Advicor

DRUG DESCRIPTION

ADVICOR (niacin xr and lovastatin) ® (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 (niacin xr and lovastatin) contains niacin extended-release and lovastatin in combination. Lovastatin, an inhibitor of 3-hydroxy-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:

Niacin Structural Formula Illustration

Lovastatin is [1S -[1(alpha)(R *), 3(alpha), 7(beta), 8(beta)(2S *, 4S *), 8a(beta)]]-1,2,3, 7,8,8a?­hexahydro-3,7-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 (niacin xr and lovastatin) 500 mg/20 mg - Iron Oxide Yellow, Iron Oxide Red.

ADVICOR (niacin xr and lovastatin) 750 mg/20 mg – FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake.

ADVICOR (niacin xr and lovastatin) 1000 mg/20 mg - Iron Oxide Red, Iron Oxide Yellow, Iron Oxide Black.

ADVICOR (niacin xr and lovastatin) 1000 mg/40 mg – Iron Oxide Red.

What are the possible side effects of lovastatin and niacin (Advicor)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • feeling like you might pass out;
  • fast or pounding heartbeats; or
  • feeling short of breath.

Less serious side effects...

Read All Potential Side Effects and See Pictures of Advicor »

What are the precautions when taking niacin xr and lovastatin (Advicor)?

Before taking this product, tell your doctor or pharmacist if you are allergic to niacin or lovastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use, stomach/intestinal ulcer, bleeding problems (such as low platelets), low levels of phosphate in the blood, gout.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy. Do not drive, use machinery, or do any activity...

Read All Potential Precautions of Advicor »


Advicor Consumer (continued)

SIDE EFFECTS: Flushing (warmth/redness/itching/tingling of the skin, especially of the face/neck), sweating, headache, dizziness, or chills may occur within 2 to 4 hours after taking this medication. Flushing may persist for a few hours. These effects should improve or go away after several weeks as your body adjusts to the medication. Stomach upset, nausea, vomiting, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: toe/joint pain, fainting, swelling ankles/feet/hands, shortness of breath, fast heartbeat, easy bruising/bleeding, black/tarry stools, vomit that looks like coffee grounds.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to niacin or lovastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use, stomach/intestinal ulcer, bleeding problems (such as low platelets), low levels of phosphate in the blood, gout.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this medication. Ask your doctor or pharmacist for more information.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. This is especially important if you are also taking medication to lower your blood pressure.

If you have diabetes, this medication may increase your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Older adults may be more sensitive to the side effects of this drug, especially muscle problems.

This medication must not be used during pregnancy. Lovastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Advicor Patient Information Including Side Effects

Brand Names: Advicor

Generic Name: lovastatin and niacin (Pronunciation: LOE va sta tin and NYE a sin)

  • What is lovastatin and niacin (Advicor)?
  • What are the possible side effects of lovastatin and niacin (Advicor)?
  • What is the most important information I should know about lovastatin and niacin (Advicor)?
  • What should I discuss with my healthcare provider before taking lovastatin and niacin (Advicor)?
  • How should I take lovastatin and niacin (Advicor)?
  • What happens if I miss a dose (Advicor)?
  • What happens if I overdose (Advicor)?
  • What should I avoid while taking lovastatin and niacin (Advicor)?
  • What other drugs will affect lovastatin and niacin (Advicor)?
  • Where can I get more information?

What is lovastatin and niacin (Advicor)?

Lovastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

The combination of lovastatin and niacin is used to lower cholesterol and triglycerides (types of fat) in the blood. Lowering your cholesterol and triglycerides can help prevent heart disease and coronary artery disease (also called atherosclerosis), conditions that can lead to heart attack, stroke, and vascular disease.

This medication is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack.

Lovastatin and niacin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of lovastatin and niacin (Advicor)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • feeling like you might pass out;
  • fast or pounding heartbeats; or
  • feeling short of breath.

Less serious side effects may include:

  • warmth, redness, or tingly feeling under your skin;
  • sweating or chills;
  • swelling;
  • headache, weakness;
  • stomach or back pain;
  • nausea, vomiting, diarrhea; or
  • itching or rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about lovastatin and niacin (Advicor)?

You should not take this medication if you are allergic to lovastatin or niacin, if you are pregnant or breast-feeding, or if you have liver disease, a stomach ulcer, or active bleeding.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take lovastatin and niacin. These effects should disappear over time as you keep taking the medication.

In rare cases, lovastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

To be sure this medication is not causing harmful effects, your liver function will need to be tested on a regular basis. Do not miss any scheduled appointments.

If you stop taking lovastatin and niacin for longer than 7 days in a row, talk with your doctor before restarting the medication. You may need to start with a lower dose.

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