Bezafibrate

Registered South African indications:

• Dyslipidaemia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment
• Hepatic impairment
• Gallbladder disease
• Nephrotic syndrome
• Dialysis
• Coadministration with HMG coA reductase inhibitors in patients with predisposing factors for mypathy
• Known photoallergic or phototoxic reactions to fibrates

Cautions

• Elderly
• Personal or family history of hereditary muscular disorders
• Previous history of muscular toxicity with fibrate or other lipid-lowering drugs
• Hypothyroidism
• Severe infection
• Trauma
• Surgery
• High alcohol intake
• Disturbances in hormone or electrolyte balances
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabrosption

Forms avail. in SA and covered in this monograph: tab, slow release tab (SR tab)

Severe hypertriglyceridaemia 
Mixed hyperlipidaemia

• Oral (SR tab): 400mg, dly
• Oral (tab): 200mg, 8hrly

To be taken after meals

Should be swallowed whole

Not established for use in children

Pregnancy 

• Contraindicated
• Adverse events have been observed in animal reproduction studies. Use is contraindicated in pregnant women. Therapy should be discontinued in women who become pregnant during therapy. Women planning pregnancy should discontinue bezafibrate several months before conception and women of childbearing potential should use effective birth control methods

Breastfeeding

• Contraindicated
• There is insufficient information on the excretion of bezafibrate or its metabolites in human milk. The medicine is likely to be responsible for adverse effects in the foetus. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from bezafibrate therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman
• There may be certain circumstances in which a benefit-risk assessment permit the prescription of bezafibrate. Expert consultation and additional resources are required

Renal Impairment

• eGFR ≥60- 89ml/min: No dose adjustment recommended
• eGFR <60ml/min: Contraindicated 

Hepatic Impairment

• Contraindicated 

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Peripheral neuropathy
• Paraesthesia
• Depression
• Insomnia

Respiratory Disorders

• Interstitial lung disease

Gastrointestinal Disorders

• Abdominal pain
• Constipation
• Dyspepsia
• Abdominal distension
• Diarrhoea
• Nausea
• Pancreatitis

Hepatobiliary Disorders

• Cholestasis
• Cholelithiasis

Genitourinary Disorders

• Acute renal failure
• Erectile dysfunction 

Endocrine and Metabolic Disorders

• Decreased appetite

Musculoskeletal Disorders

• Muscular weakness
• Myalgia
• Muscle cramp
• Rhabdomyolysis

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Urticaria
• Photosensitivity reaction
• Alopecia
• Rash
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions including anaphylactic reactions
• Pancytopenia
• Thrombocytopenic purpura

• Coumarin anticoagulants
• Antidiabetic agents
• Ion-exchange resin
• Immunosuppressant therapy
• Monoamine oxidase inhibitors
• HMG CoA reductase inhibitors
• Oestrogen-containing contraceptives
• Fibrates

None routine. Specific cases may require

• Hepatic function
• Full blood count
• Renal function
• Blood glucose
• Creatine phosphokinase

Tablet 400mg - EML (Hospital)

All other formulations - Non-EML

Bezafibrate is a fibric acid derivative. It increases the activity of triglyceride lipases involved in the catabolism of triglyceride-rich lipoproteins forming precursors for the formation of high density lipoproteins (HDL). Bezafibrate also reduce cholesterol biosynthesis which is accompanied by stimulation of the low density lipoproteins (LDL)-receptor-mediated lipoprotein catabolism. All of this results in a reduction in very low density lipoproteins (VLDL) and LDL levels and an increase in HDL levels.

Tablet 200mg

• Bezalip (Teva Pharmaceuticals) originator

Tablet 400mg

• Sandoz Bezafibrate (Sandoz)

Tablet srt 400mg

• Bezalip Retard (Teva Pharmaceuticals) originator
• Bezachole sr (Pharmacare)
• Dyna Bezafibrate sr (Pharma Dynamics)