Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

The recommended dosage for Bezalip tablets is three tablets daily, equivalent to 600mg bezafibrate. The tablets should be swallowed whole with a little fluid after each meal.

Renal impairment

In patients with renal insufficiency the dose should be adjusted according to serum creatinine levels or creatinine clearance as shown in the following table;

In dialysis patients the dosage must be further reduced. As a general rule a dosage of one Bezalip tablet every third day is recommended, to avoid overdosage. The patient should be carefully monitored.

The response to therapy is normally rapid, although a progressive improvement may occur over a number of weeks. Treatment should be withdrawn if an adequate response has not been achieved within 3 to 4 months

Child Dosage

At present there is inadequate information regarding an appropriate dosage in children

Elderly Dosage

No specific dosage reduction is necessary in elderly patients

Contra Indications

Special Precautions

Interactions

Adverse Reactions

Gastro-intestinal system:

− occasionally gastro-intestinal symptoms such as loss of appetite, feelings of fullness in the stomach and nausea may occur. These side-effects are usually transient and generally do not require withdrawal of the drug. In susceptible patients a slowly increasing dosage over 5 to 7 days may help to avoid such symptoms.

Hepato-biliary system:

− in isolated cases, increase of transaminases, cholestasis and gallstones.

Hypersensitivity:

− occasionally allergic skin reactions such as pruritus or urticaria.

− in isolated cases, photosensitivity or generalised hypersensitivity reactions may occur.

Haematology:

Isolated cases of:

− decreases in haemoglobin and leucocytes.

− thrombocytopenia, which may cause bleeding (e.g. purpura).

− pancytopenia.

Renal system:

− frequently slight increases in serum creatinine. In patients with existing impairment of renal function, if dosage recommendations are not followed, myopathy may develop (in extreme cases rhabdomyolysis).

Muscular system:

− Muscular weakness, myalgia and muscle cramps, often accompanied by a considerable increase in creatine kinase may occur. In isolated cases, severe muscular damage (rhabdomyolysis) has been observed. In cases of rhabdomyolysis, bezafibrate must be stopped immediately and renal function closely monitored.

Others:

− in rare cases, headache and dizziness, alopecia.

− isolated cases of potency disorders have been reported.

In general, most of the adverse drug reactions disappear after withdrawal of Bezalip.

Manufacturer

Drug Availability

Updated