Fenofibric Acid Dosage

Usual Adult Dose for Hypertriglyceridemia

Capsules:
-Initial dose: 45 to 135 mg orally once a day
-Maximum dose: 135 mg once a day

Tablets:
-Initial dose: 35 to 105 mg orally per day
-Maximum dose: 105 mg once a day

Comments:
-Dosages should be individualized according to patient response and if necessary, adjusted following repeat lipid determinations at 4 to 8 week intervals.

Use: As an adjunct to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia (500 mg/dL or greater); elevated TG levels of 2000 mg/dL or higher may increase the risk of developing pancreatitis

Usual Adult Dose for Hyperlipidemia

Capsules:
135 mg orally once a day

Tablets:
105 mg orally per day

Use: As an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), TG, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia

Usual Adult Dose for Dyslipidemia

Capsules:
135 mg orally once a day

Tablets:
105 mg orally per day

Use: As an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), TG, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia

Renal Dose Adjustments

Capsules:
-Mild to moderate renal dysfunction: Initiate at 45 mg orally once a day; doses should be increased only after evaluation of the effects on renal function and lipid levels at this dose
-Severe renal dysfunction: Contraindicated

Tablets:
-Mild to moderate renal dysfunction: Initiate at 35 mg orally once a day; doses should be increased only after evaluation of the effects on renal function and lipid levels at this dose
-Severe renal dysfunction: Contraindicated

Liver Dose Adjustments

Active liver disease (including primary biliary cirrhosis and unexplained persistent liver function abnormalities): Contraindicated

Dose Adjustments

Elderly: Due to the higher incidence of renal impairment in this patient population, dose selection should be based on renal function; monitor renal function during therapy.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Contraindicated

Other Comments

Administration advice:
-May be taken without regard to meals; swallow whole; do not open, crush, dissolve, or chew tablets nor capsules
-Take at least 1 hour before or 4 to 6 hours after a bile acid resin
-Tablets: Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum dose of 105 mg/day

Storage requirements:
-Protect from light and moisture.

General:
-Patients should be placed on an appropriate lipid-lowering diet prior to receiving this drug and should continue this throughout treatment.
-Every attempt should be made to control serum lipids with non-pharmacologic methods prior to initiating drug therapy (e.g., diet, exercise, control of medical problems, dose reduction of medications known to exacerbate hypertriglyceridemia, etc.).
-Drug therapy is not indicated in patients with elevations of chylomicrons and plasma TG, but who have normal levels of very-low density lipoprotein (VLDL).

Monitoring:
-Hematologic: Monitor RBC and WBC counts periodically during the first 12 months of therapy.
-Metabolic: Laboratory studies should be performed to establish that lipid levels are abnormal prior to initiating therapy; serum lipid should be monitored periodically during therapy.

Patient advice:
-Report immediately any unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever.
-Talk to your health care provider if you are pregnant, planning to become pregnant, or breastfeeding.