XATRAL XL 10/MG PR TAB 30/TAB

Indications

Approved Uses

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) (i.e., relief of lower urinary tract symptoms).

Dosage & Administration

Dosing by Condition

BPH/LUTS: 10 mg (one prolonged-release tablet) orally once daily, taken immediately after the same meal each day.

Initial Dose

10 mg once daily (prolonged-release tablet)

Maintenance Dose

10 mg once daily.

Maximum Dose

10 mg once daily.

Children's Dosage

Not approved for children.

How to Take

Swallow the 10 mg prolonged-release tablet whole with water immediately after the same meal each day; do not crush, chew, or split.

Side Effects

Side Effect Frequency

Common (≥1% to <10%): dizziness, headache, fatigue/asthenia; postural hypotension/syncope can occur (syncope is uncommon/rare but clinically important). Other reported effects include GI upset (e.g., nausea/abdominal pain/diarrhea), flushing, palpitations/tachycardia, rhinitis, and edema; rare/important: angina in patients with coronary disease and intraoperative floppy iris syndrome.

Safety & Warnings

Warnings & Precautions

Risk of postural hypotension/syncope especially at initiation; caution with cardiovascular disease and with antihypertensives/PDE5 inhibitors; discontinue/seek care if angina occurs or worsens; inform ophthalmologist before cataract surgery (IFIS); consider QT-prolongation risk; evaluate for prostate cancer before/while treating BPH; caution in severe renal impairment; not indicated for women/children.

Age Restriction

Not approved/recommended in patients <18 years; indicated for adult men with BPH (not for women/children).

Driving Warning

May cause dizziness or orthostatic hypotension; caution when driving or operating machinery

Drug Interactions

Interaction Severity

MAJOR/Contraindicated: potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) and concomitant use with other alpha-1 blockers (additive hypotension). MODERATE: PDE-5 inhibitors, antihypertensives, nitrates, and general anesthetics (additive BP lowering); moderate CYP3A4 inhibitors (e.g., diltiazem/verapamil) may increase exposure-monitor. MINOR: cimetidine (small increase in exposure).

Food Interaction

Take with food-specifically immediately after the same meal each day; avoid taking on an empty stomach due to increased hypotension risk. Grapefruit avoidance is not routinely required but caution is reasonable with strong CYP3A4 inhibitors.

Special Populations

Children

Not approved for children.

Elderly

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

Kidney Impairment

No adjustment in mild-moderate renal impairment; use caution in severe renal impairment (CrCl <30 mL/min) due to limited data and higher hypotension risk (not an absolute contraindication in most labeling).

Liver Impairment

Contraindicated in hepatic impairment (especially moderate to severe); if mild impairment is present, use only with caution and close monitoring if used at all.

Storage & Patient Advice

Stopping the Medicine

No taper is required, but do not stop without consulting the prescriber because urinary symptoms may recur and treatment should be individualized.

Patient Counseling

Take 10 mg once daily immediately after the same meal each day (food increases absorption; do not take on an empty stomach). Swallow the prolonged‑release tablet whole-do not crush, chew, or split. May cause dizziness/orthostatic hypotension or fainting, especially after the first doses-rise slowly; if faint, sit/lie down; avoid driving/operating machinery until effects are known. Avoid alcohol (can worsen hypotension/dizziness). Tell your ophthalmologist before cataract/eye surgery (risk of intraoperative floppy iris syndrome). Use caution/medical supervision with other blood‑pressure-lowering drugs, nitrates, and PDE‑5 inhibitors (e.g., sildenafil/tadalafil) due to additive hypotension risk. Continue as prescribed for BPH symptom control. Store below 25°C in the original blister.

Pharmacology

Mechanism of Action

Blocks postsynaptic alpha-1 adrenergic receptors in smooth muscle of the prostate, bladder neck, and urethra, relaxing smooth muscle and reducing bladder outlet resistance to improve urinary flow in BPH.

Onset of Action

Blood-pressure/vasodilatory effects can occur within hours of the first dose; improvement in urinary symptoms may begin within days and is typically evident within 1-2 weeks.

Duration of Effect

Approximately 24 hours (once-daily prolonged-release formulation); symptomatic benefit is maintained with continued daily dosing.

Bioavailability

Approximately 49% when taken with food; exposure/absorption is about 50% lower if taken fasting (therefore it should be taken after a meal).

Metabolism

Extensively hepatically metabolized, primarily by CYP3A4 (minor contributions from other pathways may occur); metabolites are largely inactive.

Excretion

Excreted mainly via feces/biliary (~69%) with a smaller renal/urinary component (~24%).

Protein Binding

Approximately 82% to 90% protein bound.

Product Information

Available Dosage Forms

Prolonged-release tablet (XL), Immediate-release tablet

Composition per Dose

Each prolonged-release tablet: 10 mg alfuzosin hydrochloride

Generic Availability

Yes

Urological Condition

BPH

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