DOXAZOSIN tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Preferred Pharmaceuticals Inc.

INN (שם בינלאומי):

DOXAZOSIN MESYLATE

הרכב:

DOXAZOSIN 4 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Doxazosin tablets, USP are indicated for the treatment of the signs and symptoms of BPH. Doxazosin tablets, USP 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

leaflet_short:

4 mg: Cream to yellow colored, round, biconvex uncoated tablets, debossed with “C4” on one side and breakline on other side, may have mottled appearance and supplied as follows: Recommended Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXAZOSIN- DOXAZOSIN TABLET
PREFERRED PHARMACEUTICALS 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, USP are alpha
adrenergic antagonist indicated for: (1)
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, 4 mg, 8 mg. (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
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 ACCORD HEALTHCARE INC.
AT 1-866-941-
7875 OR WWW.ACCORDHEALTHCARE.USOR FDA AT 1-800-FDA-1088OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
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: 5/2022
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 hypertension: Initiate therapy at 1 mg once daily.
Dose may be titrated as needed,
up to 16 mg once daily. ( 2.3)
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 with a phosphodiesterase-5
(PDE-5) inhibitor can result in
additive blo