niacin and simvastatin

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

What is niacin and simvastatin?

Simvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.

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.

The combination of niacin and simvastatin is used to lower cholesterol and triglycerides (types of fat) in the blood. Lowering your cholesterol and triglycerides can help prevent heart disease and coronary artery disease (also called atherosclerosis), conditions that can lead to heart attack, stroke, and vascular disease.

Niacin and simvastatin may also be used for other 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 simvastatin or niacin, if you are pregnant or breast-feeding, or if you have liver disease, a stomach ulcer, or active bleeding.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). 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 medication.

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

To be sure this medication is not causing harmful effects, your liver function will need to be tested on a regular basis. Do not miss any scheduled appointments.

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.

What should I discuss with my healthcare provider before taking niacin and simvastatin?You should not take this medication if you are allergic to simvastatin or niacin, or if you have:

• liver disease;

• a stomach ulcer;

• active bleeding; or

• if you are pregnant or breast-feeding.

Before taking niacin and simvastatin, tell your doctor if you are allergic to any drugs, or if you have:

• diabetes;

• underactive thyroid;

• gout;

• kidney disease; or

• if you are also taking amiodarone (Cordarone, Pacerone) or verapamil (Calan, Covera, Isoptin, Verelan).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take niacin and simvastatin.

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine. FDA pregnancy category X. This medication can cause birth defects. Do not use niacin and simvastatin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication. It is not known whether niacin and simvastatin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take niacin and simvastatin?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

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

Take each dose with a full glass of water. Niacin and simvastatin is usually taken at bedtime with a low-fat snack. Follow your doctor's instructions. Do not crush, chew, or break a niacin and simvastatin tablet. Swallow the pill whole. The niacin ingredient in this pill is an extended-release form. Breaking or crushing the pill may cause too much of the drug to be released at one time.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). 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 medication.

Niacin and simvastatin can cause you to have unusual results with certain medical tests. You may need to stop taking this medication for a short time if you have surgery or a major illness. Tell any doctor or surgeon who treats you that you are taking niacin and simvastatin.

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.

To be sure this medication is not causing harmful effects, your liver function will need to be tested on a regular basis. Do not miss any scheduled appointments.

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 this medication 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. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe flushing, nausea, vomiting, diarrhea, upset stomach, dizziness, fainting, and uneven heartbeats.

What should I avoid while taking niacin and simvastatin?

Avoid taking cholestyramine (Questran) or colestipol (Colestid) within 4 hours before or after you take niacin and simvastatin.

Avoid drinking hot beverages shortly after taking niacin and simvastatin. Hot drinks can worsen niacin's flushing effect (warmth, itching, redness, or tingly feeling under your skin).

Avoid drinking alcohol while taking niacin and simvastatin. Alcohol may increase your risk of liver damage, and can also worsen the flushing effects of niacin.

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.

Grapefruit and grapefruit juice may interact with niacin and simvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

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 using this medication and call your doctor at once if you have any of these serious side effects:

• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;

• feeling like you might pass out;

• fast or pounding heartbeats; or

• feeling short of breath.

Less serious side effects may include:

• warmth, redness, or tingly feeling under your skin;

• dizziness;

• sweating or chills;

• swelling;

• headache;

• stomach or back pain;

• runny nose or other cold symptoms;

• nausea, diarrhea, constipation; or

• itching or rash.

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. 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?

Before taking niacin and simvastatin, tell your doctor if you are using any of the following medicines:

• amiodarone (Cordarone, Pacerone);

• cyclosporine (Gengraf, Sandimmune, Neoral);

• danazol (Danocrine);

• digoxin (digitalis, Lanoxin);

• fenofibrate (Tricor);

• gemfibrozil (Lopid);

• a blood thinner such as warfarin (Coumadin);

• niacin, nicotinic acid, or nicotinamide (or vitamin supplements that contain niacin);

• verapamil (Calan, Covera, Isoptin);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);

• an antifungal medication such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend); or

• HIV /AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Kaletra, Norvir), or saquinavir (Invirase, Fortovase).

This list is not complete and there may be other drugs that can interact with niacin and simvastatin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about niacin and simvastatin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 06/11/2009 2:04:44 PM.