HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CARDURA XL safely and effectively. See full prescribing information for CARDURA XL.
CARDURA® XL (doxazosin mesylate extended release tablets)
Initial U.S. Approval: 1990
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
4 mg and 8 mg tablets (3)
Patients with known sensitivity to doxazosin, other quinazolines, or any of the inert ingredients (4)
WARNINGS AND PRECAUTIONS
Postural hypotension with or without syncope may occur in the first few hours after administration. (5.1)
Intraoperative Floppy Iris Syndrome has been observed during cataract surgery in some patients. Advise patients considering cataract surgery to tell their ophthalmologist that they have taken CARDURA XL tablets. (5.2)
Advise patients to be screened for the presence of prostate cancer prior to treatment and at regular intervals afterwards. (5.4)
The most commonly reported adverse reactions from clinical trials are asthenia, headache, hypotension, and dizziness. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Caution should be exercised when concomitantly administering CARDURA XL with a strong cytochrome P450 (CYP) 3A4 inhibitor. (7.1)
Concomitant administration of CARDURA XL with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. (7.3)
USE IN SPECIFIC POPULATIONS
Geriatric: Hypotension with CARDURA XL is more prevalent in patients 70 years or older. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
No Current Announcements.
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