Schedule H

Oral

• Alfuzosin prolonged-release (MR) tablets: 10 mg

• Alfuzosin immediate-release tablets: 2.5 mg (less commonly used)

(Note: 10 mg once-daily modified-release formulation is standard in clinical practice)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

⮞ Benign Prostatic Hyperplasia (BPH)

Parameter Recommendation

Starting dose 10 mg once daily (MR tablet)

Titration Not required

Usual maintenance dose 10 mg once daily

Maximum dose 10 mg per day

Key Clinical Notes:

• Administer after the same meal each day for consistent absorption

• Rule out orthostatic hypotension risk prior to initiation, particularly in patients receiving antihypertensives

• MR tablet must not be crushed, chewed, or split

Secondary Indications – Adults Only (Off-label)

⮞ Ureteric Stone Expulsion (Medical Expulsive Therapy) — OFF-LABEL

Parameter Detail

Dose 10 mg once daily

Duration 7–14 days

Supervision Specialist only / protocol-based practice

Evidence basis Indian urological practice; meta-analyses suggest benefit for distal ureteric stones <10 mm

Note Tamsulosin often preferred due to superior action on distal ureter

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable.

Alfuzosin is not indicated in children. Safety and efficacy have not been established in patients below 18 years of age.

Secondary Indications – Paediatric Doses (Off-label)

Indication Status

Neurogenic bladder / voiding dysfunction Reported in isolated cases — OFF-LABEL

Dose Not established

Supervision Paediatric urologist in tertiary care setting only

⚠️ Not recommended below 18 years except under paediatric urology specialist supervision in tertiary care setting.

• Severe hepatic impairment

• History of orthostatic hypotension

• Known hypersensitivity to alfuzosin or other quinazoline derivatives

• Concurrent use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)

• Combination with other α1-blockers (e.g., tamsulosin, silodosin) — additive hypotensive effect

• Orthostatic hypotension — increased risk in elderly or those on concurrent antihypertensives

• QT prolongation — exercise caution in patients with congenital long QT syndrome or those receiving QT-prolonging medications

• Cardiovascular instability (e.g., recent myocardial infarction, unstable angina)

• Renal impairment with CrCl <30 mL/min

• Advise patients to avoid driving or operating machinery after initial doses due to dizziness

• Intraoperative floppy iris syndrome (IFIS) — inform ophthalmologist prior to cataract surgery if alfuzosin exposure (current or past)

Parameter Detail

Risk category Not formally categorised in India; animal studies show no direct teratogenicity

Recommendation Not indicated in females; avoid use

Preferred alternatives Not applicable (drug indicated for male BPH)

Monitoring Not applicable

Parameter Detail

Compatibility Not indicated in lactating women

Excretion in milk No human data available

Recommendation Avoid; if off-label use required in exceptional cases, consider temporary discontinuation of breastfeeding

Infant monitoring Not applicable

Parameter Recommendation

Starting dose 10 mg MR once daily (same as adults)

Titration Not required due to MR formulation

Special considerations Monitor closely for postural hypotension; higher susceptibility to dizziness and falls

Practical tip Consider bedtime dosing to mitigate first-dose hypotension; exercise caution in frail patients or those on polypharmacy

Interacting Drug Mechanism / Effect Recommendation

Potent CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) Markedly increased alfuzosin plasma levels Contraindicated with MR tablet

Other α1-blockers (tamsulosin, prazosin, doxazosin) Additive hypotension Avoid combination

Nitrates (isosorbide, GTN) Enhanced hypotensive effect Avoid or use with extreme caution

QT-prolonging drugs (amiodarone, sotalol, haloperidol) Risk of torsades de pointes Use cautiously; ECG monitoring advised

Interacting Drug Mechanism / Effect Recommendation

PDE5 inhibitors (sildenafil, tadalafil) Additive hypotension Separate dosing times by ≥4 hours; close BP monitoring

Diltiazem / Verapamil Moderate CYP3A4 inhibition Monitor for enhanced hypotensive effect

Fluconazole Moderate CYP3A4 inhibition Avoid concurrent use of multiple QT-prolonging agents

Antihypertensives (ACE inhibitors, ARBs, beta-blockers) Additive BP lowering Monitor BP; adjust doses if symptomatic hypotension

• Dizziness

• Headache

• Fatigue

• Postural hypotension (especially during initial therapy)

• Nasal congestion

• Gastrointestinal discomfort or nausea

Adverse Effect Action Required

Syncope or severe hypotension Discontinue drug; supportive care

QT prolongation / torsades de pointes Discontinue drug; cardiology referral

Intraoperative floppy iris syndrome (IFIS) Inform ophthalmologist pre-surgery

Angioedema Immediate discontinuation; urgent medical care

Priapism (rare) Urological emergency

After initiation BP monitoring within 4–6 hours of first dose; assess for dizziness/syncope

Long-term Periodic BP checks; symptom inquiry for orthostatic symptoms; ECG if QT concern persists

• Alfusin (Cipla)

• Xatral OD (Sanofi)

• Alfoo (Sun Pharma / Ranbaxy)

• Alfuprost (Sun Pharma)

• Flosin (Dr Reddy's)

• Urimax-A (Cipla) — FDC with dutasteride

Price may vary; not currently under NPPA price control as standalone formulation.

• Preferred α-blocker in men with BPH who experience orthostatic intolerance with tamsulosin or silodosin

• Lower incidence of ejaculatory dysfunction compared to other α-blockers — suitable for sexually active patients

• Always administer after the same meal daily to ensure consistent drug absorption

• Inquire about planned or recent cataract surgery before initiation — IFIS risk persists even after drug discontinuation

• Avoid co-prescription with potent CYP3A4 inhibitors — risk of profound hypotension and QT prolongation

• Monitor BP carefully after first dose in elderly or patients on antihypertensive therapy

Alfuzosin; benign prostatic hyperplasia; BPH; alpha-blocker; uroselective; hypotension; elderly; tamsulosin-alternative; IFIS-risk; urology

RxIndia v0.2 — 10 Jan 2025

• CDSCO — Alfuzosin approved product insert

• Indian Pharmacopoeia

• API Textbook of Medicine (BPH section)

• AIIMS Hospital Formulary

• Urological Society of India — treatment protocols for BPH

• ICMR Clinical Guidelines for Urological disorders

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (α-blocker pharmacology)

• Indian urological practice guidelines on medical expulsive therapy (supportive for off-label indication)