DYNA-BEZAFIBRATE SR 400 mg - Pharma Dynamics

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INDICATIONS: DYNA-BEZAFIBRATE SR 400 mg is indicated for use in patients with primary hyperlipidaemia type IIa, IIb and IV. (see table below) Table: Classification of hyperlipoproteinaemias: This method, devised by Fredrickson, was adapted by the WHO. The WHO classification defines 6 types. WHO classification Lipoproteins elevated Page 2 of 10 Plasma lipids affected Cholesterol Triglyceride I Chylomicrons Normal or elevated Elevated IIa LDL Elevated Normal IIb LDL and VLDL Elevated Elevated III VLDL with Abnormally high Cholesterol content Elevated Elevated IV VLDL Normal or elevated Elevated V Chylomicrons and VLDL Elevated Elevated CONTRA-INDICATIONS: Hypersensitivity to bezafibrate. Bezafibrate should not be given to patients with severe liver or kidney dysfunction, primary biliary cirrhosis, or gallstones or gallbladder disorders. Caution has also been advised in patients with hypoalbuminaemic states such as nephrotic syndrome. In patients taking oral anticoagulant therapy, the dose of anticoagulant should be reduced by up to 50% and then adjusted as necessary. A number of other drugs may be displaced from plasma proteins by Bezafibrate, including tolbutamide and other sulphonylurea anti-diabetic agents, phenytoin and, in patients with hypoalbuminaemia, furosemide. The interaction with antidiabetic agents is complex since bezafibrate has been shown to alter glucose tolerance in both diabetic and non- diabetic patients. The dosage of antidiabetic agents may need adjusting during
concomitant bezafibrate therapy. The safety in pregnancy and lactation has not been established. DOSAGE AND DIRECTIONS FOR USE: The basis of the treatment of all disorders of lipid metabolism is by diet in the first instance. This should be prescribed by the doctor. Obese patients should lose weight. THE DOSE IS GENERALLY 1 (ONE) TABLET TAKEN IN THE EVENING OR AS DETERMINED BY THE DOCTOR. THE TABLET SHOULD BE SWALLOWED WHOLE, WITH A LITTLE FLUID, AFTER THE EVENING MEAL. Treatment with DYNA-BEZAFIBRATE SR 400 mg should be monitored over the first 8 weeks of treatment by determination of the triglyceride, total cholesterol and HDL- cholesterol levels at least three times. If no significant reduction of triglyceride and total cholesterol is obtained, treatment should be discontinued. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastrointestinal complaints such as nausea, vomiting, diarrhoea, dyspepsia, flatulence and abdominal discomfort can occur and generally disappear after 1 to 2 weeks without having to stop treatment. A few reports of weight gain, headache, dizziness, fatigue or drowsiness, skin rashes, pruritis, alopecia, impotence, anaemia and leucopenia have been reported. Occasionally slight abnormalities of liver function test and hepatomegaly occur. WARNINGS: Patients developing muscle pain, tenderness or weakness should stop therapy and consult their doctor. Elevated creatine phosphokinase concentrations may cause this syndrome; which occurs particularly in patients with hypoalbuminaemia resulting from the nephrotic syndrome or other renal impairment. Serum aminotransferase concentrations may also be raised. INTERACTIONS: When DYNA-BEZAFIBRATE SR 400 mg is used concurrently with colestyramine, an interval of 2 hours should be maintained between taking the two medicaments, since the absorption of bezafibrate is impaired by colestyramine. Page 3 of 10
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DYNA-BEZAFIBRATE SR 400 mg - Pharma Dynamics

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