EZETIMIBE- ezetimibe tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

EZETIMIBE

Composition:

EZETIMIBE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Ezetimibe tablets, USP 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: Unit dose packages of 30 (3 x 10) NDC 60687-284-21 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EZETIMIBE- EZETIMIBE TABLET
AMERICAN HEALTH PACKAGING
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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
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Indications and Usage
Addition of non-HDL lipid parameter to Monotherapy and Combination
therapy ( 1.1) 07/2011
Dosage and Administration
Patients with Renal Impairment ( 2.5) 01/2012
INDICATIONS AND USAGE
Ezetimibe 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 on cardiovascular morbidity and mortality has
not been determined.
Ezetimibe 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 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 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 P