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CARDURA® Highlights (doxazosin mesylate tablets)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CARDURA safely and effectively. See full prescribing information for CARDURA.

CARDURA® (doxazosin mesylate) tablets, for oral use
Initial U.S. Approval: 1990

INDICATIONS AND USAGE

CARDURA is an alpha1 adrenergic antagonist indicated for: (1)

  • Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
  • Treatment of Hypertension

DOSAGE AND ADMINISTRATION

  • For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose maybe titrated at 1 to 2 week intervals, up to 8 mg once daily.(2.2)
  • For the treatment hypertension: Initiate therapy at 1 mg once daily. Dose may be titrated as needed, up to 16 mg once daily. (2.3)

DOSAGE FORMS AND STRENGTHS

  • Tablets: 1 mg, 2 mg, 4 mg, 8 mg.

CONTRAINDICATIONS

  • Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in CARDURA. (4)

WARNINGS AND PRECAUTIONS

  • Postural hypotension with or without syncope may occur. (5.1)
  • Risk of Intraoperative Floppy Iris Syndrome during cataract surgery. (5.2)
  • Screen for the presence of prostate cancer prior to treatment for BPH and at regular intervals afterwards. (5.3)

ADVERSE REACTIONS

The most commonly reported adverse reactions from clinical trials are Fatigue, malaise, hypotension, and dizziness. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to doxazosin and increased risk of hypotension. (7.1)
  • Concomitant administration of CARDURA with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. (7.2)

USE IN SPECIFIC POPULATIONS

  • Hepatic Impairment: Monitor for hypotension. (8.6, 12.3)

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

Revised: 3/2019

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch