P1509384 Alfuzosin Hcl ER Tablets (INSERT).FH8

1 INDICATIONS AND USAGE Alfuzosin hydrochloride extended release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride extended release tablets are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended release tablets are not indicated for use in the pediatric population. 2 DOSAGE AND ADMINISTRATION The recommended dosage is one 10 mg alfuzosin hydrochloride extended release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride extended release tablets should be taken with food and with the same meal each day. The tablets should not be chewed or crushed. 3 DOSAGE FORMS AND STRENGTHS Alfuzosin hydrochloride extended release tablets 10 mg are white to off-white, round, biconvex, film-coated tablets, debossed with ‘X’ on one side and ‘23’ on other side. 4 CONTRAINDICATIONS 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)].