Clofibrate

(kloe-FIH-brate)

Atromid-S

Class: Antihyperlipidemic

 Action Lowers serum levels of triglycerides and very low density lipoproteins by mechanism not well established. Serum cholesterol and low density lipoproteins are lowered less predictably and less effectively.

 Indications Management of primary type III hyperlipidemia not responding to dietary changes. May be considered in adults with very high serum triglycerides (types IV and V hyperlipidemia) who present risk of abdominal pain and pancreatitis and who do not respond to diet modification.

 Contraindications Pregnancy; breastfeeding; clinically significant hepatic or renal dysfunction; primary biliary cirrhosis.

 Route/Dosage

PO 2 g qd in 2 to 4 divided doses.

 Interactions

Anticoagulants, oral: Hypoprothrombinemic effects may be enhanced. Anticoagulant dosage may need to be reduced. Furosemide: Diuretic effect may be increased. Insulin, sulfonylureas: Clofibrate may increase their effects, resulting in hypoglycemia. Probenecid: May increase the therapeutic and toxic effects of clofibrate.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Increased or decreased angina; cardiac arrhythmias; swelling and phlebitis at xanthoma site. CNS: Fatigue; dizziness; headache. DERM: Skin rash; alopecia, dry skin; dry, brittle hair; allergic reactions. GI: Nausea; cholelithiasis; cholecystitis; reactivation of peptic ulcer; vomiting; diarrhea; dyspepsia; abdominal distress. GU: Impotence; decreased libido; renal dysfunction (dysuria, hematuria, proteinuria, decreased urine output) increased creatinine phosphokinase; hyperkalemia. HEMA: Leukopenia; anemia, eosinophilia; agranulocytosis. HEPA: Hepatomegaly; increased transaminases (AST, ALT); bromosulfophthalein; increased thymolturbidity. OTHER: Myalgia (muscle cramps, aches, weakness); flulike symptoms; arthralgia; weight gain.

 Precautions

Pregnancy: Category C. Lactation: Contraindicated in nursing women. Children: Safety and efficacy not established. Carcinogenesis/Mutagenesis: Because of hepatic tumorigenicity in rodents and possible increased risk of malignancy and cholelithiasis in humans, use only as indicated. Discontinue if significant response is not obtained. Response to therapy: Clofibrate is not useful for hypertriglyceridemia of type I hyperlipidemia and has little effect on elevated cholesterol levels. Special risk patients: Use with caution in patients with history of jaundice, hepatic disease, or peptic ulcer.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Give with meals if any GI upset occurs.
• Administer daily dosage in 2 to 4 divided doses.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Document WBC and Hct/Hgb as available.
• Document baseline cholesterol and triglyceride levels and monitor changes.
• Monitor results of liver function enzyme tests.
• If patient is taking anticoagulants, monitor prothrombin time for assistance in determining appropriate dose. Monitor for signs of bleeding.
• If patient is on phenytoin, monitor for signs of toxicity such as nystagmus, ataxia, slurred speech, or blurred vision.
• If patient is taking insulin or sulfonylureas, assess for signs and symptoms of hypoglycemia.

 Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Teach patient importance of compliance with drug therapy because if triglycerides do not decrease significantly in 3 mo, drug should be discontinued. If patient takes clofibrate for xanthoma tuberosum, patient must take for ³ 1 yr to achieve therapeutic effect.
• Explain necessity of strict adherence to diet of low fat, low cholesterol, and low triglycerides.
• Advise patient to restrict alcohol intake.
• Tell patient to engage in regular exercise routine and, if appropriate, join a weight management program.
• Instruct patients with diabetes to monitor own blood glucose level through fingersticks.
• Instruct patient to notify physician if chest pain, shortness of breath, irregular heartbeat, nausea, vomiting, fever, chills, hematuria, sore throat, decreased urine output, swollen lower extremities, or flu-like symptoms occur.

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