Zetia

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Uses

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.

1.1 Primary Hyperlipidemia

Monotherapy

ZETIA®, 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)

ZETIA, 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 elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia.

Combination Therapy with Fenofibrate

ZETIA, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia.

1.2 Homozygous Familial Hypercholesterolemia (HoFH)

The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

1.3 Homozygous Sitosterolemia

ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

1.4 Limitations of Use

The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.

ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.

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History

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Other Information

ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is:

Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF.

Sources

Zetia Manufacturers

Cardinal Health

Zetia | Cardinal Health

2.1 General Dosing Information
The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.
2.2 Concomitant Lipid-Lowering Therapy
ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
2.3 Coadministration with Bile Acid Sequestrants
Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].
2.4 Patients with Hepatic Impairment
No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].
2.5 Patients with Renal Impairment
No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)]. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m2), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations (8.6)].
2.6 Geriatric Patients
No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].

No Recall
Physicians Total Care, Inc.

Zetia | Physicians Total Care, Inc.

2.1 General Dosing Information
The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.
2.2 Concomitant Lipid-Lowering Therapy
ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
2.3 Co-Administration with Bile Acid Sequestrants
Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].
2.4 Patients with Hepatic Impairment
No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].
2.5 Patients with Renal Impairment
No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)].
2.6 Geriatric Patients
No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].

No Recall
Rebel Distributors Corp

Zetia | Rebel Distributors Corp

2.1 General Dosing Information
The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.
2.2 Concomitant Lipid-Lowering Therapy
ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
2.3 Co-Administration with Bile Acid Sequestrants
Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].
2.4 Patients with Hepatic Impairment
No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].
2.5 Patients with Renal Impairment
No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)].
2.6 Geriatric Patients
No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Zetia | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

2.1 General Dosing Information
The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.
2.2 Concomitant Lipid-Lowering Therapy
ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
2.3 Co-Administration with Bile Acid Sequestrants
Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].
2.4 Patients with Hepatic Impairment
No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].
2.5 Patients with Renal Impairment
No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)].
2.6 Geriatric Patients
No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].

No Recall
Cardinal Health

Zetia | Rite Aid

this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using find right dose on chart below.If possible, use weight to dose; otherwise use age. measure with the dosing device provided. Do not use with any other device. dispense liquid slowly into the child’s mouth, toward the inner cheek if needed, repeat dose every 6 to 8 hours do not use more than 4 times a day

Dosing Chart

Weight (lb)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12 to 17 lbs

6 to 11 mos

1.25 mL

18 to 23 lbs

12 to 23 mos

1.875 mL

No Recall
Cardinal Health

Zetia | Cardinal Health

2.1 General Dosing Information
The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.
2.2 Concomitant Lipid-Lowering Therapy
ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
2.3 Coadministration with Bile Acid Sequestrants
Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].
2.4 Patients with Hepatic Impairment
No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].
2.5 Patients with Renal Impairment
No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)]. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m2), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations (8.6)].
2.6 Geriatric Patients
No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].

No Recall
Merck Sharp & Dohme Corp.

Zetia | Merck Sharp & Dohme Corp.

2.1 General Dosing Information
The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.
2.2 Concomitant Lipid-Lowering Therapy
ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
2.3 Coadministration with Bile Acid Sequestrants
Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].
2.4 Patients with Hepatic Impairment
No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].
2.5 Patients with Renal Impairment
No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)]. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m2), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations (8.6)].
2.6 Geriatric Patients
No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].

No Recall
Remedyrepack Inc.

Zetia | Remedyrepack Inc.

One 10-mg tablet once daily, with or without food (2.1) Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. (2.3, 7.4)

The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.

ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.

Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].

No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].

No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)]. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m2), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations (8.6)].

No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].

No Recall