Concise Prescribing Info
Dosage/Direction for Use
Adult: PO As conventional tab: 200 mg tid. Maintenance: 200 mg bid. As modified-release tab: 400 mg once daily.
Should be taken with food.
Gallbladder disorder, hypoalbuminaemia (e.g. nephrotic syndrome). Severe hepatic or renal impairment [CrCl <15 mL/min (conventional tab); CrCl <60 mL/min (modified-release tab)], patients undergoing dialysis. Pregnancy and lactation. Concomitant use of HMG-CoA reductase inhibitors (in patients w/ risk factors for myopathy), perhexiline maleate and MAOIs.
Special Precautions
Renal impairment [(CrCl ≥15 mL/min (conventional tab)]. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Perform serum lipids, cholesterol and triglyceride tests, fasting glucose, creatinine, and CBC periodically, and LFT after 3-6 mth.
Adverse Reactions
Anorexia, nausea, GI upset, headache, dizziness, vertigo, fatigue, skin rashes, pruritus, urticaria, photosensitivity, alopecia, impotence, anaemia, leucopoenia, thrombocytopenia, pancytopenia, decreased appetite, peripheral neuropathy, paraesthesia, depression, insomnia, abdominal pain, constipation, dyspepsia, diarrhoea, abdominal distension, pancreatitis, cholestasis, cholelithiasis, Stevens-Johnsons syndrome, toxic epidermal necrolysis, myalgia, myopathy, myositis, erectile dysfunction, interstitial lung disease, acute renal failure. Rarely, rhabdomyolysis.
Drug Interactions
Anion-exchange resins (e.g. cholestyramine) inhibit bezafibrate absorption, take at least 2 hr apart. May increase serum concentration of anticoagulants. Increased risk of renal impairment when used w/ immunosuppressants. May potentiate the therapeutic effect of sulfonylureas and insulin. Estrogens may increase lipid levels, dosing should be individualised in patients taking estrogen-containing contraceptives.
ATC Classification
C10AB02 - bezafibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
Disclaimer: This information is independently developed by CIMS based on bezafibrate 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
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