Vytorin
INDICATIONS
Primary Hypercholesterolemia
VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hypercholesterolemia 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.
Therapy with lipid-altering agents should be a component of multiple risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid- altering agents should be used in addition to an appropriate diet (including restriction of saturated fat and cholesterol) and when the response to diet and other non-pharmacological measures has been inadequate. (See NCEP Adult Treatment Panel (ATP) III Guidelines, summarized in Table 6.)
Table 6: Summary of NCEP ATP III Guidelines
| Risk Category | LDL Goal (mg/dL) |
LDL Level at Which to Initiate Therapeutic Lifestyle Changesa (mg/dL) |
LDL Level at Which to Consider Drug Therapy (mg/dL) |
| CHD or CHD risk equivalentsb (10-year risk > 20%)c |
< 100 | ≥ 100 | ≥ 130 (100-129: drug optional)d |
| 2+ Risk factorse (10-year risk ≤ 20%)c |
< 130 | ≥ 130 | 10-year risk 10-20%: ≥ 130c 10-year risk < 10%: ≥ 160c |
| 0-1 Risk factorf | < 160 | ≥ 160 | ≥ 190 (160-189: LDL-lowering drug optional) |
| a Therapeutic lifestyle changes
include: 1) dietary changes: reduced intake of saturated fats ( < 7%
of total calories) and cholesterol ( < 200 mg per day), and enhancing
LDL lowering with plant stanols/sterols (2 g/d) and increased viscous
(soluble) fiber (10-25 g/d), 2) weight reduction, and 3) increased physical
activity. b CHD risk equivalents comprise: diabetes, multiple risk factors that confer a 10-year risk for CHD > 20%, and other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm and symptomatic carotid artery disease). c Risk assessment for determining the 10-year risk for developing CHD is carried out using the Framingham risk scoring. Refer to JAMA, May 16, 2001; 285 (19): 2486-2497, or the NCEP website (http://www.nhlbi.nih.gov) for more details. d Some authorities recommend use of LDL-lowering drugs in this category if an LDL cholesterol < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. e Major risk factors (exclusive of LDL cholesterol) that modify LDL goals include cigarette smoking, hypertension (BP =140/90 mm Hg or on anti-hypertensive medication), low HDL cholesterol ( < 40 mg/dL), family history of premature CHD (CHD in male first-degree relative < 55 years; CHD in female first-degree relative < 65 years), age (men =45 years; women =55 years). HDL cholesterol =60 mg/dL counts as a “negative” risk factor; its presence removes one risk factor from the total count. f Almost all people with 0-1 risk factor have a 10-year risk < 10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. |
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Prior to initiating therapy with VYTORIN, secondary causes for dyslipidemia (i.e., diabetes, hypothyroidism, obstructive liver disease, chronic renal failure, and drugs that increase LDL-C and decrease HDL-C [progestins, anabolic steroids, and corticosteroids]), should be excluded or, if appropriate, treated. A lipid profile should be performed to measure total-C, LDL-C, HDL-C and TG. For TG levels > 400 mg/dL ( > 4.5 mmol/L), LDL-C concentrations should be determined by ultracentrifugation.
At the time of hospitalization for an acute coronary event, lipid measures should be taken on admission or within 24 hours. These values can guide the physician on initiation of LDL-lowering therapy before or at discharge.
DOSAGE AND ADMINISTRATION
The patient should be placed on a standard cholesterol-lowering diet before receiving VYTORIN and should continue on this diet during treatment with VYTORIN. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient's response. (See NCEP Adult Treatment Panel (ATP) III Guidelines, summarized in Table 6.) VYTORIN should be taken as a single daily dose in the evening, with or without food.
The dosage range is 10/10 mg/day through 10/80 mg/day. The recommended usual starting dose is 10/20 mg/day. Initiation of therapy with 10/10 mg/day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day. After initiation or titration of VYTORIN, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed. See below for dosage recommendations for patients receiving certain concomitant therapies and for those with renal insufficiency.
Patients with Homozygous Familial Hypercholesterolemia
The recommended dosage for patients with homozygous familial hypercholesterolemia is VYTORIN 10/40 mg/day or 10/80 mg/day in the evening. 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.
Patients with Hepatic Insufficiency
No dosage adjustment is necessary in patients with mild hepatic insufficiency (see PRECAUTIONS, Hepatic Insufficiency).
Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild or moderate renal insufficiency. However, for patients with severe renal insufficiency, VYTORIN should not be started unless the patient has already tolerated treatment with simvastatin at a dose of 5 mg or higher. Caution should be exercised when VYTORIN is administered to these patients and they should be closely monitored (see CLINICAL PHARMACOLOGY, Pharmacokinetics and WARNINGS, Myopathy/Rhabdomyolysis).
Geriatric Patients
No dosage adjustment is necessary in geriatric patients (see CLINICAL PHARMACOLOGY, Special Populations).
Coadministration with Bile Acid Sequestrants
Dosing of VYTORIN should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant (see PRECAUTIONS: DRUG INTERACTIONS).
Patients taking Cyclosporine or Danazol
Caution should be exercised when initiating VYTORIN in the setting of cyclosporine. In patients taking cyclosporine or danazol, VYTORIN should not be started unless the patient has already tolerated treatment with simvastatin at a dose of 5 mg or higher. The dose of VYTORIN should not exceed 10/10 mg/day.
Patients taking Amiodarone or Verapamil
In patients taking amiodarone or verapamil concomitantly with VYTORIN, the dose should not exceed 10/20 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS: DRUG INTERACTIONS, Other drug interactions).
Patients taking other Concomitant Lipid-Lowering Therapy
The safety and effectiveness of VYTORIN administered with fibrates have not been established. Therefore, the combination of VYTORIN and fibrates should be avoided (see WARNINGS, Myopathy/Rhabdomyolysis, and PRECAUTIONS: DRUG INTERACTIONS, Other drug interactions).
There is an increased risk of myopathy when simvastatin is used concomitantly with fibrates (especially gemfibrozil). Therefore, although not recommended, if VYTORIN is used in combination with gemfibrozil, the dose should not exceed 10/10 mg daily (see WARNINGS, Myopathy/Rhabdomyolysis, and PRECAUTIONS: DRUG INTERACTIONS, Other drug interactions).
HOW SUPPLIED
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.
Issued January 2008. Manufactured for: MERCK/Schering-Plough Pharmaceuticals, North Wales, PA 19454, USA. By: MSD Technology Singapore Pte. Ltd. Singapore 637766 Or Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21 27100 – Pavia Italy Or Merck Sharp & Dohme Ltd. Cramlington, Northumberland, UK NE23 3JU. FDA Rev date: 2/2008
Generic Name: Ezetimibe & Simvastatin
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