UROXATRAL®
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use UROXATRAL safely and effectively. See full prescribing information for UROXATRAL.
UROXATRAL® (alfuzosin HCl) extended-release tablets
Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
Indications and Usage (1.1) 12/2010
Warnings and Precautions, PDE5 inhibitors (5.4) 04/2010
Warnings and Precautions, Priapism (5.7) 12/2010
INDICATIONS AND USAGE
UROXATRAL is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1)
Important Limitations of Use:
UROXATRAL is not indicated for treatment of hypertension. (1.1)
UROXATRAL is not indicated for use in the pediatric population. (1.1, 8.4, 12.3)
DOSAGE AND ADMINISTRATION
10 mg once daily with food and with the same meal each day. (2)
Tablets should not be chewed or crushed (2, 12.3)
DOSAGE FORMS AND STRENGTHS
Extended-release tablet: 10 mg (3)
CONTRAINDICATIONS
•Moderate or severe hepatic impairment (4, 8.7, 12.3)
•Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) (4, 5.4, 7.1, 12.3)
•Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients (4, 6.2)
WARNINGS AND PRECAUTIONS
•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 UROXATRAL 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)
ADVERSE REACTIONS
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 sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including UROXATRAL, can potentially cause symptomatic hypotension (5.4, 7.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling 
Revised: 10/2011
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FULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND