Fibricor, Trilipix Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Fenofibric acid tablets is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL) (1.1).to reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (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 (1.3).
What should I know before taking it?
Fenofibric acid tablets are 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) ].patients with known hypersensitivity to fenofibric acid or fenofibrate [see Warnings and Precautions (5.9) ].nursing mothers [see Use in Specific Populations (8.2) ].
What important warnings are listed?
Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks of myopathy and rhabdomyolysis appears to be 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).Fenofibrate can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy (5.3).Fenofibrate can reversibly increase serum creatinine levels. Monitor renal function periodically in patients with renal insufficiency (5.4).Fenofibrate increases cholesterol excretion into the bile, leading to risk of.
How is this medication usually taken?
35-mg: White, round tablets. Debossed "AR 787". 105-mg: White, modified oval tablets. Debossed "AR 788".
What side effects are listed?
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 Sarras Health at 1-888-570-5004 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What interactions are listed?
Coumarin Anticoagulants (7.1)Bile-Acid Binding Resins (7.2)Immunosuppressants (7.3)Colchicine (7.4)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09310de5-1eaa-44ba-8d9b-2abc1ad1cc33
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.