Advicor

Name: Advicor

US Brand Name

  1. Advicor

What are the side effects of niacin and lovastatin?

The most common side effects are:

  • flushing,
  • redness,
  • warm sensation,
  • rash,
  • itching,
  • headache,
  • stomach upset,
  • nausea,
  • vomiting,
  • muscle pain, and
  • tingling in extremities.

Flushing may be reduced by taking 325 mg of aspirin 30 minutes before the niacin and by increasing the dose of niacin slowly.

Drinking hot liquids or alcohol shortly before or after niacin is taken may increase the occurrence of flushing.

Other important side effects include:

  • liver test abnormalities,
  • rhabdomyolisis,
  • kidney failure,
  • muscle pain,
  • weakness,
  • muscle tenderness,
  • increases in HbA1c and fasting serum glucose
  • memory loss,
  • forgetfulness,
  • amnesia,
  • confusion, and
  • memory impairment

Lovastatin shares side effects, such as liver and muscle damage associated with all statins. Serious liver damage caused by statins is rare. More often, statins cause abnormalities of liver tests. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test value is greater than three times the upper limit of normal, the statin usually is stopped. Liver function tests should be performed at the beginning of treatment then as needed thereafter.

Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. Rhabdomyolysis causes the release of muscle protein (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. When used alone, statins cause rhabdomyolysis in less than one percent of patients. To prevent the development of rhabdomyolysis, patients taking lovastatin should contact their health care professional immediately if they develop unexplained muscle pain, weakness, or muscle tenderness.

Statins have been associated with increases in HbA1c and fasting serum glucose levels as are seen in diabetes.

There are also post-marketing reports of memory loss, forgetfulness, amnesia, confusion, and memory impairment. Symptoms may start 1 day to years after starting treatment and resolve within a median of 3 weeks after stopping the statin.

How to use

Take this medication by mouth with a low-fat snack as directed by your doctor, usually once daily at bedtime. Taking this drug with food will increase its absorption and help reduce side effects (such as flushing, stomach upset).Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.To lessen the chance of flushing, avoid alcohol, hot beverages, and spicy foods near the time you take this medication. Taking a plain aspirin (non-enteric coated, 325 milligrams) or a nonsteroidal anti-inflammatory drug (such as ibuprofen, 200 milligrams) 30 minutes before taking this medication may help prevent flushing. Ask your doctor if this treatment is right for you (especially if you are also taking a "blood thinner" such as warfarin).The niacin in this product is an extended-release form. Your doctor may instruct you to take the individual extended-release niacin first until you reach the right dose and then switch you over to this combination product. Niacin is also available in other formulations (such as immediate- and sustained-release). Do not switch other strengths, brands, or forms of niacin with this product because doing so may cause severe liver problems.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 1 hour before or at least 4 hours after taking these medications. These products can react with this medication, preventing its full absorption.Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. If you have not taken this medication for an extended period (more than 7 days), consult your doctor or pharmacist for instructions on restarting it. You may need to restart your medication at a lower dose and slowly increase the dose over several weeks.It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick. It may take up to 4 weeks before you get the full benefit of this drug.

Description

ADVICOR® (niacin extended-release and lovastatin) is intended to facilitate the daily administration of its individual components, Niaspan® and lovastatin, when used together for the intended patient population (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION).

ADVICOR contains niacin extended-release and lovastatin in combination. Lovastatin, an inhibitor of 3hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, and niacin are both lipid-altering agents.

Niacin is nicotinic acid, or 3-pyridinecarboxylic acid. Niacin is a white, nonhygroscopic crystalline powder that is very soluble in water, boiling ethanol and propylene glycol. It is insoluble in ethyl ether. The empirical formula of niacin is C6H5NO2 and its molecular weight is 123.11. Niacin has the following structural formula:

Lovastatin is [1S -[1(alpha)(R *), 3(alpha), 7(beta), 8(beta)(2S *, 4S *), 8a(beta)]]-1,2,3, 7,8,8a-hexahydro3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl) ethyl]-1-naphthalenyl 2-methylbutanoate. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Lovastatin has the following structural formula:

ADVICOR tablets contain the labeled amount of niacin and lovastatin and have the following inactive ingredients: hypromellose, povidone, stearic acid, polyethylene glycol, titanium dioxide, polysorbate 80.

The individual tablet strengths (expressed in terms of mg niacin/mg lovastatin) contain the following coloring agents:

ADVICOR 500 mg/20 mg - Iron Oxide Yellow, Iron Oxide Red.
ADVICOR 750 mg/20 mg – FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake.
ADVICOR 1000 mg/20 mg - Iron Oxide Red, Iron Oxide Yellow, Iron Oxide Black.
ADVICOR 1000 mg/40 mg – Iron Oxide Red.

Advicor Drug Class

Advicor is part of the drug class:

  • HMG CoA reductase inhibitors in combination with other lipid modifying agents

Advicor Usage

Take Advicor exactly as prescribed.  

Advicor comes in tablet form and is taken once a day at bedtime, with a low-fat snack. Advicor tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.

If you miss a dose, take the missed dose as soon as your remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Advicor at the same time.

Other Requirements

  • Store Advicor at room temperature.
  • Keep this and all medicines out of the reach of children.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Advicor or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Advicor. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Drug Abuse and Dependence

Neither niacin nor lovastatin is a narcotic drug. Advicor has no known addiction potential in humans.

Breastfeeding

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.

Lovastatin / niacin Breastfeeding Warnings

There are no data on the excretion of lovastatin into human milk. Niacin is excreted in human milk. The effects in the nursing infant are unknown, however, the potential for serious adverse reactions in nursing infants from lipid-altering doses of lovastatin and niacin warrants that the drug(s) not be administered to nursing mothers. Lovastatin-niacin is considered contraindicated during breast-feeding by the American Academy of Pediatrics.

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