Niacin and lovastatin (Oral)

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

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

This medicine is 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.

It is important for your doctor to check your progress at regular visits to ensure that this medicine is effectively lowering your cholesterol and triglyceride (fats) levels. Blood tests may be needed to monitor for unwanted effects.

Using this medicine during pregnancy can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you may be pregnant while using this medicine, inform your doctor immediately.

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

Call your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. These could be symptoms of serious muscle issues like myopathy or immune-mediated necrotizing myopathy (IMNM).

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

Stop taking this medicine and contact your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellowing of the eyes or skin. These could indicate liver damage.

This medicine may affect blood sugar levels, which is important if you are diabetic or prediabetic. If you notice changes in your blood or urine sugar tests or have any questions, consult your doctor.

This medicine may cause some people to feel dizzy, lightheaded, drowsy, or less alert than usual. Be sure you understand how this medicine affects you before driving, operating machinery, or doing anything else that could be dangerous if you are dizzy or not alert. Change positions slowly when moving from sitting or lying down.

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

Ensure that any doctor or dentist treating you is aware that you are taking this medicine. You might need to stop using this medicine if you have major surgery, a major injury, or develop other serious health issues. It may also impact the results of certain medical tests.

This medicine may cause a side effect known as flushing, which is a feeling of warmth or redness on the face, neck, arms, and sometimes, on the upper chest. To help prevent flushing, avoid alcohol, hot beverages, and spicy foods around the time you take this medicine. Your doctor may also suggest taking aspirin 30 minutes before taking this medicine to reduce flushing.

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

In deciding to use this medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

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

Geriatric

Current studies have not shown any specific problems that would limit the effectiveness of niacin and lovastatin combination in older adults.

Breast Feeding

Research has shown that this medicine can harm infants when breastfeeding. You should either stop breastfeeding or use a different medication while taking this medicine.

Interactions with Medicines

Some medicines should not be taken together at all, while others may be used together even if there is a chance of interaction. If you are taking this medicine, it is especially important for your healthcare professional to know if you are using any of the medicines listed below. The following interactions are significant and may not include all possible interactions.

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

• Amprenavir
• Atazanavir
• Boceprevir
• Clarithromycin
• Cobicistat
• Darunavir
• Erythromycin
• Fosamprenavir
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Mibefradil
• Mifepristone
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adagrasib
• Amiodarone
• Atorvastatin
• Belzutifan
• Bezafibrate
• Ceritinib
• Cerivastatin
• Ciprofibrate
• Clofibrate
• Colchicine
• Conivaptan
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Dalfopristin
• Danazol
• Daptomycin
• Delavirdine
• Diltiazem
• Dronedarone
• Duvelisib
• Fedratinib
• Fenofibrate
• Fenofibric Acid
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Gemfibrozil
• Glecaprevir
• Ivosidenib
• Larotrectinib
• Lefamulin
• Lenacapavir
• Letermovir
• Levoketoconazole
• Lomitapide
• Lorlatinib
• Lovastatin
• Lumacaftor
• Mavacamten
• Methotrexate
• Netupitant
• Niacin
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Phenobarbital
• Pibrentasvir
• Pirtobrutinib
• Pitavastatin
• Primidone
• Quinupristin
• Ranolazine
• Ritlecitinib
• Rosuvastatin
• Simvastatin
• Tocilizumab
• Trofinetide
• Verapamil

Using this medicine with any of the following medicines may increase your risk of certain side effects, but using both may be the best treatment option for you. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are significant and may not include all possible interactions.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some situations. If used together, your doctor may change the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Using this medicine with any of the following may increase the risk of certain side effects, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Liver disease, history of—Use with caution. May worsen side effects.

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

• Bleeding, arterial (from an artery) or
• Liver disease, active or
• Liver enzymes, elevated or
• Peptic ulcer disease, active—Should not be used in 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 muscle and kidney problems.

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

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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 how 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.

In the U.S.

• Advicor

Pharmacologic Class: Vitamin B (class)

Chemical Class: Nicotinic Acid (class)

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.