DOXAZOSIN- doxazosin mesylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

DOXAZOSIN MESYLATE

Composition:

DOXAZOSIN 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerou

Product summary:

Doxazosin Tablets, USP are supplied as follows: 1 mg: Each white to off-white, scored, round, biconvex compressed tablet, engraved with 590 over bisect on one side and TV on the other side, contains doxazosin mesylate equivalent to 1 mg doxazosin (free base). They are available in bottles of 100 tablets (NDC 0093-2070-01). 2 mg: Each white to off-white, scored, capsule-shaped, biconvex compressed tablet, engraved with 593 left of bisect on one side and TV on the other side, contains doxazosin mesylate equivalent to 2 mg doxazosin (free base). They are available in bottles of 100 tablets (NDC 0093-2069-01). 4 mg: Each white to off-white, scored, modified diamond-shaped, biconvex compressed tablet, engraved with 596 over bisect on one side and TV on the other side, contains doxazosin mesylate equivalent to 4 mg doxazosin (free base). They are available in bottles of 100 tablets (NDC 0093-2068-01). 8 mg: Each white to off-white, scored, round, biconvex compressed tablet, engraved TV over bisect 598 (TV/598) on one side and 8 on the other side, contains doxazosin mesylate equivalent to 8 mg doxazosin (free base). They are available in bottles of 100 tablets (NDC 0093-2067-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXAZOSIN- DOXAZOSIN MESYLATE TABLET
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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 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
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 mesylate. (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 TEVA AT 1-888-838-2872
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)
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: 11/2021
FULL PRESCRIBIN