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:

Bryant Ranch Prepack

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 tabletsare 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 tabletsare 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 [s ee 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 Interactions (7.1 ) and Clinical Pharmacology (12.3 )] . - in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of alfuzosin hydrochloride extended-release tablets [see

Product summary:

NDC: 71335-1529-1: 30 Extended Release Tablets in a BOTTLE NDC: 71335-1529-2: 60 Extended Release Tablets in a BOTTLE NDC: 71335-1529-3: 90 Extended Release Tablets in a BOTTLE NDC: 71335-1529-4: 120 Extended Release Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALFUZOSIN HYDROCHLORIDE- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
BRYANT RANCH PREPACK
----------
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 TABLETS.
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Alfuzosin hydrochloride is an alpha adrenergic antagonist, indicated
for the treatment of signs and
symptoms of benign prostatic hyperplasia. (1)
Important Limitations of Use:
Alfuzosin hydrochloride extended-release tablets are not indicated for
treatment of hypertension. (1.1)
Alfuzosin hydrochloride extended-release tablets are not indicated for
use in the pediatric population. (1.1,
8.4, 12.3)
DOSAGE AND ADMINISTRATION
10 mg once daily with food and with the same meal each day. (2)
Tablets should not be chewed or crushed (2, 12.3)
DOSAGE FORMS AND STRENGTHS
Extended-release tablet: 10 mg (3)
CONTRAINDICATIONS
Moderate or severe hepatic impairment (4, 8.7, 12.3)
Coadministration 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 used in combination with other alpha adrenergic
antagonists (5.4, 7.2)
Prostate carcinoma should be ruled out prior to treatment (5.5)
Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may
require modifi