ALFUZOSIN HYDROCHLORIDE tablet, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Northwind Pharmaceuticals, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 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)]. - 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 al

Produktsammanfattning:

Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side. Bottles of 30 : NDC 51655-967-52 Store at 20 0 to 25 0 C (68 0 to 77 0 F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep this and all drugs out of reach of children.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

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 TABLET 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 extended-release tablets, USP, an alpha
adrenergic antagonist, are indicated for
the treatment of signs and symptoms of benign prostatic hyperplasia. (
1)
Important Limitations of Use:
Alfuzosin hydrochloride extended-release tablets, USP are not
indicated for treatment of hypertension. (
1.1)
Alfuzosin hydrochloride extended-release tablets, USP are not
indicated for use in 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 Ir