Vytorin-Generic, simvastatin 10mg + ezetimibe 10mg x 100 tabs

Manufacturer/Pricing 

Manufacturer: Merck & Co., Inc.  DEA/FDA: Rx

VYTORIN (exetimibe/simvastatin)

Patient Education - English

• Generic Name: ezetimibe and simvastatin

• Pronounced: ez ET i mibe and SIM va stat in

• Brand Name: Vytorin

What is the most important information I should know about ezetimibe and simvastatin?

You should not take ezetimibe and simvastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease.

Stop taking this medication and tell your doctor right away if you become pregnant.

Before taking ezetimibe and simvastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.

In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Avoid eating foods that are high in fat or cholesterol. Ezetimibe and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

There are many other drugs that can increase your risk of serious medical problems if you take them together with ezetimibe and simvastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

What is ezetimibe and simvastatin?

Ezetimibe reduces the amount of cholesterol absorbed by the body.

Ezetimibe and simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Ezetimibe and simvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

The combination of ezetimibe and simvastatin is used to treat high cholesterol in adults and children who are at least 10 years old.

Ezetimibe and simvastatin may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ezetimibe and simvastatin?

You should not take ezetimibe and simvastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• history of liver disease;
• history of kidney disease;
• diabetes;
• a thyroid disorder; or
• if you drink more than 2 alcoholic beverages daily.

In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid). You may also be more likely to develop this condition if you are of Chinese descent and you take high-dose ezetimibe and simvastatin while also taking medication that contains niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

Tell your doctor about all other medications you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

• amiodarone (Cordarone, Pacerone);
• danazol (Danocrine);
• nefazodone (an antidepressant);
• gemfibrozil (Lopid), fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);
• antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
• antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);
• heart or blood pressure medication such as diltiazem (Cartia, Cardizem) or verapamil (Calan, Covera, Isoptin, Verelan);
• HIV medications such as atazanavir (Reyataz), ritonavir (Norvir), lopinavir/ritonavir (Kaletra), saquinavir (Invirase), and others;
• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others); or
• drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take ezetimibe and simvastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking ezetimibe and simvastatin.

Ezetimibe and simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking ezetimibe and simvastatin.

How should I take ezetimibe and simvastatin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Ezetimibe and simvastatin is usually taken once daily in the evening, with or without food. Your doctor may occasionally change your dose to make sure you get the best results.

You may need to stop using ezetimibe and simvastatin for a short time if you have surgery or a medical emergency.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You may need to take ezetimibe and simvastatin on a long-term basis for the treatment of high cholesterol.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ezetimibe and simvastatin?

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking them within 2 hours after or 4 hours before you take ezetimibe and simvastatin.

Avoid eating foods that are high in fat or cholesterol. Ezetimibe and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit and grapefruit juice may interact with ezetimibe and simvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What are the possible side effects of ezetimibe and simvastatin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ezetimibe and simvastatin and call your doctor at once if you have any of these serious side effects:

• unexplained muscle pain, tenderness, or weakness;
• fever, unusual tiredness, and dark colored urine;
• swelling, weight gain, urinating less than usual or not at all; or
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• headache, memory problems;
• mild muscle pain;
• joint pain;
• numbness or tingly feeling;
• diarrhea;
• dizziness, depressed mood;
• sleep problems (insomnia); or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ezetimibe and simvastatin?

Tell your doctor about all other medications you use, especially:

• digoxin (Lanoxin);
• a blood thinner such as warfarin (Coumadin); or
• any other "statin" medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor).

This list is not complete and other drugs may interact with ezetimibe and simvastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ezetimibe and simvastatin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.