Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
ALFUZOSIN HYDROCHLORIDE (UNII: 75046A1XTN) (ALFUZOSIN - UNII:90347YTW5F)
Golden State Medical Supply, Inc.
ALFUZOSIN HYDROCHLORIDE
ALFUZOSIN HYDROCHLORIDE 10 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ALFUZOSIN HYDROCHLORIDE- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE GOLDEN STATE MEDICAL SUPPLY, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP INITIAL U.S. APPROVAL: 2003 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 TABLE TS. 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 extended-release tablet is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) (1) Important Limitations of Use: (1) Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. (1.1) (1) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1, 8.4, 12.3) (1) DOSAGE AND ADMINISTRATION 10 mg once daily with food and with the same meal each day. (2) (2) Tablets should not be chewed or crushed (2, 12.3) (2) DOSAGE FORMS AND STRENGTHS Extended-release tablet: 10 mg (3) (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 u Aqra d-dokument sħiħ