VYTORIN Tablet (2022)

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Organon LLC

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1. Indications and Usage

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. ...

2. Dosage and Administration

2.1 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 ...

3. Dosage Forms and Strengths

VYTORIN 10/10, (ezetimibe 10 mg and simvastatin 10 mg tablets) are white to off-white capsule-shaped tablets with code 311 on one side. VYTORIN 10/20, (ezetimibe 10 mg and simvastatin 20 mg tablets) are ...

4. Contraindications

VYTORIN is contraindicated in the following conditions: Concomitant administration of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, ...

5. Warnings and Precautions

5.1 Myopathy/Rhabdomyolysis Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase above ten times the upper limit of normal (ULN). Myopathy sometimes ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis and myopathy [see Warnings and Precautions (5.1)] Liver enzyme abnormalities ...

6.1. Clinical Trials Experience

VYTORIN Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials ...

6.2. Postmarketing Experience

Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...

7. Drug Interactions

[See Clinical Pharmacology (12.3)] VYTORIN 7.1 Strong CYP3A4 Inhibitors, Cyclosporine, or Danazol Strong CYP3A4 inhibitors: The risk of myopathy is increased by reducing the elimination ...

8. Use in Specific Populations

8.8 Chinese Patients In a clinical trial in which patients at high risk of cardiovascular disease were treated with simvastatin 40 mg/day (median follow-up 3.9 years), the incidence of myopathy was approximately ...

8.1. Pregnancy

Pregnancy Category X. [See Contraindications (4)] VYTORIN VYTORIN is contraindicated in women who are or may become pregnant. Lipid-lowering drugs offer no benefit during pregnancy, because ...

8.3. Nursing Mothers

It is not known whether simvastatin is excreted in human milk. Because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions ...

8.4. Pediatric Use

The effects of ezetimibe coadministered with simvastatin (n=126) compared to simvastatin monotherapy (n=122) have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia ...

8.5. Geriatric Use

Of the 10,189 patients who received VYTORIN in clinical studies, 3242 (32%) were 65 and older (this included 844 (8%) who were 75 and older). No overall differences in safety or effectiveness were observed ...

8.6. Renal Impairment

In the SHARP trial of 9270 patients with moderate to severe renal impairment (6247 non-dialysis patients with median serum creatinine 2.5 mg/dL and median estimated glomerular filtration rate 25.6 mL/min/1.73 ...

8.7. Hepatic Impairment

VYTORIN is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminases [See Contraindications (4) and Warnings and Precautions (5.3)]. ...

10. Overdosage

VYTORIN No specific treatment of overdosage with VYTORIN can be recommended. In the event of an overdose, symptomatic and supportive measures should be employed. Ezetimibe In clinical studies, administration ...

11. Description

VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl) ...

12.1. Mechanism of Action

VYTORIN Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. VYTORIN contains ezetimibe and simvastatin, two lipid-lowering compounds with complementary mechanisms of action. ...

12.2. Pharmacodynamics

Clinical studies have demonstrated that elevated levels of total-C, LDL-C and Apo B, the major protein constituent of LDL, promote human atherosclerosis. In addition, decreased levels of HDL-C are associated ...

12.3. Pharmacokinetics

The results of a bioequivalence study in healthy subjects demonstrated that the VYTORIN (ezetimibe and simvastatin) 10 mg/10 mg to 10 mg/80 mg combination tablets are bioequivalent to coadministration ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

VYTORIN No animal carcinogenicity or fertility studies have been conducted with the combination of ezetimibe and simvastatin. The combination of ezetimibe with simvastatin did not show evidence of mutagenicity ...

13.2. Animal Toxicology and/or Pharmacology

CNS Toxicity Optic nerve degeneration was seen in clinically normal dogs treated with simvastatin for 14 weeks at 180 mg/kg/day, a dose that produced mean plasma drug levels about 12 times higher than ...

14. Clinical Studies

14.1 Primary Hyperlipidemia VYTORIN VYTORIN reduces total-C, LDL-C, Apo B, TG, and non-HDL-C, and increases HDL-C in patients with hyperlipidemia. Maximal to near maximal response is generally achieved ...

16.1. How Supplied

VYTORIN 10/10 are white to off-white capsule-shaped tablets with code 311 on one side. They are supplied as follows: NDC 78206-174-01 bottles of 30 NDC 78206-174-02 bottles of 90 VYTORIN 10/20 are ...

16.2. Storage and Handling

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

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular ...