UROXATRAL- alfuzosin hcl tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

alfuzosin hydrochloride (UNII: 75046A1XTN) (alfuzosin - UNII:90347YTW5F)

Available from:

Concordia Pharmaceuticals Inc.

INN (International Name):

alfuzosin hydrochloride

Composition:

alfuzosin hydrochloride 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is not indicated for the treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population. UROXATRAL is 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 UROXATRAL tablets [see Adverse Reactions (6.2)] Risk Summary Uroxatral is not indicated for use in women. There are no adequate data on the developmental risk associated with use of UROXATRAL in pregnant women. B

Product summary:

UROXATRAL is supplied as follows: Package                                                            NDC Number Bottles of 100 with child-resistant closure, NDC  59212-200-10 Bottles of 30 with child-resistant closure, NDC 59212-200-30 UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP. Protect from light and moisture. Keep UROXATRAL out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

UROXATRAL - ALFUZOSIN HCL TABLET, EXTENDED RELEASE
CONCORDIA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
UROXATRAL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR UROXATRAL.
UROXATRAL (ALFUZOSIN HCL) EXTENDED-RELEASE TABLETS
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
UROXATRAL is an alpha adrenergic antagonist, indicated for the
treatment of signs and symptoms of
benign prostatic hyperplasia. (1)
Important Limitations of Use:
UROXATRAL is not indicated for treatment of hypertension. (1.1)
UROXATRAL is 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 modifications to the
surgical technique (5.6)
Discontinue UROXATRAL if symptoms of angina pectoris appear or worsen
(5.8)
Use with caution in patients with a history of QT prolongation or who
are taking