Doxazosin mesylate

Doxazosin mesylate is an FDA drug label for the active ingredient DOXAZOSIN MESYLATE manufactured by Chartwell RX, LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230609.

Generic: DOXAZOSIN MESYLATE

Manufacturer: Chartwell RX, LLC

Product Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form:

NDC: 62135-051

Application: ANDA075646

Effective: 20230609

Indications & Usage

1 INDICATIONS AND USAGE Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1 ) Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment of Hypertension

Dosage & Administration

2 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 hypertension: Initiate therapy at 1 mg once daily. Dose may be titrated as needed, up to 16 mg once daily. ( 2.3 )

Contraindications

4 CONTRAINDICATIONS The use of doxazosin mesylate is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in doxazosin mesylate tablets. ( 4 )

Warnings

Not available.

Adverse Reactions

6 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 Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.