Ezetimibe 10 mg Tablets — Generic For Zetia — Camber

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):

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).

Dosage And Administration

2)

2)

2)

Dosage Forms And Strengths

3)

Contraindications

4)

4)

Warnings And Precautions

• ( 5.1, 5.2, 5.3) 7/2023 INDICATIONS AND USAGE Ezetimibe tablets are 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 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). 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)

• ( 5.1, 5.2, 5.3) 7/2023 INDICATIONS AND USAGE Ezetimibe tablets are 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 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). 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)

5.1)

5.2)

5.3)

Adverse Reactions

o Ezetimibe administered alone (incidence ≥2% and greater than placebo): upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in

extremity, fatigue, and influenza. (

6.1)

o Ezetimibe coadministered with a statin (incidence ≥2% and greater than statin alone): nasopharyngitis, myalgia, upper respiratory tract infection,

arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue. (

6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

7)

7)

7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2024