Indicated for:

Patients with Hypercholesterolemia Requiring Modifications of Lipid Profiles:

• Reduce elevated Total–C, LDL-C, Apo B, non-HDL-C, TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.

• Reduce TG in patients with hypertriglyceridemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.

SIMCOR is indicated to reduce TG in patients with hypertriglyceridemia when treatment with simvastatin
monotherapy or niacin extended-release monotherapy is considered inadequate.

The dose of niacin extended-release should not be increased by more than 500 mg daily every 4 weeks.

The efficacy and safety of doses of SIMCOR greater than 2000/40 mg daily have not been studied and are therefore not recommended.

Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses. Patients previously receiving niacin products other than niacin extended-release (NIASPAN) should be started on SIMCOR at the lowest recommended starting dose.

SIMCOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Active liver disease or unexplained transaminase elevations are contraindications to the use of SIMCOR.

Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of SIMCOR ingestion.

Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products, caution should be used when prescribing SIMCOR in doses that exceed 1000/20 mg/day to Chinese patients.

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.

All patients starting therapy with SIMCOR, or whose dose of SIMCOR is being increased, should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing SIMCOR. SIMCOR therapy should be discontinued immediately if myopathy is diagnosed or suspected. Predisposing factors for myopathy include advanced age (≥65 years), female gender, uncontrolled hypothyroidism, and renal impairment.

SIMCOR is contraindicated in patients with: 

• Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Active peptic ulcer disease
• Arterial bleeding
• Concomitant administration of strong CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) 
• Concomitant administration of gemfibrozil, cyclosporine, or danazol 
• Concomitant administration of verapamil or diltiazem 
• Women who are pregnant or may become pregnant
• Nursing mothers

The risk of myopathy, including rhabdomyolysis, is increased by concomitant administration of amlodipine or ranolazine.

Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be exercised when prescribing SIMCOR with colchicine.

Simvastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which inhibit this metabolic pathway can raise the plasma levels of simvastatin and may increase the risk of myopathy. These include itraconazole, ketoconazole, and posaconazole, the macrolide antibiotics erythromycin and clarithromycin, and the ketolide antibiotic telithromycin, HIV protease inhibitors, boceprevir, telaprevir, the antidepressant nefazodone, or large quantities of grapefruit juice (>1 quart daily), and combination of these drugs with SIMCOR is contraindicated. If treatment with itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with SIMCOR must be suspended during the course of treatment.

In patients taking Amiodarone, Amlodipine or Ranolazine, the dose of SIMCOR should not exceed 1000/20 mg/day.

With other reductase inhibitors, clinically evident bleeding and/or increased prothrombin time has been reported in a few patients taking coumarin anticoagulants concomitantly.

Concomitant use of aspirin may decrease the metabolic clearance of niacin.

Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

Nutritional supplements containing large doses of niacin or related compounds may potentiate the adverse effects of SIMCOR.

Niacin treatment can increase fasting blood glucose.

Niacin can reduce platelet count.

Niacin can cause small increases in PT.

Elevated uric acid levels have occurred with niacin therapy.

Small dose-related reductions in phosphorous levels were seen in clinical studies with niacin.

SIMCOR may cause fetal harm when administered to a pregnant woman. If SIMCOR is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

SIMCOR contains simvastatin and nicotinic acid. Nicotinic acid is excreted into human milk and it is not known whether simvastatin is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Because of the potential for serious adverse reactions in nursing infants, women who require SIMCOR treatment should not breastfeed their infant.

GoToSource

• Dosage greater than 2000/40 mg per day. GoToSource

• Use in patients under the age of 18. GoToSource

Myopathy (muscle disease) and rhabdomyolysis (breakdown of muscle tissue). GoToSource

Liver injury, cognitive impairment including memory loss, forgetfulness, amnesia, memory impairment, confusion, increased blood sugar and increased glycosylated hemoglobin (HbA1c) levels. GoToSource

Niacin flushing. GoToSource

New-onset diabetes and increased risk of haemorrhagic stroke. GoToSource

Gastritis (inflammation of the lining of the stomach), myalgia ( muscle pain, weakness, or cramps), urticaria (hives), upper gastrointestinal bleeding, blurred vision, mildly decreased platelet counts and atrial fibrillation (irregular, rapid heart rate).  GoToSource

Gout and pruritus (itchy skin). GoToSource

Lawsuits filed for myopathy, kidney failure and rhabdomyolysis.