Simcor

DRUG DESCRIPTION

SIMCOR (simvastatin niacin extended release) tablets contain niacin extended-release (NIASPAN) and simvastatin in combination. Simvastatin, an inhibitor of HMG-CoA reductase, and niacin are both lipid-altering agents.

Niacin Extended-Release

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

Simvastatin

Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3-7-dimethyl-8-[2-(tetrahydro-4?­hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1?,3?,7?,8?(2S*4S*),-8a?]]. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol, and ethanol. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin has the following structural formula:

SIMCOR (simvastatin niacin extended release) is available for oral administration as tablets containing 500 mg of niacin extended-release (NIASPAN) and 20 mg simvastatin (SIMCOR (simvastatin niacin extended release) 500/20 mg), 500 mg of niacin extended-release (NIASPAN) and 40 mg simvastatin (SIMCOR (simvastatin niacin extended release) 500/40 mg), 750 mg of niacin extended-release (NIASPAN) and 20 mg simvastatin (SIMCOR (simvastatin niacin extended release) 750/20 mg), 1000 mg of niacin extended-release (NIASPAN) and 20 mg simvastatin (SIMCOR (simvastatin niacin extended release) 1000/20 mg) and 1000 mg of niacin extended-release (NIASPAN) and 40 mg simvastatin (SIMCOR (simvastatin niacin extended release) 1000/40 mg). Each tablet contains the following inactive ingredients: hypromellose, povidone, stearic acid, polyethylene glycol, butylated hydroxyanisole, FD&C Blue #2, lactose monohydrate, titanium dioxide, triacetin. SIMCOR (simvastatin niacin extended release) 500/20 mg, SIMCOR (simvastatin niacin extended release) 750/20 mg, and SIMCOR (simvastatin niacin extended release) 1000/20 mg also contain iron oxide.

What are the possible side effects of niacin and simvastatin (Simcor)?

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 Simcor »

What are the precautions when taking simvastatin niacin extended release (Simcor)?

Before taking this product, tell your doctor or pharmacist if you are allergic to niacin or simvastatin; 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, stomach/intestinal ulcer, bleeding problems, kidney disease, alcohol use, 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...

Read All Potential Precautions of Simcor »


Simcor Consumer (continued)

SIDE EFFECTS: Flushing (warmth/redness/itching/tingling of the skin, especially of the face/neck), sweating, 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. Upset stomach, nausea, 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 right away if any of these unlikely but serious side effects occur: severe dizziness, fainting, fast/pounding heartbeat, swelling ankles/feet/hands, shortness of breath, toe/joint pain, easy bruising/bleeding, black/tarry stools, vomit that looks like coffee grounds.

This medication may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away 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 right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 simvastatin; 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, stomach/intestinal ulcer, bleeding problems, kidney disease, alcohol use, 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 product. Ask your doctor or pharmacist for more information.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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

This medication must not be used during pregnancy. Simvastatin 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.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Simcor Patient Information Including Side Effects

Brand Names: Simcor

Generic Name: niacin and simvastatin (Pronunciation: NYE a sin and SIM va stat in)

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

What is niacin and simvastatin (Simcor)?

Simvastatin 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 niacin and simvastatin 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.

Niacin and simvastatin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of niacin and simvastatin (Simcor)?

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;
  • dizziness;
  • sweating or chills;
  • swelling;
  • headache;
  • stomach or back pain;
  • runny nose or other cold symptoms;
  • nausea, diarrhea, constipation; or
  • itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about niacin and simvastatin (Simcor)?

You should not take this medication if you are allergic to simvastatin 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 niacin and simvastatin. These effects should disappear over time as you keep taking the medication.

In rare cases, simvastatin 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 niacin and simvastatin 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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