DOXAZOSIN MESYLATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Par Pharmaceutical

INN (Mezinárodní Name):

DOXAZOSIN MESYLATE

Složení:

DOXAZOSIN 1 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DOXAZOSIN MESYLATE- DOXAZOSIN MESYLATE TABLET
PAR PHARMACEUTICAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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 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. (3)
CONTRAINDICATIONS
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
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 PA