Adult Dosing
Hypercholesterolemia, hypertriglyceridemia, mixed dyslipidemia
- 500 mg/20 mg (niacin/simvastatin) - 2000 mg/40 mg (niacin/simvastatin) PO qhs with a low-fat snack
- Patients not currently on niacin extended-release and patients currently on niacin products other than niacin extended-release: Start with a single 500 mg/20 mg (niacin/simvastatin) tab PO qhs
- Patients already taking simvastatin 20-40 mg requiring additional management of their lipid levels: Start with a single 500 mg/40 mg (niacin/simvastatin) tab PO qhs
- Avoid increasing the dose of niacin extended-release by more than 500 mg daily q4 wks
- Maintenance dose: 1000 mg/20 mg to 2000 mg/40 mg (two 1000/20 mg tablets) PO qd depending on patient tolerability and lipid levels
- Safety and efficacy of doses >2000 mg/40 mg daily have not been established and are therefore not recommended
- On discontinuation of therapy for an extended period of time (>7 days), consider re-titration as tolerated
- Consider pretreatment with 325 mg aspirin 30 minutes before niacin/simvastatin dose to reduce the frequency or severity of flushing. Flushing, pruritus, and GI distress are also reduced by gradually increasing the niacin dose and avoiding administration on an empty stomach
- Due to the increased risk of hepatotoxicity with other modified-release (sustained-release or time-release) niacin preparations or immediate-release (crystalline) niacin, therapy with this combination drug should only be substituted for equivalent doses of niacin extended-release
Notes- Give with a low fat snack as a single daily dose in the evening
- Swallow them whole; do not cut, crush, or chew before swallowing
- In patients receiving amiodarone, amlodipine, or ranolazine, the maximum dose of niacin/simvastatin is 1000 mg/20 mg/day
- Exercise caution when prescribing therapy in doses >1000 mg/20 mg/day to Chinese patients 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
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Avoid substituting this combination drug for equivalent doses of immediate-release (crystalline) niacin. Initiate therapy with 500 mg/20 mg (niacin/simvastatin) and titrate appropriately to the desired therapeutic response in patients switching from immediate-release niacin to niacin/simvastatin combination therapy
- Start therapy at a dose of 500 mg/40 mg (niacin/simvastatin) once daily at bedtime in patients already taking simvastatin 20-40 mg but having need to additionally manage their lipid levels. Avoid doses >2000/40 mg
- Myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) more than ten times the ULN and sometimes as rhabdomyolysis with or without acute renal failure have been reported with the use of simvastatin. Consider periodic CK determinations in patients starting this therapy
- Advanced age (65 years), female gender, uncontrolled hypothyroidism, and renal impairment are the predisposing factors for myopathy. High levels of statin activity in plasma also increases the risk of myopathy
- The incidence of myopathy, including rhabdomyolysis, was significantly higher in patients taking 80 mg of simvastatin as compared to the lower doses and other statin therapies with similar or greater LDL-C-lowering efficacy. Also, an increased incidence of myopathy and rhabdomyolysis was noted during the first year of treatment with simvastatin 80 mg and decreased notably during the subsequent years of treatment
- Before initiating niacin/simvastatin therapy, inform all patients about the risk of myopathy including rhabdomyolysis and advise them to promptly report any unexplained muscle pain, tenderness or weakness. Discontinue the drug immediately if myopathy is suspected or diagnosed
- Immune-mediated necrotizing myopathy (IMNM) characterized by proximal muscle weakness and elevated serum creatine kinase has been reported with statin use, and may persist despite discontinuation of statin treatment
- Strong CYP3A4 inhibitors (itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice) should not be used concomitantly, as they may increase the plasma levels of simvastatin resulting in increased risk of myopathy and rhabdomyolysis
- Myopathy and/or rhabdomyolysis have occurred when simvastatin is used in combination with lipid-altering doses (1 gram/day) of niacin. Weigh the potential benefits and risks of the therapy and carefully monitor for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial month of treatment or during any period of upward dosage titration of either drug. Discontinue therapy if myopathy is diagnosed or suspected
- Avoid use in combination with drugs that cause myopathy/rhabdomyolysis such as fibrates
- Perform dose escalation with caution in patients with complicated medical histories predisposing to rhabdomyolysis such as renal insufficiency
- Suspend therapy for a few days before elective major surgery and when any major acute medical or surgical condition supervenes (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic/endocrine/electrolyte disorders, or uncontrolled seizures)
- Severe hepatic toxicity, including fulminant hepatic necrosis, has occurred in patients who have substituted modified-release niacin products for immediate-release (crystalline) niacin at equivalent doses. Use in patients having active liver disease or unexplained transaminase elevations is contraindicated
- Persistent increases in serum transaminases levels (>3 x ULN) have been reported with simvastatin component of this combination drug. Discontinue therapy on persistent elevation of transaminase levels to >3 times the ULN and association with symptoms of nausea, fever, and/or malaise
- Perform liver function tests before initiation of treatment and repeat as clinically indicated. Withdraw therapy if AST or ALT levels >3 x ULN. Use cautiously in patients with a past history of liver disease or who consume substantial quantities of alcohol
- Abnormal LFTs have been reported in patients undergoing therapy. Perform LFTs before initiation of therapy then q12 wks for the first 6 months, and periodically thereafter
- Monitor patients developing increased transaminase levels with a second liver function evaluation to confirm the finding and follow it thereafter with frequent LFTs until the abnormality returns to normal
- Therapy may cause increase in fasting blood glucose. Closely observe diabetic or potentially diabetic patients, particularly during the first few months of therapy. Adjustment of diet and/or hypoglycemic therapy or discontinuation of therapy may be essential
- Reductions in platelet count and phosphorus levels have been reported; therapy may cause small increases in prothrombin time and uric acid levels
- Monitor CK levels periodically during therapy
- HMG-CoA reductase inhibitors may increase HbA1C and fasting serum glucose levels
Cautions: Use cautiously in:
Supplemental Patient Information
- Inform patients of the potential risk of myopathy, including rhabdomyolysis associated with this therapy; advise them to promptly report any unexplained muscle pain, tenderness or weakness
- Inform patients that flushing is a common side effect of the therapy, and usually subsides by itself after a few weeks of use
- Instruct patients to avoid ingestion of alcohol, hot drinks, and spicy foods during therapy to minimize flushing
- Advise women of childbearing age to use an effective method of birth control to prevent pregnancy while on therapy; instruct them to stop therapy and immediately inform their health professional if they become pregnant during therapy
- Advise patients to promptly report their physician if they experience any symptoms that may indicate liver injury such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice
Pregnancy Category:X
Breastfeeding: Unsafe. Relevant literature for use of simvastatin during breastfeeding does not exist. Due to a concern with disruption of infant lipid metabolism, simvastatin should not be used in nursing mothers. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 27 January 2011). Niacin is excreted in breastmilk; however, the actual infant dose or infant dose as a percent of maternal dose is unknown. It is not known if simvastatin is excreted in breast milk. Due to potential for serious adverse reactions in nursing infants and disruption of infant lipid metabolism, breastfeeding is not recommended during therapy. Manufacturer recommends to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Simcor (niacin/simvastatin)
- ETABS:
- 500 mg/20 mg
- 750 mg/20 mg
- 1000 mg/20 mg
- 500 mg/40 mg
- 1000 mg/40 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Simcor 1000-20 MG TB24 [Bottle] (ABBOTT)
90 mg = $460
270 mg = $1318.02 - Simcor 500-20 MG TB24 [Bottle] (ABBOTT)
90 mg = $258
270 mg = $744 - Simcor 1000-40 MG TB24 [Bottle] (ABBOTT)
30 mg = $160
90 mg = $437.99
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.