Simcor

Simcor is a prescription medication used to treat high cholesterol and high triglycerides. Simcor is a single product containing 2 medications: niacin and simvastatin. The niacin component is a B-complex vitamin, which may work by increasing the breakdown and removal of certain fats in the blood by increasing the activity of a certain enzyme. The simvastatin component belongs to a group of drugs called HMG-CoA reductase inhibitors, also known as statins. It works by blocking the production of cholesterol in the body. 

This medication comes in tablet form and is usually taken once daily at bedtime, with a low fat snack. 

Common side effects of Simcor include flushing, itching, and headache.

Simcor is a prescription medication used to treat high cholesterol and high triglycerides.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• AbbVie Inc.

Serious side effects have been reported with Simcor. See the “Simcor Precautions” section.

Common side effects of Simcor include the following:

• headache
• itching
• nausea
• back pain
• diarrhea

Flushing is the most common side effect of Simcor. Flushing happens when tiny blood vessels near the surface of the skin (especially on the face, neck, chest and/or back) open wider. Symptoms of flushing may include any or all of the following:

• warmth
• redness
• itching
• tingling of the skin

Flushing may occur with the following symptoms:

• dizziness
• fast heart rate
• a noticeably rapid, strong, or irregular heartbeat (palpitations)
• shortness of breath
• sweating
• burning sensation/skin burning sensation
• chills
• retaining fluid/swelling (edema) 

Flushing does not always happen. If it does, it is usually within 2 to 4 hours after taking a dose of Simcor. Flushing may last for a few hours. Flushing is more likely to happen when you first start taking Simcor or when your dose of Simcor is increased. Flushing may get better after several weeks.

If you wake up at night because of flushing, get up slowly, especially if you:

• feel dizzy or faint
• take blood pressure medicines

To lower your chance of flushing:

• Ask your doctor if you can take aspirin to help lower the flushing side effect from Simcor. You can take aspirin (up to the recommended dose of 325 mg) about 30 minutes before you take Simcor to help lower the flushing side effect.
• Do not drink hot beverages (including coffee), alcohol, or eat spicy foods around the time you take Simcor.
• Take Simcor with a low-fat snack to lessen upset stomach.

This is not a complete list of Simcor side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. 

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

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. No drug interactions have been evaluated for Simcor by the manufacturer. However, the following drugs have been noted to have interactions with the 2 medicines in Simcor (niacin and simvastatin):

• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• calcium channel blockers such as amlodipine (Norvasc), verapamil (Calan, Isoptin, Covera, Verelan), and diltiazem (Cardizem)
• fibrates such as gemfibrozil (Lopid) or fenofibrate (TriCor)
• ranolazine (Ranexa)
• propranolol (Inderal)
• digoxin (Lanoxin)
• warfarin (Coumadin, Jantoven)
• colchicine (Colcrys)
• aspirin
• medicines that lower blood pressure such as guanethidine (Ismelin), methyldopa (Aldomet), beta-blockers like bisoprolol (Zebeta) , vasodilators like hydralazine (Apresoline), angiotensin-­converting enzyme (ACE) inhibitors like enalapril (Vasotec, Vaseretic), angiotensin receptor II blockers (ARBs) like valsartan (Diovan) and direct renin inhibitors (DRIs) like aliskiren (Tekturna)
• cholestyramine (Questran) and colestipol (Colestid)
• nutritional supplements containing large doses of niacin or related compounds

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

Serious side effects have been reported with Simcor including the following:

• heart problems. Use of Simcor may cause an increase in the following: coronary heart disease death, nonfatal heart attack, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures.
• a disease of muscle tissue (myopathy) and/or a breakdown of muscle tissue that releases a damaging protein into the blood (rhabdomyolysis). This is a condition in which muscle tissue breaks down, releasing proteins into the blood that can damage other organs, especially the kidney. The risk increases with higher doses. Tell your healthcare provider right away about any unexplained muscle pain, tenderness, or weakness.
• liver damage.  Your doctor will probably order a blood test to measure liver function before you start taking Simcor. 
• changes in your blood test values. Increases in blood sugar, increases in HbA1c, reduction in platelets (cells which help with clotting), increase in the time it takes your blood to clot (increase in prothrombin time), increase in uric acid, and decrease in phosphorus.

Do not take Simcor if you:

• are allergic to Simcor or any of its ingredients
• have active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• have active peptic ulcer disease
• have arterial bleeding
• use strong CYP3A4 inhibitors such as itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone
• use gemfibrozil, cyclosporine, danazol, verapamil or diltiazem
• are pregnant or may become pregnant
• are breastfeeding

Grapefruit and grapefruit juice may interact with Simcor and lead to potentially dangerous effects, including muscle injury. Discuss the use of grapefruit products with your doctor. 

Avoid alcohol, hot beverages, and spicy foods around the time you take Simcor to minimize flushing.

Before taking Simcor, tell your doctor about all of your medical conditions. Especially tell your doctor if:

• are allergic to Simcor or any of its ingredients
• have active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• have active peptic ulcer disease
• have arterial bleeding
• use strong CYP3A4 inhibitors such as itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone
• use gemfibrozil, cyclosporine, danazol, verapamil or diltiazem
• are pregnant or may become pregnant
• are breastfeeding

Tell you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Simcor falls into category X. It has been shown that women taking Simcor during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if simvastatin, a component of Simcor, is excreted in human breast milk. Niacin, the other component of Simcor, has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Simcor, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. 

• Take Simcor exactly as prescribed.

• Simcor comes in tablet form and is given once a day at bedtime, with a low fat snack.

• If you miss a dose, take the missed dose as soon as you 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 Simcor at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your blood pressure
• previous medications used and the doses tried
• how you respond to this medication
• your other medical conditions

The recommended starting doses of Simcor to treat high cholesterol and high triglycerides are listed below.

• not currently on niacin extended-release or currently on niacin products other than niacin extended-release: a single 500/20 mg tablet daily at bedtime, with a low fat snack
• already taking simvastatin 20 to 40 mg and need additional treatment: Simcor dose of 500/40 mg once daily at bedtime, with a low fat snack
  • ​The dose of niacin extended-release should not be increased by more than 500 mg daily every 4 weeks

​The recommended maintenance dose for Simcor is 1000/20 mg to 2000/40 mg (two 1000/20 mg tablets) once daily.

• The efficacy and safety of doses of Simcor greater than 2000/40 mg daily have not been studied and are therefore not recommended.
• Patients taking amiodarone, amlodipine or ranolazine should not exceed a dose of 1000/20 mg/day of Simcor.
• Because of an increased risk for a disease of muscle tissue (myopathy) in Chinese patients taking simvastatin 40 mg along with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products. Caution should be used when using Simcor in doses that exceed 1000/20 mg/day in Chinese patients. 

If you take too much Simcor, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store at room temperature, 68º-77ºF (20º-25ºC).
• Keep this and all medications out of the reach of children.