DOXAZOSIN- doxazosin mesylate tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

PD-Rx Pharmaceuticals, Inc.

INN (שם בינלאומי):

DOXAZOSIN MESYLATE

הרכב:

DOXAZOSIN 4 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Doxazosin Tablets, USP are available as tablets for oral administration. Each tablet contains doxazosin mesylate, USP equivalent to 4 mg of doxazosin. The 4 mg tablets are blue, round tablets debossed with M over D11 on one side of the tablet and scored on the other side. They are available as follows: NDC 55289-600-30 bottles of 30 tablets NDC 55289-600-90 bottles of 90 tablets Recommended Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXAZOSIN- DOXAZOSIN MESYLATE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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 :
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 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 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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) 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 tablets 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: 5/201