EZETIMIBE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

EZETIMIBE

Composition:

EZETIMIBE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ezetimibe is indicated: 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. Ezetimibe is contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see Adverse Reactions (6.2)] . When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ezetimibe is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated. Refer to the Prescribing Information of these products for a list of their contraindications [see Warnings and Precautions (5.1)] . 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 anim

Product summary:

Ezetimibe tablets, USP 10 mg, are white to almost white, oval tablets debossed with "SZ" on one side and '499' on other side. They are supplied as follows: NDC 0781-5690-31 bottles of 30 NDC 0781-5690-92 bottles of 90 NDC 0781-5690-05 bottles of 500 NDC 0781-5690-10 bottles of 1000 NDC 0781-5690-13 unit dose packages of 100 Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature.] Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EZETIMIBE- EZETIMIBE TABLET
SANDOZ INC
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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 is 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 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).
10-mg orally once daily, with or without food (2)
Administer ezetimibe 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
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