Each UROXATRAL extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The empirical formula of alfuzosin hydrochloride is C 19 H 27 N 5 O 4 •HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is: The tablet also contains the following inactive ingredients: colloidal silicon dioxide (NF), ethylcellulose (NF), hydrogenated castor oil (NF), hydroxypropyl methylcellulose (USP), magnesium stearate (NF), mannitol (USP), microcrystalline cellulose (NF), povidone (USP), and yellow ferric oxide (NF). Chemical Structure

UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Important Limitations of Use: UROXATRAL is not indicated for treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use UROXATRAL is not indicated for the treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population.

UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10. Extended-release tablet: 10 mg

The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, Uroxatral 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. 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 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 Prostate carcinoma should be ruled out prior to treatment Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique Discontinue UROXATRAL if symptoms of angina pectoris appear or worsen 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 UROXATRAL. 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 UROXATRAL concomitantly with anti-hypertensive medication and nitrates. Care should be taken when UROXATRAL is administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications

Patients with Renal Impairment Caution should be exercised when UROXATRAL is administered in patients with severe renal impairment (creatinine clearance < 30 mL/min)

Patients with Hepatic Impairment UROXATRAL is contraindicated for use in patients with moderate or severe hepatic impairment . Although the pharmacokinetics of UROXATRAL have not been studied in patients with mild hepatic impairment, caution should be exercised when UROXATRAL is administered to such patients

Drug-Drug Interactions Potent CYP3A4 Inhibitors : UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) since alfuzosin blood levels are increased . Other alpha adrenergic antagonists: UROXATRAL is an alpha adrenergic antagonist and should not be used in combination with other alpha adrenergic antagonist . Phosphodiesterase-5 (PDE5) Inhibitors: PDE5-inhibitors are also vasodilators. Caution is advised for concomitant use of PDE5-inhibitors and UROXATRAL, as this combination can potentially cause symptomatic hypotension

Prostatic Carcinoma Carcinoma of the prostate and benign prostatic hyperplasia (BPH) cause many of the same symptoms. These two diseases frequently coexist. Therefore, patients thought to have BPH should be examined to rule out the presence of carcinoma of the prostate prior to starting treatment with UROXATRAL

Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been observed during cataract surgery in some patients on or previously treated with alpha adrenergic antagonists. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient's ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha adrenergic antagonist therapy prior to cataract surgery

Priapism Rarely (probably less than 1 in 50,000), alfuzosin, like other alpha adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition )

Coronary Insufficiency If symptoms of angina pectoris should appear or worsen, UROXATRAL should be discontinued

Patients with Congenital or Acquired QT Prolongation Use with caution in patients with acquired or congenital QT prolongation or who are taking medications that prolong the QT interval .

Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including UROXATRAL, can potentially cause symptomatic hypotension 7.1 CYP3A4 Inhibitors UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased

Alpha Adrenergic Antagonists The pharmacokinetic and pharmacodynamic interactions between UROXATRAL and other alpha adrenergic antagonists have not been determined. However, interactions may be expected, and UROXATRAL should not be used in combination with other alpha adrenergic antagonists

Antihypertensive Medication and Nitrates There may be an increased risk of hypotension/postural hypotension and syncope when taking UROXATRAL concomitantly with anti-hypertensive medication and nitrates

PDE5 Inhibitors Caution is advised when alpha adrenergic antagonists, including UROXATRAL, are co-administered with PDE5 inhibitors. Alpha adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension .