Simvastatin/ niacin

Generic Name: simvastatin/niacin (SIM-va-STAT-in/NYE-a-sin)
Brand Name: Simcor

Simvastatin/ niacin is used for:

Lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL) ("good") cholesterol levels. It is used along with an appropriate diet. It may also be used for other conditions as determined by your doctor.

Simvastatin/niacin is an HMG-CoA reductase inhibitor and niacin combination. The HMG-CoA reductase inhibitor works by reducing the production of certain fatty substances in the body, including cholesterol. The niacin works by reducing low-density lipoprotein (LDL) ("bad") cholesterol and triglycerides and increasing HDL cholesterol.

Do NOT use simvastatin/ niacin if:

  • you are allergic to any ingredient in simvastatin/niacin
  • you are pregnant, may become pregnant, or are breast-feeding
  • you have liver problems, unexplained abnormal liver function tests, active peptic ulcer disease, or certain types of active bleeding (arterial bleeding)
  • you take boceprevir, clarithromycin, cobicistat, cyclosporine, danazol, diltiazem, erythromycin, fibrates (eg, clofibrate, fenofibrate, gemfibrozil), an HIV protease inhibitor (eg, ritonavir), itraconazole, ketoconazole, nefazodone, posaconazole, telaprevir, telithromycin, verapamil, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

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Before using simvastatin/ niacin:

Some medical conditions may interact with simvastatin/niacin. 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 able to become pregnant
  • 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 have a history of liver problems; abnormal liver function tests; yellowing of the skin or eyes; kidney problems; diabetes; underactive thyroid; electrolyte, endocrine, or metabolism problems; blood or bleeding problems (eg, low blood platelet levels); low blood pressure; gout; muscle pain or weakness; seizures; or ulcers
  • if you are dehydrated, have a severe infection or a recent serious injury, or are very ill
  • if you drink large amounts of alcohol or if you have a history of alcohol abuse
  • if you are scheduled to have surgery or if you have received an organ transplant
  • if you have taken or are taking immediate-release (short-acting) niacin, another product that contains niacin, or vitamins or other supplements that contain niacin or nicotinamide
  • if you have not previously taken simvastatin or a long-acting niacin. Simvastatin/niacin should only be used in patients who already take simvastatin or long-acting niacin

Some MEDICINES MAY INTERACT with simvastatin/niacin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, amlodipine, azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), boceprevir, cobicistat, colchicine, cyclosporine, danazol, diltiazem, dronedarone, fibrates (eg, clofibrate, fenofibrate, gemfibrozil), HIV protease inhibitors (eg, ritonavir), lomitapide, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, ranolazine, telaprevir, telithromycin, or verapamil because the risk of myopathy (eg, muscle pain, tenderness, weakness) may be increased
  • Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by simvastatin/niacin
  • Certain medicines for high blood pressure (eg, clonidine, prazosin) because the risk of a sudden drop in blood pressure when sitting or standing up, which may cause dizziness or light-headedness, may be increased by simvastatin/niacin

This may not be a complete list of all interactions that may occur. Ask your health care provider if simvastatin/niacin 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.

How to use simvastatin/ niacin:

Use simvastatin/niacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take simvastatin/niacin by mouth at bedtime with a low-fat snack (eg, low-fat yogurt, banana, crackers with a glass of low-fat milk), unless your doctor tells you otherwise. Taking simvastatin/niacin with a low-fat snack may reduce flushing and stomach upset from simvastatin/niacin. Do not take simvastatin/niacin on an empty stomach.
  • Do not drink alcohol or hot drinks, or eat spicy foods around the time you take simvastatin/niacin. This may also help to reduce the risk of flushing.
  • Swallow simvastatin/niacin whole. Do not break, crush, or chew before swallowing.
  • Eating grapefruit or drinking grapefruit juice may increase the amount of simvastatin/niacin in your blood, which may increase your risk of 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 1 quart daily) while you are using simvastatin/niacin. Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking simvastatin/niacin.
  • If you take cholestyramine or colestipol, take simvastatin/niacin at least 4 to 6 hours after you take cholestyramine or colestipol.
  • Take simvastatin/niacin on a regular schedule to get the most benefit from it. Taking simvastatin/niacin at the same time each day will help you remember to take it.
  • Continue to take simvastatin/niacin even if you feel well. Do not miss any doses.
  • If you miss a dose of simvastatin/niacin, 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. If you miss taking simvastatin/niacin for several days in a row, contact your doctor before you start to take it again. Your dose may need to be adjusted.

Ask your health care provider any questions you may have about how to use simvastatin/niacin.

Important safety information:

  • Simvastatin/niacin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use simvastatin/niacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Simvastatin/niacin may cause liver problems. Rarely, severe and sometimes fatal liver failure has been reported in patients taking simvastatin/niacin. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with simvastatin/niacin, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking simvastatin/niacin. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
  • For best results, simvastatin/niacin 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.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Tell your doctor or dentist that you take simvastatin/niacin before you receive any medical or dental care, emergency care, or surgery. Simvastatin/niacin may need to be stopped for a few days before certain types of surgery.
  • Flushing may occur with simvastatin/niacin and can last for several hours. Take simvastatin/niacin at bedtime so that flushing will occur during sleep, unless your doctor tells you otherwise. If you are awakened by flushing at night, get up slowly, especially if you feel dizzy or faint, or if you are taking blood pressure medicines. Taking aspirin 30 minutes before you take simvastatin/niacin may lessen flushing. Talk with your doctor to see if you should take aspirin before you take simvastatin/niacin or if flushing becomes bothersome.
  • Muscle problems (myopathy) may occur with simvastatin/niacin. The risk of muscle problems may be greater in people who take higher doses of simvastatin/niacin, in people older than 64 years old, in females, or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin), especially in Chinese patients. Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort. Tell your doctor if you have muscle problems that persist even after your doctor has told you to stop taking simvastatin/niacin.
  • Certain conditions may increase your risk of serious muscle problems. These may include dehydration; low blood pressure; major surgery or injury; severe infection; uncontrolled seizures; or serious metabolism, endocrine, or electrolyte problems. Contact your doctor right away if you develop one of these conditions.
  • Diabetes patients - Simvastatin/niacin may increase your blood sugar levels. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Rarely, changes to the skin, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern.
  • Simvastatin/niacin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Simvastatin/niacin has niacin in it. Before you start any new medicine, check the label to see if it has niacin or nicotinamide in it too. This includes vitamins and other supplements. If it does or you are not sure, check with your doctor or pharmacist.
  • Women who are able to become pregnant should use effective birth control while taking simvastatin/niacin. Check with your doctor if you have questions about using birth control.
  • Lab tests, including liver function, blood sugar, blood cholesterol, and creatine phosphokinase (CPK) blood levels, may be performed while you use simvastatin/niacin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use simvastatin/niacin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • Simvastatin/niacin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not take simvastatin/niacin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Simvastatin/niacin is found in breast milk. Do not breast-feed while taking simvastatin/niacin.

Possible side effects of simvastatin/ niacin:

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:

Back pain; diarrhea; dizziness; flushing (eg, itching, redness, tingling, warmth); headache; nausea; runny or stuffy nose; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or persistent tingling; change in the amount of urine produced; confusion; dark or red-colored urine; dark, tarry, or bloody stools; decreased sexual ability; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased sweating; joint pain; loss of appetite; memory problems; muscle pain, tenderness, or weakness (with or without fever and fatigue); pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; severe or persistent nausea or stomach or back pain; shortness of breath; swelling of the hands, legs, or feet; trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomiting; yellowing of the eyes or skin.

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. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of simvastatin/niacin:

Store simvastatin/niacin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep simvastatin/niacin out of the reach of children and away from pets.

General information:

  • If you have any questions about simvastatin/niacin, please talk with your doctor, pharmacist, or other health care provider.
  • Simvastatin/niacin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take simvastatin/niacin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about simvastatin/niacin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to simvastatin/niacin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using simvastatin/niacin.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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