VYTORIN- ezetimibe and simvastatin tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Merck Sharp & Dohme Corp.

INN (International Name):

ezetimibe

Sammensætning:

ezetimibe 10 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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: NDC 66582-311-31 bottles of 30 NDC 66582-311-54 bottles of 90 NDC 66582-311-87 bottles of 10,000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.) 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 66582-312-31 bottles of 30 NDC 66582-312-54 bottles of 90 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 66582-313-31 bottles of 30 NDC 66582-313-54 bottles of 90 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 66582-315-31 bottles of 30 NDC 66582-315-54 bottles of 90 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.

Autorisation status:

New Drug Application

Produktets egenskaber

VYTORIN- EZETIMIBE AND SIMVASTATIN TABLET
MERCK SHARP & DOHME 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 AND SIMVASTATIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions
Immune-Mediated Necrotizing Myopathy (5.2)
9/2020
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
evidence of muscle toxicity. (2.2)
Patients who are currently tolerating the 10/80-mg dose of VYTORIN who
need to be initiated on an interacting drug
that is contraindicated or is associated with a dose cap for
simvastatin should be switched to an alternative statin or
statin-based regimen with less potential for the drug-drug
interaction. (2.2)
Due to the increased risk of myopathy, including rhabdomyolysis,
associated with the 10/80-mg dose of VYTORIN,
patients