Doxazosin 4 mg Tablets — Generic For Cardura — Upsher-Smith

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

DOXAZOSIN tablets, for oral use

Initial U.S. Approval: 1990

Indications And Usage

Doxazosin tablets are an alpha

1adrenergic 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 may be titrated at 1 to 2 week intervals, up to 8 mg once daily. (

2.2)

For the treatment of 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 doxazosin tablets. (

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 Upsher-Smith Laboratories, LLC at 1-855-899-9180 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 doxazosin tablets 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: 7/2021