EZETIMIBE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

EZETIMIBE

Composition:

EZETIMIBE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ezetimibe tablets are indicated: - 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 combinat

Product summary:

Ezetimibe tablets, USP 10 mg, are white to off white, capsule-shaped tablets debossed with "713 " on one side and plain on the other side. They are supplied as follows: NDC 0591-3713-30 bottles of 30  NDC 0591-3713-19 bottles of 90 NDC 0591-3713-05 bottles of 500  Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EZETIMIBE- EZETIMIBE TABLET
ACTAVIS PHARMA, INC.
----------
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 is indicated (1):
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 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 (1).
DOSAGE AND ADMINISTRATION
10-mg orally once daily, with or without food (2)
Administer ezetimibe tablets either ≥2 hours before or ≥4 hours
after administration of a bile acid
sequestrant. (2)
Assess LDL-C when clinically appropriate, as early as 4 weeks after
initiating ezetimibe tablets. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg (3)
CONTRAINDICATIONS
Hyper