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:

Physicians Total Care, Inc.

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 unav

Tóm tắt sản phẩm:

No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side. They are supplied as follows: 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: 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: 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: Storage Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

VYTORIN - EZETIMIBE AND SIMVASTATIN TABLET
PHYSICIANS TOTAL CARE, INC.
----------
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
Recommended Dosing (2.1) 01/2012
Restricted Dosing for 10/80 mg (2.2) 06/2011
Coadministration with Other Drugs (2.3) 10/2011
Patients with Homozygous Familial Hypercholesterolemia (2.4) 06/2011
Patients with Renal Impairment/Chronic Kidney Disease (2.6) 01/2012
Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of
Niacin-Containing Products (2.8) 06/2011
Contraindications (4) 02/2012
Warnings and Precautions
Myopathy/Rhabdomyolysis (5.1) 02/2012
Liver Enzymes (5.2) 01/2012
Endocrine Function (5.4) 10/2011
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
Dose range is 10/10 mg/day to 10/40 mg/day. (2.1)
Recommended usual starting dose is 10/10 or 10/20 mg/day. (2.1)
Due to the increased risk of myopathy, including rhabdomyolysis, use
of the 10/80-mg dose of VYTORIN should be
restricted to patients who have been taking VYTORIN 10/80 mg
chronically (e.g., for 12 months or more) without
evi