Fenofibric Acid Dosage

Medically reviewed by Drugs.com. Last updated on Nov 4, 2022.

Applies to the following strengths: 45 mg; 135 mg; 35 mg; 105 mg

Usual Adult Dose for:

Hypertriglyceridemia
Hyperlipidemia
Dyslipidemia

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

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.
Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Elevated triglycerides (TG) levels of 2000 mg/dL or higher may increase the risk of developing pancreatitis; the effect of therapy reducing this risk has not been adequately studied.

Uses:

As an adjunct to diet to reduce TG in patients with severe hypertriglyceridemia (500 mg/dL or greater)

Usual Adult Dose for Hyperlipidemia

Capsules:
135 mg orally once a day

Tablets:
105 mg orally once a 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

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

CONTRAINDICATIONS:

Hypersensitivity to fenofibric acid or fenofibrate
Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities
Severe renal impairment, including those receiving dialysis
Preexisting gallbladder disease
Nursing mothers

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 or 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: Lipid levels prior to initiating therapy and periodically during therapy; monitor HDL-C within the first few months of initiating therapy
Renal: Monitor renal function periodically in patients with renal insufficiency
Liver: Monitor liver function (ALT, AST, total bilirubin) at baseline, and periodically during therapy
Musculoskeletal: Measure creatine phosphokinase levels as appropriate

Patient advice:

Patients should be advised to continue to follow an appropriate lipid-modifying diet.
Patients should understand the potential risks of therapy and instructed to report unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever; to report symptoms of liver injury such as jaundice, abdominal pain, or dark urine.
Talk to your health care provider if you are pregnant, planning to become pregnant, or breastfeeding; patients should not breastfeed during treatment and for 5 days after the final dose.