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Indications & Important Safety Information
TriCor Type IIa/IIb Indications (1)
- TriCor is indicated as adjunctive therapy to diet in adult
patients with primary hypercholesterolemia or mixed dyslipidemia
(Fredrickson types IIa and IIb) to: increase high-density lipoprotein
cholesterol (HDL-C), reduce triglycerides (TG), reduce low-density
lipoprotein cholesterol (LDL-C), reduce total cholesterol (Total-C),
reduce apolipoprotein B (Apo B).
- Lipid-altering agents should be used in addition to a diet
restricted in saturated fat and cholesterol when response to diet and
nonpharmacological interventions alone has been inadequate.
TriCor Type IV/V Indications (1)
- TriCor is indicated as adjunctive therapy to diet for
treatment of adult patients with hypertriglyceridemia (Fredrickson
types IV and V hyperlipidemia). Improving glycemic control in
diabetic patients with fasting chylomicronemia usually obviates the
need for drug therapy.
- The effect of TriCor on pancreatitis risk reduction in
patients with markedly elevated serum TG has not been adequately
studied.
- Drug therapy is not indicated for patients with type I
hyperlipoproteinemia.
- The use of TriCor should be considered only when reasonable
attempts have been made to obtain satisfactory results with nondrug
methods such as diet, exercise, and reduction of alcohol intake. If
the decision is made to use TriCor, the patient should be instructed
that this does not reduce the importance of adhering to diet.
Diseases or drugs which contribute to hyperlipidemia should be
evaluated and appropriate interventions begun.
Important Safety Information (1)
- TriCor is contraindicated in patients with: hypersensitivity
to fenofibrate; hepatic or severe renal dysfunction including primary
biliary cirrhosis; unexplained persistent liver function abnormality;
and preexisting gallbladder disease.
- Fenofibrate has been associated with increases in serum
transaminases. Regular liver function monitoring should be performed,
and therapy discontinued if enzyme levels persist >3 times the
normal limit.
- Fenofibrate may lead to cholelithiasis. If cholelithiasis is
confirmed, TriCor should be discontinued.
- TriCor may increase the effects of coumarin-type
anticoagulants. Dosage adjustment based on frequent prothrombin
time/INR determinations is advisable.
- The combined use of TriCor and HMG-CoA reductase inhibitors
should be avoided unless the benefit of further alterations in lipid
levels is likely to outweigh the increased risk. This combination has
been associated with rhabdomyolysis, markedly elevated creatine
kinase levels and myoglobinuria, leading to acute renal failure.
- TriCor may occasionally be associated with myositis,
myopathy, or rhabdomyolysis. Muscle pain, tenderness, or weakness
should have prompt medical evaluation. Discontinue TriCor if markedly
elevated CPK levels occur or myopathy/myositis is suspected or
diagnosed.
- The effect of TriCor on coronary heart disease morbidity and
mortality and noncardiovascular mortality has not been established.
- Other precautions include increases in serum creatinine that tend to be reversible, pancreatitis, hypersensitivity
reactions, venothromboembolic events, and hematologic changes
- Adverse events most frequently observed in clinical trials:
abnormal liver function tests; respiratory disorder; abdominal pain;
back pain; and headache.
Reference
- TriCor tablets package insert, Abbott Laboratories.
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