Alfuzosin

Alfuzosin is a selective antagonist of post-synaptic alpha 1 -adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.

• Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablet is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.ICD-10: N40.0

• Alfuzosin hydrochloride extended-release tablets are contraindicated for use: in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [ see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3) ]. with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ].contraindicated

The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day. The tablets should not be chewed or crushed. 10 mg once daily with food and with the same meal each day. ( 2 ) Tablets should not be chewed or crushed ( 2 , 12.3 )

Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates ( 5.1 ) Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min) ( 5.2 , 8.6 , 12.3 ) Use with caution in patients with mild hepatic impairment ( 5.3 , 8.7 , 12.3 ) Should not be used in combination with other alpha adrenergic antagonists ( 5.4 , 7.2 ) Prostate carcinoma should be ruled out prior to treatment ( 5.5 ) Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique ( 5.6) Discontinue alfuzosin hydrochloride extended-release tablets if symptoms of angina pectoris appear or worsen ( 5.8 ) Use with caution in patients with a history of QT prolongation or who are taking medications which prolong the QT interval ( 5.9 , 12.2 ) 5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of alfuzosin hydrochloride extended-release tablets. As with other alpha-adrenergic antagonists, there is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur. There may be an increased risk of hypotension/postural hypotension and syncope when taking alfuzosin hydrochloride extended-release tablets concomitantly with anti-hypertensive medication and nitrates.

Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800- 706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The incidence of adverse reactions has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received alfuzosin hydrochloride 10 mg extended-release tablets. In these trials, 4% of patients taking alfuzosin hydrochloride 10 mg extended-release tablets withdrew from the trial due to adverse reactions, compared with 3% in the placebo group. Table 1 summarizes adverse reactions that occurred in ≥2% of patients receiving alfuzosin hydrochloride extended-release tablets, and at a higher incidence than that of the placebo group. In general, the adverse reactions seen in long-term use were similar in type and frequency to the events described below for the 3-month trials.

8.1 Pregnancy Risk Summary Alfuzosin hydrochloride extended-release tablets are not indicated for use in women. There are no adequate data on the developmental risk associated with the use of alfuzosin hydrochloride extended-release tablets in pregnant women . Based on findings from animal studies alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at up to 1200 times the MRHD of 10 mg via AUC in rats and 3 times in rabbits, via body surface area. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancy is 2 to 4% and 15 to 20%, respectively. Data Animal data Alfuzosin was not teratogenic, embryotoxic or fetotoxic in rats at plasma exposure levels (based on AUC of unbound drug) up to 1200 times (maternal oral dose of 250 mg/kg/day) the maximum recommended human dose (MRHD) of 10 mg. In rabbits administered up to 3 times the MRHD (based on body surface area) (maternal oral dose of 100 mg/kg/day) no embryofetal toxicity or teratogenicity was observed. Gestation was slightly prolonged in rats at exposure levels (based on AUC of unbound drug) approximately 12 times (greater than 5 mg/kg/day oral maternal dose) the MRHD, but difficulties with parturition were not observed.

Metabolism

The pharmacokinetics of alfuzosin hydrochloride extended-release tablets have been evaluated in adult healthy male volunteers after single and/or multiple administration with daily doses ranging from 7.5 mg to 30 mg, and in patients with BPH at doses from 7.5 mg to 15 mg. Absorption The absolute bioavailability of alfuzosin hydrochloride extended-release 10 mg tablets under fed conditions is 49%.

Should overdose of alfuzosin hydrochloride extended-release tablets lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then the administration of intravenous fluids should be considered. If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed. Alfuzosin is 82% to 90% protein bound; therefore, dialysis may not be of benefit.

• Jun 12, 2003NDANDA021287Advanz Pharma
• Jul 18, 2011ANDAANDA079013Apotex Inc
• Jul 18, 2011ANDAANDA079057Sun Pharm
• Jan 17, 2012ANDAANDA090284Invagen Pharms
• Aug 30, 2012ANDAANDA079060Aurobindo Pharma Ltd
• Jan 28, 2016ANDAANDA203192Unichem

1. 1Dizziness3265.8%
2. 2Drug Ineffective3185.6%
3. 3Fatigue2865.1%
4. 4Dyspnoea2364.2%
5. 5Asthenia2023.6%
6. 6Diarrhoea1953.5%
7. 7Fall1873.3%
8. 8Nausea1813.2%
9. 9Hypotension1763.1%
10. 10Headache1673.0%
11. 11Off Label Use1592.8%
12. 12Drug Interaction1532.7%
13. 13Malaise1412.5%
14. 14Death1342.4%
15. 15Pneumonia1312.3%

The 10 most recently updated of 56 ClinicalTrials.gov registrations naming Alfuzosin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Alfuzosin and Mirabegron for Double-J Stent Symptoms
  Completed · Observational · 100 enrolled · University of Gaziantep
  NCT07018934updated 2025-06-13
• Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions
  Unknown · Phase 1 · Interventional · 44 enrolled · Pharma Nueva
  NCT06316336updated 2024-03-18
• The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions
  Unknown · Phase 1 · Interventional · 44 enrolled · International Bio service
  NCT06228339updated 2024-01-29
• Evaluation of Symptom-specific Goal Achievement
  Completed · Phase 4 · Interventional · 130 enrolled · Samsung Medical Center
  NCT00836823updated 2023-11-01
• Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)
  Completed · Interventional · 6 enrolled · University Hospitals Cleveland Medical Center
  NCT00256399updated 2022-08-15
• Intermittent Catheterization Versus Trial Without Catheter
  Unknown · Interventional · 200 enrolled · Moscow State University of Medicine and Dentistry
  NCT05094947updated 2021-10-26
• The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
  Completed · Phase 4 · Interventional · 232 enrolled · Asan Medical Center
  NCT00696761updated 2021-02-17
• Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
  Completed · Phase 3 · Interventional · 272 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT00103402updated 2020-06-12
• Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions
  Completed · Phase 2 · Interventional · 74 enrolled · Mayo Clinic
  NCT01834729updated 2019-01-29
• An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
  Completed · Phase 3 · Interventional · 74 enrolled · Chesapeake Urology Research Associates
  NCT00893113updated 2018-03-09

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• Terazosinalpha-Adrenergic Blocker80%

Frequently asked questions

How does Alfuzosin work?

Alfuzosin is a selective antagonist of post-synaptic alpha 1 -adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.

What is Alfuzosin used for?

According to FDA labeling, Alfuzosin carries indications including: Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablet is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Alfuzosin?

Alfuzosin is classified as Alpha-adrenoreceptor antagonists, alpha-Adrenergic Blocker, Adrenergic alpha-Antagonists, Adrenergic alpha1-Antagonists, Cytochrome P450 3A4 Inhibitors, Decreased Bladder Sphincter Tone, Decreased Urethra Smooth Muscle Tone, Prostatic Alteration.

What are the brand names for Alfuzosin?

Alfuzosin is marketed under brand names including UroXatral.

What are the contraindications for Alfuzosin?

Alfuzosin labeling lists contraindications including: Alfuzosin hydrochloride extended-release tablets are contraindicated for use: in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [ see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3) ]. with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ].. Always consult the full prescribing information and a clinician.