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.

Primary Hyperlipidemia

Monotherapy

ZETIA¹, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) 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, and Apo B 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-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with mixed hyperlipidemia.

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.

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.

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.

General Dosing Information

The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.

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.

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].

Patients with Hepatic Impairment

No dosage adjustment is necessary in patients with mild hepatic impairment [see WARNINGS and PRECAUTIONS].

Patients with Renal Impairment

No dosage adjustment is necessary in patients with renal impairment [see CLINICAL PHARMACOLOGY].

Geriatric Patients

No dosage adjustment is necessary in geriatric patients [see CLINICAL PHARMACOLOGY].

Dosage Forms And Strengths

10-mg tablets are white to off-white, capsule-shaped tablets debossed with "414" on one side.

Storage And Handling

No. 3861 - Tablets ZETIA, 10 mg, are white to off- white, capsule-shaped tablets debossed with “414” on one side. They are supplied as follows:

NDC 66582-414-31 bottles of 30
NDC 66582-414-54 bottles of 90
NDC 66582-414-74 bottles of 500
NDC 66582-414-28 unit dose packages of 100.

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture.

Issued June 2008. Manufactured for: Merck/Schering-Plough Pharmaceuticals, North Wales, PA 19454, USA. By: Schering Corporation Kenilworth, NJ 07033, USA or Merck & Co., Inc. Whitehouse Station, NJ 08889, USA. FDA rev date: 6/5/2008

Bookmark this page: