EZETIMIBE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Ezetimibe (UNII: EOR26LQQ24) (Ezetimibe - UNII:EOR26LQQ24)

Tillgänglig från:

Major Pharmaceuticals

INN (International namn):

Ezetimibe

Sammansättning:

Ezetimibe 10 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska 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. 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 to

Produktsammanfattning:

Ezetimibe tablets, USP 10 mg are white to off-white, flat-face, beveled edge, capsule shaped tablets; engraved "APO" on one side and "EZ 10" on the other side. They are supplied as follows: Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6664-04 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

EZETIMIBE- EZETIMIBE TABLET
MAJOR PHARMACEUTICALS
----------
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
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 tablets are an inhibitor of intestinal cholesterol (and
related phytosterol) absorption indicated as
an adjunct to diet to:
5.
6.
7.
8.
Limitations of Use (1.4)
3.
4.
DOSAGE AND ADMINISTRATION
3.
4.
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg (3)
CONTRAINDICATIONS
3.
4.
WARNINGS AND PRECAUTIONS
4.
5.
6.
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 tablets should occur either ≥2 hours before or
≥4 hours after administration of a
bile acid sequestrant. (2.3, 7.4)
Statin contraindications apply when ezetimibe is used with a statin:
4.
5.
6.
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