FENOFIBRIC ACID DELAYED-RELEASE 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?
FENOFIBRIC ACID DELAYED-RELEASE 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?
1 INDICATIONS AND USAGE Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: Reduce TG in patients with severe hypertriglyceridemia ( 1.1 ). Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2 ). Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1 ). 1.1 Treatment of Severe Hypertriglyceridemia Fenofibric acid delayed-release capsules are.
What should I know before taking it?
Fenofibric acid delayed-release capsules 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 ( 5.2)] . patients with preexisting gallbladder disease [see Warnings and Precautions ( 5.5)] . nursing mothers [see Use in Specific Populations ( 8.2)] . patients with hypersensitivity to fenofibric acid or fenofibrate [see Warnings and Precautions ( 5.9)] .
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibric acid. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist ( 5.2 ). Myopathy and rhabdomyolysis: Have been reported in patients taking fenofibrate. Risks are increased in elderly patients and patients with diabetes, renal failure, hypothyroidism, or statin co-administration ( 5.3 ). Serum creatinine: Fenofibric acid can reversibly increase serum creatinine.
How is this medication usually taken?
Fenofibric acid delayed-release capsules 45 mg are the Size '3' Hard gelatin capsules of opaque reddish brown color cap imprinted with '167' in black ink, opaque yellow color body imprinted with '167' in black ink and filled with white to off white round, biconvex coated mini tablets.Fenofibric acid delayed release capsules 135 mg are the Size '0' Hard gelatin capsules of opaque blue color cap imprinted with '168' in black ink, opaque yellow color body imprinted with '168' in black ink and filled with white to off white round, biconvex coated mini tablets.
What side effects are listed?
The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions ( 5.1)] Hepatoxicity [see Warnings and Precautions ( 5.2)] Pancreatitis [see Warnings and Precautions ( 5.7)] Hypersensitivity reactions [see Warnings and Precautions ( 5.9)] Venothromboembolic disease [see Warnings and Precautions ( 5.10)]
What interactions are listed?
7 DRUG INTERACTIONS Coumarin Anticoagulants: ( 7.1 ). Bile Acid Binding Resins: ( 7.2 ). Immunosuppressants: ( 7.3 ). 7.1 Coumarin Anticoagulants Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR. Caution should be exercised when oral coumarin anticoagulants are given in conjunction with fenofibric acid. The dosage of the anticoagulant should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized [see Warnings and Precautions ( 5.6 )]. 7.2 Bile Acid Binding Resins Since bile acid binding.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=302ffbf8-448e-4729-949f-40d457e30ab4
⚠️ 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.