Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ALFUZOSIN HYDROCHLORIDE (UNII: 75046A1XTN) (ALFUZOSIN - UNII:90347YTW5F)
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
ORAL
PRESCRIPTION DRUG
Alfuzosin hydrochloride tablets USP, are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride is not indicated for the treatment of hypertension. Alfuzosin hydrochloride is not indicated for use in the pediatric population. Alfuzosin hydrochloride 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 compon
Alfuzosin Hydrochloride Extended-Release Tablets, USP 10 mg are available as off white, round, biconvex tablets debossed with 'IG' on one side and "302" on other. Alfuzosin Hydrochloride Extended-Release Tablets are supplied as follows: Package NDC Number Bottles of 30 70934-961-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Keep alfuzosin hydrochloride out of reach of children.
Abbreviated New Drug Application
ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE- ALFUZOSIN HYDROCHLORIDE TABLET DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS ---------- 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 EXTENDED-RELEASE TABLETS, USP FOR ORAL USE INITIAL U.S. APPROVAL: 2003 INDICATIONS AND USAGE Alfuzosin hydrochloride extended-release tablet USP, is an alpha adrenergic antagonist, indicated for 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) Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical tech Soma hati kamili