Indications: Used to treat hypertriglyceridemia, hypercholesterolemia, and mixed hyperlipidemia.
Approval date: July 25, 2007
Date of revision: June 24, 2009 October 01, 2010 December 01, 2015
Please read the instructions carefully and use under the guidance of a physician.
Common name: benzabate tablets
Product Name: Abetta
English name: Bezafibrate Tablets
Phonetic script (Hanyu Pinyin): Benshabeite Pian
The main ingredient is bezabate.
Chemical name: 2- [4- [2- (4-chlorobenzamido) ethyl] phenoxy] -2-methylpropionic acid.
Molecular formula: C 19 H 20 C1N0 4
Molecular weight: 361.82
[Properties] This product is a film-coated tablet, which appears white or flesh-like after removing the coating.
Benzabate tablets are taken orally 200-400 mg (1-2 tablets) 3 times a day. May be taken with or after meals. Those with good curative effect can maintain 400mg twice daily (2 tablets) each time. For renal dysfunction, adjust the dose according to creatinine clearance at 40-60ml / min, 400mg twice daily (2 tablets); 15-40ml / min, once daily or every other day, 400mg each (2 tablets) ); Below 15ml / min, once every 3 days, 400mg (2 tablets) each time.
1. The most common adverse reactions are gastrointestinal upset, such as indigestion, anorexia, nausea, vomiting, fullness, stomach upset, etc. Other rare adverse reactions are headache, dizziness, fatigue, rash, itching , Impotence, anemia, and decreased white blood cell count.
2. Occasionally cholelithiasis or myositis (myalgia, fatigue). This product is a chlorobutyric acid derivative, which may cause myositis, myopathy, and rhabdomyolysis syndrome, leading to an increase in blood creatine phosphokinase. Rhabdomyolysis occurs mainly as myalgia with elevated blood creatine phosphokinase, myoglobinuria, and can cause renal failure, but it is rare. Patients with nephrotic syndrome and other kidney damage leading to decreased albumin or hyperthyroidism have an increased risk of myopathy.
3. Occasionally elevated blood aminotransferases.
1. Those who are allergic to benzabate are prohibited.
2. Patients with gallbladder disease and gallstone disease are prohibited. This product may make the symptoms of gallbladder disease worse.
3. Patients with liver insufficiency or primary biliary cirrhosis are contraindicated.
4. Disable patients with severe renal insufficiency, because taking this product in patients with renal insufficiency may cause rhabdomyolysis and severe hyperkalemia; patients with nephrotic syndrome caused by decreased albumin are forbidden because of the risk of myopathy increase.
1. This product interferes with the diagnosis. ① The hemoglobin and white blood cell count may be reduced. ② Blood aminotransferase may increase. ③ Increased serum creatinine.
2. Periodic inspection should be performed during medication: ① whole blood and platelet count; ② liver and kidney function test; ③ blood lipid; ④ blood creatine phosphokinase.
3. Cholelithiasis, significant abnormal liver function, suspicious myopathy symptoms (such as myalgia, tenderness, fatigue, etc.) or blood creatine phosphokinase should be discontinued clinically after administration.
4. While treating hyperlipidemia, it is necessary to pay attention to and treat various primary diseases that can cause hyperlipidemia, such as hypothyroidism and diabetes. Certain drugs can also cause hyperlipidemia, such as estrogen, thiazide diuretics, and beta blockers. After discontinuation, no corresponding antihyperlipidemic treatment is needed.
5. Diet therapy is always the first method to treat hyperlipidemia, plus exercise and weight loss methods will be superior to any form of drug treatment.
[Medication for pregnant and lactating women]
The safety of this product during pregnancy is not established, so it is not recommended for pregnant women. Whether this product is secreted into milk is unknown, so it should not be taken by lactating women.
The efficacy and safety of children taking this product have not been confirmed by experimental studies, so it should not be applied.
[Medication for elderly patients]
The elderly should adjust the dosage according to liver and kidney function. In case of renal dysfunction, the dosage of this product should be appropriately reduced.
1. This product can significantly enhance the effect of oral anticoagulants. When used with it, pay attention to reduce the dose of oral anticoagulants, and often monitor the prothrombin time to adjust the dose of anticoagulants. Its mechanism of action is uncertain, probably because this product can replace warfarin from its protein binding site, thereby enhancing its effect.
2. When this product is combined with other drugs with a high protein binding rate, they can also be replaced from the protein binding site, resulting in enhanced effects, such as tolbutamide and other sulfonylurea hypoglycemic agents, phenytoin, furfur Sammy et al., Taking the above drugs during hypolipidemic treatment, should adjust the dose of hypoglycemic agents and other drugs.
3. The combination of chlorobutyric acid derivatives and HMG-CoA reductase inhibitors, such as lovastatin, for the treatment of hyperlipidemia will increase the risk of severe muscle toxicity between the two, which may cause myalgia, rhabdomyolysis, and blood Myopathies such as acid phosphate kinase elevation should be avoided in combination as much as possible.
4. This product is mainly excreted by the kidney. When combined with immunosuppressive agents such as cyclosporine, it can increase the blood concentration and nephrotoxicity of the latter, which may lead to the deterioration of renal function. It should be reduced or discontinued. Attention should also be paid when this product is used in combination with other nephrotoxic drugs.
5. This product can increase the effect of hypoglycemic agents.
[Drug overdose] There is currently no report on drug overdose of this product. If overdose occurs, corresponding supportive therapy should be taken for symptoms of poisoning.
[Pharmacology and Toxicology]
This product is a lipid-lowering drug of chlorobutyric acid derivatives. There are two mechanisms for its lipid-lowering effect. One is that this product increases the activity of lipoprotein lipase and liver lipase, promotes the catabolism of very low-density lipoprotein, and reduces the level of blood triglycerides. Secondly, this product reduces the secretion of very low density lipoprotein. This product lowers blood LDL and cholesterol, possibly by enhancing the clearance of receptor-bound LDL. This product has a stronger effect on lowering blood triglycerides than lowering blood cholesterol, and also increases high density lipoprotein. In addition, this product can still reduce fibrinogen. Existing research has not found that this product has carcinogenic and mutagenic effects.
This product is absorbed quickly after oral administration and is almost complete. Peak plasma concentration was reached 2 hours after oral administration. The plasma protein binding rate of this product is 95%. It is mainly excreted by the kidney, 50% of which is the original form, and the rest are metabolites; a small amount is excreted by the stool. T1 / 2 is 1.5 to 2 hours, and can be up to 20 hours in patients with renal disease and peritoneal dialysis.
[Storage] Sealed and stored in a cool (not more than 20 C) dry place.
[Packing] Packed in aluminum plate, 10 pieces / board, 2 plates / box.
[Validity] 24 months
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition Two
[Approval number] National Medicine Standard H20010013