fenofibrate


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fenofibrate

 [fen″o-fi´brāt]
an agent chemically related to clofibrate, used to treat hyperlipidemia; administered orally.

fenofibrate

Antara, Apo-Fenofibrate (CA), Fenogal (UK), Lipantil (UK), Lipofen, Lofibra, Nu-Fenofibrate (CA), Tricor, Triglide, Supralip (UK)

Pharmacologic class: Fibric acid derivative

Therapeutic class: Antihyperlipidemic

Pregnancy risk category C

Action

Inhibits triglyceride synthesis in liver, reducing levels of low- and very-low-density lipoproteins. Also increases uric acid secretion.

Availability

Capsules: 50 mg, 150 mg

Capsules (micronized): 43 mg, 67 mg, 130 mg, 134 mg, 200 mg

Tablets: 48 mg, 50 mg, 54 mg, 145 mg, 160 mg

Indications and dosages

Adjunct to dietary therapy to reduce elevated low-density lipoproteins (LDL)-C, total cholesterol, triglycerides, and apolipoprotein B; to increase high-density lipoprotein-C level in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb)

Adults: 1 tablet (145 or 160 mg), 1 capsule (150 mg), or 1 micronized capsule (130 or 200 mg) P.O. daily

Hypertriglyceridemia

Adults: Initially, 50 to 150 mg P.O. daily (capsule); 43 to 200 mg P.O. daily (micronized capsule); 48 to 160 mg P.O. daily (tablet)

Dosage adjustment

• Renal impairment

• Elderly patients

Off-label uses

• Polymetabolic syndrome X

Contraindications

• Hypersensitivity to drug

• Hepatic disease or unexplained, persistent liver function test abnormalities

• Severe renal impairment

• Gallbladder disease

• Breastfeeding

Precautions

Use cautiously in:

• pancreatitis, cholelithiasis

• patients receiving warfarin concurrently

• pregnant patients

• children.

Administration

Before giving, be aware of potentially serious interactions, such as with nephrotoxic drugs.

• Administer with meals.

• Give bile acid sequestrants at least 1 hour before or 4 to 6 hours after fenofibrate.

Adverse reactions

CNS: drowsiness, dizziness, fatigue, headache, migraine, insomnia, depression, vertigo, nervousness, anxiety, paresthesia, hypotonia, neuralgia

CV: tachycardia, varicose veins, phlebitis, angina, hypertension, hypotension, peripheral vascular disease, vasodilation, ECG abnormalities, coronary artery disease, arrhythmias, ventricular extrasystoles, myocardial infarction, atrial fibrillation

EENT: conjunctivitis, abnormal vision, cataracts, refraction disorder, otitis media, rhinitis, sinusitis, pharyngitis, laryngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, dyspepsia, gastritis, gastroenteritis, esophagitis, duodenal or peptic ulcer, colitis, cholelithiasis, cholecystitis, rectal disorder, rectal hemorrhage

GU: urinary frequency, dysuria, cystitis, urolithiasis, prostatic disorder, gynecomastia, vaginal candidiasis, decreased libido, renal dysfunction

Hematologic: eosinophilia, anemia, lymphadenopathy, thrombocytopenia, leukopenia

Hepatic: fatty liver deposits

Metabolic: hyperuricemia, gout, hypoglycemia

Musculoskeletal: back, muscle, or joint pain; myositis; arthritis; tenosynovitis; arthrosis; bursitis

Respiratory: respiratory disorders, bronchitis, increased cough, dyspnea, pneumonia, asthma

Skin: rash, pruritus, urticaria, bruising, acne, eczema, diaphoresis, dermatitis, herpes simplex, herpes zoster, alopecia, nail disorder

Other: weight loss or gain, edema, fever, flulike symptoms, hypersensitivity reactions

Interactions

Drug-drug. Bile acid sequestrants (resins): decreased absorption and efficacy of fenofibrate

Immunosuppressants, other nephrotoxic drugs: increased risk of renal toxicity

Oral anticoagulants: increased risk of bleeding

Statins (such as simvastatin): rhabdomyolysis, acute renal failure

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, creatinine, gamma-glutamyltransferase, uric acid: increased values

Granulocytes, hemoglobin, neutrophils, platelets, white blood cells (WBCs): decreased values

Liver function tests: abnormal results

Drug-food. Any food: increased drug absorption

Drug-behaviors. Alcohol use: elevated triglyceride level

Patient monitoring

• Assess creatine kinase and lipid levels and liver function test results.

• Monitor CBC and WBC count. Expect these to decrease at start of therapy, then stabilize.

Patient teaching

• Instruct patient to take with meals for best effect.

• Remind patient that he still needs to follow a triglyceride-lowering diet.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Advise patient to minimize GI upset by eating frequent, small servings of food and drinking plenty of fluids.

• Tell patient that drug may take up to 2 months to alter lipid values.

• Inform breastfeeding patient that she must choose between taking fenofibrate and breastfeeding.

• Tell female patient to inform prescriber if she is pregnant.

• Inform patient that he'll undergo regular blood testing.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.

fenofibrate

Tricor®, Lipanthyl® An agent used to manage super-high serum TG levels uncontrolled by diet alone or in Pts at risk for pancreatitis

fenofibrate

A fibrate anticholesterol drug used to treat high blood cholesterol levels that fail to respond to diet modification. A brand name is Lipantil Micro.
References in periodicals archive ?
Fenofibrate Tablets, USP are 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 (HDLC) in adult patients with primary hypercholesterolernla or mixed dyslipidemia.
The study also aimed to develop a method for preparation of an inclusion complex of fenofibrate with HP[beta]CD that is efficient and economical, simple, and less time consuming than other methods.
"In people with type 2 diabetes at high risk for cardiovascular disease, intensive glycemic control may result in a long-term reduction in macroalbuminuria; however, intensive BP control and fenofibrates may increase the risk for adverse kidney events," conclude the authors.
AAC was performed in 36 rats, which were divided into the AAC rats group (vehicle, oral gavage), AAC+Fenofibrate (60mg/kg, oral gavage) group, and AAC+ Fenofibrate (120mg/kg, oral gavage) group.
Among them, FGF21 concentrations were also measured in 9595 patients after the 6-week active fenofibrate run-in (i.e., time of randomization).
Key words: Drug-induced thrombocytopenia, Fenofibrate, Adverse drug reaction
Moreover, we investigated the effects of PPAR activation on the regulation of these LADPs in HFD-induced obese mice treated with fenofibrate or pioglitazone for 20 weeks.
From table 4, it is derived that the number of patients receiving various drug combinations and the most favoured combination amongst the various options available to the physicians was atorvastatin and fenofibrate which was prescribed in 54% of the patients on polytherapy.
Fenofibrate reduced total cardiovascular events, mainly due to fewer non-fatal myocardial infarctions and revascularisations but the difference in primary outcome was insignificant between the two groups.
The medication consists of 100mg of Levothyroxine, 5mg of Warfarin, Fenofibrate, Cardioplen, Omeprazole, Venlafaxine, Lisinopril, Eletrictan and Furosemide.
The large, "real practice" study examined more than 20,000 older Ontario residents who had started new prescriptions for fenofibrate (a form of fibrate medication).
Fenoglide, or fenofibrate, is used for the treatment of high cholesterol and high triglyceride levels.