Triglide (Fenofibrate) - Indications and Dosage

INDICATIONS AND USAGE

Primary Hypercholesterolemia or Mixed Dyslipidemia

      Triglide is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

Severe Hypertriglyceridemia

      Triglide is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.

      Markedly elevated levels of serum triglycerides (e.g., >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

Important Limitations of Use

      Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions ].

DOSAGE AND ADMINISTRATION

General Considerations

      Patients should be placed on an appropriate lipid-lowering diet before receiving Triglide, and should continue this diet during treatment with Triglide. Triglide tablets can be given without regard to meals. Patients should be advised to swallow Triglide tablets whole. Do not crush, dissolve or chew tablets.

      The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hypercholesterolemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

      Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Triglide if lipid levels fall significantly below the targeted range. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 160 mg once daily.

Primary Hypercholesterolemia or Mixed Dyslipidemia

      The dose of Triglide is 160 mg once daily.

Severe Hypertriglyceridemia

      The initial dose is 50 to 160 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 160 mg once daily.

Impaired Renal Function

      Treatment with Triglide should be initiated at a dose of 50 mg per day in patients with mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Triglide should be avoided in patients with severe renal impairment [see Use in Special Populations and   Clinical Pharmacology ].

Geriatric Patients

      Dose selection for the elderly should be made on the basis of renal function [See Use in Specific Populations  and Clinical Pharmacology ].

DOSAGE FORMS AND STRENGTHS

• 50 mg: Round off-white tablets. Debossed “FH 50”
  
• 160 mg: Round off-white tablets. Debossed “FH 160”