Pronunciation:

NYE-a-sin, loe-va-STAT-in

Brand Names:

• Advicor

Classifications:

Pharmacologic—

Vitamin B (class)

Chemical—

Nicotinic Acid (class)

Uses of This Medicine:

Niacin and lovastatin combination is used together with a proper diet to help lower cholesterol and triglyceride (fat) levels in the blood. This medicine may help prevent medical problems (eg, heart attacks, stroke) that are caused by fat clogging the blood vessels.

Niacin and lovastatin combination medicine is a combination of two drugs that work together to lower cholesterol and lipid (fat) disorders. Niacin is vitamin B3, which reduces the amount of cholesterol in the blood. Lovastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works to reduce the amount of cholesterol in the blood by blocking an enzyme that is needed to make cholesterol.

This medicine was available only with your doctor's prescription. The Advicor(R) product will no longer be marketed in the United States as of April 18, 2016.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

The use of niacin and lovastatin combination is not recommended in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of niacin and lovastatin combination in the elderly.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir
• Atazanavir
• Boceprevir
• Ceritinib
• Clarithromycin
• Cobicistat
• Darunavir
• Dasabuvir
• Erythromycin
• Fosamprenavir
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lonafarnib
• Lopinavir
• Mibefradil
• Mifepristone
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Ombitasvir
• Paritaprevir
• Posaconazole
• Ribociclib
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Troleandomycin
• Tucatinib
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Amiodarone
• Atorvastatin
• Avacopan
• Azathioprine
• Bezafibrate
• Carbamazepine
• Ceftobiprole Medocaril
• Cerivastatin
• Ciprofibrate
• Clofibrate
• Colchicine
• Conivaptan
• Cyclosporine
• Dabrafenib
• Dalfopristin
• Danazol
• Daptomycin
• Darolutamide
• Delavirdine
• Diltiazem
• Dronedarone
• Duvelisib
• Elafibranor
• Elexacaftor
• Eltrombopag
• Encorafenib
• Fedratinib
• Fenofibrate
• Fenofibric Acid
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Gemfibrozil
• Glecaprevir
• Ivosidenib
• Larotrectinib
• Lefamulin
• Lenacapavir
• Letermovir
• Levoketoconazole
• Lomitapide
• Lorlatinib
• Lovastatin
• Lumacaftor
• Mercaptopurine
• Methotrexate
• Netupitant
• Niacin
• Olutasidenib
• Omaveloxolone
• Phenobarbital
• Pibrentasvir
• Pirtobrutinib
• Pitavastatin
• Primidone
• Quinupristin
• Ranolazine
• Ritlecitinib
• Rosuvastatin
• Simvastatin
• Suzetrigine
• Tazemetostat
• Ticagrelor
• Tocilizumab
• Trofinetide
• Verapamil
• Voclosporin
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Apalutamide
• Azithromycin
• Bosentan
• Clopidogrel
• Mavacamten
• Oat Bran
• Pectin
• St John's Wort
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Liver disease, history of—Use with caution. May cause side effects to become worse.

• Angina (severe chest pain), unstable or
• Diabetes or
• Gout or
• Heart attack, acute—Use with caution. May make these conditions worse.

• Bleeding, arterial (coming from an artery) or
• Liver disease, active or
• Liver enzymes, elevated or
• Peptic ulcer disease, active—Should not be used in patients with these conditions.

• Electrolyte disorders, severe or
• Endocrine disorders, severe or
• Epilepsy (seizures), not well-controlled or
• Hypotension (low blood pressure) or
• Metabolic disorders, severe or
• Sepsis (severe infection in the blood)—Patients with these conditions may be at risk of developing muscle and kidney problems.

• Kidney disease—Use with caution. The effects this medicine may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more or less of it and do not take it more often or for a longer time than your doctor ordered. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

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

It is best to take this medicine at bedtime, with a low-fat meal or snack. Do not take it on an empty stomach.

If you are taking danazol (Danocrine®), diltiazem (Cardizem®), or verapamil (Calan®, Isoptin®, Verelan®) together with lovastatin, your lovastatin dose should not be higher than 20 milligrams (mg) per day, unless otherwise directed by your doctor. Do not use more than 40 mg per day of lovastatin together with amiodarone (Cordarone®). When used together with higher doses of lovastatin, these medicines may increase your risk of muscle injury and could result in kidney problems.

Tell your doctor if you regularly drink grapefruit juice. Drinking large amounts of grapefruit juice (more than 1 quart each day) while taking this medicine may increase your risk of muscle injury and could result in kidney problems.

Do not drink large amounts of alcohol with lovastatin. This could cause liver injury.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  • For high cholesterol:
    • Adults—At first, 500 milligrams (mg) of niacin and 20 mg of lovastatin (combined in one tablet) once a day, at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2000 mg of niacin and 40 mg of lovastatin per day.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have not taken this medicine for more than 7 days, check with your doctor. You may need to have your dose reduced before you can start taking this medicine again.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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

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.

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 this medicine 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.

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 cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine 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.

This medicine should not be taken with vitamins containing niacin or nicotinamide.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine 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.

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Cough or hoarseness

feeling of warmth

fever or chills

lower back or side pain

pain

painful or difficult urination

redness, itching, or tingling of the face, neck, arms, and occasionally, upper chest

Less common

Abdominal or stomach pain

blurred vision

cramping pain or stiffness

difficulty moving

dry mouth

dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

joint pain

muscle aches, weakness, tenderness, or pain

nausea

swollen joints

unexplained weight loss

unusual tiredness or weakness

vomiting

Rare

Dark-colored urine

muscle cramps, pain, spasm, or stiffness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

general feeling of discomfort or illness

headache

itching skin

loss of appetite

nausea

rash

runny nose

shivering

shortness of breath

sore throat

sweating

trouble sleeping

Less common

Acid or sour stomach

belching

heartburn

indigestion

lack or loss of strength

stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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