ALFUZOSIN HYDROCHLORIDE 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:

Torrent Pharmaceuticals Limited

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Composition:

ALFUZOSIN HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. - 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 angioedem

Product summary:

Alfuzosin hydrochloride extended-release tablets, USP 10 mg are white to off white, round shape, flat face beveled edge tablets debossed with '1021'on one side and '10' on other side. Alfuzosin hydrochloride extended-release tablets, USP are supplied as follows: Package                                                                             NDC Number Bottles of 30                                                                      13668 - 021 - 30 Bottles of 100                                                                    13668 - 021 - 01 Bottles of 500                                                                    13668 - 021 - 05 90 Unit Dose Tablets                                                         13668 - 021 - 64 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP   Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Keep alfuzosin hydrochloride extended-release tablets, USP out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALFUZOSIN HYDROCHLORIDE- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
TORRENT PHARMACEUTICALS LIMITED
----------
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 USP,FOR ORAL USE
INITIAL U.S.
APPROVAL: 2003
INDICATIONS AND USAGE
Alfuzosin hydrochloride extended-release tablets, USP are 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, USP are not
indicated for treatment of hypertension. (
1.1)
Alfuzosin hydrochloride extended-release tablets, USP 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 Fl