Friday, July 21, 2023

fenofibrate (fen-o-fi-brate) Antara, Fenoglide, Fenomax, Lipidil EZ, LipidilMicro, Lipidil Supra, Lipofen, Lofibra, Tricor, Triglide

 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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