Niacin and Simvastatin

Niacin and simvastatin is a prescription medication used to treat high cholesterol and high triglycerides. Niacin and simvastatin is a single product containing 2 medications: niacin and simvastatin. The niacin component is a B-complex vitamin, which may work by increasing the breakdown and removal of certain fats in the blood by increasing the activity of a certain enzyme. The simvastatin component belongs to a group of drugs called HMG-CoA reductase inhibitors, also known as statins. It works by blocking the production of cholesterol in the body. 

This medication comes in tablet form and is usually taken once daily at bedtime, with a low fat snack. 

Common side effects of niacin and simvastatin include flushing, itching, and headache.

Niacin and simvastatin is a prescription medication used to treat high cholesterol and high triglycerides.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your blood pressure
• previous medications used and the doses tried
• how you respond to this medication
• your other medical conditions

The recommended starting doses of niacin and simvastatin to treat high cholesterol and high triglycerides are listed below.

• not currently on niacin extended-release or currently on niacin products other than niacin extended-release: a single 500/20 mg tablet daily at bedtime, with a low fat snack
• already taking simvastatin 20 to 40 mg and need additional treatment: 500/40 mg once daily at bedtime, with a low fat snack
  • ​The dose of niacin extended-release should not be increased by more than 500 mg daily every 4 weeks

​The recommended maintenance dose for niacin and simvastatin is 1000/20 mg to 2000/40 mg (two 1000/20 mg tablets) once daily.

• The efficacy and safety of doses of niacin and simvastatin greater than 2000/40 mg daily have not been studied and are therefore not recommended.
• Patients taking amiodarone, amlodipine or ranolazine should not exceed a dose of 1000/20 mg/day of niacin and simvastatin.
• Because of an increased risk for a disease of muscle tissue (myopathy) in Chinese patients taking simvastatin 40 mg along with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products. Caution should be used when using niacin and simvastatin in doses that exceed 1000/20 mg/day in Chinese patients. 

Serious side effects have been reported with niacin and simvastatin including the following:

• heart problems. Use of niacin and simvastatin may cause an increase in the following: coronary heart disease death, nonfatal heart attack, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures.
• a disease of muscle tissue (myopathy) and/or a breakdown of muscle tissue that releases a damaging protein into the blood (rhabdomyolysis). This is a condition in which muscle tissue breaks down, releasing proteins into the blood that can damage other organs, especially the kidney. The risk increases with higher doses. Tell your healthcare provider right away about any unexplained muscle pain, tenderness, or weakness.
• liver damage.  Your doctor will probably order a blood test to measure liver function before you start taking niacin and simvastatin. 
• changes in your blood test values. Increases in blood sugar, increases in HbA1c, reduction in platelets (cells which help with clotting), increase in the time it takes your blood to clot (increase in prothrombin time), increase in uric acid, and decrease in phosphorus.

Do not take niacin and simvastatin if you:

• are allergic to niacin and simvastatin or any of its ingredients
• have active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• have active peptic ulcer disease
• have arterial bleeding
• use strong CYP3A4 inhibitors such as itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone
• use gemfibrozil, cyclosporine, danazol, verapamil or diltiazem
• are pregnant or may become pregnant
• are breastfeeding

Serious side effects have been reported with niacin and simvastatin. See the “Niacin and simvastatin Precautions” section.

Common side effects of niacin and simvastatin include the following:

• headache
• itching
• nausea
• back pain
• diarrhea

Flushing is the most common side effect of niacin and simvastatin. Flushing happens when tiny blood vessels near the surface of the skin (especially on the face, neck, chest and/or back) open wider. Symptoms of flushing may include any or all of the following:

• warmth
• redness
• itching
• tingling of the skin

Flushing may occur with the following symptoms:

• dizziness
• fast heart rate
• a noticeably rapid, strong, or irregular heartbeat (palpitations)
• shortness of breath
• sweating
• burning sensation/skin burning sensation
• chills
• retaining fluid/swelling (edema) 

Flushing does not always happen. If it does, it is usually within 2 to 4 hours after taking a dose of niacin and simvastatin. Flushing may last for a few hours. Flushing is more likely to happen when you first start taking niacin and simvastatin or when your dose of niacin and simvastatin is increased. Flushing may get better after several weeks.

If you wake up at night because of flushing, get up slowly, especially if you:

• feel dizzy or faint
• take blood pressure medicines

To lower your chance of flushing:

• Ask your doctor if you can take aspirin to help lower the flushing side effect from niacin and simvastatin. You can take aspirin (up to the recommended dose of 325 mg) about 30 minutes before you take niacin and simvastatin to help lower the flushing side effect.
• Do not drink hot beverages (including coffee), alcohol, or eat spicy foods around the time you take niacin and simvastatin.
• Take niacin and simvastatin with a low-fat snack to lessen upset stomach.

This is not a complete list of niacin and simvastatin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. 

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

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. No drug interactions have been evaluated for the combination of niacin and simvastatin by the manufacturer. However, the following drugs have been noted to have interactions with niacin and simvastatin:

• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• calcium channel blockers such as amlodipine (Norvasc), verapamil (Calan, Isoptin, Covera, Verelan), and diltiazem (Cardizem)
• fibrates such as gemfibrozil (Lopid) or fenofibrate (TriCor)
• ranolazine (Ranexa)
• propranolol (Inderal)
• digoxin (Lanoxin)
• warfarin (Coumadin, Jantoven)
• colchicine (Colcrys)
• aspirin
• medicines that lower blood pressure such as guanethidine (Ismelin), methyldopa (Aldomet), beta-blockers like bisoprolol (Zebeta) , vasodilators like hydralazine (Apresoline), angiotensin-­converting enzyme (ACE) inhibitors like enalapril (Vasotec, Vaseretic), angiotensin receptor II blockers (ARBs) like valsartan (Diovan) and direct renin inhibitors (DRIs) like aliskiren (Tekturna)
• cholestyramine (Questran) and colestipol (Colestid)
• nutritional supplements containing large doses of niacin or related compounds

This is not a complete list of potential niacin and simvastatin drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Niacin and simvastatin falls into category X. It has been shown that women taking niacin and simvastatin during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if simvastatin is excreted in human breast milk. Niacin has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from niacin and simvastatin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.