Indications
With dietary therapy to decrease LDL cholesterol, total
cholesterol, triglycerides, and apolipoprotein B in adult
patients with hypercholesterolemia or mixed dyslipidemia.
With dietary management in the treatment of hypertriglyceridemia
(types IV and V hyperlipidemia) in
patients who are at risk for pancreatitis and do not respond
to nondrug therapy.
Action
Fenofibric acid primarily inhibits triglyceride synthesis.
Therapeutic Effects: Lowering of cholesterol and
triglycerides with subsequent decreased risk of pancreatitis.
Pharmacokinetics
Absorption: Well absorbed (60%) after oral administration;
absorptionqby food.
Distribution: Unknown.
Protein Binding: 99%.
Metabolism and Excretion: Rapidly converted to
fenofibric acid, which is the active metabolite; fenofibric
acid is metabolized by the liver. Fenofibric acid
and its metabolites are primarily excreted in urine
(60%).
Half-life: 20 hr.
TIME/ACTION PROFILE (lowering of
triglycerides)
ROUTE ONSET PEAK DURATION
PO unknown 2 wk unknown
Contraindications/Precautions
Contraindicated in: Hypersensitivity; Hepatic impairment
(including primary biliary cirrhosis); Pre-existing
gallbladder disease; Severe renal impairment;
Concurrent use of HMG-CoA reductase inhibitors; Lactation:
Potential for tumorigenicity noted in animal
studies; discontinue breast feeding.
Use Cautiously in: Concurrent warfarin or HMGCoA
reductase inhibitor therapy; OB: Embryocidal and
teratogenic in animal studies; use only if potential benefits
outweigh risks to the fetus; Pedi: Safety not established;
Geri: Age-relatedpin renal function may make
older patients more susceptible to adverse reactions.
Adverse Reactions/Side Effects
CNS: fatigue/weakness, headache. CV: PULMONARY EMBOLISM,
arrhythmias, deep vein thrombosis. GI: cholelithiasis,
pancreatitis. Derm: rash, urticaria.Metab:
pHDL levels. MS: rhabdomyolysis. Misc: hypersensitivity
reactions.
Interactions
Drug-Drug:qanticoagulant effects of warfarin.
HMG-CoA reductase inhibitorsqrisk of rhabdomyolysis
(concurrent use should be avoided). Absorption
ispby bile acid sequestrants (fenofibrate should be
given 1 hr before or 4–6 hr after).qrisk of nephrotoxicity
with cyclosporine. Concurrent use with colchicine
mayqrisk of rhabdomyolysis.
Route/Dosage
Primary hypercholesterolemia/mixed
dyslipidemia
PO (Adults): Antara—90 mg/day initially; Fenoglide—
120 mg/day; Lofibra—200 mg/day initially;
Tricor—145 mg/day initially; Triglide—160 mg/day
initially; Lipofen—50 mg daily.
Hypertriglyceridemia
PO (Adults): Antara—30–90 mg/day; Fenoglide—
40–120 mg/day; Lofibra—67–200 mg/day initially;
Tricor—48–145 mg/day initially; Triglide—50–160
mg/day initially; Lipofen—50 mg daily.
Renal impairment/Geriatric patients
PO (Adults): Antara—30 mg/day; Fenoglide—start
at 40 mg/day; Lofibra—67 mg/day; Tricor—48 mg/
day.
Availability (generic available)
Tablets (Tricor): 48 mg, 145 mg. Cost: Generic—
48 mg $171.86/90, 145 mg $515.58/90. Tablets
(Fenoglide): 40 mg, 120 mg. Cost: 40 mg $289.44/
90, 120 mg $869.40/90. Tablets (Triglide): 50 mg,
160 mg. Cost: Generic—160 mg $176.40/100. Micronized
tablets (Lofibra): 54 mg, 100 mg, 160
mg. Cost: Generic—54 mg $71.29/90, 160 mg
$213.88/90. Micronized capsules (Antara): 30 mg,
90 mg. Capsules (Lipofen): 50 mg, 150 mg. Cost: 50
mg $213.58/90, 150 mg $468.24/90. Micronized capsules (Lofibra): 67 mg, 134 mg, 200 mg. Cost:
Generic—67 mg $74.95/100, 134 mg $199.62/100,
200 mg $266.45/100.
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