TRICOR- fenofibrate tablet
AbbVie Inc.
1 INDICATIONS AND USAGE
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
TRICOR 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.
1.2 Severe Hypertriglyceridemia
TRICOR 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 obviate 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.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of TRICOR 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 (5.1)].
2 DOSAGE AND ADMINISTRATION
2.1 General Considerations
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
CONTRAINDICATIONS
TRICOR is contraindicated in:
patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)].
patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions (5.3)].
patients with preexisting gallbladder disease [see Warnings and Precautions (5.5)].
nursing mothers [see Use in Specific Populations (8.3)].
patients with known hypersensitivity to fenofibrate or fenofibric acid [see Warnings and Precautions (5.9)].
5 WARNINGS AND PRECAUTIONS
5.1 Mortality and Coronary Heart Disease Morbidity
The effect of TRICOR on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.
OVERDOSAGE
There is no specific treatment for overdose with TRICOR. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.
11 DESCRIPTION
TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
The empirical formula is C20 H21 O4 Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82�C. Fenofibrate is a white solid which is stable under ordinary conditions.
Inactive Ingredients
Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate.
In addition, individual tablets contain:
48 mg tablets
polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake.
145 mg tablets
polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The active moiety of TRICOR is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate.
The lipid-modifying effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor ? (PPAR?). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity).
The resulting decrease in TG produces an alteration in the size and composition of LDL from small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly. Activation of PPAR? also induces an increase in the synthesis of apolipoproteins A-I, A-II and HDL-cholesterol.
Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.
PATIENT COUNSELING INFORMATION
Patients should be advised:
of the potential benefits and risks of TRICOR.
not to use TRICOR if there is a known hypersensitivity to fenofibrate or fenofibric acid.
of medications that should not be taken in combination with TRICOR.
that if they are taking coumarin anticoagulants, TRICOR may increase their anti-coagulant effect, and increased monitoring may be necessary.
to continue to follow an appropriate lipid-modifying diet while taking TRICOR.
to take TRICOR once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
to return for routine monitoring.
to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking TRICOR.
to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.
Manufactured for AbbVie Inc., North Chicago, IL 60064, U.S.A.