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CARDURA® (XL) (doxazosin mesylate extended release tablets) Highlights

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

Warnings and Precautions, Priapism (5.9)6/2015

INDICATIONS AND USAGE

CARDURA XL is an alpha1 adrenergic antagonist indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. (1)

CARDURA XL is not indicated for the treatment of hypertension. (1)

DOSAGE AND ADMINISTRATION

Recommended starting dose (initial therapy or switching from immediate-release): 4 mg once daily with breakfast (2.1, 2.2)

Dose range: 4 to 8 mg once daily (2.1)

DOSAGE FORMS AND STRENGTHS

4 mg and 8 mg tablets (3)

CONTRAINDICATIONS

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)

Caution should be used when administering to patients with preexisting severe gastrointestinal narrowing or coronary insufficiency. (5.3, 5.7)

Advise patients to be screened for the presence of prostate cancer prior to treatment and at regular intervals afterwards. (5.4)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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)

Hepatic Impairment: CARDURA XL is not recommended for patients with severe hepatic impairment and should be administered with caution to patients with mild or moderate hepatic impairment. (8.6, 12.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2017

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