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Drug Interactions between cerivastatin and Nicobid Tempules

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

niacin cerivastatin

Applies to: Nicobid Tempules (niacin) and cerivastatin

ADJUST DOSE: Severe myopathy and rhabdomyolysis have been reported with concomitant use of HMG-CoA reductase inhibitors (i.e., statins) and niacin. The mechanism is unknown; however, the development of myopathy has been associated with both the administration of statins alone and lipid-modifying dosages of niacin (1 g/day or more) alone. Certain populations may be more susceptible to the interaction. In a double-blind, randomized cardiovascular outcomes trial for simvastatin, the incidence of myopathy was found to be higher in patients of Chinese descent (0.43%) compared to patients not of Chinese descent (0.03%) taking 40 mg simvastatin and lipid-modifying dosages of a niacin-containing product. The cause of the increased risk is unknown, and it is also unknown if the increased risk applies to other Asian populations or to other statins when given to Chinese patients.

MANAGEMENT: Concomitant use of statins with lipid-modifying dosages of niacin (1 g/day or more) should be approached cautiously and only if the benefit of further alterations in lipid levels is anticipated to outweigh the potential risks. Addition of niacin to statin therapy typically provides little additional reduction in LDL cholesterol, but further reductions of triglycerides and increases in HDL cholesterol may be attained. If the combination is prescribed, lower dosages of the statin should be considered. Coadministration of simvastatin with high doses of niacin (1 g/day or more) is not recommended in Chinese patients due to an increased risk of myopathy. Lovastatin labeling recommends that the dosage not exceed 20 mg daily when prescribed with lipid-modifying dosages of niacin. All patients should be advised to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by fever, malaise and/or dark colored urine. Therapy should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed.

References

  1. Mauro VF "Clinical pharmacokinetics and practical applications of simvastatin." Clin Pharmacokinet 24 (1993): 195-202
  2. Mauro VF, MacDonald JL "Simvastatin: a review of its pharmacology and clinical use." DICP 25 (1991): 257-64
  3. Reaven P, Witztum JL "Lovastatin, nicotinic acid, and rhabdomyolysis." Ann Intern Med 109 (1988): 597-8
  4. 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
  5. Malloy MJ, Kane JP, Kunitake ST, Tun P "Complementarity of colestipol, niacin, and lovastatin in treatment of severe familial hypercholesterolemia." Ann Intern Med 107 (1987): 616-23
  6. "Product Information. Mevacor (lovastatin)." Merck & Co., Inc PROD (2002):
  7. "Product Information. Zocor (simvastatin)." Merck & Co., Inc PROD (2001):
  8. "Product Information. Lipitor (atorvastatin)." Parke-Davis PROD (2001):
  9. "Product Information. Baycol (cerivastatin)." Bayer PROD (2001):
  10. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  11. "Product Information. Vytorin (ezetimibe-simvastatin)." Merck & Co., Inc (2004):
  12. FDA. U.S. Food and Drug Administration "FDA drug safety communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm204882.htm" (2010):
View all 12 references

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Drug and food interactions

Moderate

cerivastatin food

Applies to: cerivastatin

GENERALLY AVOID: Coadministration with grapefruit juice may increase the plasma concentrations of atorvastatin. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. When a single 40 mg dose of atorvastatin was coadministered with 240 mL of grapefruit juice, atorvastatin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 16% and 37%, respectively. Greater increases in Cmax (up to 71%) and/or AUC (up to 2.5 fold) have been reported with excessive consumption of grapefruit juice (>=750 mL to 1.2 liters per day). Clinically, high levels of HMG-CoA reductase inhibitory activity in plasma is associated with an increased risk of musculoskeletal toxicity. Myopathy manifested as muscle pain and/or weakness associated with grossly elevated creatine kinase exceeding ten times the upper limit of normal has been reported occasionally. Rhabdomyolysis has also occurred rarely, which may be accompanied by acute renal failure secondary to myoglobinuria and may result in death.

ADJUST DOSING INTERVAL: Fibres such as oat bran and pectin may diminish the pharmacologic effects of HMG-CoA reductase inhibitors by interfering with their absorption from the gastrointestinal tract.

MANAGEMENT: Patients receiving therapy with atorvastatin should limit their consumption of grapefruit juice to no more than 1 liter per day. Patients should be advised to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by fever, malaise and/or dark colored urine. Therapy should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed. In addition, patients should either refrain from the use of oat bran and pectin or, if concurrent use cannot be avoided, to separate the administration times by at least 2 to 4 hours.

References

  1. Richter WO, Jacob BG, Schwandt P "Interaction between fibre and lovastatin." Lancet 338 (1991): 706
  2. McMillan K "Considerations in the formulary selection of hydroxymethylglutaryl coenzyme a reductase inhibitors." Am J Health Syst Pharm 53 (1996): 2206-14
  3. "Product Information. Lipitor (atorvastatin)." Parke-Davis PROD (2001):
  4. 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
  5. Bailey DG, Malcolm J, Arnold O, Spence JD "Grapefruit juice-drug interactions." Br J Clin Pharmacol 46 (1998): 101-10
  6. Lilja JJ, Kivisto KT, Neuvonen PJ "Grapefruit juice increases serum concentrations of atorvastatin and has no effect on pravastatin." Clin Pharmacol Ther 66 (1999): 118-27
  7. Neuvonen PJ, Backman JT, Niemi M "Pharmacokinetic comparison of the potential over-the-counter statins simvastatin, lovastatin, fluvastatin and pravastatin." Clin Pharmacokinet 47 (2008): 463-74
View all 7 references

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Moderate

niacin food

Applies to: Nicobid Tempules (niacin)

GENERALLY AVOID: Ethanol can exacerbate the cutaneous flushing that is a common side effect of niacin. At least one case of delirium and lactic acidosis has been reported with coadministration of these drugs, although data are limited.

MANAGEMENT: Coadministration should probably be discouraged, particularly since chronic consumption of large amounts of alcohol is associated with hyperlipidemia.

References

  1. Schwab RA, Bachhuber BH "Delirium and lactic acidosis caused by ethanol and niacin coingestion." Am J Emerg Med 9 (1991): 363-5

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Minor

niacin food

Applies to: Nicobid Tempules (niacin)

A single case has been reported in which cutaneous flushing and tremors were noted in a woman who was taking niacin while wearing a nicotine patch. The mechanism is suspected to be synergistic cutaneous vasodilatory effects. The clinical significance of this possible interaction is not known.

References

  1. Rockwell KA Jr "Potential interaction between niacin and transdermal nicotine." Ann Pharmacother 27 (1993): 1283-8

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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