TRIGLIDE is indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb).

Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).

TRIGLIDE is indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).

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 TRIGLIDE therapy on reducing this risk has not been studied.

Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low-density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia (Nikkila, 1983).

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol 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 hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated.

Estrogen therapy, like thiazide diuretics and beta-blockers, is 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.

The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. (See WARNINGS and PRECAUTIONS.)

C = cholesterol; IDL = intermediate density lipoprotein; LDL = low-density lipoprotein; TG = triglycerides; VLDL = very low-density lipoprotein

^† CHD = coronary heart disease

^†† Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this category.

^††† Almost all people with 0-1 risk factor have 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary.

Patients should be placed on an appropriate lipid-lowering diet before receiving TRIGLIDE and should continue on this diet during treatment with TRIGLIDE.

TRIGLIDE may be administered with or without food.

For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of TRIGLIDE is 160 mg per day.

For adult patients with hypertriglyceridemia, the initial dose is 50 mg to 160 mg once daily.

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 per day.

Treatment with TRIGLIDE should be initiated at a dose of 50 mg/day in patients with impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose.

In the elderly, the initial dose should likewise be limited to 50 mg/day. 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.

TRIGLIDE (fenofibrate) tablets is available as a tablet in two strengths:

50 mg round off-white tablets debossed with "FH 50" are available
in bottles of 90 tablets (NDC 59630-480-90).
160 mg round off-white tablets debossed with "FH 160" are available
in bottles of 90 tablets (NDC 59630-485-90).

Storage: Store at 20 - 25°C (68 - 77°F); excursions permitted between 15 - 30°C (59 - 86°F). (See USP Controlled Room Temperature). Protect from light and moisture.

Goldberg AC, et al. Fenofibrate for the Treatment of Type IV and V Hyperlipoproteinemias: A Double-Blind, Placebo-Controlled Multicenter US Study. Clinical Therapeutics 1989; 11: 69-83.

Nikkila EA. Familial lipoprotein lipase deficiency and related disorders of chylomicron metabolism. In: Stanbury JB, ed. The metabolic basis of inherited disease: McGraw-Hill, 1983; 622-642.

Brown WV, et al. Effects of Fenofibrate on Plasma Lipids: Double-Blind, Multicenter Study In Patients with Type IIA or IIB Hyperlipidemia. Arteriosclerosis, 1986; 6: 670-678.

Manufactured for First Horizon Pharmaceutical^Ã? Corporation by SkyePharma Production SAS, France. Made in France.
FF-PI-2 Rev. 11/05
FDA revision date: 07/03/06

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