EZETIMIBE AND SIMVASTATIN tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24), SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)

Verfügbar ab:

Ascend Laboratories, LLC

INN (Internationale Bezeichnung):

EZETIMIBE

Zusammensetzung:

EZETIMIBE 10 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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. Ezetimibe and Simvastatin Tablets are 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.  Ezetimibe and Simvastatin Tablets are 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

Produktbesonderheiten:

Storage Store at 20 to 25o C (68 to 77 o F). [See USP Controlled Room Temperature.] Keep container tightly closed.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

EZETIMIBE AND SIMVASTATIN - EZETIMIBE AND SIMVASTATIN TABLET
ASCEND LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EZETIMIBE AND
SIMVASTATIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR EZETIMIBE
AND SIMVASTATIN TABLETS.
EZETIMIBE AND SIMVASTATIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions
Myopathy/Rhabdomyolysis (5.1) 10/2019
Immune-Mediated Necrotizing Myopathy (5.2) 9/2020
INDICATIONS AND USAGE
Ezetimibe and Simvastatin Tablets, 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 Ezetimibe and Simvastatin Tablets on
cardiovascular morbidity and mortality
over and above that demonstrated for simvastatin has been established.
Ezetimibe and Simvastatin Tablets 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
Ezetimibe and Simvastatin Tablets should be restricted to patients who
have been taking
Ezetimibe and Simvastatin Tablets 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 Ezetimibe
and Simvastatin Tablets
who need to be initiated on an interacting drug that is
contraindicated or is associated with a dose cap
for si