Yes

Antilipemic Agent (Fibric Acid)

Adjunct to dietary therapy in the management of hyperlipidemias associated with high triglyceride levels (Types III, IV, V); primarily lowers triglycerides and very low density lipoprotein

C

Hypersensitivity to clofibrate or any component; significant hepatic or renal dysfunction; primary biliary cirrhosis

Possible increased risk of malignancy and cholelithiasis. No evidence of cardiovascular mortality benefit. Anemia and leukopenia have been reported. Elevations in serum transaminases can be seen. Discontinue if lipid response is not seen. Use with caution in peptic ulcer disease. Flu-like symptoms may occur. Be careful in patient selection; this is not a first- or second-line choice. Other agents may be more suitable.

Common: Gastrointestinal: Nausea, diarrhea

Less common:

Central nervous system: Headache, dizziness, fatigue

Gastrointestinal: Vomiting, loose stools, heartburn, flatulence, abdominal distress, epigastric pain

Neuromuscular & skeletal: Muscle cramping, aching, weakness, myalgia

Frequency unknown:

Central nervous system: Fever

Cardiovascular: Chest pain, cardiac arrhythmias

Dermatologic: Rash, urticaria, pruritus, alopecia, dry,brittle hair, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome

Endocrine & metabolic: Weight gain, polyphagia, gynecomastia, hyperkalemia

Gastrointestinal: Stomatitis, gallstones, pancreatitis, gastritis, peptic ulcer, weight gain

Genitourinary: Impotence, decreased libido

Hematologic: Leukopenia, anemia, eosinophilia, agranulocytosis, thrombocytopenic purpura

Hepatic: Increased liver function test, hepatomegaly, jaundice

Renal: Dysuria, hematuria, proteinuria, renal toxicity, (allergic), rhabdomyolysis-induced renal failure

Neuromuscular & skeletal: Myalgia, myopathy, myositis, arthralgia, rhabdomyolysis, increased creatinine phosphokinase (CPK), rheumatoid arthritis, tremor

Local: Thrombophlebitis

Ocular: Photophobic

Miscellaneous: Flu-like syndrome, increased sweating, systemic lupus erythematosus

Symptoms of overdose include nausea, vomiting, diarrhea, GI distress

Following GI decontamination, treatment is supportive

Chlorpropamide: May increase risk of hypoglycemia.

Furosemide: Increased blood levels of both in hypoalbuminemia.

HMG-CoA reductase inhibitors (atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, simvastatin) may increase the risk of myopathy and rhabdomyolysis. The manufacturer warns against the concomitant use. However, combination therapy with statins has been used in some patients with resistant hyperlipidemias (with great caution).

Insulin: Hypoglycemic effects may be potentiated by an unknown mechanism.

Probenecid may decrease the clearance of clofibrate.

Rifampin: Decreased clofibrate blood levels.

Sulfonylureas (including glyburide, glipizide): Hypoglycemic effects may be potentiated by an unknown mechanism.

Warfarin: Increased hypoprothrombinemic response; monitor INRs closely when clofibrate is initiated or discontinued.

Mechanism is unclear but thought to reduce cholesterol synthesis and triglyceride hepatic-vascular transference

Absorption: Occurs completely; intestinal transformation is required to activate the drug

Distribution: V_d: 5.5 L/kg; crosses the placenta

Protein binding: 95%

Metabolism: In the liver to an inactive glucuronide ester

Half-life: 6-24 hours, increases significantly with reduced renal function; with anuria: 110 hours

Time to peak serum concentration: Within 3-6 hours

Elimination: 40% to 70% excreted in urine

Adults: Oral: 500 mg 4 times/day; some patients may respond to lower doses

Cl_cr >50 mL/minute: Administer every 6-12 hours

Cl_cr 10-50 mL/minute: Administer every 12-18 hours

Cl_cr <10 mL/minute: Avoid use

Hemodialysis: Elimination is not enhanced via hemodialysis; supplemental dose is not necessary

Serum lipids, cholesterol and triglycerides, LFTs, CBC

creatine phosphokinase [CPK] (S); alkaline phosphatase (S), cholesterol (S), glucose, uric acid (S)

There is no clear benefit for clofibrate use over other established lipid-lowering therapies on decreasing cardiovascular morbidity and mortality

May cause sedation or dizziness

Rare reports of agranulocytosis; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

This drug will have to be taken long-term and ongoing follow-up is essential. Adherence to a cardiac risk reduction program, including adherence to prescribed diet, is of major importance. This drug may cause stomach upset; if this occurs, take medication with food or milk. Report chest pain, shortness of breath, irregular heartbeat, palpitations, severe stomach pain with nausea and vomiting, persistent fever, sore throat, or unusual bleeding or bruising. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Do not breast-feed.

Monitor serum lipids, LFTs, CBC

Capsule: 500 mg

Cumming A, "Acute Renal Failure and Interstitial Nephritis After Clofibrate Treatment," Br Med J, 1980, 281(6254):1529-30.

Gugler R, "Clinical Pharmacokinetics of Hypolipidaemic Drugs," Clin Pharmacokinet, 1978, 3(6):425-39.

Wong SS, "Stevens-Johnson Syndrome Induced by Clofibrate," Acta Derm Venereol, 1994, 74(6):475.