Classifications: antilipemic; fibrate; Therapeutic: cholesterol-lowering agent; fibrate
Pregnancy Category: C
600 mg tablets
Fibric acid derivative with lipid regulating properties. Blocks lipolysis of stored triglycerides in adipose tissue and inhibits
hepatic uptake of fatty acids.
Decreases VLDL and therefore triglyceride synthesis. Produces a moderate increase in HDL cholesterol levels and reduces levels
of total and LDL cholesterol and triglycerides.
Patients with very high serum triglyceride levels (above 750 mg/dL) (type IV and V hyperlipidemia) who have not responded
to intensive diet restriction and are at risk of pancreatitis and abdominal pain. Also severe familial hypercholesterolemia
(type IIa or IIb) that developed in childhood and has failed to respond to dietary control or to other cholesterol-lowering
Gallbladder disease, biliary cirrhosis, hepatic or severe renal dysfunction; pregnancy (category C), lactation. Safety and
efficacy in children <18 y are not established.
Diabetes mellitus, hypothyroidism; renal impairment, cholelithiasis.
Route & Dosage
Adult: PO 600 mg b.i.d. 30 min before morning and evening meal, may increase up to 1500 mg/d
- Give 30 min before breakfast and evening meal.
- Store at 15°30° C (59°86° F) unless otherwise directed.
Adverse Effects (≥1%)CNS:
Headache, dizziness, blurred vision. GI: Abdominal
or epigastric pain,
diarrhea, nausea, vomiting, flatulence. Hematologic:
Eosinophilia, mild decreases in Hct, Hgb. Musculoskeletal:
Painful extremities, back pain, muscle cramps, myalgia, arthralgia, swollen joints. Skin:
Rash, dermatitis, pruritus, urticaria. Endocrine:
Hypokalemia, moderate hyperglycemia.
May potentiate hypoprothrombinemic effects of oral anticoagulants
increases risk of myopathy and rhabdomyolysis; may increase hypoglycemic effects of antidiabetic medications
Readily from GI tract. Peak:
12 h. Metabolism:
Undergoes enterohepatic circulation. Elimination:
In urine; 6% in feces. Half-Life:
Assessment & Drug Effects
- Lab tests: Monitor baseline and at regular intervals during first year of therapy for serum LDL and VLDL, triglycerides, total
cholesterol, CBC, blood glucose, liver function tests.
- Note: Mild decreases in WBC, Hgb, Hct may occur during early stage of treatment but generally stabilize with continued therapy.
- Notify physician if the lipid response is not adequate after 3 mo of therapy.
- Notify physician if patient presents S&S suggestive of cholelithiasis or cholecystitis; gallbladder studies may be indicated.
Symptoms often occur during the night or early morning; jaundice may or may not be present.
Patient & Family Education
- Notify physician promptly if unexplained bleeding occurs (e.g., easy bruising, epistaxis, hematuria).
- Do not drive or engage in other potentially hazardous activities until response to drug is known.
- Note: Patients with high serum triglyceride levels are generally advised to lose excess weight and to restrict carbohydrate and
alcohol intake (alcohol increases serum triglyceride levels).