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U.S. Department of Health and Human Services

Safety

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Simcor (niacin ER/simvastatin) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

Summary View

 

CONTRAINDICATIONS

Simcor is contraindicated in the following conditions:
  • Concomitant administration of strong CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone)
 

WARNINGS AND PRECAUTIONS

Myopathy/Rhabdomyolysis
  • Simcor therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Simcor therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy.
Drug Interactions
  • Certain drugs which inhibit this metabolic pathway can raise the plasma levels of simvastatin and may increase the risk of myopathy. These include boceprevir, telaprevir,
Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis (table)
  • Strong CYP3A4 inhibitors, e.g.,-Boceprevir Telaprevir: Contraindicated with Simcor  
  • Amiodarone:   Do not exceed 1000/20 mg Simcor daily
  • It is recommended that liver enzyme tests be obtained prior to initiating therapy with Simcor and repeated as clinically indicated. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including simvastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Simcor, promptly interrupt therapy. If an alternate etiology is not found do not restart Simcor.
Endocrine Function
  • Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including simvastatin.
 

ADVERSE REACTIONS

Postmarketing Experience
Simvastatin
  • The following additional adverse reactions have been identified during postapproval use of simvastatin. Fatal and non-fatal hepatic failure
  • There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
 

PATIENT COUNSELING INFORMATION

Liver Enzymes
  • It is recommended that liver enzyme tests be performed before the initiation of Simcor, and if signs or symptoms of liver injury occur. All patients treated with Simcor should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.