ALFUZOSIN HYDROCHLORIDE ER tablet extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ALFUZOSIN HYDROCHLORIDE (UNII: 75046A1XTN) (ALFUZOSIN - UNII:90347YTW5F)

זמין מ:

AvKARE, Inc.

INN (שם בינלאומי):

ALFUZOSIN HYDROCHLORIDE

הרכב:

ALFUZOSIN HYDROCHLORIDE 10 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ALFUZOSIN HYDROCHLORIDE ER- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE
TABLE TS.
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP FOR ORAL USE INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Indications and Usage (1.1) 12/2010
Warnings and Precautions, PDE5 inhibitors (5.4) 04/2010
Warnings and Precautions, Priapism (5.7) 12/2010
INDICATIONS AND USAGE
Alfuzosin hydrochloride extended-release tablet, USP is an alpha
adrenergic antagonist, indicated for the treatment of signs
and symptoms of benign prostatic hyperplasia. (1) (1)
(1)
Important Limitations of Use: (1)
Alfuzosin hydrochloride extended-release tablets, USP are not
indicated for treatment of hypertension. (1.1) (1)
Alfuzosin hydrochloride extended-release tablets, USP are not
indicated for use in the pediatric population. (1.1, 8.4, 12.3)
(1)
(1)
DOSAGE AND ADMINISTRATION
10 mg once daily with food and with the same meal each day. (2) (2)
Tablets should not be chewed or crushed (2, 12.3) (2)
(2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablet: 10 mg (3) (3)
CONTRAINDICATIONS
Moderate or severe hepatic impairment (4, 8.7, 12.3)
Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole,
itraconazole, ritonavir) (4, 5.4, 7.1, 12.3)
Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or
any of the ingredients (4, 6.2)
WARNINGS AND PRECAUTIONS
Postural hypotension/syncope: Care should be taken in patients with
symptomatic hypotension or who have had a
hypotensive response to other medications or are concomitantly treated
with antihypertensive medication or nitrates
(5.1)
Use with caution in patients with severe renal impairment (creatinine
clearance <30 mL/min) (5.2, 8.6, 12.3)
Use with caution in patients with mild hepatic impairment (5.3, 8.7,