ALFUZOSIN HYDROCHLORIDE tablet, extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Northwind Pharmaceuticals, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 )

제품 요약:

Alfuzosin hydrochloride extended-release tablets, USP 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 with child-resistant cap…..................... NDC 51655-432-52 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.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ALFUZOSIN HYDROCHLORIDE- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
NORTHWIND PHARMACEUTICALS, LLC
----------
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 su