Rosuvastatin + Ezetimibe interactions

Food & lifestyle

• alcohol

  Moderate

  Synergy

  Concomitant use of statin medication with substantial quantities of alcohol may increase the risk of hepatic injury.

  What to do: Patients should be counseled to avoid substantial quantities of alcohol in combination with statin medications and clinicians should be aware of the increased risk for hepatotoxicity in these patients.

  9 sources

  1. "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb (2001):
  2. "Product Information. Zocor (simvastatin)." Merck & Co., Inc (2001):
  3. "Product Information. Lescol (fluvastatin)." Novartis Pharmaceuticals (2001):
  4. "Product Information. Lipitor (atorvastatin)." Parke-Davis (2001):
  5. "Product Information. Altocor (lovastatin)." Andrx Pharmaceuticals (2002):
  6. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  8. Cerner Multum, Inc. "Australian Product Information." O 0

  Show all 9 sourcesShow fewer sources

  9. "Product Information. Livalo (pitavastatin)." Kowa Pharmaceuticals America (formerly ProEthic) (2010):

Conditions

Conditions in which Rosuvastatin + Ezetimibe needs care, as documented in this source.

• Liver Diseases

  Major

  Ezetimibe is partially metabolized in the liver. After a single 10 mg dose, the mean area under the plasma concentration-time curve (AUC) for total ezetimibe was increased approximately 1.7-fold, 3- to 4-fold, and 5- to 6-fold, in patients with mild (Child-Pugh score 5 to 6), moderate (Child-Pugh score 7 to 9), and severe hepatic impairment (Child-Pugh score 10 to 15), respectively, compared to healthy subjects. Due to the unknown effects of increased exposure to ezetimibe in patients with moderate or severe hepatic impairment, therapy with ezetimibe is not recommended in these patients. The combination of ezetimibe with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels.

  1 source

  1. "Product Information. Zetia (ezetimibe)." Schering-Plough Corporation (2002):

• Rhabdomyolysis

  Major

  Severe myopathy, including rhabdomyolysis with acute renal failure secondary to myoglobinuria, has been reported rarely with the use of HMG-CoA reductase inhibitors. The myopathy may be dose-related and is characterized by muscle aches and/or weakness in conjunction with increases in creatine phosphokinase (CPK) values exceeding 10 times the upper limit of normal. Therapy with HMG-CoA reductase inhibitors should be administered cautiously in patients with preexisting myopathy, in those with predisposing factors for myopathy or with a history of myoneural disorder, since it may delay the recognition or confound the diagnosis of a drug-induced musculoskeletal effect. Patients should be advised to report promptly any unusual muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Periodic CPK determinations may be considered in some patients, although the value of such monitoring is uncertain. HMG-CoA reductase inhibitor therapy should be withdrawn if markedly elevated CPK levels occur or if drug-related myopathy is diagnosed or suspected.

  35 sources

  1. Schalke BB, Schmidt B, Toyka K, Hartung H-P "Pravastatin-associated inflammatory myopathy." N Engl J Med 327 (1992): 649-50
  2. Pierce LR, Wysowski DK, Gross TP "Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy." JAMA 264 (1990): 71-5
  3. Walker JF "Simvastatin: the clinical profile." Am J Med 87 (1989): s44-6
  4. Simons LA "Simvastatin in severe primary hypercholesterolemia: efficacy, safety, and tolerability in 595 patients over 18 weeks. The Principal Investigators." Clin Cardiol 16 (1993): 317-22
  5. McGovern ME, Mellies MJ "Long-term experience with pravastatin in clinical research trials." Clin Ther 15 (1993): 57-64
  6. Reaven P, Witztum JL "Lovastatin, nicotinic acid, and rhabdomyolysis." Ann Intern Med 109 (1988): 597-8
  7. "Lovastatin 5-year safety and efficacy study. Lovastatin Study Groups I through IV." Arch Intern Med 153 (1993): 1079-87
  8. Corpier CL, Jones PH, Suki WN, et al. "Rhabdomyolysis and renal injury with lovastatin use. Report of two cases in cardiac transplant recipients." JAMA 260 (1988): 239-41

  Show all 35 sourcesShow fewer sources

  9. East C, Alivizatos PA, Grundy SM, Jones PH, Farmer JA "Rhabdomyolysis in patients receiving lovastatin after cardiac transplantation." N Engl J Med 318 (1988): 47-8
  10. Norman DJ, Illingworth DR, Munson J, Hosenpud J "Myolysis and acute renal failure in a heart-transplant recipient receiving lovastatin." N Engl J Med 318 (1988): 46-7
  11. Wallace CS, Mueller BA "Lovastatin-induced rhabdomyolysis in the absence of concomitant drugs." Ann Pharmacother 26 (1992): 190-2
  12. Bilheimer DW "Long-term clinical tolerance of lovastatin and simvastatin." Cardiology 77 (1990): 58-65
  13. "Product Information. Mevacor (lovastatin)." Merck & Co., Inc (2002):
  14. "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb (2001):
  15. "Product Information. Zocor (simvastatin)." Merck & Co., Inc (2001):
  16. Chariot P, Abadia R, Agnus D, Danan C, Charpentier C, Gherardi RK "Simvastatin-induced rhabdomyolysis followed by a MELAS syndrome." Am J Med 94 (1993): 109-10
  17. McDonagh J, Winocour P, Walker DJ "Musculoskeletal manifestations during simvastatin therapy." Br J Rheumatol 32 (1993): 647-8
  18. Levy RI, Troendle AJ, Fattu JM "A quarter century of drug treatment of dyslipoproteinemia, with a focus on the new HMG-CoA reductase inhibitor fluvastatin." Circulation 87 (1993): i45-53
  19. "Product Information. Lescol (fluvastatin)." Novartis Pharmaceuticals (2001):
  20. Fernandezzatarain G, Navarro V, Garcia H, Villatoro J, Calvo C "Rhabdomyolysis and acute renal failure associated with lovastatin." Nephron 66 (1994): 483-4
  21. Jokubaitis LA "Updated clinical safety experience with fluvastatin." Am J Cardiol 73 (1994): d18-24
  22. Lees RS, Lees AM "Rhabdomyolysis from the coadministration of lovastatin and the antifungal agent itraconazole." N Engl J Med 333 (1995): 664-5
  23. Ahmand S "Lovastatin-induced myopathy in a hypothyroid patient." J Fam Pract 41 (1995): 227-8
  24. Pedersen TR, Berg K, Cook TJ, Faergeman O, Haghfelt T, Kjekshus J, Miettinen T, Musliner TA, Olsson AG, Pyorala K, Thorgeirsso "Safety and tolerability of cholesterol lowering with simvastatin during 5 years in the scandinavian simvastatin survival study." Arch Intern Med 156 (1996): 2085-92
  25. Bakker-Arkema RG, Davidson MH, Goldstein RJ, Davignon J, Isaacsohn JL, Weiss SR, Keilson LM, Brown WV, Miller VT, Shurzinske LJ, Black DM "Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia." JAMA 275 (1996): 128-33
  26. "Product Information. Lipitor (atorvastatin)." Parke-Davis (2001):
  27. Vanpuijenbroek EP, Dubufvereijken PWG, Spooren PFMJ, Vandoormaal JJ "Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil." J Intern Med 240 (1996): 403-4
  28. "Product Information. Baycol (cerivastatin)." Bayer (2001):
  29. Grunden JW, Fisher KA "Lovastatin-induced rhabdomyolysis possibly associated with clarithromycin and azithromycin." Ann Pharmacother 31 (1997): 859-63
  30. Iliadis EA, Rosenson RS "Long-term safety of pravastatin-gemfibrozil therapy in mixed hyperlipidemia." Clin Cardiol 22 (1999): 25-8
  31. van Puijenbroek EP, Du Buf-Vereijken PW, Spooren PF, van Doormaal JJ "Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil." J Intern Med 240 (1996): 403-4
  32. Alvarez JM, Rawdanowiz TJ, Goldstein J "Rhadbdomyolysis after coronary artery bypass grafting in a patient receiving simvastatin." J Thorac Cardiovasc Surg 116 (1998): 654-5
  33. Pogson GW, Kindred LH, Carper BG "Rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy." Am J Cardiol 83 (1999): 1146
  34. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  35. "Product Information. Livalo (pitavastatin)." Kowa Pharmaceuticals America (formerly ProEthic) (2010):

• Cognitive Dysfunction

  Moderate

  Cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) have been observed in patients receiving statins. The reports are usually not serious, and reversible upon statin discontinuation. Caution is recommended when using these agents in patients with cognitive impairment.

  6 sources

  1. "Product Information. Mevacor (lovastatin)." Merck & Co., Inc (2002):
  2. "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb (2001):
  3. "Product Information. Zocor (simvastatin)." Merck & Co., Inc (2001):
  4. "Product Information. Lescol (fluvastatin)." Novartis Pharmaceuticals (2001):
  5. "Product Information. Lipitor (atorvastatin)." Parke-Davis (2001):
  6. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):

• Diabetes Mellitus

  Moderate

  Increases in HbA1c and fasting serum glucose levels have been reported with the use of certain HMG-CoA reductase inhibitors. Caution should be exercised when using these agents in diabetic patients and close monitoring is recommended.

  7 sources

  1. "Product Information. Mevacor (lovastatin)." Merck & Co., Inc (2002):
  2. "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb (2001):
  3. "Product Information. Zocor (simvastatin)." Merck & Co., Inc (2001):
  4. "Product Information. Lescol (fluvastatin)." Novartis Pharmaceuticals (2001):
  5. "Product Information. Lipitor (atorvastatin)." Parke-Davis (2001):
  6. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  7. "Product Information. Livalo (pitavastatin)." Kowa Pharmaceuticals America (formerly ProEthic) (2010):

• Hematuria

  Moderate

  An association between rosuvastatin and the development of proteinuria and microscopic hematuria was observed among treated patients during clinical trials. Patients with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing should be instructed to reduce the dose of rosuvastatin according to clinical standards. Therapy with rosuvastatin should be administered cautiously in patients showing abnormal urinalysis. Monitoring for proteinuria and hematuria is recommended.

  1 source

  1. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):

• Kidney Diseases

  Moderate

  Some HMG-CoA reductase inhibitors such as fluvastatin, have not been studied in patients with severe renal impairment or end-stage renal disease. Some others such as pitavastatin and simvastatin, require a dose reduction when used in this group of patients. Caution and close monitoring is advised when using these drugs in patients with renal impairment.

  7 sources

  1. "Product Information. Mevacor (lovastatin)." Merck & Co., Inc (2002):
  2. "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb (2001):
  3. "Product Information. Zocor (simvastatin)." Merck & Co., Inc (2001):
  4. "Product Information. Lescol (fluvastatin)." Novartis Pharmaceuticals (2001):
  5. "Product Information. Lipitor (atorvastatin)." Parke-Davis (2001):
  6. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  7. "Product Information. Livalo (pitavastatin)." Kowa Pharmaceuticals America (formerly ProEthic) (2010):

• Kidney Diseases

  Moderate

  No dosage adjustment of ezetimibe is necessary in patients with renal impairment. However, when ezetimibe therapy is given in combination with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m2), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring is recommended.

  1 source

  1. "Product Information. Zetia (ezetimibe)." Schering-Plough Corporation (2002):

• Rhabdomyolysis

  Moderate

  Myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs. In post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin prior to initiating ezetimibe. However, rhabdomyolysis has been reported with ezetimibe monotherapy and with the addition of ezetimibe to agents known to be associated with increased risk of rhabdomyolysis, such as fibrates. In the presence of muscle symptoms and a CPK level >10 × the ULN indicative of myopathy, ezetimibe and any statin or fibrate that the patient is taking concomitantly should be immediately discontinued if myopathy is diagnosed or suspected.

  1 source

  1. "Product Information. Zetia (ezetimibe)." Schering-Plough Corporation (2002):

Therapeutic duplication

Drug classes that overlap with Rosuvastatin + Ezetimibe, so taking both doubles up the same effect. This source publishes no per-row citations for duplication.

• hmg co-a reductase inhibitors

  The recommended maximum number of medicines in the 'HMG Co-A reductase inhibitors' category to be taken concurrently is usually one.Your list includes two medicines belonging to the 'HMG Co-A reductase inhibitors' category.

  Example product in the source data (US market): Lovastatin/niacin

• hmg co-a reductase inhibitors

  The recommended maximum number of medicines in the 'HMG Co-A reductase inhibitors' category to be taken concurrently is usually one.Your list includes two medicines belonging to the 'HMG Co-A reductase inhibitors' category.

  Example product in the source data (US market): Vytorin

• hmg co-a reductase inhibitors

  The recommended maximum number of medicines in the 'HMG Co-A reductase inhibitors' category to be taken concurrently is usually one.Your list includes two medicines belonging to the 'HMG Co-A reductase inhibitors' category.

  Example product in the source data (US market): Lypqozet

• hmg co-a reductase inhibitors

  The recommended maximum number of medicines in the 'HMG Co-A reductase inhibitors' category to be taken concurrently is usually one.Your list includes two medicines belonging to the 'HMG Co-A reductase inhibitors' category.

  Example product in the source data (US market): Simvastatin/sitagliptin

• hmg co-a reductase inhibitors

  The recommended maximum number of medicines in the 'HMG Co-A reductase inhibitors' category to be taken concurrently is usually one.Your list includes two medicines belonging to the 'HMG Co-A reductase inhibitors' category.

  Example product in the source data (US market): Niacin/simvastatin

• hmg co-a reductase inhibitors

  The recommended maximum number of medicines in the 'HMG Co-A reductase inhibitors' category to be taken concurrently is usually one.Your list includes two medicines belonging to the 'HMG Co-A reductase inhibitors' category.

  Example product in the source data (US market): Caduet