Fenofibric Acid Dosage

This dosage information may not include all the information needed to use Fenofibric Acid safely and effectively. See additional information for Fenofibric Acid.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Hyperlipidemia

The following adult dose recommendations are only for fenofibric acid marketed as the trade name Trilipix (TM):

Mixed Dyslipidemia treatment therapy coadministered with an HMG-CoA reductase inhibitor (statin): 135 mg orally daily. For convenience, the daily dose may be taken at the same time as a statin, according to the dosing recommendations for each medication. Coadministration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks.

Severe Hypertriglyceridemia:
Initial dose: 45 to 135 mg orally once daily.
Maintenance dose: Dosage should be individualized according to patient response, and adjusted if needed following repeat lipid determinations at 4 to 8 week intervals.
Maximum dose: 135 mg orally once daily

Primary Hyperlipidemia or Mixed Dyslipidemia: 135 mg orally once daily

The following adult dose recommendations are only for fenofibric acid marketed as the trade name Fibricor (TM):

Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of fenofibric acid. Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose of 105 mg daily.

Primary Hyperlipidemia or Mixed Dyslipidemia: 105 mg orally once daily

Severe Hypertriglyceridemia:
Initial dose: 35 to 105 mg orally daily.
Maintenance: Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.
Maximum: 105 mg orally daily

Renal Dose Adjustments

The following renal dose adjustment recommendations are only for fenofibric acid marketed as the trade name Trilipix (TM):
Severe renal impairment: not recommended
Mild-to-moderate renal impairment: Initial dose: 45 mg once daily and should only be increased after evaluation of the effects on renal function and lipid levels at this dose.

The following renal dose adjustment recommendations are only for fenofibric acid marketed as the trade name Fibricor (TM):
Severe renal impairment: not recommended
Mild-to-moderate renal impairment: Initial dose: 35 mg once daily and should only be increased after evaluation of the effects on renal function and lipid levels at this dose.

Liver Dose Adjustments

Trilipix (TM): No data available

Fibricor (TM): Fenofibrate (administered over a range of doses with the higher dose equivalent to 105 mg fenofibric acid) has been associated with increases in serum transaminases {AST (SGOT) or ALT (SGPT)}. The incidence of increases in transaminases observed with fenofibrate therapy may be dose related. Periodic monitoring of liver tests should be performed for the duration of therapy with Fibricor (TM) and therapy discontinued if enzyme levels persist above 3 times the normal limit.

Dose Adjustments

Consideration should be given to reducing the dosage of fenofibric acid if lipid levels fall significantly below the targeted range.

Dose selection for the elderly and patients with impaired renal function should be made on the basis of renal function.

Elderly patients with normal renal function should require no dose modifications.

Precautions

Fenofibric acid should be avoided in patients who have severe renal impairment and the dose should be reduced in patients with mild to moderate renal impairment.

Fenofibric acid is substantially excreted by the kidney as fenofibric acid glucuronide, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Since elderly patients have a higher incidence of renal impairment, the dose selection for the elderly should be made on the basis of renal function.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Not recommended

Other Comments

Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid as monotherapy or coadministered with a statin, and should continue this diet during treatment.

Fenofibric acid may be taken without regard to meals.

Since bile-acid binding resins may bind other drugs given concurrently, patients should take fenofibric acid at least 1 hour before or 4 to 6 hours after taking another drug.

For convenience, the daily dose of fenofibric acid may be taken at the same time as a statin, according to the dosing recommendations for each medication.

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