EZETIMIBE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

EZETIMIBE

Composition:

EZETIMIBE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ezetimibe tablets are indicated: When ezetimibe tablet is used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use. Risk Summary There are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the MRHD, based on AUC (see Data) . Ezetimibe should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When ezetimibe is administered with a statin, refer to the Prescribing Information for the statin. The estimated background risk of major birth defects and miscarriage for the indic

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: Bottles of 30, NDC 68462-226-30 Bottles of 90, NDC 68462-226-90 Bottles of 500, NDC 68462-226-05 Bottles of 1000, NDC 68462-226-10 Unit-dose packages of 100, NDC 68462-226-11 Store Ezetimibe Tablets, USP at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EZETIMIBE- EZETIMIBE TABLET
GLENMARK PHARMACEUTICALS INC., USA
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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
RECENT MAJOR CHANGES
Indications and Usage (1) 7/2023
Dosage and Administration (2) 7/2023
Contraindications (4) 7/2023
Warnings and Precautions (5.1, 5.2, 5.3) 7/2023
INDICATIONS AND USAGE
Ezetimibe tablets are indicated (1):
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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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In combination with a statin, or alone when additional low density
lipoprotein cholesterol (LDL-C)
lowering therapy is not possible, as an adjunct to diet to reduce
elevated LDL-C in adults with primary
hyperlipidemia, including heterozygous familial hypercholesterolemia
(HeFH).
In combination with a statin as an adjunct to diet to reduce elevated
LDL-C in pediatric patients 10
years of age and older with HeFH.
In combination with fenofibrate as an adjunct to diet to reduce
elevated LDL C in adults with mixed
hyperlipidemia.
In combination with a statin, and other LDL-C lowering therapies, to
reduce elevated LDL C levels in
adults and in pediatric patients 10 years of age and older with
homozygous familial
hypercholesterolemia (HoFH).
As an adjunct to diet for the reduction of elevated sitosterol and
campesterol levels in adults and in
pediatric patients 9 years of age and older with homozygous familial
sitosterolemia.
When ezetimibe tablets are used in combination with a statin,
fenofibrate, or other LDL-C lowering
therapies, refer to the Prescribing Information of these products for
information on the safe and
effective use (1).
10-mg o once daily, with or without food (2.1)
Administer ezetimibe tablets either ≥2 hours before or ≥4 hours
after administration of a bile acid
sequestrant. (2)
Assess LDL-C whe