening: Prostate cancer should be ruled out before initiating treatment because symptoms overlap with BPH.
• Intraoperative floppy iris syndrome (IFIS): Patients undergoing cataract surgery may experience complications related to prior or current use of alfuzosin. Inform your ophthalmologist.
• Priapism: Rarely, prolonged and painful erections unrelated to sexual activity may occur, requiring urgent medical attention.
• Coronary ischemia: Discontinue if angina symptoms appear or worsen.
• QT prolongation: Use with caution in patients with risk factors or taking drugs that prolong the QT interval.

Common side effects reported in clinical studies (≥2% incidence and higher than placebo) include dizziness, upper respiratory infection, headache, and fatigue.

Less frequent side effects (1–2% incidence) include abdominal pain, dyspepsia, constipation, nausea, impotence, bronchitis, sinusitis, and pharyngitis.

Post-marketing reports also include edema, tachycardia, chest pain, atrial fibrillation, diarrhea, vomiting, liver injury, rhinitis, priapism, rash, pruritus, urticaria, angioedema, toxic epidermal necrolysis, flushing, and thrombocytopenia.

• Potent CYP3A4 inhibitors: Contraindicated due to increased alfuzosin levels (e.g., ketoconazole, itraconazole, ritonavir).
• Other alpha-adrenergic antagonists: Avoid combination due to potential additive effects.
• Antihypertensives and nitrates: Increased risk of hypotension and syncope.
• PDE5 inhibitors: Caution advised; combined vasodilatory effects may cause symptomatic hypotension.

Alfuzosin is not indicated for use in women. Animal studies showed no fetal harm at very high doses, but human data are lacking. There is no information on alfuzosin presence in breast milk or effects on nursing infants.

This product is not approved for pediatric use; clinical trials showed no benefit in children with neurologic bladder dysfunction.