Advicor

Name: Advicor

What is the dosage for niacin and lovastatin?

The recommended starting dose for Advicor is one tablet (500/20 mg). Doses can be increased by 500 mg of niacin every 4 weeks based on the response of the blood cholesterol level. Doses greater than 2000/40 mg are not recommended. Individuals already stabilized on niacin extended-release tablets can be directly switched to the niacin equivalent dose of Advicor. Individuals taking extended-release niacin and lovastatin separately can be switched to an equivalent dose of Advicor.

Other forms of niacin (for example, sustained-release, timed-release or immediate-release) are not equivalent to extended-release niacin in Advicor. Therefore, Advicor is not interchangeable with these niacin preparations, and patients taking these preparations should be switched and stabilized on extended-release niacin before switching to Advicor.

Advicor should be administered at bedtime with a low fat snack. Since there is evidence that at least some drugs in the same class as lovastatin lower cholesterol more when taken at night than in the morning. If Advicor is discontinued for longer than 7 days, therapy should be resumed at the lowest dose.

Advicor Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your doctor if you take:

  • medications for blood pressure
  • aspirin
  • bile acid sequestrants (colestipol and cholestyramine)
  • macrolide antibiotics
    • clarithromycin
    • telithromycin
  • HIV protease inhibitors
    • indinavir
    • nelfinavir
    • ritonavir
    • saquinavir
  • azole antifungals
    • ketoconazole
    • itraconazole
    • posaconazole
    • voriconazole
  • nefazodone
  • erythromycin
  • gemfibrozil
  • cyclosporine
  • verapamil
  • diltiazem
  • amiodarone
  • warfarin
  • colchicine
  • digoxin
  • alcohol

This is not a complete list of Advicor drug interactions.  Ask your doctor or pharmacist for more information.

Advicor Food Interactions

Grapefruit and grapefruit juice may interact with Advicor and lead to potentially dangerous effects.  Discuss the use of grapefruit products with your doctor.

Advicor and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. No studies have been conducted with Advicor in nursing mothers. Because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of niacin and lovastatin, Advicor should not be taken while a woman is breastfeeding.

Niacin has been reported to be excreted in human milk. It is not known whether lovastatin is excreted in human milk.

Proper Use of Advicor

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.

Uses of Advicor

  • 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.

What are some side effects that I need to call my doctor about right away?

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 Advicor.
  • 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.

Contraindications

Advicor is contraindicated in patients with a known hypersensitivity to niacin, lovastatin or any component of this medication, active liver disease or unexplained persistent elevations in serum transaminases (see WARNINGS), active peptic ulcer disease, or arterial bleeding.

Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) (see WARNINGS, Myopathy/Rhabdomyolysis).

Pregnancy and lactation - Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase, such as lovastatin, to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, Advicor is contraindicated in women who are pregnant and in lactating mothers. Advicor may cause fetal harm when administered to pregnant women. Advicor should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, Advicor should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus (see PRECAUTIONS, Pregnancy).

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