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Pharmacologic class: Fibric acid derivative
Therapeutic class: Antihyperlipidemic
Pregnancy risk category C
Inhibits triglyceride synthesis in liver, reducing levels of low- and very-low-density lipoproteins. Also increases uric acid secretion.
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
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)
• Renal impairment
• Elderly patients
• Polymetabolic syndrome X
• Hypersensitivity to drug
• Hepatic disease or unexplained, persistent liver function test abnormalities
• Severe renal impairment
• Gallbladder disease
Use cautiously in:
• pancreatitis, cholelithiasis
• patients receiving warfarin concurrently
• pregnant patients
☞ 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.
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
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
• 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.
• 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.