Tricor, Triglide, Lofibra, Antara
Classifications: antilipemic; Therapeutic: cholesterol-lowering agent
Pregnancy Category: C
48 mg, 50 mg, 154 mg, 160 mg tablets; 43 mg, 67 mg, 87 mg, 134 mg, 200 mg capsules or 50 mg, 100 mg, 150 mg, 160 mg capsules
Fibric acid derivative with lipid-regulating properties. Lowers plasma triglycerides apparently by inhibiting triglyceride
synthesis and, as a result, lowers VLDL production as well as stimulates the catabolism of triglyceride-rich lipoprotein (e.g.,
VLDL). Produces a moderate increase in HDL cholesterol levels in most patients.
Effectiveness indicated by reduction in the level of serum triglycerides and VLDL production; interferes with synthesis of
Adjunctive therapy to diet for patients with high triglycerides.
Hypersensitivity to fenofibrate or other fibric acid derivatives (e.g., clofibrate, benzofibrate); liver or severe kidney
dysfunction; unexplained liver function abnormality; preexisting hepatic disease; primary biliary cirrhosis; preexisting gallbladder
disease; pregnancy (category C); lactation; thrombocytopenia. Safety and efficacy in children <10 y (capsules), <18 y (Tricor
tablets) are not established.
Concomitant therapy with HMG-CoA reductase inhibitors (e.g., lovastatin, pravastatin, simvastatin), oral anticoagulant medications;
renal impairment, older adults; history of bleeding disorders; myelosuppression.
Route & Dosage
Adult: PO 54 mg q.d. (max: 160 mg/d)
- Limit dose to 54 mg/d in older adults or those with impaired kidney function.
- Give at least 1 h before or 46 h after cholestyramine.
- Store at 15°30° C (59°86° F) in a tightly closed container and protect from light.
Adverse Effects (≥1%)Body as a Whole:
, infections, flu-like syndrome, localized pain, arthralgia. CNS:
Headache, paresthesia, dizziness, insomnia
Dyspepsia, eructation, flatulence, nausea, vomiting, abdominal pain, constipation
, diarrhea, increased appetite. Respiratory:
Cough, rhinitis, sinusitis
Pruritus, rash. Special Senses:
Earache, eye floaters, blurred vision, conjunctivitis
, eye irritation, Urogenital:
Decreased libido, polyuria, vaginitis
May potentiate anticoagulant effects of warfarin;
combination with an hmg-c
oa reductase inhibitor (statin)
may result in rhabdomyolysis or acute renal failure; cholestyramine, colestipol
may decrease absorption (give fenofibrate 1 h before or 46 h after bile acid sequestrants
); may increase risk of nephrotoxicity of cyclosporine.
Well absorbed from the GI tract; increased with food. Peak:
68 h. Distribution:
99% protein bound; excreted in breast milk. Metabolism:
Rapidly hydrolyzed by esterases to active metabolite, fenofibric acid. Elimination:
60% in urine, 25% in feces. Half-Life:
Assessment & Drug Effects
- Lab tests: Periodically monitor lipid levels, liver functions, and CBC with differential.
- Discontinue therapy after 2 mo if adequate lipid reduction is not achieved with the maximum dose of 201 mg/d.
- Assess for muscle pain, tenderness, or weakness and, if present, monitor CPK level. Withdraw drug with marked elevations of
CPK or if myopathy is suspected.
- Monitor patients on coumarin-type drugs closely for prolongation of PT/INR.
Patient & Family Education
- Contact physician immediately if any of the following develops: Unexplained muscle pain, tenderness, or weakness, especially
with fever or malaise; yellowing of skin or eyes; nausea or loss of appetite; skin rash or hives.
- Inform physician regarding concurrent use of cholestyramine, oral anticoagulants, or cyclosporine.