DOXAZOSIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

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 available as tablets for oral administration. Each tablet contains doxazosin mesylate, USP equivalent to 1 mg, 2 mg or 4 mg of doxazosin. The 2 mg are available as pink round tablets debossed with M over D10 on one side of the tablet and scored on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5659-0 Recommended Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXAZOSIN- DOXAZOSIN TABLET
CARDINAL HEALTH
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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 :
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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1
Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
Treatment of Hypertension
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 of hypertension: Initiate therapy at 1 mg once
daily. Dose may be titrated as needed, up to 16 mg
once daily. ( 2.3)
Tablets: 1 mg, 2 mg, 4 mg, 8 mg.
Hypersensitivity to doxazosin, other quinazolines, or any other
ingredient in doxazosin tablets. ( 4)
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)
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)
Hepatic Impairment: Monitor for hypotension. ( 8.6, 12.3)
SEE 17 FOR PATIENT COUNSELING INFORMATIO