ALFUZOSIN HYDROCHLORIDE tablet, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Apotex Corp.

INN (Nama Antarabangsa):

ALFUZOSIN HYDROCHLORIDE

Komposisi:

ALFUZOSIN HYDROCHLORIDE 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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, and ritonavir, since alfuzosin blood levels are increased [see

Ringkasan produk:

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 60505-2850-9) 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.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ALFUZOSIN HYDROCHLORIDE- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
APOTEX CORP.
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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 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)
Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may
require modi