niacin and simvastatin

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Generic Name: niacin and simvastatin (NYE a sin and SIM va stat in)
Brand Names: Simcor

What is niacin and simvastatin?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Simvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

The combination of niacin and simvastatin is used to lower cholesterol and triglycerides (types of fat) in the blood.

Niacin and simvastatin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about niacin and simvastatin? You should not take this medication if you are allergic to niacin (Niaspan, Niacor, and others) or simvastatin (Zocor, Vytorin), if you are pregnant or breast-feeding, or if you have liver disease, severe bleeding, or a stomach ulcer. In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Never take niacin and simvastatin in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.

There are many other drugs that should not be used together with niacin and simvastatin. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Simvastatin can harm an unborn baby or cause birth defects. Do not use niacin and simvastatin if you are pregnant.

Before taking niacin and simvastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, gout, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.

What should I discuss with my healthcare provider before taking niacin and simvastatin? You should not take this medication if you are allergic to niacin (Niaspan, Niacor, and others) or simvastatin (Zocor, Vytorin), if you are pregnant or breast-feeding, or if you have liver disease, severe bleeding, or a stomach ulcer. In rare cases, niacin and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid). You may also be more likely to develop this condition if you are of Chinese descent

The following drugs can increase your risk of serious muscle problems if you take them together with simvastatin. These drugs should not be used while you are taking niacin and simvastatin:

amiodarone (Cordarone, Pacerone);

cyclosporine (Gengraf, Neoral, Sandimmune);

danazol (Danocrine);

diltiazem (Cartia, Cardizem, Tiazac);

gemfibrozil (Lopid);

nefazodone (an antidepressant);

verapamil (Calan, Covera, Isoptin, Verelan);

the antibiotics clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), and telithromycin (Ketek);

the antifungal medications itraconazole (Sporanox), ketoconazole (Nizoral), and posaconazole (Noxafil); or

the HIV/AIDS medications atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), saquinavir (Invirase), and tipranavir (Aptivus).

Before you start taking niacin and simvastatin, tell your doctor if you are already using any of these other medicines:

amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide); or

ranolazine (Ranexa).

To make sure you can safely take niacin and simvastatin at any dose, tell your doctor if you have any of these other conditions:

history of liver disease; history of kidney disease;

diabetes;

gout;

a thyroid disorder;

if you drink more than 2 alcoholic beverages daily; or

if you are switched to this medication from regular niacin, nicotinic acid, or nicotinamide (or vitamin supplements that contain niacin).

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take niacin and simvastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking niacin and simvastatin. Niacin and simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking niacin and simvastatin. How should I take niacin and simvastatin?

Take exactly as prescribed. Never take this medicine in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.

Niacin and simvastatin is usually taken at bedtime with a low-fat snack. Follow your doctor's instructions. Do not take niacin and simvastatin on an empty stomach.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Niacin can cause certain side effects such as dizziness, sweating, chills, flushing (warmth, redness, or tingly feeling under your skin), fast or pounding heartbeats, shortness of breath, or feeling like you might pass out. These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin and simvastatin. These effects should disappear over time as you keep taking the medicine.

Your doctor may recommend you take aspirin 30 minutes before you take niacin and simvastatin to prevent certain side effects. Do not take aspirin without your doctor's advice. Follow the label directions or your doctor's instructions about how much aspirin to take.

You may need to stop using niacin and simvastatin for a short time if you have:

uncontrolled seizures;

an electrolyte imbalance (such as high or low potassium levels in your blood);

severely low blood pressure;

a severe infection or illness;

dehydration; or

surgery or a medical emergency.

If you stop taking niacin and simvastatin for longer than 7 days in a row, talk with your doctor before restarting the medication. You may need to start with a lower dose.

Niacin can raise your blood sugar, and may cause unusual results with certain medical tests. Tell any doctor who treats you that you are using niacin and simvastatin.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function should be tested every 3 to 6 months. Visit your doctor regularly. You may need to take niacin and simvastatin on a long-term basis for the treatment of high cholesterol. Do not stop taking this medication unless your doctor tells you to.

Niacin and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

See also: Niacin and simvastatin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking niacin and simvastatin? Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not drink more than 1 quart of grapefruit juice daily.

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking them within 4 to 6 hours before or after you take niacin and simvastatin.

Avoid eating foods that are high in fat or cholesterol. Niacin and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage. Niacin and simvastatin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking niacin and simvastatin and call your doctor at once if you have any of these serious side effects:

unexplained muscle pain, tenderness, or weakness;

fever, unusual tiredness, and dark colored urine;

swelling, weight gain, urinating less than usual or not at all; or

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

headache, mild dizziness;

diarrhea, mild nausea;

mild skin rash;

back pain; or

flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Niacin and simvastatin Dosing Information

Usual Adult Dose for Hyperlipidemia:

Initial (for patients not currently on niacin extended-release and patients currently on niacin products other than niacin extended-release): 500 mg-20 mg orally once daily at bedtime with a low fat snack.
Patients already taking simvastatin 20 to 40 mg who need additional management of their lipid levels may be started on a niacin-simvastatin dose of 500 mg-40 mg once daily at bedtime.
Maintenance (depending on patient tolerability and lipid levels): 1000 mg-20 mg to 2000 mg-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 efficacy and safety of doses of niacin-simvastatin greater than 2000 mg-40 mg daily have not been studied and are therefore not recommended. If niacin-simvastatin therapy is discontinued for an extended period of time (greater than 7 days), re-titration as tolerated is recommended.

What other drugs will affect niacin and simvastatin?

Tell your doctor about all other medications you use, especially:

colchicine (Colcrys);

digoxin (Lanoxin);

blood pressure medication;

a blood thinner such as warfarin (Coumadin, Jantoven);

other medicines that contain niacin (Advicor, Niaspan, Niacor, Slo-Niacin, and others); or

any other "statin" medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Vytorin).

This list is not complete and other drugs may interact with niacin and simvastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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niacin and simvastatin

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