Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ALFUZOSIN HYDROCHLORIDE (UNII: 75046A1XTN) (ALFUZOSIN - UNII:90347YTW5F)
Torrent Pharmaceuticals Limited
ALFUZOSIN HYDROCHLORIDE
ALFUZOSIN HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Citiți documentul complet