ALFUZOSIN HYDROCHLORIDE tablet, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Golden State Medical Supply, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets, USP 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, a

Dettagli prodotto:

Alfuzosin hydrochloride extended-release tablets, USP 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 90 (NDC 51407-829-90) Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F 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, USP out of reach of children.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ALFUZOSIN HYDROCHLORIDE- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. 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
INITIAL U.S. APPROVAL: 2003
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)
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)
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 used in combination with other alpha adrenergic
antagonists ( 5.4, 7.2)
Prostate carcinoma should be ruled out prior to treatment ( 5.5)