ARUDEL (VYTORIN) INDICATIONS
Arudel is used for treating high cholesterol along with a cholesterol-lowering diet. Arudel is a combination of 2 medicines. Ezetimibe works by reducing the amount of cholesterol that your body absorbs from your diet. Simvastatin is an HMG-CoA reductase inhibitor or "statin." It works by blocking an enzyme that is necessary for your body to make cholesterol. Lowering cholesterol levels in the blood reduces the chance of heart disease, heart attacks, and strokes. Arudel has not been shown to reduce heart attacks or strokes more than simvastatin alone.
ARUDEL (VYTORIN) INSTRUCTIONS
Use Arudel as directed by your doctor.
- Take Arudel by mouth with or without food, preferably in the evening, unless directed otherwise by your doctor.
- Taking Arudel at the same time each day will help you remember to take it.
- If you also take a bile acid sequestrant (eg, cholestyramine, colestipol, colesevelam), do not take it within 2 hours before or 4 hours after taking Arudel. Check with your doctor if you have questions.
- For best results, Arudel should be used along with exercise, a low-cholesterol/low-fat diet, and a weight-loss program if you are overweight. Follow the diet and exercise program given to you by your health care provider.
- Eating grapefruit or drinking grapefruit juice may increase the amount of Arudel in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than one quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Arudel.
- Most people with high cholesterol do not feel sick. Continue to take Arudel even if you feel well. Do not miss any doses.
- If you miss a dose of Arudel, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Arudel.
ARUDEL (VYTORIN) STORAGE
Store Arudel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Arudel out of the reach of children and away from pets.
ARUDEL (VYTORIN) MORE INFO:
Active Ingredients: Ezetimibe, Simvastatin.
Do NOT use Arudel if:
- you are allergic to any ingredient in Arudel
- you have liver problems or ongoing abnormal liver function test results
- you are taking another medicine that contains simvastatin or ezetimibe
- you are taking an HIV protease inhibitor (eg, nelfinavir, lopinavir, ritonavir), itraconazole, ketoconazole, a macrolide or ketolide antibiotic (eg, clarithromycin, erythromycin, troleandomycin), mibefradil, or nefazodone
- you are pregnant or breast-feeding.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Arudel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are a woman of childbearing age
- if you have kidney problems, muscle problems, or a family history of muscle problems; low blood pressure; uncontrolled seizures; or serious metabolic, endocrine, or electrolyte problems
- if you are scheduled for major surgery, have recently had a major trauma, or have a severe infection or history of alcohol abuse
- if you have had an organ transplant and are taking medicine to suppress a rejection reaction.
Some medicines may interact with Arudel. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amiodarone, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), azole antifungals (eg, itraconazole, ketoconazole), cyclosporine, danazol, delavirdine, diltiazem, fibrates (eg, clofibrate, fenofibrate), fluconazole, gemfibrozil, HIV protease inhibitors (eg, ritonavir), imatinib, macrolide antibiotics (eg, erythromycin), macrolide immunosuppressives (eg, tacrolimus), mibefradil, nefazodone, niacin, nicotinic acid, streptogramins, telithromycin, verapamil, or voriconazole because side effects, such as muscle pain, may occur
- Bosentan, carbamazepine, cholestyramine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Arudel's effectiveness
- Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Arudel.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Arudel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Important safety information:
- Arudel may cause dizziness, drowsiness, or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Arudel with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
- It may take several weeks for Arudel to work.
- Proper dental care is important while you are taking Arudel. Brush and floss your teeth and visit the dentist regularly.
- Arudel may harm your liver. Your risk may be greater if you drink alcohol while you are using Arudel. Talk to your doctor before you take Arudel or other fever reducers if you drink more than 3 drinks with alcohol per day.
- Arudel may cause injury to your muscles, especially when taken at higher doses or when taken with certain other medicines. Contact your doctor right away if you experience muscle pain, tenderness, or weakness, especially with a fever.
- Some patients taking Arudel have reported poor memory or trouble sleeping. If you experience these effects, check with your doctor.
- Lab tests, including blood cholesterol levels, liver function tests, or muscle tests, may be performed while you use Arudel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Arudel should be used with extreme caution in children younger 10 years; safety and effectiveness in these children have not been confirmed.
- Pregnancy and breast-feeding: Do not use Arudel if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Arudel is found in breast milk. Do not breastfeed while taking Arudel.
All medicines may cause side effects, but many people have no, or minor, side effects.
Check with your doctor if any of these most common side effects persist or become bothersome:
Diarrhea; flu-like symptoms; headache; pain in the arms or legs; tiredness; upper respiratory tract infection.
Seek medical attention right away if any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; change in the amount of urine; chest pain; dark urine; depression; fast heartbeat; fever; loss of appetite; muscle tenderness, pain, or weakness; nausea; numbness, tingling, burning, or weakness in the arms, hands, feet, or legs; pale stools; stomach tenderness; unexplained pain in the stomach or mid-upper back; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.