EZETIMIBE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

REMEDYREPACK INC.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 Tablets, 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 Tablets, 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 elev

Resumen del producto:

Ezetimibe Tablets, USP 10 mg, are white to off white capsule shaped, flat faced, beveled edge tablets, debossed with ‘A25’ on one side and plain on other side. They are supplied as follows: NDC: 70518-2262-00 PACKAGING: 90 in 1 BOTTLE PLASTIC Storage Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

EZETIMIBE- EZETIMIBE TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EZETIMIBE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EZETIMIBE
TABLETS.
EZETIMIBE TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Ezetimibe Tablet is an inhibitor of intestinal cholesterol (and
related phytosterol) absorption indicated as
an adjunct to diet to:
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)
Limitations of Use ( 1.4)
The effect of Ezetimibe Tablets on cardiovascular morbidity and
mortality has not been determined.
Ezetimibe Tablets has not been studied in Fredrickson Type I, III, IV,
and V dyslipidemias.
DOSAGE AND ADMINISTRATION
One 10-mg tablet once daily, with or without food ( 2.1)
Dosing of Ezetimibe Tablets should occur either ≥2 hours before or
≥4 hours after administration of a
bile acid sequestrant. ( 2.3, 7.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg ( 3)
CONTRAINDICATIONS
• Statin contraindications apply when Ezetimibe Tablet 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 hypersensitivity to product components ( 4, 6.2)
WARNINGS AND PRECAUTIONS
Ezetimibe Tablet is not recommended in patients with moderate or
severe hepatic impairment. ( 5.4,
8.7, 12.3)
Liver enzyme abnormalit