Niacin and Simvastatin

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Niacin and Simvastatin Brand Name– Simcor

What is Niacin and Simvastatin

Niacin and simvastatin is an oral combination product containing simvastatin, a hydroxymethylglutaryl CoA (HMG-CoA) reductase inhibitor, and extended-release niacin.

Niacin and simvastatin reduces total cholesterol, LDL cholesterol, non-HDL cholesterol, apolipoprotein B, triglycerides, and increases HDL cholesterol in patients with primary type II hyperlipidemia, mixed dyslipidemia, or hypertriglyceridemia when monotherapy with niacin extended-release or simvastatin is inadequate.

In clinical trials, niacin and simvastatin was found to not be superior to simvastatin alone in lowering LDL cholesterol but was superior to simvastatin in lowering triglycerides and increasing HDL.

No incremental benefit has been established for niacin; simvastatin on cardiovascular morbidity and mortality above that seen with monotherapy with simvastatin and niacin.

In addition, the combination of niacin (1500—2000 mg/day PO) and simvastatin did not result in a greater reduction in the incidence of cardiovascular events than simvastatin alone in the AIM-HIGH trial, which randomized patients with stable cardiovascular disease and mean baseline LDL-C levels of 74 mg/dL.

Simcor was approved by the FDA on February 18, 2008.

Indications

  • hypercholesterolemia
  • hyperlipoproteinemia

For the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, non-HDL cholesterol, or triglyceride concentrations, and to increase HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa or IIb hyperlipoproteinemia); or to treat Fredrickson Type IV (hypertriglyceridemia, increased VLDL)

NOTE: Because of the risk of hepatotoxicity related with sustained-release or time-release niacin preparations or immediate-release (crystalline) niacin, the combination product niacin; simvastatin should only be substituted for equivalent doses of niacin extended release (Niaspan).

Side Effects

  1. abdominal pain
  2. alopecia
  3. amnesia
  4. anaphylactoid reactions
  5. angina
  6. angioedema
  7. arthralgia
  8. asthenia
  9. back pain
  10. blurred vision
  11. bullous rash
  12. cataracts
  13. chills
  14. cholestasis
  15. cirrhosis
  16. Co-Enzyme Q-10 deficiency
  17. confusion
  18. constipation
  19. depression
  20. diabetes mellitus
  21. diaphoresis
  22. diarrhea
  23. dizziness
  24. drowsiness
  25. dysarthria
  26. dyspepsia
  27. dysphagia
  28. dyspnea
  29. edema
  30. elevated hepatic enzymes
  31. eosinophilia
  32. erythema multiforme
  33. fatigue
  34. fever
  35. flatulence
  36. flushing
  37. headache
  38. hemolytic anemia
  39. hepatic failure
  40. hepatic necrosis
  41. hepatitis
  42. hyperbilirubinemia
  43. hyperglycemia
  44. hyperuricemia
  45. hypophosphatemia
  46. hypotension
  47. immune-mediated necrotizing myopathy
  48. impotence (erectile dysfunction)
  49. infection
  50. insomnia
  51. interstitial lung disease
  52. jaundice
  53. laryngeal edema
  54. leukopenia
  55. lupus-like symptoms
  56. maculopapular rash
  57. malaise
  58. muscle cramps
  59. muscle paralysis
  60. musculoskeletal pain
  61. myalgia
  62. myasthenia
  63. myoglobinuria
  64. myopathy
  65. nausea
  66. orthostatic hypotension
  67. palpitations
  68. pancreatitis
  69. paresthesias
  70. peptic ulcer
  71. peripheral edema
  72. peripheral neuropathy
  73. peripheral vasodilation
  74. photosensitivity
  75. pruritus
  76. purpura
  77. rash
  78. renal tubular obstruction
  79. rhabdomyolysis
  80. rhinitis
  81. sinus tachycardia
  82. skin discoloration
  83. Stevens-Johnson syndrome
  84. syncope
  85. thrombocytopenia
  86. toxic epidermal necrolysis
  87. urticaria
  88. vasculitis
  89. vesicular rash
  90. vomiting

Monitoring Parameters

  • blood glucose
  • creatine phosphokinase (CPK)
  • LFTs
  • serum cholesterol profile
  • serum uric acid

Contraindications

  • alcoholism
  • anticoagulant therapy
  • Asian patients
  • bleeding
  • breast-feeding
  • children
  • cholestasis
  • coagulopathy
  • contraception requirements
  • diabetes mellitus
  • electrolyte imbalance
  • endocrine disease
  • females
  • geriatric
  • gout
  • hepatic disease
  • hepatic encephalopathy
  • hepatitis
  • hypophosphatemia
  • hypotension
  • hypothyroidism
  • infants
  • infection
  • jaundice
  • myopathy
  • peptic ulcer disease
  • pregnancy
  • renal disease
  • renal failure
  • renal impairment
  • rhabdomyolysis
  • seizure disorder
  • surgery
  • thrombocytopenia
  • trauma

Interactions

  • Acarbose
  • Acetohexamide
  • Albiglutide
  • Aliskiren; Amlodipine
  • Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
  • Alogliptin
  • Alogliptin; Metformin
  • Alogliptin; Pioglitazone
  • Alpha-blockers
  • Alpha-glucosidase Inhibitors
  • Amiodarone
  • Amlodipine
  • Amlodipine; Atorvastatin
  • Amlodipine; Benazepril
  • Amlodipine; Celecoxib
  • Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
  • Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
  • Amlodipine; Olmesartan
  • Amlodipine; Telmisartan
  • Amlodipine; Valsartan
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Amprenavir
  • Angiotensin II receptor antagonists
  • Angiotensin-converting enzyme inhibitors
  • Aprepitant, Fosaprepitant
  • Aspirin, ASA; Pravastatin
  • Atazanavir
  • Atazanavir; Cobicistat
  • Atorvastatin
  • Atorvastatin; Ezetimibe
  • Barbiturates
  • Bempedoic Acid
  • Bempedoic Acid; Ezetimibe
  • Beta-blockers
  • Bile acid sequestrants
  • Boceprevir
  • Bortezomib
  • Bosentan
  • Calcium-channel blockers
  • Canagliflozin
  • Canagliflozin; Metformin
  • Carbamazepine
  • Central-acting adrenergic agents
  • Ceritinib
  • Cerivastatin
  • Chlorpropamide
  • Chlorzoxazone
  • Cimetidine
  • Ciprofloxacin
  • Clarithromycin
  • Cobicistat
  • Colchicine
  • Colchicine; Probenecid
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dabigatran
  • Dabrafenib
  • Daclatasvir
  • Danazol
  • Dapagliflozin
  • Dapagliflozin; Metformin
  • Dapagliflozin; Saxagliptin
  • Daptomycin
  • Darunavir
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Deferasirox
  • Delavirdine
  • Digoxin
  • Diltiazem
  • Dronedarone
  • Dulaglutide
  • Duvelisib
  • Efavirenz
  • Efavirenz; Emtricitabine; Tenofovir
  • Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
  • Elbasvir; Grazoprevir
  • Elexacaftor; tezacaftor; ivacaftor
  • Eltrombopag
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
  • Empagliflozin
  • Empagliflozin; Linagliptin
  • Empagliflozin; Linagliptin; Metformin
  • Empagliflozin; Metformin
  • Encorafenib
  • Eplerenone
  • Epoprostenol
  • Ertugliflozin; Metformin
  • Ertugliflozin; Sitagliptin
  • Erythromycin
  • Erythromycin; Sulfisoxazole
  • Eslicarbazepine
  • Ethanol
  • Etravirine
  • Everolimus
  • Exenatide
  • Fedratinib
  • Fenofibrate
  • Fenofibric Acid
  • Flibanserin
  • Fluconazole
  • Fluvastatin
  • Fluvoxamine
  • Fosamprenavir
  • Fostamatinib
  • Fostemsavir
  • Gemfibrozil
  • Glecaprevir; Pibrentasvir
  • Glimepiride
  • Glimepiride; Pioglitazone
  • Glimepiride; Rosiglitazone
  • Glipizide
  • Glipizide; Metformin
  • Glyburide
  • Glyburide; Metformin
  • grapefruit juice
  • Hydantoins
  • Hydrochlorothiazide, HCTZ; Propranolol
  • Idelalisib
  • Iloprost
  • Imatinib
  • Incretin Mimetics
  • Indinavir
  • Insulin Degludec; Liraglutide
  • Insulin Glargine; Lixisenatide
  • Insulins
  • Isavuconazonium
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Itraconazole
  • Ivacaftor
  • Ivosidenib
  • Ketoconazole
  • Lanthanum Carbonate
  • Lefamulin
  • Leflunomide
  • Letermovir
  • Linagliptin
  • Linagliptin; Metformin
  • Liraglutide
  • Lixisenatide
  • Lomitapide
  • Loop diuretics
  • Lopinavir; Ritonavir
  • Lovastatin
  • Lovastatin; Niacin
  • Lumacaftor; Ivacaftor
  • Lumacaftor; Ivacaftor
  • Mecamylamine
  • Metformin
  • Metformin; Pioglitazone
  • Metformin; Repaglinide
  • Metformin; Rosiglitazone
  • Metformin; Saxagliptin
  • Metformin; Sitagliptin
  • Mifepristone
  • Miglitol
  • Mitotane
  • Nateglinide
  • Nefazodone
  • Nelfinavir
  • Netupitant, Fosnetupitant; Palonosetron
  • Nevirapine
  • Niacin, Niacinamide
  • Nicardipine
  • Obeticholic Acid
  • Ombitasvir; Paritaprevir; Ritonavir
  • Omeprazole; Amoxicillin; Rifabutin
  • Oxcarbazepine
  • Pazopanib
  • Perindopril; Amlodipine
  • Pexidartinib
  • Pitavastatin
  • Posaconazole
  • Potassium-sparing diuretics
  • Pramlintide
  • Pravastatin
  • Propranolol
  • Protease inhibitors
  • Quinine
  • Raltegravir
  • Ranolazine
  • Red Yeast Rice
  • Repaglinide
  • Reserpine
  • Ribociclib
  • Ribociclib; Letrozole
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Riluzole
  • Ritonavir
  • Rosuvastatin
  • Saquinavir
  • Sarilumab
  • Saxagliptin
  • Semaglutide
  • Siltuximab
  • Simeprevir
  • Simvastatin; Sitagliptin
  • Sirolimus
  • Sitagliptin
  • Sofosbuvir; Velpatasvir
  • Sofosbuvir; Velpatasvir; Voxilaprevir
  • St. John’s Wort, Hypericum perforatum
  • Sulfonylureas
  • Tacrolimus
  • Telaprevir
  • Telbivudine
  • Telithromycin
  • Teriflunomide
  • Tesamorelin
  • Tezacaftor; Ivacaftor
  • Thiazide diuretics
  • Thiazolidinediones
  • Ticagrelor
  • Tipranavir
  • Tocilizumab
  • Tolazamide
  • Tolbutamide
  • Tolvaptan
  • Trandolapril; Verapamil
  • Treprostinil
  • Tucatinib
  • Vasodilators
  • Verapamil
  • Voriconazole
  • Warfarin
  • Zafirlukast

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