Simcor is a combination of two drugs - Niacin and Simvastatin. They work together to treat cholesterol disorders. Niacin is a vitamin B3, while simvastatin belongs to the group of HMG CoA inhibitors of statins.
Simcor (Niacin and Simvastatin) uses:
-
Primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia:
- They are used for reducing total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), non-high density lipoprotein cholesterol (non-HDL-C), and triglycerides.
- They are also helpful in increasing high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia combining with standard cholesterol-lowering diet when simvastatin or niacin monotherapy is inadequate.
Note:
- Niacin is not recommended as primary or secondary therapy for dyslipidemias.
- Although niacin consistently affects surrogate markers, especially low-density lipoprotein C, it is not effective in reducing cardiovascular disease outcomes as compared to statin use and may cause harm.
- In two large clinical trials, a combination of niacin and simvastatin did not reduce cardiovascular morbidity and mortality.
- It is effective in high triglyceride levels (>500 mg/dL) or in dyslipidemia for patients who do not achieve a positive outcome or have an intolerance to a statin or other alternative therapy.
Guideline recommendations:
-
Simvastatin:
- It is used in the primary and secondary prevention of atherosclerotic cardiovascular disease to reduce the risk in selected adult patients.
Simcor (Niacin and Simvastatin) Dose in Adults
Simcor dose for the treatment of primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia:
Note:
Niacin is no more used for treatment except in specific clinical situations (eg, hypertriglyceridemia [>500 mg/dL], if not able to achieve the desired response or intolerance to other therapies.
It is not for use as initial therapy of dyslipidemias. Doses depend on baseline low-density lipoprotein cholesterol levels, the recommended goal of therapy, and the individual response.
-
Patients naïve to niacin extended-release therapy or currently on immediate-release niacin:
- Niacin extended-release 500 mg/simvastatin 20 mg once daily at bedtime,
- The dose should be increased every one month as needed in increments of not more than 500 mg of niacin.
-
Patients currently on simvastatin (20 to 40 mg daily):
- Niacin extended-release 500 mg/simvastatin 40 mg once daily at bedtime increasing dose every one month as needed in increments of not more than 500 mg of niacin.
-
Maintenance dose:
- Niacin extended release 1,000 to 2,000 mg/simvastatin 20 to 40 mg once daily.
- The maximum daily dose is niacin ER 2,000 mg/simvastatin 40 mg.
Note:
- If therapy is interrupted for >one week, reinstitution of therapy should begin with the smallest dose followed by re-titration as tolerated.
- It may be substituted for the equivalent dose of niacin extended-release, however, the manufacturer does not recommend direct substitution with immediate-release preparations.
Simcor dose adjustment with concomitant medications:
-
Amiodarone, amlodipine, or ranolazine:
- The maximum dose of niacin extended-release is 1,000 mg/simvastatin 20 mg per day
-
Lomitapide:
- Simvastatin dose reduction by 50% when starting lomitapide.
- Simvastatin dose should not exceed 20 mg/day (or 40 mg daily for those who previously tolerated simvastatin 80 mg daily for ≥1 year without evidence of muscle toxicity).
Simcor dose in children:
The safety and efficacy of the drug in children has not been establsihed.
Pregnancy Risk Factor X
- It is not recommended for women who are pregnant or wish to conceive.
Use simvastatin and niacin during breastfeeding
- Breastfeeding women should not use it.
- Breast milk contains Niacin.
- It is not known if simvastatin secreted in breastmilk.
Simcor Dose adjustment in renal disease:
-
Mild to moderate impairment:
- There are no dosage adjustments provided in the manufacturer’s labeling (combination has not been studied).
- Use with caution.
-
Severe renal impairment:
- There are no dosage adjustments provided in the manufacturer’s labeling (combination has not been studied).
- Use with extreme caution or avoid unless the patient already tolerating simvastatin doses ≥10 mg.
Simcor Dose adjustment in liver disease:
- There are no dosage adjustments provided in the manufacturer's labeling (combination has not been studied).
- Contraindicated in patients with active liver disease or transaminitis.
Common Side Effects of Simcor (Niacin and simvastatin):
- Cardiovascular:
- Flushing
-
Central nervous system:
- Headache
-
Dermatologic:
- Pruritus
-
Gastrointestinal:
- Diarrhea
- Nausea
-
Neuromuscular & skeletal:
- Back pain
Uncommon Side effects of Simcor (Niacin and simvastatin)
-
Endocrine & Metabolic:
- Abnormal Thyroid Function Test
- Decreased Serum Phosphate
- Increased Amylase
- Increased Gamma-Glutamyl Transferase
- Increased Lactate Dehydrogenase
- Increased Uric Acid
-
Hematologic & Oncologic:
- Increase In Fasting Plasma Glucose
- Prolonged Prothrombin Time
- Thrombocytopenia
-
Hepatic:
- Increased Serum Alkaline Phosphatase
- Increased Serum Bilirubin
- Increased Serum Transaminases
-
Neuromuscular & Skeletal:
- Increased Creatine Phosphokinase
Contraindication to Simcor (Niacin and simvastatin):
- Hypersensitivity to simvastatin, niacin or any other component of the formulation
- Additional conditions may include:
- Transaminitis or active hepatic diseases,
- Active peptic ulcer disease
- arterial hemorrhage,
- pregnancy,
- Breastfeeding
- Combination of strong CYP3A4 inhibitors such as:
- Clarithromycin
- Erythromycin
- Protease inhibitors, such as boceprevir or telaprevir.
- itraconazole,
- ketoconazole,
- Nefazodone
- posaconazole,
- voriconazole,
- telithromycin,
- cobicistat containing products,
- amiodarone,
- Cyclosporine
- danazol,
- Diltiazem
- dronedarone,
- gemfibrozil is also known as
- verapamil.
Warnings and precautions
-
Pruritus and flushing:
- Flushing and pruritus can be side effects of Niacin.
- These side effects can be managed with a gradual increase of dose, giving with or without food, avoid ethanol, hot or spicy foods, liquids and/or taking aspirin half an hour before therapy.
- Flushing can be significantly reduced by extended-release preparations
- If severe cutaneous symptoms persist, the drug should be stopped immediately.
-
Gastrointestinal effects:
- It can cause vomiting, diarrhea, and gastrointestinal distress. This can be treated by increasing the dose gradually and eating with food.
- Patients with active pepticul disease should not take it.
- If you experience undiagnosed abdominal pain, weight loss, or any other symptoms of the gastrointestinal system, it is important to stop therapy.
-
Hematologic effects
- Depending on the dose, there may be a reduction in platelet count or an increase in prothrombin times.
-
Hepatotoxicity:
- When immediate-release (crystalline niacin) was replaced with the same dose sustained niacin product, severe hepatotoxicity and fulminant liver necrosis have occurred.
- To achieve the desired result, patients should start with low doses and then increase their dosage.
- It is possible to have persistent serum transaminitis. This can be controlled with dose reduction, drug interruption and discontinuation.
- Treatment should be stopped immediately if fatal hepatotoxicity is observed with clinical signs of hyperbilirubinemia or jaundice. It should be stopped immediately if an alternative cause is not found.
- At baseline, liver enzyme tests should always be performed.
- If hepatic Transaminase levels rise to more than 3x the normal limit or if you experience nausea, fever, and/or other symptoms, discontinue use.
-
Hypophosphatemia
- Niacin can result in small but statistically significant dose-related hypophosphatemia.
- Patients at high risk of hypophosphatemia should be monitored monthly for a low level of phosphorus.
-
Myopathy and rhabdomyolysis
- Rhabdomyolysis can occur with/without acute renal failure secondary to myoglobinuria and/or myopathy depending on the dose is increased with high doses of simvastatin (80 mg) or niacin (doses >=1 g/day).
- Combinations with strong CYP3A4 inhibitors can increase myopathy risk.
- Patients with uncontrolled hypothyroidism, patients who are taking colchicine, or patients over 65 years old, should be cautious.
- HMG-CoA reductase inhibitors are associated with immune-mediated necrotizing myopathy.
- Patients should be aware of any tenderness, myalgia or brown urine. This is especially important if it's accompanied by malaise, fever, or other symptoms.
- If creatinine levels are markedly elevated, discontinue therapy.
-
Cardiovascular disease
- Patients with unstable angina and myocardial damage should be cautious.
- Patients who received immediate-release (crystalline niacin) had a higher incidence of atrial fibrillation than those who received placebo.
- In the event of new-onset atrial fibrillation, discontinue treatment.
-
Diabetes:
- Niacin can cause new-onset DM, or worsening glucose tolerance for diabetics.
- Patients with diabetes should be cautious.
- It may be necessary to monitor glucose levels and adjust diet.
- If persistent hyperglycemia persists during therapy, discontinue treatment.
-
Gout
- Hyperuricemia can be caused by Niacin, so it is not recommended for acute gout.
-
Renal impairment
- Avoid severe renal impairment.
- Myopathy risk may be increased by renal impairment.
Niacin and simvastatin: Drug Interaction
|
Risk Factor C (Monitor therapy) |
|
|
Acipimox |
May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). |
|
Antidiabetic Agents |
Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. |
|
Aprepitant |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Asunaprevir |
May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). |
|
Azithromycin (Systemic) |
May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. |
|
Bosentan |
May decrease the serum concentration of Simvastatin. |
|
Clofazimine |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
CYP3A4 Inducers (Moderate) |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
CYP3A4 Inhibitors (Moderate) |
May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). |
|
Daclatasvir |
May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). |
|
Deferasirox |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Duvelisib |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Efavirenz |
May decrease the serum concentration of Simvastatin. |
|
Elbasvir |
May increase the serum concentration of Simvastatin. |
|
Eltrombopag |
May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. |
|
Erdafitinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Erdafitinib |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Eslicarbazepine |
May decrease the serum concentration of Simvastatin. |
|
Etravirine |
May decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). This applies to atorvastatin, lovastatin and simvastatin. Conversely, levels of fluvastatin may be increased. Management: Dose adjustment of the HMG-CoA reductase inhibitor may be warranted. No interaction is expected with rosuvastatin, pravastatin, or pitavastatin. |
|
Fenofibrate and Derivatives |
May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). |
|
Fluconazole |
May increase the serum concentration of Simvastatin. |
|
Fosaprepitant |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Fosnetupitant |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Fostamatinib |
May increase the serum concentration of Simvastatin. |
|
Grazoprevir |
May increase the serum concentration of Simvastatin. |
|
Green Tea |
May increase the serum concentration of Simvastatin. Specifically, Simvastatin lactone concentrations may be increased. |
|
HMG-CoA Reductase Inhibitors (Statins) |
Niacin may enhance the adverse/toxic effect of HMGCoA Reductase Inhibitors (Statins). |
|
Imatinib |
May decrease the metabolism of Simvastatin. |
|
Ivosidenib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Larotrectinib |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Netupitant |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Niacinamide |
May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). |
|
Palbociclib |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
PAZOPanib |
Simvastatin may enhance the adverse/toxic effect of PAZOPanib. Specifically, the risk for ALT/AST elevations may be increased. |
|
Raltegravir |
May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). |
|
Repaglinide |
HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Repaglinide. |
|
Rosuvastatin |
Niacin may enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. |
|
Rupatadine |
May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for increased CPK and/or other muscle toxicities may be increased. |
|
Sarilumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Siltuximab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Simeprevir |
May increase the serum concentration of Simvastatin. |
|
Teriflunomide |
May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. |
|
Tocilizumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Trabectedin |
HMG-CoA Reductase Inhibitors (Statins) may enhance the myopathic (rhabdomyolysis) effect of Trabectedin. |
|
Vitamin K Antagonists (eg, warfarin) |
HMG-CoA Reductase Inhibitors (Statins) may enhance the anticoagulant effect of Vitamin K Antagonists. |
|
Risk Factor D (Consider therapy modification) |
|
|
Alcohol (Ethyl) |
May enhance the adverse/toxic effect of Niacin. |
|
Amiodarone |
May increase the serum concentration of Simvastatin. Management: Consider using a non-interacting statin (pravastatin) in patients on amiodarone. If combined, limit the adult simvastatin dose to 20 mg daily and monitor for evidence of simvastatin toxicities (eg, myalgia, liver function test elevations, rhabdomyolysis). |
|
AmLODIPine |
May increase the serum concentration of Simvastatin. Management: Avoid the concurrent use of amlodipine with simvastatin when possible. If used together, avoid doses of simvastatin greater than 20 mg/day (for adults). |
|
Bezafibrate |
May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Bezafibrate may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). More specifically, bezafibrate may increase the serum concentration of fluvastatin Management: Monitor patients closely for myopathy with concomitant use of bezafibrate and HMG-CoA reductase inhibitors. Concomitant use is contraindicated in patients predisposed to myopathy and alternative therapy should be considered. |
|
Bile Acid Sequestrants |
May decrease the absorption of Niacin. |
|
Ciprofibrate |
May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Management: Avoid the use of HMG-CoA reductase inhibitors and ciprofibrate if possible. If concomitant therapy is considered, benefits should be carefully weighed against the risks, and patients should be monitored closely for signs/symptoms of muscle toxicity. |
|
Colchicine |
May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Colchicine may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). |
|
CYP3A4 Inducers (Strong) |
May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. |
|
Cyproterone |
May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Avoid use of statins metabolized by CYP3A4 (eg, simvastatin) and consider avoiding fluvastatin as well in patients receiving high dose cyproterone (300 mg/day). Consider use of pravastatin, rosuvastatin, or pitavastatin if statin therapy is needed. |
|
Dabigatran Etexilate |
Simvastatin may enhance the anticoagulant effect of Dabigatran Etexilate. Management: Consider an alternative HMG-CoA reductase inhibitor (statin) in patients taking dabigatran who require statin therapy. If used together, monitor patients closely for signs and symptoms of bleeding. |
|
Dabrafenib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). |
|
DAPTOmycin |
HMG-CoA Reductase Inhibitors (Statins) may enhance the adverse/toxic effect of DAPTOmycin. Specifically, the risk of skeletal muscle toxicity may be increased. Management: Consider temporarily stopping HMG-CoA reductase inhibitor therapy prior to daptomycin. If used together, regular (i.e., at least weekly) monitoring of CPK concentrations is recommended. |
|
DilTIAZem |
Simvastatin may increase the serum concentration of DilTIAZem. DilTIAZem may increase the serum concentration of Simvastatin. Management: Avoid concurrent use of diltiazem with simvastatin when possible. If used together, limit adult doses to simvastatin 10 mg/day and diltiazem 240 mg/day; avoid Simcor (simvastatin/niacin) because fixed simvastatin doses exceed the maximum. |
|
Dronedarone |
May increase the serum concentration of Simvastatin. Management: Limit simvastatin to a max of 10 mg/day (in adults). Increase monitoring for signs of simvastatin toxicity (e.g., myositis, rhabdomyolysis). |
|
Enzalutamide |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. |
|
Fosphenytoin |
May decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). |
|
Lanthanum |
HMG-CoA Reductase Inhibitors (Statins) may decrease the serum concentration of Lanthanum. Management: Administer HMG-CoA reductase inhibitors at least two hours before or after lanthanum. |
|
Lercanidipine |
May increase the serum concentration of Simvastatin. Management: Administer lercanidipine in the morning and simvastatin in the evening in patients receiving these drugs in combination. |
|
Lomitapide |
May increase the serum concentration of Simvastatin. Management: Reduce the recommended simvastatin dose by 50%. Generally, limit the maximum adult simvastatin dose to 20 mg/day. A 40 mg/day dose can be considered in patients who previously received 80 mg/day for at least a year without evidence of muscle toxicity. |
|
Lorlatinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. |
|
Mitotane |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. |
|
Niacin |
May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. Niacin may increase the serum concentration of Simvastatin. Management: Use of simvastatin with niacin should be avoided in Chinese patients; some non-US labeling state this combination is not recommended in any Asian patients. |
|
Phenytoin |
May decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). |
|
QuiNINE |
May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Consider using a lower starting dose and lower maintenance/maximum doses of atorvastatin, simvastatin, or lovastatin when used together with quinine. |
|
Ranolazine |
May increase the serum concentration of Simvastatin. Management: Avoid the concurrent use of ranolazine with simvastatin when possible. If used together, avoid doses of simvastatin greater than 20 mg/day. |
|
Rifamycin Derivatives |
May decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Consider use of noninteracting antilipemic agents (note: pitavastatin concentrations may increase with rifamycin treatment). Monitor for altered HMG-CoA reductase inhibitor effects. Rifabutin and fluvastatin, or possibly pravastatin, may pose lower risk. |
|
Simvastatin |
Niacin may enhance the myopathic (rhabdomyolysis) effect of Simvastatin. Niacin may increase the serum concentration of Simvastatin. Management: Use of simvastatin with niacin should be avoided in Chinese patients; some non-US labeling state this combination is not recommended in any Asian patients. |
|
St John's Wort |
May increase the metabolism of HMG-CoA Reductase Inhibitors (Statins). Management: Consider avoiding the concomitant administration of St Johns Wort with interacting HMG-CoA reductase inhibitors in order to avoid the potential for decreased antilipemic effects. Monitor for decreased effects during concomitant therapy. |
|
St John's Wort |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. |
|
Stiripentol |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. |
|
Ticagrelor |
May increase the serum concentration of Simvastatin. Management: Avoid using doses of simvastatin greater than 40 mg/day with ticagrelor. This specific recommendation is found in the U.S. prescribing information but not in the Canadian product monograph. |
|
Tolvaptan |
May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. |
|
Verapamil |
May increase the serum concentration of Simvastatin. Management: Avoid concurrent use of verapamil with simvastatin when possible. If used together, limit adult maximum simvastatin dose to 10 mg/day, and avoid Simcor (simvastatin/niacin) because fixed simvastatin doses in the product exceed this maximum. |
|
Voxilaprevir |
May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest statin dose possible if combined with voxilaprevir and monitor patients for increased statin effects/toxicities. Avoid concomitant use of voxilaprevir with rosuvastatin or pitavastatin, and limit pravastatin doses to 40 mg daily. |
|
Risk Factor X (Avoid combination) |
|
|
Clarithromycin |
May increase the serum concentration of Simvastatin. |
|
Conivaptan |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
CycloSPORINE (Systemic) |
May increase the serum concentration of Simvastatin. |
|
CYP3A4 Inhibitors (Strong) |
May increase the serum concentration of Simvastatin. |
|
Danazol |
May increase the serum concentration of Simvastatin. |
|
Erythromycin (Systemic) |
May increase the serum concentration of Simvastatin. |
|
Fusidic Acid (Systemic) |
May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for muscle toxicities, including rhabdomyolysis may be significantly increased. Management: Avoid concurrent use whenever possible. Use is listed as contraindicated in product characteristic summaries in several countries, although UK labeling suggests that use could be considered under exceptional circumstances and with close supervision. |
|
Fusidic Acid (Systemic) |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Gemfibrozil |
May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. Gemfibrozil may increase the serum concentration of Simvastatin. Concentrations of the active simvastatin acid metabolite may also be increased by gemfibrozil. |
|
Glecaprevir and Pibrentasvir |
May increase the serum concentration of Simvastatin. |
|
Grapefruit Juice |
May increase the serum concentration of Simvastatin. |
|
Idelalisib |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Letermovir |
May increase the serum concentration of Simvastatin. |
|
MiFEPRIStone |
May increase the serum concentration of Simvastatin. Management: Avoid simvastatin during and 2 weeks following mifepristone for treatment of hyperglycemia in Cushing's syndrome. The interaction magnitude could be lower with single doses used to terminate pregnancy, but neither effect has been studied clinically. |
|
Protease Inhibitors |
May increase the serum concentration of Simvastatin. |
|
Red Yeast Rice |
May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). |
|
Telithromycin |
May increase the serum concentration of Simvastatin. |
Monitoring parameters while using Simcor:
2013 ACC/AHA Blood Cholesterol Guideline recommendations:
-
Lipid panel (total cholesterol, HDL, LDL, triglycerides):
- Baseline lipid panel/ fasting lipid profile within 4 to 12 weeks after starting or dose adjustment and every 3 to 12 months (as clinically indicated) thereafter.
- If 2 consecutive low-density lipoprotein levels are <40 mg/dL, dose reduction should be done.
-
Hepatic transaminase levels:
- Baseline measurement of hepatic transaminase levels (ie, ALT); measure liver function if symptoms point to hepatotoxicity (eg, unusual fatigue or weakness, loss of appetite, abdominal pain, dark-colored urine or yellowing of skin or sclera) during therapy.
-
Creatinine phosphokinase:
- CPK should not be routinely measured.
- Baseline CPK measurement is reasonable for some individuals (for instance, family history of statin intolerance, muscle disease, clinical presentation, combination therapy that may increase risk of myopathy).
- May measure creatinine phosphokinase in patients with symptoms of pain, tenderness, stiffness, cramping, weakness, generalized fatigue.
-
Diabetes Mellitus:
- If new-onset DM occurs during therapy, continue statin therapy and advise a healthy diet, exercise, avoid smoking, and weight control.
- Baseline fasting blood glucose or hemoglobin A and uric acid before starting and repeated during up-titration to a maintenance dose and every 6 months thereafter is recommended.
-
Neuropsychiatric features:
- In the case of confusional state or memory impairment, evaluation of non-statin causes such as exposure to other drugs, systemic and neuropsychiatric causes, and the possibility of adverse effects associated with statin therapy should be taken into account.
-
Manufacturer's labeling:
- Check Platelets/prothrombin time if on anticoagulants, phosphorus if predisposed to hypophosphatemia
How to administer Simcor (Niacin and simvastatin)?
- Administer the tablets whole. They should not be broken, crushed or chewed and given with a low-fat snack at bedtime.
- To prevent flushing symptoms premedication with aspirin half-hour before the dose is recommended.
- Alcohol ingestion, hot or spicy foods/liquids concurrently with niacin should be avoided.
Mechanism of action of Simcor (Niacin and simvastatin):
Niacin is a component of two coenzymes which is necessary for tissue respiration, lipid metabolism, and glycogenolysis. It inhibits the synthesis of very low-density lipoproteins.
Simvastatin is a derivative of lovastatin that acts by competitively inhibiting 3-hydroxy-3 methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that is responsible for catalyzing the rate-limiting step in cholesterol biosynthesis. Statins can be used to decrease high-sensitivity CRP levels. They also have pleiotropic effects such as increased endothelial function and reduced inflammation.
See individual agents, Niacin and simvastatin.
International Brands of Niacin and simvastatin:
- Simcor
- Cardioserve
- Mvastacin
- Zontolip
Niacin and simvastatin Brands in Pakistan:
No Brands Available in Pakistan.
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