FENOFIBRATe  (fen-o-fi'brate)  Tricor, Triglide, Lofibra, Antara Classifications: antilipemic; Therapeutic: cholesterol-lowering agent Pregnancy Category: C
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Availability
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
Action
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.
Therapeutic Effect
Effectiveness indicated by reduction in the level of serum triglycerides and VLDL production; interferes with synthesis of
serum triglycerides.
Uses
Adjunctive therapy to diet for patients with high triglycerides.
Contraindications
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.
Cautious Use
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
Hypertriglyceridemia Adult: PO 54 mg q.d. (max: 160 mg/d)
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Administration
Oral
- 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: Asthenia,
fatigue, infections, flu-like syndrome, localized pain, arthralgia.
CNS: Headache, paresthesia, dizziness,
insomnia.
CV: Arrhythmia.
GI: Dyspepsia, eructation, flatulence, nausea, vomiting, abdominal pain,
constipation, diarrhea, increased appetite.
Respiratory: Cough, rhinitis,
sinusitis.
Skin: Pruritus, rash.
Special Senses: Earache, eye floaters, blurred vision,
conjunctivitis, eye irritation,
Urogenital: Decreased libido, polyuria,
vaginitis.
Interactions
Drug: May potentiate anticoagulant effects of
warfarin; combination with an
hmg-co
a 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.
Pharmacokinetics
Absorption: 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: 20 h.
Nursing Implications
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.