EZETIMIBE- ezetimibe tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24)

Fáanlegur frá:

Par Pharmaceutical Inc

INN (Alþjóðlegt nafn):

EZETIMIBE

Samsetning:

EZETIMIBE 10 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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. Monotherapy Ezetimibe, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins) Ezetimibe, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LD

Vörulýsing:

Ezetimibe tablets 10 mg, are white to off-white, capsule-shaped, flat, beveled edged tablets engraved with ‘G80’ on one side and plain on the other side. They are supplied as follows: NDC 49884-228-11 bottles of 30 NDC 49884-228-09 bottles of 90 NDC 49884-228-05 bottles of 500 Storage Store at 20o to 25o C (68o to 77o F); excursions permitted to 15º to 30o C (59º to 86o F) [See USP controlled room temperature]. Protect from moisture.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

EZETIMIBE- EZETIMIBE TABLET
PAR PHARMACEUTICAL INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EZETIMIBE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR EZETIMIBE.
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Indications and Usage
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Dosage and Administration
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INDICATIONS AND USAGE
Ezetimibe is an inhibitor of intestinal cholesterol (and related
phytosterol) absorption indicated as an adjunct to diet to:
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Limitations of Use (1.4)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Addition of non-HDL lipid parameter to Monotherapy and Combination
therapy (1.1) 07/2011
Patients with Renal Impairment (2.5) 01/2012
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with
primary hyperlipidemia, alone or in
combination with an HMG-CoA reductase inhibitor (statin) (1.1)
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with
mixed hyperlipidemia in combination with
fenofibrate (1.1)
Reduce elevated total-C and LDL-C in patients with homozygous familial
hypercholesterolemia (HoFH), in
combination with atorvastatin or simvastatin (1.2)
Reduce elevated sitosterol and campesterol in patients with homozygous
sitosterolemia (phytosterolemia) (1.3)
The effect of ezetimibe on cardiovascular morbidity and mortality has
not been determined.
Ezetimibe has not been studied in Fredrickson Type I, III, IV, and V
dyslipidemias.
One 10-mg tablet once daily, with or without food (2.1)
Dosing of ezetimibe should occur either ≥2 hours before or ≥4
hours after administration of a bile acid sequestrant.
(2.3, 7.4)
Tablets: 10 mg (3)
Statin contraindications apply when ezetimibe is used with a statin:
Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase levels (4, 5.2)
Women who are pregnant or may become pregnant (4, 8.1)
Nursing mothers (4, 8.3)
Known hypersensiti