In the U.S.—

Other commonly used names for niacin are nicotinic acid or vitamin B₃.

• Antihyperlipidemic

Niacin extended-release and Lovastatin (NYE-a-sin and LOE-va-sta-tin ) combination medicine is used to help lower high cholesterol and fat levels in the blood. This may help prevent medical problems caused by cholesterol and fat clogging the blood vessels.

Niacin extended-release and lovastatin combination medicine combines two drugs that work together to treat cholesterol and lipid (fat) disorders. Niacin is a B-complex vitamin that reduces the amount of cholesterol in the blood. Lovastatin belongs to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

This combination medicine should not be used until after your body has adjusted to each of the individual medicines. Be sure to check with your doctor about this.

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 niacin extended-release and lovastatin combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to niacin and lovastatin. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, particularly saturated fat, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Pregnancy—Niacin extended-release and lovastatin combination should not be used during pregnancy or by women who plan to become pregnant in the near future. This medicine blocks the formation of cholesterol, which is necessary for the fetus to develop properly. Niacin extended-release and lovastatin combination may cause birth defects or other problems in the baby if taken during pregnancy. If you are a woman of child-bearing age and your doctor wants you to take this medicine, it is very important that an effective form of birth control be used during treatment with this medicine. Check with your doctor immediately if you think you have become pregnant while taking this medicine. Be sure you have discussed this with your doctor.

Breast-feeding—Niacin extended-release and lovastatin combination is not recommended for use during breast-feeding because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of niacin extended-release and lovastatin combination in children with use in other age groups.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 niacin extended-release and lovastatin combination, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alcohol, excessive use—Excessive amounts of alcohol while taking niacin extended-release and lovastatin combination can worsen the adverse effects of this medicine on the liver

• Anticoagulants (blood thinners such as warfarin [Coumadin])—Use with niacin extended-release and lovastatin combination may increase the risk of bleeding.

• Antihypertensives (medicine for high blood pressure)—Effects on blood pressure may be increased.

• Clarithromycin (e.g., Biaxin) or
• Clofibrate (e.g., Atromid-S) or
• Cyclosporine (e.g., Neoral, Sandimmune) or
• Erythromycin (e.g., E-Mycin) or
• Fenofibrate (e.g., Tricor) or
• Gemfibrozil (e.g., Lopid) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) or
• Nefazodone (e.g., Serzone) or
• Protease Inhibitors (medicine used to treat HIV and AIDS such as indinavir [Crixivan], nelfinavir [Viracept], ritonavir [Norvir], and saquinavir [Invirase])—Use of these medicines with niacin extended-release and lovastatin combination may increase the risk of developing muscle problems.

• Vitamins or supplements containing niacin or related compounds such as nicotinamide—Use of these medicines may increase the risk of developing adverse effects from niacin extended-release and lovastatin combination.

• Bleeding problems or
• Diabetes mellitus (sugar diabetes) or
• Endocrine problems or
• Gout or
• Heart Disease or
• Liver disease or
• Low blood pressure or
• Stomach Ulcer—Niacin extended-release and lovastatin combination may make these conditions worse.

• Kidney Disease—Effects of niacin extended-release and lovastatin combination may be increased because of slower removal of medicine from the body.

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use 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.

Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed to keep your cholesterol levels down.

Follow carefully the special diet your doctor gave you.This is an important part of controlling your condition, and is necessary if the medicine is to work properly.

Do not drink any grapefruit juice around the time you take this medicine. It may be best to drink any grapefruit juice approximately 12 hours before or after you take your medicine. In addition, do not drink grapefruit juice in large quantities (more than one quart per day) while you are being treated with niacin extended-release and lovastatin combination. To do so may increase the risk of developing muscle problems. Check with your doctor if you have any questions.

Take this medicine at bedtime after eating a low fat snack. Swallow the tablet whole. Do not crush, break, or chew the tablet before you swallow it.

This medicine may cause you to have skin flushing which makes your face, neck, arms and occasionally, your upper chest to feel warm and look red. Flushing usually starts about two to four hours after you take your medicine, and may last up to several hours. Flushing can also cause itching and/or a tingling sensation. A more intense episode of flushing may include dizziness or faintness. If you take your medicine at bedtime, you may sleep through any flushing that occurs. If awakened by flushing, rise slowly to minimize the potential for dizziness or fainting. Avoiding alcohol or hot drinks may reduce the flushing. This effect should lessen after several weeks as your body gets used to the medicine. However, if the problem continues or gets worse, check with your doctor.

Dosing—

The dose of niacin extended-release and lovastatin combination 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 niacin extended-release and lovastatin combination. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • • Adults—The starting dose is usually, 500 milligrams (mg) of niacin extended-release and 20 mg of lovastatin (combined in one tablet) one time a day, at bedtime with a low fat snack. Then your doctor may increase your dose a little at a time every 4 weeks, as your body gets used to the medicine, until your cholesterol is controlled.
    • Children—Use and dose must be determined by your doctor.

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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your doctor how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Check with your doctor immediately if you have dark-colored urine, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak.Niacin extended-release and lovastatin combination may cause a serious, but rare, problem called rhabdomyolysis. It is important to call your doctor right away if you have any of these symptoms.

It is very important that your doctor check your progress at regular visits.This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and that it does not cause unwanted side effects. At regular intervals, your doctor will want to do routine blood tests.

For diabetic patients: This medicine may affect blood sugar levels. 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.

Do not stop taking niacin extended-release and lovastatin combination without first checking with your doctor. When you stop taking this medicine, your blood cholesterol levels may increase again.

Check with your doctor immediately if you think that you may be pregnant. Niacin extended-release and lovastatin combination may cause birth defects or other problems in the baby if taken during pregnancy.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking 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
  • Asthenia, such as, lack or loss of strength;  infection, such as, cough or hoarseness, fever or chills, lower back or side pain, painful or difficult urination;  pain 
  
  

• Less common
  • Abdominal pain, such as, stomach pain;  hyperglycemia, such as, abdominal pain, blurred vision, dry mouth, fatigue, dry skin, fruit-like breath odor, increased hunger, increased thirst, increased urination, nausea, unexplained weight loss, vomiting;  myalgia, such as, difficulty in moving, joint pain, muscle aching, cramping pain or stiffness, swollen joints;  myopathy, such as, muscle aches, weakness, tenderness, or pain;  stomach pain 
  
  

• Rare
  • Rhabdomyolysis, such as, dark-colored urine, fever, muscle cramps, pain, spasm, or stiffness, unusual tiredness or weakness 
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Cardiac arrhythmia, such as, chest pain or discomfort, dizziness, fainting, fast, slow or irregular heartbeat, lightheadedness, pounding or rapid pulse;  diarrhea;  dizziness;  flushing, severe, such as, feeling of warmth, redness, itching, and/or tingling of the face, neck, arms, and occasionally, upper chest, dizziness, fainting;  hypotension, such as, blurred vision, confusion, dizziness, faintness, lightheadedness when getting up from a lying or sitting position, sudden sweating, unusual tiredness or weakness;  nausea and vomiting;  syncope, such as, fainting 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Chills;  diarrhea;  flu syndrome, such as, chills, diarrhea, fever, general feeling of discomfort or illness, headache, joint pain, loss of appetite, muscle aches and pains, nausea, runny nose, shivering, sore throat, sweating, trouble sleeping, unusual tiredness or weakness, vomiting;  flushing, such as, feeling of warmth, redness, itching, and/or tingling of the face, neck, arms, and occasionally, upper chest;  edema, such as, swelling ;  headache;  nausea;  pruritus, such as, itching skin;  rash ;  shortness of breath;  sweating;  syncope, such as, feeling faint or fainting ;  tachycardia, such as, fast, pounding, or irregular heartbeat or pulse 
  
  

• Less common
  • dyspepsia, such as, acid or sour stomach, belching, heartburn, indigestion, stomach discomfort, upset or pain 
  
  

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