1 What is Vytorin?

Brand: Vytorin

Generic: Ezetimibe and Simvastatin

Vytorin is used in combination with proper diet to treat high cholesterol and triglyceride levels in the blood. This drug combination may help prevent medical problems caused by Atherosclerosis.

These drugs generally reduce the absorption of cholesterol from foods and the production of cholesterol in your body. This drug combination requires a prescription.

2 What to Know Before Using

Before using Vytorin, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children 10 to 17 years of age have not reported any pediatric-specific problems that would limit the utility of Ezetimibe and Simvastatin combination while safety and efficacy of Ezetimibe and Simvastatin combination in children younger than 10 years of age have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of Ezetimibe and Simvastatin combination. Caution is required in giving this drug to elderly patients since they are more likely to have age-related muscle problems.

Fetal abnormalities have been reported in studies of pregnant women and animals. This drug contraindicated in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Strong CYP3A4 Inhibitors
  • Cyclosporine
  • Danazol
  • Gemfibrozil
  • Amiodarone
  • Dronedarone
  • Ranolazine
  • Calcium Channel Blockers
  • Niacin
  • Digoxin
  • Cholestyramine
  • Fenofibrates
  • Coumarin Anticoagulants
  • Colchicine

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

3 Proper Usage

Proper usage of Vytorin requires strict adherence to your doctor’s orders. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.

A personal diet plan low in fats, sugars, and/or cholesterol may be advised by your healthcare professional before prescribing any lipid-lowering drug. Take this drug with or without food.

Your dose should not be higher than Ezetimibe 10 milligrams plus Simvastatin 10 mg per day if you are taking Diltiazem (CardizemВ®), Dronedarone (MultaqВ®), or Verapamil (CalanВ®, IsoptinВ®, VerelanВ®) together with Ezetimibe and Simvastatin combination.

It is not recommended to use more than Ezetimibe 10 mg plus Simvastatin 20 mg per day together with Amiodarone (CordaroneВ®), Amlodipine (NorvascВ®), Lomitapide (Juxtapidв„ў), or Ranolazine (RanexaВ®).

These limitations are intended to prevent any risk of muscle injury and kidney problems. Take it at least 2 hours after or 4 hours before you take this drug if you are also using Cholestyramine (QuestranВ®).

An increase in the risk of injury and kidney problems may occur when large amounts of grapefruit juice are taken while taking this drug. Drinking large amounts of alcohol with this drug is not recommended to prevent any unwanted effects on the liver.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults and children 10 to 17 years of age with high cholesterol are initially given one tablet with ezetimibe 10 milligrams plus simvastatin 10 mg or ezetimibe 10 mg plus simvastatin 20 mg once a day in the evening.

Your healthcare professional may adjust your dose as needed. The doses must not exceed 10 mg for Ezetimibe and 40 mg for Simvastatin per day. Use and dose in children younger than 10 years of age must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light.

Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Vytorin, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness and unwanted effects of the drug.

Check with your healthcare professional immediately if you think that you may be pregnant as this drug may cause birth defects or other problems in the baby if taken during pregnancy. 

This drug combination is contraindicated to other drugs such as:

certain antibiotics such as:

  • Clarithromycin
  • Erythromycin
  • Itraconazole
  • Ketoconazole
  • Posaconazole
  • Telithromycin
  • Voriconazole
  • NizoralВ®

or drugs to treat HIV/AIDS such as:

This is to prevent any risk of muscle injury and kidney problems. Chinese patients who are taking large amounts of Niacin together with this drug may have an increased risk for muscle injury. Talk to your healthcare professional if you are Chinese or have Chinese ancestry and take large amounts of Niacin.

Consult with your healthcare professional immediately if you have symptoms of Myopathy or immune-mediated Necrotizing Myopathy such as unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. This is more common when high doses of Simvastatin with Ezetimibe are used.

Check with your healthcare professional immediately if you have symptoms of Rhabdomyolysis such as:

  • Dark-colored urine
  • Diarrhea
  • Fever
  • Muscle cramps or spasms
  • Muscle pain or stiffness
  • Feel very tired or weak as this can result in kidney problems

Seek medical attention if you experience symptoms of liver problems such as:

  • Headache
  • Stomach pain
  • Vomiting
  • Dark-colored urine
  • Loss of appetite
  • Weight loss
  • General feeling of tiredness or weakness
  • Light-colored stools
  • Upper right stomach pain
  • Yellow eyes or skin

Inform any health care professional or dentist that you are using this drug. You may need to stop using this drug if you have a major surgery, a major injury, or you develop other serious health problems.

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

Make sure you meet with your doctor in using Vytorin to avoid unwanted potential side effects. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • Abdominal or Stomach fullness
  • Bloating
  • Chills
  • Constipation
  • Darkened urine
  • Fast heartbeat
  • Fever
  • Hives
  • Hoarseness
  • Indigestion
  • Itching
  • Joint pain
  • Large hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Loss of appetite, nausea, pains in the stomach, side, or abdomen
  • Possibly radiating to the back
  • Rash, Redness of the skin
  • Shortness of breath
  • Stiffness
  • Swelling of the eyelids, face, lips, hands, or feet
  • Tightness in the chest
  • Trouble breathing or swallowing
  • Vomiting
  • Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

6 Related Clinical Trials