Generic Medicine Info
Should be taken with food.
Active liver disease including primary biliary cirrhosis, unexplained persistent liver function abnormality, severe renal impairment (GFR <30 mL/min/1.73 m2), pre-existing gallbladder disease, pancreatitis (with the exception of acute pancreatitis due to severe hypertriglyceridaemia, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen). Lactation.
Special Precautions
Patients with pre-disposing factors for myopathy and/or rhabdomyolysis (diabetes mellitus, personal or familial history of hereditary muscular disorders, hypoalbuminaemia, hypothyroidism, high alcohol intake, concomitant use with HMG-CoA reductase inhibitors), risk factors for venous thromboembolism. Mild to moderate renal impairment. Elderly. Pregnancy. Monitoring Parameters Monitor blood counts, lipid profile, LFT during therapy and periodically thereafter.
Adverse Reactions
Significant: Cholelithiasis, agranulocytosis, thrombocytopenia, hypersensitivity, myopathy, rhabdomyolysis, pancreatitis, venous thromboembolism, elevated level of serum transaminase. Blood and lymphatic system disorders: Decreased haemoglobin and leukocytes. Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea, flatulence. Investigations: Increased serum creatinine, urea. Musculoskeletal and connective tissue disorders: Diffuse myalgia, myopathy, muscular cramps and weakness. Nervous system disorders: Headache, dizziness. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, sinusitis, rhinitis. Skin and subcutaneous tissue disorders: Rash, pruritus. urticaria, alopecia, photosensitivity.
Drug Interactions
May increase risk of ciclosporin-induced nephrotoxicity. May increase risk of bleeding with oral anticoagulants (e.g. warfarin). Increased risk of myopathy and rhabdomyolysis with colchicine, HMG-CoA reductase inhibitors, and other fibrates. May enhance adverse effects of ezetimibe. May decrease absorption with bile acid sequestrants (except colesevelam).
ATC Classification
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
Disclaimer: This information is independently developed by CIMS based on fenofibrate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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