Pravastatin Sodium 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 Pravastatin Sodium needs care, as documented in this source.

• Kidney Diseases

  Major

  Pravastatin is partially eliminated by the kidney. Drug and/or metabolite accumulation may occur in patients with significant renal impairment, which may increase the risk of adverse effects, including hepatic and musculoskeletal toxicities. Therapy with pravastatin should be administered cautiously in patients with severely impaired renal function. A lower initial dosage may be appropriate, accompanied by close clinical monitoring.

  7 sources

  1. Pan HY, DeValut AR, Wang-Iverson D, et al. "Comparative pharmacokinetics and pharmacodynamics of pravastatin and lovastatin." J Clin Pharmacol 30 (1990): 1128-35
  2. Halstenson CE, Triscari J, DeVault A, Shapiro B, Keane W, Pan H "Single-dose pharmacokinetics of pravastatin and metabolites in patients with renal impairment." J Clin Pharmacol 32 (1992): 124-32
  3. Pan HY, Morrison RA, Singhvi SM, Frantz BM, Waclawski AP, Willard DA "Disposition of pravastatin sodium (SQ 31,000), a tissue-selective HMG-CoA reductase inhibitor, in healthy subjects." Clin Res 36 (1988): a368
  4. "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb (2001):
  5. Quion JAV, Jones PH "Clinical pharmacokinetics of pravastatin." Clin Pharmacokinet 27 (1994): 94-103
  6. Lennernas H, Fager G "Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors. Similarities and differences." Clin Pharmacokinet 32 (1997): 403-25
  7. Sigurbjornsson S, Kjartansdottir T, Johannsson M, Kristinsson J, Sigurdsson G "A pharmacokinetic evaluation of pravastatin in middle-aged and elderly volunteers." Eur J Drug Metab Pharmacokinet 23 (1998): 13-8

• Liver Diseases

  Major

  The use of HMG-CoA reductase inhibitors is contraindicated in patients with active liver disease or unexplained, persistent elevations of serum transaminases. HMG-CoA reductase inhibitors are extensively metabolized by the liver. Decreased drug metabolism may lead to accumulation and increased risk of toxicity, including biochemical abnormalities of liver function and, rarely, jaundice, hepatitis, cirrhosis, fatty change in the liver, and fulminant hepatic necrosis. Therapy with HMG-CoA reductase inhibitors should be administered cautiously in patients with a history of liver disease and/or heavy alcohol use. A lower initial dosage may be appropriate, and clinical monitoring of liver transaminase levels according to the individual product package labeling is recommended. Patients who develop elevated ALT or AST levels during therapy should be monitored until abnormalities resolve. If an increase above 3 times the upper limit of normal persists, consideration should be given to a reduction in dosage or withdrawal of therapy.

  42 sources

  1. Pan HY, DeValut AR, Wang-Iverson D, et al. "Comparative pharmacokinetics and pharmacodynamics of pravastatin and lovastatin." J Clin Pharmacol 30 (1990): 1128-35
  2. Arnon R, Eisenberg S "Lovastatin-induced hepatitis." Isr J Med Sci 28 (1992): 101-2
  3. Mauro VF "Clinical pharmacokinetics and practical applications of simvastatin." Clin Pharmacokinet 24 (1993): 195-202
  4. Mauro VF, MacDonald JL "Simvastatin: a review of its pharmacology and clinical use." DICP 25 (1991): 257-64
  5. Duggan DE, Chen IW, Bayne WF, Halpin RA, Duncan CA, Schwartz MS, Stubbs RJ, Vickers S "The physiological disposition of lovastatin." Drug Metab Dispos 17 (1989): 166-73
  6. Pentikainen PJ, Saraheimo M, Schwartz JI, Amin RD, Schwartz MS, Brunner-Ferber F, Rogers JD "Comparative pharmacokinetics of lovastatin, simvastatin and pravastatin in humans." J Clin Pharmacol 32 (1992): 136-40
  7. Everett DW, Chando TJ, Didonato GC, Singhvi SM, Pan HY, Weinstein SH "Biotransformation of pravastatin sodium in humans." Drug Metab Dispos 19 (1991): 740-8
  8. Walker JF "Simvastatin: the clinical profile." Am J Med 87 (1989): s44-6

  Show all 42 sourcesShow fewer sources

  9. 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
  10. McGovern ME, Mellies MJ "Long-term experience with pravastatin in clinical research trials." Clin Ther 15 (1993): 57-64
  11. "Lovastatin 5-year safety and efficacy study. Lovastatin Study Groups I through IV." Arch Intern Med 153 (1993): 1079-87
  12. Geddes JA "Cholestatic jaundice associated with lovastatin (mevacor) therapy." Can Med Assoc J 143 (1990): 13-4
  13. McQueen MJ "Cholestatic jaundice associated with lovastatin (Mevacor) therapy." Can Med Assoc J 142 (1990): 841-2
  14. Bilheimer DW "Long-term clinical tolerance of lovastatin and simvastatin." Cardiology 77 (1990): 58-65
  15. Pan HY, Morrison RA, Singhvi SM, Frantz BM, Waclawski AP, Willard DA "Disposition of pravastatin sodium (SQ 31,000), a tissue-selective HMG-CoA reductase inhibitor, in healthy subjects." Clin Res 36 (1988): a368
  16. "Product Information. Mevacor (lovastatin)." Merck & Co., Inc (2002):
  17. "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb (2001):
  18. "Product Information. Zocor (simvastatin)." Merck & Co., Inc (2001):
  19. 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
  20. Dain JG, Fu E, Gorski J, Nicoletti J, Scallen TJ "Biotransformation of fluvastatin sodium in humans." Drug Metab Dispos 21 (1993): 567-72
  21. Tse FL, Jaffe JM, Troendle A "Pharmacokinetics of fluvastatin after single and multiple doses in normal volunteers." J Clin Pharmacol 32 (1992): 630-8
  22. "Product Information. Lescol (fluvastatin)." Novartis Pharmaceuticals (2001):
  23. Halpin RA, Ulm EH, Till AE, Kari PH, Vyas KP, Hunninghake DB, Duggan DE "Biotransformation of lovastatin .5. species differences in invivo metabolite profiles of mouse, rat, dog, and human." Drug Metab Dispos 21 (1993): 1003-11
  24. Jokubaitis LA "Updated clinical safety experience with fluvastatin." Am J Cardiol 73 (1994): d18-24
  25. Davidson MH, on behalf of the FLUENT Investigators Group "Fluvastatin long-term extension trial (FLUENT): summary of efficacy and safety." Am J Med 96 Suppl (1994): 96 (suppl)
  26. Quion JAV, Jones PH "Clinical pharmacokinetics of pravastatin." Clin Pharmacokinet 27 (1994): 94-103
  27. Grimbert S, Pessayre D, Degott C, Benhamou JP "Acute hepatitis induced by HMG-coa reductase inhibitor, lovastatin." Dig Dis Sci 39 (1994): 2032-3
  28. Smit JW, Wijnne HJ, Schobben F, Sitsen A, Debruin TW, Erkelens DW "Effects of alcohol and fluvastatin on lipid metabolism and hepatic function." Ann Intern Med 122 (1995): 678-80
  29. Smit JWA, Wijnne HJA, Schobben F, Sitsen A, Debruin TWA, Erkelens DW "Effects of alcohol consumption on pharmacokinetics, efficacy, and safety of fluvastatin." Am J Cardiol 76 (1995): a89-96
  30. 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
  31. "Product Information. Lipitor (atorvastatin)." Parke-Davis (2001):
  32. Boberg M, Angerbauer R, Fey P, Kanhai WK, Karl W, Kern A, Ploschke J, Radtke M "Metabolism of cerivastatin by human liver microsomes in vitro. Characterization of primary metabolic pathways and of cytochrome P45 isozymes involved." Drug Metab Dispos 25 (1997): 321-31
  33. "Product Information. Baycol (cerivastatin)." Bayer (2001):
  34. Cilla DD Jr, Whitfield LR, Gibson DM, Sedman AJ, Posvar EL "Multiple-dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG-CoA reductase, in healthy subjects." Clin Pharmacol Ther 60 (1996): 687-95
  35. Lea AP, McTavish D "Atorvastatin. A review of its pharmacology and therapeutic potential in the management of hyperlipidaemias." Drugs 53 (1997): 828-47
  36. Cilla DD Jr, Gibson DM, Whitfield LR, Sedman AJ "Pharmacodynamic effects and pharmacokinetics of atorvastatin after administration to normocholesterolemic subjects in the morning an evening." J Clin Pharmacol 36 (1996): 604-9
  37. Posvar EL, Radulovic LL, Cilla DD Jr, Whitfield LR, Sedman AJ "Tolerance and pharmacokinetics of single-dose atorvastatin, a potent inhibitor of HMG-CoA reductase, in healthy subjects." J Clin Pharmacol 36 (1996): 728-31
  38. Lennernas H, Fager G "Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors. Similarities and differences." Clin Pharmacokinet 32 (1997): 403-25
  39. Muck W, Unger S, Kawano K, Ahr G "Inter-ethnic comparisons of the pharmacokinetics of the HMG-CoA reductase inhibitor cerivastatin." Br J Clin Pharmacol 45 (1998): 583-90
  40. Hartleb M, Rymarczyk G, Januszewski K "Acute cholestatic hepatitis associated with pravastatin." Am J Gastroenterol 94 (1999): 1388-90
  41. Nakad A, Bataille L, Hamoir V, Sempoux C, Horsmans Y "Atorvastatin-induced acute hepatitis with absence of cross-toxicity with simvastatin." Lancet 353 (1999): 1763-4
  42. "Product Information. Livalo (pitavastatin)." Kowa Pharmaceuticals America (formerly ProEthic) (2010):

• 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):

• 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):

Therapeutic duplication

Drug classes that overlap with Pravastatin Sodium, 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): Roszet

• 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