Alfuzosin

Selected U.S. extended-release tablets treat signs and symptoms of benign prostatic hyperplasia in adult men. Assess for prostate cancer before treatment because conditions can coexist and produce similar symptoms. This profile does not establish a ureteral-stone or other off-label regimen.

Alfuzosin is not indicated to treat hypertension, for children, or for women. Its blood-pressure effects are a safety consideration, not an additional approved indication. This reference covers the selected U.S. 10 mg oral ER product, not non-U.S. immediate-release schedules.

Take one 10 mg ER tablet once daily with food, after the same meal each day. Swallow whole; do not split, chew, or crush. Absorption is approximately 50% lower while fasting. The selected label does not provide a lower-dose titration ladder, a 20 mg escalation, or a universal interruption/restart algorithm; do not copy another alpha blocker’s regimen.

Use caution with severe renal impairment (CrCl <30 mL/min); the label supplies no numerical renal reduction schedule. Mild hepatic impairment is unstudied and requires caution. Moderate or severe hepatic impairment (Child-Pugh B/C) is contraindicated, rather than managed by an invented reduced dose.

Do not use with moderate/severe hepatic impairment (Child-Pugh B/C), potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, or known hypersensitivity to alfuzosin or tablet components. Other alpha blockers are directed against in warnings/interactions; that distinction does not make coadministration acceptable.

The selected U.S. label has no boxed warning. Syncope, prohibited combinations, priapism, and hepatic contraindications still require active prevention and counseling.

Common trial reactions include dizziness, headache, fatigue, and upper respiratory tract infection. Postmarketing reports include arrhythmia, liver injury, hypersensitivity/angioedema, severe skin reactions, thrombocytopenia, and priapism; voluntary reports do not establish frequency. Overdose can cause hypotension requiring urgent cardiovascular support, supine positioning, IV fluids/vasopressors as indicated, and renal monitoring. High protein binding limits dialysis benefit; contact emergency/poison services rather than using a home reversal.

Potent CYP3A4 inhibitors are contraindicated because exposure rises. Diltiazem, a moderate inhibitor and antihypertensive, also raises exposure and can add hypotension; no universal reduced-dose workaround is supplied. Cimetidine modestly increases exposure. Review the complete medication list rather than treating a short example list as exhaustive.

Do not combine with other alpha adrenergic antagonists. Antihypertensive medicines and nitrates increase hypotension/syncope concerns; PDE5 inhibitors can produce symptomatic hypotension. QT-prolonging drugs require caution. Small digoxin and warfarin interaction studies do not show the studied interaction, but are not proof that every clinical combination is risk-free.

The product is not indicated for women. Adequate human pregnancy data and milk/infant-effect or milk-production data are absent. Animal reproductive findings do not establish human safety or an approved pregnancy regimen.

There is no pediatric indication. A neurologic-bladder trial in ages 2–16 did not demonstrate efficacy, and children under 2 were not studied. Older adult trials showed no overall efficacy/safety difference, but increased sensitivity remains possible; assess orthostasis, falls, and interacting medicines.

Exposure rises approximately 50% with renal impairment; severe-renal safety data are limited, so use caution below CrCl 30 without inventing a dose algorithm. Mild hepatic PK is unstudied. Child-Pugh B/C raises exposure roughly three- to fourfold and is contraindicated. Dialysis is not established as a dose-management strategy.

Alfuzosin blocks postsynaptic alpha-1 adrenoceptors in the prostate and related lower urinary tract tissues, relaxing smooth muscle and improving flow and BPH symptoms. Vascular effects account for hypotension concerns; do not assume symptom selectivity eliminates systemic effects.

Fed ER bioavailability is approximately 49%, with peak concentration about 8 hours after repeated 10 mg doses and apparent half-life about 10 hours. Protein binding is 82–90%. Extensive hepatic metabolism is primarily CYP3A4-mediated; about 11% of the dose is excreted unchanged in urine. Radioactivity after a labeled oral solution dose was predominantly recovered in feces. These data do not approve an IV or alternative oral formulation.

Assess urinary symptoms, prostate-cancer evaluation, blood-pressure symptoms/falls, cardiac/QT history, kidney/liver function, and interacting medicines before and during therapy. Reassess for new/worsening angina and severe adverse effects. Ask about planned eye surgery and any past alpha-blocker treatment; the label supplies no universal laboratory/ECG interval for every patient.

Take after the same meal, swallow intact, and avoid driving/hazardous activity until effects are known. If dizzy, lie down with legs/feet raised and contact the clinician if symptoms persist. Seek immediate care for a persistent painful erection, severe allergy, fainting, or significant overdose. Tell the eye surgeon about prior/current treatment and discuss all prescription, OTC, and herbal medicines.

Aurobindo 10 mg ER tablets are white/off-white, round, biconvex, film-coated, marked X on one side and 23 on the other. Representative 30-count bottle: NDC 84386-153-30. Other generic appearances differ; historical Uroxatral terminology does not establish current branded availability.

Covered formulation: oral alfuzosin hydrochloride ER tablet, 10 mg. No pediatric formulation, IV route, or non-U.S. immediate-release strength is substituted by this profile.

Store at 20–25°C, with permitted excursions 15–30°C. Dispense in a tight, light-resistant container; protect from light and moisture. Keep out of children’s reach and preserve tablets whole.