DOSAGE AND ADMINISTRATION The patient should be placed on a standard cholesterol-lowering diet before receiving ZETIA and should continue on this diet during treatment with ZETIA. The recommended dose of ZETIA is 10 mg once daily. ZETIA can be administered with or without food. ZETIA may be administered with an HMG-CoA reductase inhibitor for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the HMG-CoA reductase inhibitor, according to the dosing recommendations for the HMG-CoA reductase inhibitor. Patients with Hepatic Insufficiency No dosage adjustment is necessary in patients with mild hepatic insufficiency (see PRECAUTIONS, Hepatic Insufficiency). Patients with Renal Insufficiency No dosage adjustment is necessary in patients with renal insufficiency (see CLINICAL PHARMACOLOGY, Special Populations). Geriatric Patients No dosage adjustment is necessary in geriatric patients (see CLINICAL PHARMACOLOGY, Special Populations). Co-administration with Bile Acid Sequestrants Dosing of ZETIA should occur either 2 hours before or 4 hours after administration of a bile acid sequestrant (see PRECAUTIONS, Drug Interactions). HOW SUPPLIED No. 3861 -Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with "414" on one side. They are supplied as follows: NDC 66582-414-31 bottles of 30 15 15 Page 16 ZETIA (ezetimibe) 25751817T REV 01 16 NDC 66582-414-54 bottles of 90 NDC 66582-414-74 bottles of 500 NDC 66582-414-28 unit dose packages of 100. Storage Store at 25 C (77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature.] Protect from moisture. Issued March 2003 Printed in USA. Manufactured for: Merck/ Schering-Plough Pharmaceuticals North Wales, PA 19454, USA By: Schering Corporation Kenilworth, NJ 07033, USA 16 | ||||
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