Tricor (fenofibrate)

TRICOR (fenofibrate) – a peroxisome proliferator receptor alpha (PPARα) activator commonly used to treat certain lipid disorders.

FDA approved uses: TriCor is 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; For treatment of adult patients with severe hypertriglyceridemia. Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

Available dosage forms: Tablets – 48, 145 mg.

Usual dosage: The recommended doses of Tricor vary with the condition being treated and with renal function – Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 145 mg once daily. Severe hypertriglyceridemia: Initial dose of 48 to 145 mg once daily. Maximum dose is 145 mg. Renally impaired patients: Initial dose of 48 mg once daily. Geriatric patients: Select the dose on the basis of renal function.

Contraindications: TriCor (fenofibrate hydrochloride) is contraindicated in the following conditions – Hypersensitivity to fenofibrate; Hepatic dysfunction; Severe renal dysfunction; Gallbladder disease; Nursing mothers.

Special warnings: 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. TRICOR can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy. TRICOR can reversibly increase serum creatinine levels. Renal function should be monitored periodically in patients with renal impairment. TRICOR increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. 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.

Adverse reactions (side effects) of these medications: The most common side effects of TriCor include abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis. Other adverse events reported include abdominal pain, back pain, headache, nausea, constipation, increased CPK, respiratory disorders, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasm, hepatitis, cirrhosis, anemia arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases and asthenia.

Common drug interactions: Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR. Caution should be exercised when coumarin anticoagulants are given in conjunction with TRICOR.

Special instructions for patients: Take this medication exactly as directed by physician. Inform physician of all medications, supplements, and herbal preparations you are taking and any change to your medical condition. Inform physicians prescribing a new medication that you are taking TRICOR. Inform your physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.

Full prescribing information may be found at the manufacturer‘s official website Product Info at Abbvie, Inc. or at the U.S. Food and Drug Administration’s website at TriCor Info at Drugs@FDA

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