A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tricor Indications, Dosage, Storage, Stability - Fenofibrate
Tricor Indications, Dosage, Storage, Stability - Fenofibrate
INDICATIONS AND USAGE
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
|
|
Type
|
Lipoprotein Elevated
|
Major
|
Minor
|
|
I (rare)
|
chylomicrons
|
TG
|
«C
|
|
IIa
|
LDL
|
C
|
–
|
|
IIb
|
LDL, VLDL
|
C
|
TG
|
|
III (rare)
|
IDL
|
C, TG
|
–
|
|
IV
|
VLDL
|
TG
|
«C
|
|
V (rare)
|
chylomicrons, VLDL
|
TG
|
«
|
|
C=cholesterol
|
|
TG=triglycerides
|
|
LDL=low density lipoprotein
|
|
VLDL=very low density lipoprotein
|
|
IDL=intermediate density lipoprotein
|
| |
|
NCEP Treatment Guidelines: LDL-C Goals and Cutpoints
for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
|
|
Risk Category
|
LDL Goal (mg/dL)
|
LDL Level at Which to Initiate Therapeutic Lifestyle Changes
(mg/dL)
|
LDL Level at which to Consider Drug Thereapy (mg/dL)
|
|
CHD † or CHD risk equivalents (10-years risk
>20%)
|
<100
|
³ 100
|
³130 (100-129:drug optional)††
|
|
2+ Risk Factors (10-year risk £20%)
|
<130
|
³ 130
|
10-year risk 10%-20%:³130 10-Year
risk <10%: ³160
|
|
0-1 Risk Factor†††
|
<160
|
³ 160
|
³190 (160-189: LDL-
lowering drug optional)
|
|
† 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. 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.
|
DOSAGE AND ADMINISTRATION
Patients should be placed on an appropriate lipid-lowering
diet before receiving TRICOR, and should continue this diet during treatment
with TRICOR. TRICOR tablets should be given with meals, thereby optimizing the
bioavailability of the medication.
For the treatment of adult patients with primary hypercholesterolemia
or mixed hyperlipidemia, the initial dose of TRICOR is 160 mg per day.
For adult patients with hypertriglyceridemia, the initial dose
is 54 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 per day.
Treatment with TRICOR should be initiated at a dose of 54 mg/day
in patients having 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 54 mg/day.
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.
HOW SUPPLIED
TRICOR® (fenofibrate tablets) is available in
two strengths:
54 mg yellow tablets, imprinted with a and Abbo-Code identification
letters "TA", available in bottles of 90 (NDC 0074-4009-90).
160 mg white tablets, imprinted with a and Abbo-Code identification
letters "TC", available in bottles of 90 (NDC 0074-4013-90).
Storage
Store at controlled room temperature, 15-30°C (59-86°F). Keep
out of the reach of children. Protect from moisture.
Manufactured for Abbott Laboratories, North Chicago, IL 60064,
U.S.A. by Laboratoires Fournier, S.A., 21300 Chenôve, France
REFERENCES
1. GOLDBERG AC, et al. Fenofibrate for the Treatment
of Type IV and V Hyperlipoproteinemias: A Double-Blind, Placebo-Controlled Multicenter
US Study. Clinical Therapeutics, 11, pp. 69-83, 1989.
2. NIKKILA EA. Familial Lipoprotein Lipase Deficiency and
Related Disorders of Chylomicron Metabolism. In Stanbury J.B., et al. (eds.):
The Metabolic Basis of Inherited Disease, 5th edition, McGraw-Hill, 1983,
Chap. 30, pp. 622-642.
3. BROWN WV, et al. Effects of Fenofibrate on Plasma
Lipids: Double-Blind, Multicenter Study In Patients with Type IIA or IIB Hyperlipidemia.
Arteriosclerosis. 6, pp. 670-678, 1986.
Revised: February, 2003 Ref.: 03-5240-R2, ABBOTT
LABORATORIES 04B-030-C474-1 MASTER, NORTH CHICAGO, IL 60064, U.S.A. PRINTED
IN U.S.A.
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