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Fenoglide (Fenofibrate) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Coumarin Anticoagulants

Caution should be exercised when coumarin anticoagulants are given in conjunction with Fenoglide. The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized. [see Concomitant Coumarin Anticoagulants.]

Cyclosporine

Because cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including Fenoglide, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using Fenoglide with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.

HMG-CoA Reductase Inhibitors

The combined use of fenofibric acid derivatives, particularly gemfibrozil, and HMG-CoA reductase inhibitors results in an increased risk of rhabdomyolysis and myoglobinuria leading in a high proportion of cases to acute renal failure. [See Concomitant HMG-CoA Reductase Inhibitors.]

The combined use of Fenoglide and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.

In a single-dose drug interaction study in 23 healthy adults the concomitant administration of fenofibrate and pravastatin resulted in no clinically important difference in the pharmacokinetics of fenofibric acid, pravastatin, or its active metabolite 3α-hydroxy iso-pravastatin when compared to either drug given alone.

Bile-Acid Resins

Since bile acid sequestrants may bind other drugs given concurrently, patients should take Fenoglide at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption.

OVERDOSAGE

There is no specific treatment for overdose with Fenoglide. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

CONTRAINDICATIONS

  • Fenoglide is contraindicated in patients with severe renal dysfunction, including those receiving dialysis [see Clinical Pharmacology.]
  • Fenoglide is contraindicated in patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions.]
  • Fenoglide is contraindicated in patients with gallbladder disease [see Warnings and Precautions.]
  • Fenoglide is contraindicated in nursing mothers [see Use in Specific Populations.]
  • Fenoglide is contraindicated in patients who have a known hypersensitivity to fenofibrate, such as severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. [see Warnings and Precautions.]

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