Bezafibrate oral modified release
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral modified release formulations of bezafibrate.
Mixed hyperlipidaemia when statin is contraindicated or not tolerated
Severe hypertriglyceridaemia with or without low HDL cholesterol
The recommended dosage is 400mg bezafibrate once daily either in the morning or at night.
Patients with Renal Impairment
The modified release tablet is contraindicated in patients with renal impairment (creatinine clearance less than 60 ml/minute or serum creatinine greater than 135 micromol/L). Such patients should be treated with standard release bezafibrate 200mg tablets using an appropriately reduced daily dosage.
Special care is needed in patients with renal impairment, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity (rhabdomyolysis). Discontinue bezafibrate immediately and monitor renal function closely if myotoxicity is suspected or creatine kinase concentration increases significantly.
Children under 18 years
Creatine kinase levels over 5 times upper limit of normal
Photoallergic or phototoxic reactions to fibrates
Renal impairment - creatinine clearance below 60ml/minute
Severe hepatic impairment
Precautions and Warnings
Family history of hereditary muscular disorders
Patients over 65 years
Predisposition to myopathy or rhabdomyolysis
Glucose-galactose malabsorption syndrome
Hereditary muscular disorder
History of muscular toxicity secondary to fibrates
History of muscular toxicity secondary to HMG-CoA reductase inhibitors
Advise ability to drive/operate machinery may be affected by side effects
Correct hypothyroidism before treatment
Exclude/correct secondary causes of dyslipidaemia prior to treatment
May contain polysorbate
Some formulations contain lactose
If cholelithic symptoms occur perform appropriate diagnostic procedures
Monitor antidiabetic drug treatment
Monitor creatine kinase levels in patients at risk of rhabdomyolysis
Monitor diabetic patients during initiation of therapy
Advise patients to report muscle pain/tenderness/weakness
Discontinue if myopathy is suspected
Discontinue if an adequate response not achieved within 3 months
Discontinue if creatine kinase concentration increases significantly
Discontinue immediately if rhabdomyolysis occurs
Dietary restrictions should be maintained
Female: Ensure adequate contraception during treatment
Bezafibrate should be used alongside diet and other measures such as weight loss, physical activity and adequate treatment of other metabolic disorders such as diabetes and gout.
Secondary causes of dyslipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemia, obstructive liver disease, pharmacological treatment and alcoholism should be adequately treated before therapy starts.
Bezafibrate is known to alter the composition of bile and isolated reports of gallstones have been reported.
Oestrogens may lead to a rise in lipid levels. The use of bezafibrate in patients taking oestrogens or oestrogen-containing preparations must considered on an individual basis.
Bezafibrate is contraindicated in patients with severe hepatic disease (other than fatty infiltration of the liver associated with raised triglyceride values).
Patients susceptible to the gastrointestinal effects of bezafibrate should initiate treatment by slowly increasing the dose over 5 to 7 days (see other formulations).
The response to therapy is normally rapid, however a progressive improvement may be apparent over a number of weeks. Treatment should be withdrawn if a sufficient therapeutic response has not been achieved within 3 to 4 months.
If bezafibrate is given in combination with anion-exchange resins, they must be taken a minimum of 2 hours apart.
Pregnancy and Lactation
Bezafibrate is contraindicated during pregnancy.
Use of bezafibrate during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of bezafibrate during pregnancy. Potential risks are unknown.
Bezafibrate is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues bezafibrate or discontinues breastfeeding. At the time of writing there is insufficient information on the excretion of bezafibrate or its metabolites in human milk. A risk to the infant cannot be excluded.
Acute renal failure
Creatine phosphokinase increased
Decreased alkaline phosphatase
Gamma glutamyl transferase (GGT) decreased
Gamma glutamyl transferase (GGT) increased
Increase in serum transaminases
Increased platelet count
Interstitial lung disease
Serum creatinine increased
Toxic epidermal necrolysis
White blood cell count decreased
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2016
Summary of Product Characteristics: Bezalip Mono 400mg tablets. Actavis UK Limited. Revised October 2015.
Summary of Product Characteristics: Fibrazate XL 400mg Modified Release Tablets. Sandoz Ltd. Revised October 2015.
Summary of Product Characteristics: Lipozate 400mg prolonged-release tablets. Noumed Life Sciences Ltd. Revised January 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 December 2022
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