Simvastatin/niacin (By mouth)

Introduction

Niacin (NYE-a-sin), Simvastatin (sim-va-STAT-in)

Lowers high levels of cholesterol and triglycerides (fats) in your blood. This is a combination of 2 medicines. It contains vitamin B3 (niacin) and an HMG-CoA inhibitor (simvastatin), which is sometimes called a "statin."

Brand Name(s)

Simcor

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you had an allergic reaction to simvastatin or niacin. Do not use this medicine if you are pregnant or breastfeeding, or if you have active liver disease, a stomach ulcer, or any areas where you are bleeding. Do not use niacin/simvastatin if you are also using the following medicines: cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, Biaxin®, Ery-Tab®, Ketek®, Nizoral®, Noxafil®, or Sporanox®), certain blood pressure medicines (such as amiodarone, diltiazem, verapamil, Calan®, Cardizem®, Cordarone®, or Verelan®), or certain medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Agenerase®, Crixivan®, Invirase®, Kaletra®, Lexiva®, Norvir®, Reyataz®, or Viracept®). Using these medicines together can cause serious side effects.

How to Use This Medicine

Long Acting Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine with food or milk. It is best to take this medicine at bedtime, with a low-fat meal or snack.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is only part of a complete plan for lowering cholesterol and triglycerides in your blood.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using amlodipine (Norvasc®), colchicine (Colcrys®), digoxin (Lanoxin®), ranolazine (Ranexa®), voriconazole (Vfend®), other medicine to lower cholesterol (such as cholestyramine, colestipol, fenofibrate, Colestid®, Questran®, or Tricor®). medicine to treat HIV or AIDS (such as lamivudine, stavudine, zidovudine, Combivir®, Epivir®, or Zerit®), or a blood thinner (such as warfarin, Coumadin®).
• If you are also using cholestyramine (Questran®) or colestipol (Colestid®), take it at least 4 to 6 hours before you take this medicine.
• Do not drink alcohol while you are using this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.Do not drink more than 1 quart of grapefruit juice each day.
• Do not take vitamins containing niacin or nicotinamide while you are using this medicine.
• Do not drink hot beverages and eat spicy foods while you are taking this medicine. These items may cause you to feel hot, warm or flushed, and this medicine might do the same.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have kidney disease, diabetes, gout, thyroid problems, a history of muscle pain or weakness, or a history of liver disease. Tell your doctor if you drink alcohol on a regular basis.
• Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. If it is accompanied by unusual tiredness or fever, it may be a muscle condition called rhabdomyolysis, which can lead to serious kidney problems.
• Chinese patients who are taking large amounts of niacin (1 gram per day or more) together with simvastatin may have an increased risk for muscle injury. Caution is advised when Chinese patients are taking doses of niacin/simvastatin above 1000 mg/20 mg per day.
• Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
• Do not change your dose without checking first with your doctor. The 80 mg dose of simvastatin may increase your risk to have serious muscle problems.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• This medicine may affect blood sugar levels. This is important if you are diabetic or prediabetic. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.
• This medicine may make you dizzy or lightheaded. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. Change positions slowly when getting up from a sitting or lying position.
• Do not stop using this medicine without asking your doctor. You may need a special diet to keep your cholesterol levels from going up after you stop using the medicine.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine may cause a side effect called flushing. Flushing is a feeling of warmth or redness on the face, neck, arms, and occasionally, on the upper chest. Your doctor may recommend that you take aspirin 30 minutes before taking this medicine to prevent flushing.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Muscle pain, tenderness, or weakness.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Back pain.
• Diarrhea or stomach pain.
• Headache or dizziness.
• Skin itching.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088