ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Avera McKennan Hospital

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Composition:

ALFUZOSIN HYDROCHLORIDE 10 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE- ALFUZOSIN HYDROCHLORIDE
TABLET
AVERA MCKENNAN HOSPITAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALFUZOSIN HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALFUZOSIN
HYDROCHLORIDE.
ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Indications and Usage (1.1) 12/2010
Warnings and Precautions, PDE5 inhibitors (5.4) 04/2010
Warnings and Precautions, Priapism (5.7) 12/2010
INDICATIONS AND USAGE
Alfuzosin hydrochloride is an alpha adrenergic antagonist, indicated
for the treatment of signs and symptoms of benign
prostatic hyperplasia. (1)
Important Limitations of Use:
Alfuzosin hydrochloride is not indicated for the treatment of
hypertension. (1.1)
Alfuzosin hydrochloride 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)
Intraoperati