VYTORIN- ezetimibe and simvastatin tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

ezetimibe (UNII: EOR26LQQ24) (ezetimibe - UNII:EOR26LQQ24), simvastatin (UNII: AGG2FN16EV) (simvastatin - UNII:AGG2FN16EV)

Sẵn có từ:

Rebel Distributors Corp

INN (Tên quốc tế):

ezetimibe

Thành phần:

ezetimibe 10 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

VYTORIN- EZETIMIBE AND SIMVASTATIN TABLET
REBEL DISTRIBUTORS CORP
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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