TRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet:

• To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
• For treatment of adult patients with severe hypertriglyceridemia (1.2).

Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).

• Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 145 mg once daily (2.2).
• Severe hypertriglyceridemia: Initial dose of 48 to 145 mg once daily. Maximum dose is 145 mg (2.3).
• Renally impaired patients: Initial dose of 48 mg once daily (2.4).
• Geriatric patients: Select the dose on the basis of renal function (2.5).
• Maybe taken without regard to meals (2.1).

Oral Tablets: 48 mg and 145 mg (3).
CONTRAINDICATIONS

• Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks for myopathy and rhabdomyolysis are increased when fibrates are co-administered with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism (5.2).
• TRICOR can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy (5.3).
• TRICOR can reversibly increase serum creatinine levels (5.4). Renal function should be monitored periodically in patients with renal impairment (8.6).
• TRICOR increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated (5.5).
• Exercise caution in concomitant treatment with oral coumarin anticoagulants. Adjust the dosage of coumarin anticoagulant to maintain the prothrombin time/INR at the desired level to prevent bleeding complications (5.6).
 
ADVERSE REACTIONS

The most common adverse reactions (> 2% and at least 1% greater than placebo) are abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis (6).
To report SUSPECTED ADVERSE REACTIONS, contact Abbott Laboratories at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

• Coumarin anticoagulants: (7.1).
• Immunosuppressants: (7.2).
• Bile acid resins: (7.3).

• Geriatric Use: Dose selection for the elderly should be made on the basis of renal function