ALFUZOSIN HYDROCHLORIDE tablet, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 )

Proizvod sažetak:

Alfuzosin hydrochloride extended-release tablets 10 mg are available as white to off white, round shaped, biconvex, uncoated tablet debossed with ‘956’ on one side and plain on other side. Alfuzosin hydrochloride extended-release tablets are supplied as follows: Bottles of 30’s….................... NDC 70934-306-30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep alfuzosin hydrochloride extended-release tablets out of reach of children. Dispense in a tight, light-resistant container as defined in the USP.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ALFUZOSIN HYDROCHLORIDE- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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)