ALFOSIN XR 10/MG PR TAB 30/TAB

Indications

Approved Uses

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men (relief of LUTS).

Dosage & Administration

Dosing by Condition

BPH/LUTS: 10 mg extended-release orally once daily, taken immediately after the same meal each day; maximum 10 mg once daily.

Initial Dose

10 mg once daily after a meal

Maintenance Dose

10 mg once daily.

Maximum Dose

10 mg once daily for the extended-release formulation.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Hepatic impairment: contraindicated in moderate to severe hepatic impairment; use caution in mild impairment. Renal impairment: no adjustment generally needed, but use caution in severe renal impairment (CrCl <30 mL/min). Administration: take immediately after the same meal each day; swallow whole (do not crush/chew).

How to Take

Swallow the tablet whole with a glass of water immediately after the same meal each day. Do not crush, chew, or split the tablet.

Side Effects

Common Side Effects

Dizziness, headache, fatigue/asthenia, orthostatic hypotension (postural dizziness/syncope), gastrointestinal upset (e.g., nausea/abdominal pain).

Side Effect Frequency

Common: dizziness, headache, fatigue/asthenia, and upper respiratory symptoms (e.g., rhinitis/URTI). Less common but clinically important: orthostatic hypotension/syncope, palpitations/tachycardia, GI upset (nausea/abdominal pain/diarrhea), flushing; rare/serious: priapism, angioedema, and intraoperative floppy iris syndrome (IFIS).

Safety & Warnings

Contraindications

Hypersensitivity to alfuzosin/excipients; hepatic impairment (at least moderate-severe; severe clearly contraindicated); concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir); concomitant use with other alpha-1 blockers.

Warnings & Precautions

Risk of postural hypotension/syncope (especially initiation/restart); assess for prostate cancer before/while treating LUTS; caution with cardiovascular disease/angina and with antihypertensives/nitrates/PDE5 inhibitors; inform ophthalmologist before cataract surgery (IFIS); caution in QT-prolongation risk; caution in severe renal impairment; avoid in clinically significant hepatic impairment; not intended for women/children.

Age Restriction

Not approved/recommended in patients <18 years; indicated for adult men with BPH.

Driving Warning

May cause dizziness, lightheadedness, or fainting (especially when rising from sitting or lying position); avoid driving or operating hazardous machinery until effects are known

Drug Interactions

Drug Interactions

Contraindicated with potent CYP3A4 inhibitors; avoid/contraindicated with other alpha-blockers; caution with antihypertensives and nitrates; caution with PDE5 inhibitors (risk of symptomatic hypotension); caution with anesthetics and moderate CYP3A4 inhibitors.

Interaction Severity

MAJOR/Contraindicated: strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) due to markedly increased exposure and hypotension risk. MAJOR: other alpha-blockers (additive hypotension; generally avoid). MODERATE: antihypertensives/nitrates and PDE5 inhibitors (additive hypotension); moderate CYP3A4 inhibitors (e.g., diltiazem/verapamil) increase levels-use caution.

Food Interaction

Take with food-specifically immediately after the same meal each day; avoid taking on an empty stomach.

Special Populations

Children

Not approved for children.

Elderly

Standard adult dosing (10 mg once daily); no dose adjustment required based on age alone, but elderly patients may be more susceptible to orthostatic hypotension - monitor blood pressure carefully at initiation

Kidney Impairment

No adjustment generally needed in mild-moderate renal impairment; use with caution in severe renal impairment (CrCl <30 mL/min).

Liver Impairment

Contraindicated in moderate to severe hepatic impairment; use with caution in mild impairment.

Storage & Patient Advice

Stopping the Medicine

No taper is required; may stop, but advise prescriber review because LUTS/BPH symptoms can recur.

Overdose

Expected toxicity: marked hypotension/syncope (± reflex tachycardia); management is supportive with supine positioning, IV fluids and vasopressors as needed; consider GI decontamination if early; dialysis is unlikely to help (high protein binding).

Patient Counseling

Take 1 tablet (alfuzosin XR 10 mg) once daily immediately after the same meal each day; swallow whole-do not crush, chew, or split. May cause dizziness/orthostatic hypotension (especially after the first dose or when restarting); rise slowly and use caution with driving/operating machinery until you know your response; alcohol can worsen dizziness/low blood pressure. Seek urgent care for fainting, chest pain, or a prolonged/painful erection (priapism). Tell your eye surgeon before cataract/glaucoma surgery (risk of intraoperative floppy iris syndrome). Avoid strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir) and review all medicines with your clinician. If a dose is missed, take the next dose after the next meal-do not double.

Monitoring Requirements

Monitor blood pressure/orthostatic symptoms especially at initiation, after interruptions, or with interacting hypotensive drugs; assess BPH symptom response (e.g., IPSS) and urinary flow/retention symptoms.

Pharmacology

Mechanism of Action

Blocks postsynaptic alpha-1 adrenergic receptors in smooth muscle of the prostate, bladder neck/base, and prostatic urethra, relaxing smooth muscle and reducing urethral resistance to improve urine flow in BPH.

Onset of Action

Hemodynamic effects (e.g., blood pressure lowering/orthostatic symptoms) can occur within hours after the first dose; improvement in lower urinary tract symptoms may begin within 2-3 days to 1 week, with maximal benefit typically over 2-4 weeks.

Duration of Effect

Hemodynamic and alpha-1 blockade effects persist for approximately 24 hours after a dose (supports once-daily extended-release dosing); symptom control is maintained with continued daily dosing.

Half-Life

Approximately 10 hours for the extended-release formulation.

Bioavailability

Approximately 49% when taken with food (fed state); bioavailability is significantly lower when fasting, so it should be taken after a meal.

Metabolism

Extensive hepatic metabolism, primarily via CYP3A4, producing mostly inactive metabolites.

Excretion

Elimination is mainly fecal/biliary (~69%) with renal excretion ~24%; only a small fraction is excreted unchanged in urine (about 11% of the dose).

Protein Binding

Approximately 82-90% protein bound.

Product Information

Available Dosage Forms

Extended-release (prolonged-release) oral tablet (this product: 10 mg XR).

Composition per Dose

Each prolonged-release tablet: 10 mg alfuzosin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

BPH

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