? Prescribing info.
(alfuzosin HCl) extended-release tablets Rx only
Item info.
These highlights do not include all the info. needed to use UROXATRAL safely and effectively. See full prescribing info. for UROXATRAL.
UROXATRAL? (alfuzosin HCl) extended-release tablets
Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
Indications and USAge 12/2010
Warnings and Precautions, PDE5 inhibitors 04/2010
Warnings and Precautions, Priapism 12/2010
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
10 mg once daily with food and with the same meal each day.
Tablets should not be chewed or crushed (2, 12.3)
DOSAGE FORMS AND STRENGTHS
Extended-release tablet: 10 mg
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 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 (5.4, 7.2)
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 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 higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue.
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)
(alfuzosin HCl) extended-release tablets
Rx only
Item info.
These highlights do not include all the info. needed to use UROXATRAL safely and effectively. See full prescribing info. for UROXATRAL.
UROXATRAL? (alfuzosin HCl) extended-release tablets
Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
Indications and USAge
12/2010
Warnings and Precautions, PDE5 inhibitors
04/2010
Warnings and Precautions, Priapism
12/2010
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
10 mg once daily with food and with the same meal each day.
Tablets should not be chewed or crushed (2, 12.3)
DOSAGE FORMS AND STRENGTHS
Extended-release tablet: 10 mg
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 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 (5.4, 7.2)
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 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 higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue.
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)
