Bezafibrate


Full Generic Medicine Info
Dosage/Direction for Use

Oral
Hyperlipidaemias
Adult: As conventional tab: 200 mg tid, may increase dose gradually, to avoid GI symptoms, over 5-7 days. Maintenance: 200 mg bid. As modified-release tab: 400 mg once daily.
Renal impairment: Dialysis patients: Contraindicated.
CrCl (ml/min)Dosage Recommendation
<15As conventional tab: Contraindicated.
15-40 As conventional tab: 200 mg daily or on alternate days.
>40-60 As conventional tab: 400 mg daily.
<60As modified-release tab: Contraindicated.
Hepatic impairment: Severe: Contraindicated.
Administration
Should be taken with food.
Contraindications
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.
Overdosage
Symptoms: Rhabdomyolysis. Management: Symptomatic treatment.
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.
Potentially Fatal: Potential hepatotoxic effect when used w/ perhexiline maleate or MAOIs. Increased risk of myopathy in predisposed patients who are taking HMG-CoA reductase inhibitors.
Action
Bezafibrate, a fibric acid derivative, reduces VLDL and LDL while increasing HDL levels. It increases the activity of triglyceride lipases involved in the catabolism of triglyceride-rich lipoproteins and inhibits hepatic acetyl co-enzyme A carboxylase synthesis.
Absorption: Rapid and almost completely absorbed in the GI tract. Time to peak serum concentration: 1-2 hr (conventional); 3-4 hr (modified-release).
Distribution: Volume of distribution: Approx 17 L. Plasma protein binding: 94-96%.
Excretion: Via urine (95%, 50% as unchanged drug and 20% as glucuronides); faeces (3%). Elimination half-life: 1-2 hr.
Storage
Oral: Store between 15-30°C.
CIMS Class
Dyslipidaemic Agents
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 © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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