DOXAZOSIN MESYLATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Golden State Medical Supply, Inc.

INN (International Adı):

DOXAZOSIN MESYLATE

Kompozisyon:

DOXAZOSIN 1 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Doxazosin mesylate tablets are indicated for the treatment of the signs and symptoms of BPH. Doxazosin mesylate 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 Press

Ürün özeti:

Doxazosin mesylate tablets, USP are available as 1 mg, white tablet, oval shape, partially bisected on one side, debossed with "1" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P16" on the other side; 2 mg, yellow tablet, oval shape, partially bisected on one side, debossed with "2" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P17" on the other side; 4 mg, orange tablet, oval shape, partially bisected on one side, debossed with "4" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P18" on the other side; and 8 mg, green tablet, oval shape, partially bisected on one side, debossed with "8" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P19" on the other side. Bottles of 100: 1 mg  NDC 60429-953-01    2 mg NDC 60429-954-01    4 mg NDC 60429-955-01    8 mg NDC 60429-956-01        Bottles of 1000: 1 mg NDC 60429-953-10   2 mg NDC 60429-954-10   4 mg NDC 60429-955-10   8 mg NDC 60429-956-10 Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

DOXAZOSIN MESYLATE- DOXAZOSIN MESYLATE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
DOXAZOSIN MESYLATE TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXAZOSIN MESYLATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DOXAZOSIN MESYLATE
TABLETS.
DOXAZOSIN MESYLATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Doxazosin mesylate is an alpha
adrenergic antagonist indicated for: (1)
Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
Treatment of Hypertension
DOSAGE AND ADMINISTRATION
1. 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)
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)
DOSAGE FORMS AND STRENGTHS
1. Tablets: 1 mg, 2 mg, 4 mg, 8 mg.
CONTRAINDICATIONS
1. Hypersensitivity to doxazosin, other quinazolines, or any other
ingredient in doxazosin mesylate
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 DAVA PHARMACEUTICALS AT
1-800-444-
4011OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
1. Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to
doxazosin and increased risk of
hypotension ( 7.1)
2. 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, 1