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Vytorin

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Vytorin

Indications
Dosage
How Supplied

INDICATIONS

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

VYTORIN® is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.

Homozygous Familial Hypercholesterolemia (HoFH)

VYTORIN is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Limitations of Use

No incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.

VYTORIN has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The usual dosage range is 10/10 mg/day to 10/40 mg/day. The recommended usual starting dose is 10/10 mg/day or 10/20 mg/day. VYTORIN should be taken as a single daily dose in the evening, with or without food. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day in the absence of moderate to severe renal impairment (estimated glomerular filtration rate < 60 mL/min/1.73 m²). After initiation or titration of VYTORIN, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed.

Restricted Dosing for 10/80 mg

Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 10/80-mg dose of VYTORIN should be restricted to patients who have been taking VYTORIN 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see WARNINGS AND PRECAUTIONS].

Patients who are currently tolerating the 10/80-mg dose of VYTORIN who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction.

Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 10/80-mg dose of VYTORIN, patients unable to achieve their LDL-C goal utilizing the 10/40-mg dose of VYTORIN should not be titrated to the 10/80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering.

Coadministration with Other Drugs

Patients taking Verapamil, Diltiazem, or Dronedarone

Patients with Homozygous Familial Hypercholesterolemia

The recommended dosage for patients with homozygous familial hypercholesterolemia is VYTORIN 10/40 mg/day in the evening [see DOSAGE AND ADMINISTRATION, Restricted Dosing for 10/80 mg]. VYTORIN should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of VYTORIN should be reduced by 50% if initiating lomitapide. VYTORIN dosage should not exceed 10/20 mg/day (or 10/40 mg/day for patients who have previously taken simvastatin 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.

Patients with Hepatic Impairment

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

Patients with Renal Impairment/Chronic Kidney Disease

In patients with mild renal impairment (estimated GFR ≥ 60 mL/min/1.73 m²), no dosage adjustment is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate < 60 mL/min/1.73 m², the dose of VYTORIN is 10/20 mg/day in the evening. In such patients, higher doses should be used with caution and close monitoring [see WARNINGS AND PRECAUTIONS; CLINICAL PHARMACOLOGY].

Geriatric Patients

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

Chinese Patients Taking Lipid-Modifying Doses ( ≥ 1 g/day Niacin) of Niacin-Containing Products

Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses ( ≥ 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with VYTORIN doses exceeding 10/20 mg/day coadministered with lipid-modifying doses ( ≥ 1 g/day niacin) of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive VYTORIN 10/80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See WARNINGS AND PRECAUTIONS]

HOW SUPPLIED

Dosage Forms And Strengths

  • VYTORIN® 10/10, (ezetimibe 10 mg/simvastatin 10 mg tablets) are white to off-white capsule-shaped tablets with code “311” on one side.
  • VYTORIN® 10/20, (ezetimibe 10 mg/simvastatin 20 mg tablets) are white to off-white capsule-shaped tablets with code “312” on one side.
  • VYTORIN® 10/40, (ezetimibe 10 mg/simvastatin 40 mg tablets) are white to off-white capsule-shaped tablets with code “313” on one side.
  • VYTORIN® 10/80, (ezetimibe 10 mg/simvastatin 80 mg tablets) are white to off-white capsule-shaped tablets with code “315” on one side.

Storage And Handling

No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code “311” on one side.

They are supplied as follows:

NDC 66582-311-31 bottles of 30
NDC
66582-311-54 bottles of 90
NDC
66582-311-82 bottles of 1000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC
66582-311-87 bottles of 10,000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC
66582-311-28 unit dose packages of 100.

No. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code “312” on one side.

They are supplied as follows:

NDC 66582-312-31 bottles of 30
NDC
66582-312-54 bottles of 90
NDC
66582-312-82 bottles of 1000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC
66582-312-87 bottles of 10,000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC
66582-312-28 unit dose packages of 100.

No. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code “313” on one side.

They are supplied as follows:

NDC 66582-313-31 bottles of 30
NDC
66582-313-54 bottles of 90
NDC 66582-313-74 bottles of 500 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC
66582-313-86 bottles of 5000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC 66582-313-52 unit dose packages of 50.

No. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code “315” on one side.

They are supplied as follows:

NDC 66582-315-31 bottles of 30
NDC
66582-315-54 bottles of 90
NDC 66582-315-74 bottles of 500 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC 66582-315-66 bottles of 2500 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC 66582-315-52 unit dose packages of 50.

Storage

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.

Storage of 10,000, 5000, and 2500 count bottles

Store bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.

Manufactured by: MSD International GmbH (Singapore Branch) Singapore 637766 Or Merck Sharp & Dohme (Italia) S.p.A. Via Emilia 21, Pavia 27100, Italy Or Merck Sharp & Dohme Ltd. Cramlington, Northumberland NE23 3JU, UK Or Jointly manufactured by: Merck Sharp & Dohme (Italia) S.p.A. Via Emilia 21, Pavia 27100, Italy and MSD International GmbH (Singapore Branch) Singapore 637766.Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & Co., INC., Whitehouse Station, NJ 08889, USA. Revised: 10/2013

Last reviewed on RxList: 11/18/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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