EZETIMIBE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals NY LLC

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 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

Product summary:

Ezetimibe tablets USP, 10 mg are supplied as white to off-white, capsule-shaped tablets debossed with “AA69” on one side and plain on other side. They are supplied as follows: Bottles of 30:               NDC 69238-1154-3 Bottles of 90:               NDC 69238-1154-9 Bottles of 500:             NDC 69238-1154-5 Bottles of 1000:           NDC 69238-1154-1 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EZETIMIBE- EZETIMIBE TABLET
AMNEAL PHARMACEUTICALS NY LLC
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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 tablets are 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 have 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 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 is not recommended in patients with moderate or severe
hepatic impairment. (5.4, 8.7, 12.3)
Liver enzyme abnormalities and monitoring: Persist