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Tricor (Fenofibrate) - Indications and Dosage



Treatment of Hypercholesterolemia

TRICOR is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C 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).

Treatment of Hypertriglyceridemia

TRICOR is also 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 TRICOR therapy on reducing this risk has not been adequately 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 hyperlipoproteinemia2.

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 hyperlipidemia, 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.

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).

Fredrickson Classification of Hyperlipoproteinemias
Lipid Elevation

C = cholesterol

TG = triglycerides

LDL= low density lipoprotein

VLDL= very low density lipoprotein

IDL = intermediate density lipoprotein

Type Lipoprotein Elevated Major Minor
I (rare) chylomicrons TG ↑↔C
III (rare) IDL C, TG -
V (rare) chylomicrons, VLDL TG ↑↔ C
NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
Risk Category LDL Goal
LDL Level at Which to Initiate Therapeutic
Lifestyle Changes
LDL Level at Which to Consider Drug Therapy

†   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 judgement also may call for deferring drug therapy in this subcategory.

†††   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.

CHD or CHD risk equivalents
(10-year risk > 20%)
< 100 ≥ 100 ≥ 130
(100-129: drug optional)††
2+ Risk Factors
(10-year risk ≤ 20%)
< 130 ≥ 130 10-year risk 10%-20%: ≥ 130
10-year risk < 10%: ≥ 160
0-1 Risk Factor††† < 160 ≥ 160 ≥ 190
(160-189: LDL-lowering drug optional)

After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.


Patients should be placed on an appropriate lipid-lowering diet before receiving TRICOR, and should continue this diet during treatment with TRICOR. TRICOR tablets can be given without regard to meals.

For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of TRICOR is 145 mg per day.

For adult patients with hypertriglyceridemia, the initial dose is 48 to 145 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 145 mg per day.

Treatment with TRICOR should be initiated at a dose of 48 mg/day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose.

Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of TRICOR if lipid levels fall significantly below the targeted range.


TRICOR® (fenofibrate tablets) is available in two strengths:

48 mg yellow tablets, imprinted with “Abbott “A” logo” and Abbo-Code identification letters "FI", available in:

bottles of 30 (NDC 54868-5224-0),

bottles of 90 (NDC 54868-5224-1).

145 mg white tablets, imprinted with “Abbott “A” logo”and Abbo-Code identification letters "FO", available in:

bottles of 30 (NDC 54868-5203-0),

bottles of 90 (NDC 54868-5203-1).


Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

[See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

Manufactured for Abbott Laboratories, North Chicago, IL 60064, U.S.A.

by Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill Co. Cork, Ireland.

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK    74146

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