Niacin and lovastatin

In the U.S.

• Advicor

Available Dosage Forms:

• Tablet
• Tablet, Extended Release

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Vitamin B (class)

Chemical Class: Nicotinic Acid (class)

It is important that your doctor check your progress at regular visits to make sure that niacin and lovastatin is working properly to lower your cholesterol and triglyceride (fats) levels. Blood tests may be needed to check for unwanted effects.

Using niacin and lovastatin 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.

Do not use lovastatin/niacin if you are also using the following medicines: boceprevir (Victrelis®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, Nizoral®), or certain medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®). Using these medicines together can cause serious side effects.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These may be symptoms of serious muscle problems such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark-colored urine, have a fever, have muscle cramps or spasms, have muscle pain or stiffness, feel very tired or weak, or have diarrhea. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Stop using niacin and lovastatin and 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 liver damage.

niacin and lovastatin 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.

niacin and lovastatin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to niacin and lovastatin before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Change positions slowly when getting up from a sitting or lying position.

niacin and lovastatin should not be taken with vitamins containing niacin or nicotinamide.

Make sure any doctor or dentist who treats you knows that you are using niacin and lovastatin. You may need to stop using niacin and lovastatin if you have major surgery, a major injury, or you develop other serious health problems. It may also affect the result of certain medical tests.

niacin and lovastatin 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. To avoid flushing, alcohol, hot beverages, and spicy foods should be avoided around the time you take niacin and lovastatin. Additionally, your doctor may recommend that you take aspirin 30 minutes before taking niacin and lovastatin to prevent flushing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• It is used to slow the progress of heart disease.
• It is used to lower bad cholesterol and raise good cholesterol (HDL).
• It is used to lower triglycerides.

• If you have an allergy to lovastatin, niacin, or any other part of niacin and lovastatin.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take niacin and lovastatin.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with niacin and lovastatin. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with this medicine.
• If you have any of these health problems: Bleeding problems, liver problems or rise in liver enzymes, or ulcer disease.

This is not a list of all drugs or health problems that interact with niacin and lovastatin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take niacin and lovastatin. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have your blood work checked. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Follow the diet and workout plan that your doctor told you about.
• Do not take colesevelam, colestipol, or cholestyramine within 4 hours of niacin and lovastatin.
• Avoid grapefruit and grapefruit juice.
• Avoid or limit drinking alcohol to less than 3 drinks a day. Drinking too much alcohol may raise your chance of liver disease. Alcohol may cause more flushing.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking niacin and lovastatin, call your doctor right away.
• Use birth control that you can trust to prevent pregnancy while taking this medicine.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• A burning, numbness, or tingling feeling that is not normal.
• Very bad dizziness or passing out.
• Chest pain or pressure.
• Shortness of breath.
• Sweating a lot.
• Not able to pass urine or change in how much urine is passed.
• This medicine may cause muscle pain, tenderness, or weakness. Sometimes, a very bad muscle problem may happen that may lead to kidney problems. Rarely, deaths have happened in people who get these problems when taking drugs like this one. Call your doctor right away if you have muscle pain, tenderness, or weakness that is not normal (with or without fever or feeling out of sorts). Call your doctor right away if you have muscle signs that last after your doctor has told you to stop taking niacin and lovastatin.
• Very bad and sometimes deadly liver problems have happened with this medicine. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, variable release, oral:

Advicor 500/20: Niacin 500 mg [extended release] and lovastatin 20 mg [immediate release] [DSC]

Advicor 750/20: Niacin 750 mg [extended release] and lovastatin 20 mg [immediate release] [DSC]

Advicor 1000/20: Niacin 1000 mg [extended release] and lovastatin 20 mg [immediate release] [DSC]

Advicor 1000/40: Niacin 1000 mg [extended release] and lovastatin 40 mg [immediate release] [DSC]

• Advicor [DSC]

Dosage forms are a fixed combination of niacin and lovastatin. Patients not currently on niacin extended release must start niacin extended release/lovastatin at the lowest dose.

Primary hypercholesterolemia/mixed dyslipidemia: Oral: Lowest dose: Niacin extended release 500 mg/lovastatin 20 mg once daily at bedtime with a low-fat snack; may increase by not more than 500 mg (niacin extended release) once daily at bedtime at 4-week intervals (maximum dose: niacin extended release 2000 mg/lovastatin 40 mg daily). Note: If therapy is interrupted for >7 days, reinstitution of therapy should begin with the lowest dose followed by retitration as needed.

Not for use as initial therapy of dyslipidemias. May be substituted for equivalent dose of Niaspan; however, manufacturer does not recommend direct substitution with other niacin products.

Dosage adjustment for lovastatin component with concomitant medications:

Amiodarone: Maximum recommended lovastatin dose: 40 mg daily

Danazol, diltiazem, dronedarone, or verapamil: Initial lovastatin dose: 10 mg daily (dosage unavailable with combination product; use separate components); Maximum recommended lovastatin dose: 20 mg daily

Continue standard cholesterol-lowering diet during therapy. Administer with a low-fat snack. Avoid intake of large quantities of grapefruit juice (≥1 quart/day); may increase toxicity.

Red yeast rice contains variable amounts of several compounds that are structurally similar to HMG-CoA reductase inhibitors, primarily monacolin K (or mevinolin) which is structurally identical to lovastatin; concurrent use of red yeast rice with HMG-CoA reductase inhibitors may increase the incidence of adverse and toxic effects (Lapi, 2008; Smith, 2003).