|[General Name] Bezafibrate Tablets
[Commodity Name] Abeita
[Chemical Composition] p-[4-(chlorobenzoyl-amino-ethyl)-phenoxy]-B-methylpropionic acid
[Properties] The product is film coated tablet with white or grayish white contents
[Pharmacological Mechanism and Toxicity] Bezafibrate is a ramification of clofibrate which is a regulating agent of blood lipid.
1. It promotes the activity of triglyceride lipases thus accelerates the degradation of VLDL and decreases serum triglyceride.
2. It reduces the secretion of VLDL. It lowers blood VLDL and cholesterol concentration probably by eliminating the receptor-combined LDL. It produces more significant effects on reduction of blood cholesterol than triglyceride. It also increases the concentration of HDL and reduces fibrinogen. Carcinogenesis and potential mutational effects are not reported yet.
[Pharmacokinetics] Quickly and almost thoroughly absorbed with oral administration. Peak concentration appears within 2 hours and plasma protein binding of bezafibrate is 95%. Renal metabolism predominates in the elimination of bezafibrate, mostly excreted in the urine with little appearing in the feces. Approximately 50% of a dose is excreted unchanged. The t1/2 Bof bezafibrate is 1.5 to 2 hours. In patient undergoing peritoneal dialysis, t1/2 ?is about 20 hours.
[Indications] It is used for patients suffering from high blood triglyceride, cholesterolaemia and complicated hyperlipaemia.
[Administration and Dosage]
For adult: Oral administration, three times a day, 200-400mg each time for therapy. 400mg twice a day for maintainance.
For renal dysfunction: Regulate dosage according to CRE clearance rate. 40-60ml/min, 400mg twice daily; 15-4-ml/min, 400mg daily or every other day; 15ml/min and lower, 400mg three times daily
1.GIT complaints, loss of appetite, nausea, fullness of stomach. (generally reversible within two weeks of having stopped treatment). Impotence, hair loss, allergic reactions are rarely reported.
2.Myositis-like pains or muscular weakness in the muscles of the extremities (with and without simultaneous elevation of CPK).
On initiating treatment there may be a transient rise in the lithogenic index. The associated elevated excretion of cholesterol is a manifestation of mobilisation and elimination of cholesterol from the body.
3. Elevated aminopherase produces ocassionally
1. Allergy to bezafibrate
2. Gallbladder disease and cholelithiasis
3. Hepatic impairment and primary biliary cirrhosis
4. Severe renal dysfunction and nephrotic syndrome
1. The product may interfere with following laboratory test
1) It may decrease the result for hemoglobin and WBC accounting.
2) It may increase blood aminopherase.
3) It may increase blood CRE
2. Following examination should be carried out periodically during medication
1) Whole blood test and platelet accounting
2) Hepatic and renal function test
3) Blood lipid test
4) Blood CPK
3. Immediately stop medication when cholelithiasis, significant hepatic dysfunction, suspected myositis or markedly elevated blood PKR occurs.
4. Taking care of any primary disease while treating secondary hyperlipaemia, such as hypothyroidism and diabetes.
5. Dietetics is always a preferred treatment for hyperlipaemia besides physical exercises and reasonable weight loss.
[Pregnancy and lactation] The complete assurance of taking this medicine isnot yet conformed for pregnancy and lactation, thus it is not suggested for pregnant or breast-feeding women.
[Children] The complete assurance of taking this medicine is not conformed for children thus it is not suggested for children.
[Elderly patients] Elderly patients should adjust dosage according to their hepatic and renal function. It is suggested to accordingly reduce the dosage for patients with renal dysfunction .
1. The product may markedly enhance the action of anticoagulant. Thrombinogen time should be monitored in order to adjust the dosage of anticoagulant accordingly.
2. It may interfere with agents of high protein combining rate and enhance their actions consequently, therefore relevant agents such as benzene sulfaurea drugs should be reduced accordingly.
3. As a ramification of clofibrate, it is not suggested to be administered together with other HMG-CoA reductase inhibitors in case myopathy may occur.
4. It degrades mainly through the kidneys, any nephrotoxic drugs should not be used simultaneously.
5. It may enhance the action of hypoglycemic agents.
No relevant reports. Supporting treatment should be carried out according to the toxic symptoms
[Specification] 0.2g/tablet 0.2g x 20 tablets
[Storage] Keep in a cool dry place tightly sealed avoiding light
[Validity] Two years tentatively.
[Approval number] (gyzz) H20010013
[Manufacturer] Tianjin TASLY HOLDING GROUP.CO.LTD
[International Distribution Center] Tianjin Tasly International Trade Company