Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Doxazosin Tablets, USP are available as tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, or 8 mg of doxazosin as the free base. NDC and Pack Size Strength Description NDC 62135-051-90 (Bottle of 90) 1 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "105" on the other side. NDC 62135-052-90 (Bottle of 90) 2 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "106" on the other side. NDC 62135-053-90 (Bottle of 90) 4 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "107" on the other side. NDC 62135-054-90 (Bottle of 90) 8 mg White to off-white, round scored tablets, debossed with "C" over bisect "E" on one side and "108" on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Avoid excessive heat. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Keep this and all medication out of the reach of children.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Doxazosin Tablets, USP 1 mg - NDC 62135-051-90 - 90's Bottle Label Doxazosin Tablets, USP 2 mg - NDC 62135-052-90 - 90's Bottle Label Doxazosin Tablets, USP 4 mg - NDC 62135-053-90 - 90's Bottle Label Doxazosin Tablets, USP 8 mg - NDC 62135-054-90 - 90's Bottle Label Doxazosin Tablets, USP 1 mg - NDC 62135-051-90 - 90's Bottle Label Doxazosin Tablets, USP 2 mg - NDC 62135-052-90 - 90's Bottle Label Doxazosin Tablets, USP 4 mg - NDC 62135-053-90 - 90's Bottle Label Doxazosin Tablets, USP 8 mg - NDC 62135-054-90 - 90's Bottle Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING Doxazosin Tablets, USP are available as tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, or 8 mg of doxazosin as the free base. NDC and Pack Size Strength Description NDC 62135-051-90 (Bottle of 90) 1 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "105" on the other side. NDC 62135-052-90 (Bottle of 90) 2 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "106" on the other side. NDC 62135-053-90 (Bottle of 90) 4 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "107" on the other side. NDC 62135-054-90 (Bottle of 90) 8 mg White to off-white, round scored tablets, debossed with "C" over bisect "E" on one side and "108" on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Avoid excessive heat. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Keep this and all medication out of the reach of children.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Doxazosin Tablets, USP 1 mg - NDC 62135-051-90 - 90's Bottle Label Doxazosin Tablets, USP 2 mg - NDC 62135-052-90 - 90's Bottle Label Doxazosin Tablets, USP 4 mg - NDC 62135-053-90 - 90's Bottle Label Doxazosin Tablets, USP 8 mg - NDC 62135-054-90 - 90's Bottle Label Doxazosin Tablets, USP 1 mg - NDC 62135-051-90 - 90's Bottle Label Doxazosin Tablets, USP 2 mg - NDC 62135-052-90 - 90's Bottle Label Doxazosin Tablets, USP 4 mg - NDC 62135-053-90 - 90's Bottle Label Doxazosin Tablets, USP 8 mg - NDC 62135-054-90 - 90's Bottle Label
Overview
Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23 H 25 N 5 O 5 · CH 4 O 3 S and the molecular weight is 547.6. It has the following structure: Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate. "Image Description"
Indications & 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
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 )
Warnings & 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 )
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 )
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.
Drug Interactions
Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to doxazosin and increased risk of hypotension. ( 7.1 ) Concomitant administration of doxazosin mesylate with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ( 7.2 )
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