Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ezetimibe (UNII: EOR26LQQ24) (ezetimibe - UNII:EOR26LQQ24), simvastatin (UNII: AGG2FN16EV) (simvastatin - UNII:AGG2FN16EV)
Rebel Distributors Corp
ezetimibe
ezetimibe 10 mg
ORAL
PRESCRIPTION DRUG
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. VYTORIN is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. VYTORIN is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavai
No. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code “312” on one side. They are supplied as follows: NDC 21695-325-30 bottles of 30 No. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code “313” on one side. They are supplied as follows: NDC 21695-339-30 bottles of 30 No. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code “315” on one side. They are supplied as follows: NDC 21695-827-30 bottles of 30 Storage Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed. Storage of 10,000, 5000, and 2500 count bottles Store bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening. Manufactured for: MERCK/Schering-Plough Pharmaceuticals North Wales, PA 19454, USA By: MSD Technology Singapore Pte. Ltd. Singapore 637766 Or Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21 27100 – Pavia, Italy Or Merck Sharp & Dohme Ltd. Cramlington, Northumberland, UK NE23 3JU Or Jointly manufactured by: Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21 27100 – Pavia, Italy and MSD Technology Singapore Pte. Ltd. Singapore 637766 U.S. Patent Nos. 5,846,966 and RE37,721 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
New Drug Application
VYTORIN- EZETIMIBE AND SIMVASTATIN TABLET REBEL DISTRIBUTORS CORP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VYTORIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VYTORIN. VYTORIN (EZETIMIBE/SIMVASTATIN) TABLETS INITIAL U.S. APPROVAL: 2004 RECENT MAJOR CHANGES Dosage and Administration Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of Niacin-Containing Products (2.6) 03/2010 Coadministration with Other Drugs (2.7) 03/2010 Warnings and Precautions Myopathy/Rhabdomyolysis (5.1) 03/2010 INDICATIONS AND USAGE VYTORIN , which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to: reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. (1.1) reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. (1.2) Limitations of Use (1.3) No incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. VYTORIN has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. DOSAGE AND ADMINISTRATION Dosage range is 10/10 mg/day through 10/80 mg/day. (2.1) Recommended usual starting dose is 10/20 mg/day. (2.1) Dosing of VYTORIN should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. (2.7, 7.5) DOSAGE FORMS AND STRENGTHS Tablets (ezetimibe mg/simvastatin mg): 10/10, 10/20, 10/40, 10/80 (3) CONTRAINDICATIONS Hypersensitivity to any component of this medication (4, 6.2) Active liver disease or unexplained persistent elevations of hepatic transaminase levels (4, 5.2) Women who are pregnant or may become pregnant (4, 8.1) Nursing mothers (4, 8.3) WARNINGS AND PRECAUTIONS Patients should be advised to Läs hela dokumentet