ALFUZOSIN HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Composition:

ALFUZOSIN HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. Alfuzosin hydrochloride extended-release tablets are contraindicated for use: - in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].  in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].  - with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactio

Product summary:

Alfuzosin hydrochloride extended release tablets 10 mg are yellow, round, flat-faced beveled-edge tablets. Engraved “APO” on one side, “ALF” over “10” on the other side. They are supplied as follows: Bottles of 30 (NDC 54868-6329-0) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight, light-resistant container [see USP]. Protect from light and moisture. Keep alfuzosin hydrochloride extended release tablets out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
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 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 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 are not indicated for
treatment of hypertension. (1.1) (1)
Alfuzosin hydrochloride extended-release tablets 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,
12.3)
Should not be