Vytorin 10-40 Oral

Uses

This medication is a combination of two drugs, ezetimibe and simvastatin. It is used along with a proper diet to help lower bad cholesterol (LDL) and fats (triglycerides) in the blood while raising good cholesterol (HDL). This product is generally prescribed after non-drug treatment (e.g., diet change, increase in exercise, weight loss if overweight) have not been fully successful at lowering cholesterol. Reducing your cholesterol and fats help prevent strokes and heart attacks. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Simvastatin is an enzyme blocker (HMG-CoA reductase inhibitor), also known as a "statin," which reduces the amount of cholesterol that your body makes normally each day.

Simvastatin is used in adults and children (10 years of age and older). Young girls must have had their menstrual periods for at least one year before starting this medication.

How to use Vytorin 10-40 Oral

Read the Patient Information Leaflet provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth usually once daily in the evening, with or without food; or as directed by your doctor.

Dosage is based on your medical condition, response to therapy, and use of certain interacting medicines. Many of the drugs listed in the Drug Interactions section in this handout may increase the chances of muscle injury when used with simvastatin. Consult your doctor or pharmacist for more details.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit juice can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details.

If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take ezetimibe/simvastatin at least 2 hours before, or at least 4 hours after, these other medications.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It may take up to 2 weeks before the full benefit of this drug takes effect.

It is important to continue taking this medication even if you feel well. Most people with high cholesterol or fat levels in their blood do not feel sick.

Before taking ezetimibe/simvastatin, tell your doctor or pharmacist if you think you are allergic to it; or to other drugs called "statins"; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of liver disease, kidney disease, alcohol use.

Developing severe muscle damage, which is rare, can sometimes lead to serious kidney problems (see the Side Effects section in this handout). This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before you stop taking your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis or severe metabolic, endocrine, or electrolyte disorders), very low blood pressure, uncontrolled seizures.

Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially muscle damage.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that young girls and women of child-bearing age use effective birth control to prevent pregnancy while taking this drug. One of these drugs (simvastatin) may cause harm to your unborn child.

It is not known if either drug passes into breast milk. A drug similar to simvastatin passes into breast milk, and because of this drug's potential risk of undesirable effects on a nursing infant, breast-feeding is not recommended while using ezetimibe/simvastatin. Consult your doctor before breast-feeding.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES:

Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood cholesterol levels, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

For best results, this product should be used along with exercise, a low-cholesterol or low-fat diet, and a weight-loss program if you are overweight. Also to help reduce your risk of heart attacks and strokes, check your blood pressure regularly, seek medical treatment if your blood pressure is high, and stop smoking. Consult your doctor for more details.

MISSED DOSE:

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Headache may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes and skin, dark urine, severe fatigue, stomach/abdominal pain, persistent nausea.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

See also How To Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: certain azole antifungals (e.g., itraconazole, ketoconazole), delavirdine, HIV protease inhibitors (e.g., ritonavir, amprenavir, lopinavir), certain macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin), nefazodone, telithromycin.

If you are currently using any of these medications, tell your doctor or pharmacist before starting ezetimibe/simvastatin.

Use caution if you are taking the following drugs in combination with this product because serious side effects such as muscle injury (myopathy) could sometimes occur: fibrates (e.g., gemfibrozil, fenofibrate), high-dose niacin (1 gram or more per day).

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), danazol, daptomycin, digoxin, other drugs which affect certain liver enzymes (CYP 3A4 substrates, inhibitors, and inducers such as amiodarone, cyclosporine, diltiazem, verapamil, rifampin, St. John's wort, carbamazepine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.