Simcor

What is Simcor used for?

Simcor is a prescription medicine that is used to lower bad cholesterol and raise good cholesterol (HDL). It is used to lower triglycerides.

Description

SIMCOR 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:

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-[1α,3α,7β,8β(2S*4S*),-8aβ]]. 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 is available for oral administration as tablets containing 500 mg of niacin extended-release (NIASPAN) and 20 mg simvastatin (SIMCOR 500/20 mg), 500 mg of niacin extended-release (NIASPAN) and 40 mg simvastatin (SIMCOR 500/40 mg), 750 mg of niacin extended-release (NIASPAN) and 20 mg simvastatin (SIMCOR 750/20 mg), 1000 mg of niacin extended-release (NIASPAN) and 20 mg simvastatin (SIMCOR 1000/20 mg) and 1000 mg of niacin extended-release (NIASPAN) and 40 mg simvastatin (SIMCOR 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 500/20 mg, SIMCOR 750/20 mg, and SIMCOR 1000/20 mg also contain iron oxide.

 Mechanism of Action

Niacin

Niacin functions in the body after conversion to nicotinamide adenine dinucleotide (NAD) in the NAD coenzyme system. The mechanism by which niacin alters lipid profiles is not completely understood and may involve several actions, including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity (which may increase the rate of chylomicron triglyceride removal from plasma). Niacin decreases the rate of hepatic synthesis of VLDL-C and LDL-C, and does not appear to affect fecal excretion of fats, sterols, or bile acids.

Simvastatin

Simvastatin is a prodrug and is hydrolyzed to its active ß-hydroxyacid form, simvastatin acid, after administration. Simvastatin is a specific inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthetic pathway for cholesterol. In addition, simvastatin reduces VLDL and TG and increases HDL-C.

Before taking Simcor, tell your doctor:

• If you are allergic to Simcor; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Bleeding problems, liver problems or rise in liver enzymes, or ulcer disease.
• If you are pregnant or may be pregnant. Do not take Simcor if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take Simcor.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Simcor, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with Simcor. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with Simcor.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Simcor with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Simcor?

• Tell all of your health care providers that you take Simcor. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Follow the diet and workout plan that your doctor told you about.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take colesevelam, colestipol, or cholestyramine within 4 hours of Simcor.
• Avoid grapefruit and grapefruit juice.
• Avoid or limit drinking alcohol to less than 3 drinks a day. Drinking too much alcohol may raise your chance of liver disease. Alcohol may cause more flushing.
• If you are Chinese, talk with your doctor. You could have a greater risk of muscle problems.
• If you are 65 or older, use Simcor with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Simcor, call your doctor right away.
• Use birth control that you can trust to prevent pregnancy while taking Simcor.

How is Simcor best taken?

Use Simcor as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Simcor as you have been told by your doctor or other health care provider, even if you feel well.
• Take at bedtime after a low-fat snack.
• Do not take on an empty stomach.
• Swallow whole. Do not chew, break, or crush.
• Avoid alcohol, hot drinks, or spicy foods when it is time to take Simcor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• If you miss taking Simcor for a few days in a row, call your doctor before you start taking it again.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Simcor that I need to call my doctor about immediately?

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, swallowing, 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.
• Very bad dizziness or passing out.
• Chest pain or pressure.
• A fast heartbeat.
• 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 Simcor.
• Very bad and sometimes deadly liver problems have happened with Simcor. 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.

What are some other side effects of Simcor?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing. Taking aspirin 30 minutes before taking Simcor may help. If you wake up at night with flushing, get up slowly if you feel like passing out or you are dizzy.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Simcor?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL 750 MG/20 MG

Simcor® Niacin Extended-Release/ Simvastatin Tablets 750 mg/20 mg

PRINCIPAL DISPLAY PANEL – 1000 MG/20 MG

• Simcor® Niacin Extended-Release/ Simvastatin Tablets 1000 mg/20 mg

 

• Simcor® Niacin Extended-Release/ Simvastatin Tablets 1000 mg/40 mg

SRC: NLM .