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niacin extended-release and lovastatin (Oral route)

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

Commonly used brand name(s)

In the U.S.

  • Advicor

Available Dosage Forms:

  • Tablet
  • Tablet, Extended Release

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Vitamin B

Chemical Class: Nicotinic Acid (class)

Uses For lovastatin and niacin

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

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Niacin extended-release 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.

lovastatin and niacin is available only with your doctor's prescription.

Before Using lovastatin and niacin

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 lovastatin and niacin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lovastatin and niacin 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.

Pediatric

Use of niacin extended-release and lovastatin combination is not recommended in children.

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 lovastatin and niacin, 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 lovastatin and niacin 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
  • Clarithromycin
  • Cobicistat
  • Darunavir
  • Erythromycin
  • Fosamprenavir
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Mibefradil
  • Mifepristone
  • Nefazodone
  • Nelfinavir
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Voriconazole

Using lovastatin and niacin 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.

  • Amiodarone
  • Atorvastatin
  • Bezafibrate
  • Carbamazepine
  • Ceritinib
  • Cerivastatin
  • Ciprofibrate
  • Clofibrate
  • Colchicine
  • Conivaptan
  • Cyclosporine
  • Dabrafenib
  • Dalfopristin
  • Danazol
  • Daptomycin
  • Delavirdine
  • Diltiazem
  • Dronedarone
  • Erlotinib
  • Eslicarbazepine Acetate
  • Fenofibrate
  • Fenofibric Acid
  • Fluconazole
  • Gemfibrozil
  • Lomitapide
  • Lovastatin
  • Mitotane
  • Niacin
  • Piperaquine
  • Pitavastatin
  • Primidone
  • Quinupristin
  • Ranolazine
  • Rosuvastatin
  • Siltuximab
  • Simvastatin
  • Verapamil

Using lovastatin and niacin 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.

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

Interactions with Food/Tobacco/Alcohol

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 lovastatin and niacin 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 lovastatin and niacin, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Using lovastatin and niacin 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 lovastatin and niacin, 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 lovastatin and niacin. 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 lovastatin and niacin may be increased because of slower removal of the medicine from the body.

Proper Use of lovastatin and niacin

Take lovastatin and niacin 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, lovastatin and niacin 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 lovastatin and niacin, 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 lovastatin and niacin 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 lovastatin and niacin 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 lovastatin and niacin 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 lovastatin and niacin. 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 extended-release and 20 mg of lovastatin (combined in one tablet) once a day, at bedtime. Your doctor may gradually increase your dose every 4 weeks until your cholesterol is controlled. However, the dose is usually not more than 2000 mg of niacin extended-release and 40 mg of lovastatin per day.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of lovastatin and niacin, 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 lovastatin and niacin for more than 7 days, check with your doctor. You may need to have your dose reduced before you can start taking lovastatin and niacin 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 lovastatin and niacin

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

Using lovastatin and niacin 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 lovastatin and niacin 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.

lovastatin and niacin 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.

lovastatin and niacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to lovastatin and niacin 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.

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

Make sure any doctor or dentist who treats you knows that you are using lovastatin and niacin. You may need to stop using lovastatin and niacin 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.

lovastatin and niacin 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 lovastatin and niacin. Additionally, your doctor may recommend that you take aspirin 30 minutes before taking lovastatin and niacin 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.

lovastatin and niacin Side Effects

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

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

Symptoms of overdose
  • Chest pain or discomfort
  • confusion
  • diarrhea
  • dizziness
  • dizziness, faintness, lightheadedness when getting up from a lying or sitting position
  • fainting
  • fast, slow or irregular heartbeat
  • lightheadedness
  • pounding or rapid pulse
  • sudden sweating

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.

See also: Side effects (in more detail)

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