Aluminum Clofibrate Tablets

This product is a lipid-regulating drug of clofibric acid derivatives. It does not decompose in the stomach and has no irritation to the stomach. It decomposes into clofibrate in the alkaline environment of the intestine to work. It achieves the purpose of lowering blood lipids by reducing the amount of very low-density lipoprotein, but its mechanism of lowering blood lipids is not fully understood. It may involve inhibiting the release of liver lipoproteins (especially very low-density lipoproteins) and cholesterol synthesis, changing the synthesis of triglycerides in the liver, strengthening the action of lipoprotein esterase, increasing the secretion of steroids and excretion from feces, and increasing the clearance of triglycerides (very low-density lipoproteins) in the circulation; the anti-diabetes insipidus effect of this product comes from the stimulation of the posterior pituitary gland to release antidiuretics. Animal experiments have shown that long-term and large-scale use of this product can lead to the occurrence of benign or malignant tumors. If 1-2 times the maximum human dose is used for a long time in mice and rats (counted by body surface area mg/m2), compared with the control group, it can lead to an increase in the incidence of benign and malignant liver tumors.

The chemical name of this product is: bis[(alpha;-p-chlorophenoxy)isobutyric acid]aluminum hydroxide salt. Its structural formula is: Molecular formula: C20H21AlCl2O7 Molecular weight: 471.27

This product is white tablets.

This product is used to treat hyperlipidemia in adults who have not responded well to dietary control therapy. Its triglyceride-lowering effect is more obvious than its cholesterol-lowering effect, and is effective for hyperlipoproteinemia of type III, IV, and V. However, this product cannot completely replace dietary control therapy and can only be used as an auxiliary treatment based on dietary control. In addition, clofibrate is currently used clinically for atherosclerosis and its secondary diseases, such as coronary artery disease, cerebrovascular disease, peripheral vascular disease, and arterial disease caused by diabetes.

The usual oral dose for adults is 0.25-0.5g at a time, 3-4 times a day. In order to reduce gastrointestinal reactions, this product should be taken with food. It is advisable to use a small dose at the beginning and then gradually increase it. However, the prescribed dose should be reached within the first month of treatment, and it is best to adopt a decreasing method when stopping the drug. Sometimes the effect is not significant within the first month of taking the drug, but it can be effective if it is continued. It needs to be taken for a long time. After stopping the drug, serum cholesterol and triglycerides may rise or even exceed the original level, so diet control therapy should be adopted and blood lipids should be monitored until it is stable. If the treatment is ineffective for 3 months, the drug should be stopped, but the treatment of nodular xanthomas may take a year. Patients with liver and kidney dysfunction need to reduce the dosage of the drug.

1 Clinically, the most common adverse reactions are gastrointestinal tract reactions, such as nausea, diarrhea, vomiting, loss of appetite, and flatulence. 2 Long-term use of this product can significantly increase the risk of cholelithiasis; it can aggravate the symptoms of gallbladder diseases and require surgery. 3 There is an increased risk of peripheral vascular disease, pulmonary embolism, thrombophlebitis, angina pectoris, arrhythmia, and intermittent claudication. Clinically, chest pain, shortness of breath, and angina pectoris are occasionally seen; blood creatine phosphokinase and blood aminotransferase increase, but not due to myocardial infarction. 4 Less common adverse reactions include: ① arrhythmia; ② leukopenia or anemia with fever, chills, hoarseness, back pain, and dysuria; ③ hematuria, oliguria, and edema of the feet and lower limbs due to renal toxicity. 5. Clinically rare adverse reactions that require attention when they persist include: flu-like syndrome (myalgia, fatigue, cramps, which are actually elevated blood creatine phosphokinase, related to drug-induced myositis, myopathy, rhabdomyolysis, etc., and are common in patients with kidney disease), headache, stomach pain, sexual dysfunction, vomiting, etc. 6. Using this product to treat hyperlipidemia can reduce the incidence of non-fatal myocardial infarction, but it does not necessarily reduce the mortality rate of cardiovascular disease and the occurrence of fatal myocardial infarction. 7. This product increases the risk of death caused by non-cardiovascular causes.

1. Patients who are allergic to aluminum clofibrate are contraindicated. 2. Patients with primary biliary cirrhosis are contraindicated because this product can promote increased cholesterol excretion and increase the already high cholesterol level. 3. Patients with liver and kidney dysfunction are contraindicated because taking this product may cause rhabdomyolysis and severe hyperkalemia in patients with renal dysfunction.

Precautions for children: Not clear yet. Precautions for pregnancy and lactation: 1. Women of childbearing age who take this product should take strict contraceptive measures. If they are preparing to become pregnant, they should stop taking the drug several months before conception. 2. Pregnant women are prohibited from using this product. The effects of this product on pregnancy are not well studied. It is not known whether this product will cause harm to the fetus or affect reproductive function. However, animal experiments have shown that this product can pass through the placental barrier and accumulate in the fetus. The plasma drug concentration is higher than that of the mother. It may be that the enzyme system for the fetus to excrete this product has not yet matured. 3. It is forbidden for lactating women because the active metabolites of this product can be excreted into breast milk. Precautions for the elderly: If the elderly have poor renal function, the dosage of this product should be appropriately reduced.

1. When this product is used simultaneously with anticoagulants, its anticoagulant effect can be significantly increased. Therefore, the prothrombin time should be measured frequently to adjust the dosage of anticoagulants to keep it within the ideal range and prevent the occurrence of bleeding complications. 2. When this product is used simultaneously with furosemide, the effects of both drugs can be increased. It can cause myopathy, muscle stiffness and diuresis, especially for patients with hypoproteinemia. 3. This product can replace the protein binding sites of acidic drugs such as phenytoin or tolbutamide. Therefore, when used in combination with the above drugs or other drugs with high protein binding rates, attention should be paid to increasing the efficacy of the latter. For example, when used in combination with oral hypoglycemic tolbutamide, its hypoglycemic effect can be enhanced. 4. This product may cause myopathy or rhabdomyolysis. Therefore, it should be avoided as much as possible in combination with HMG-CoA reductase inhibitors such as pravastatin and simvastatin to reduce the risk of severe muscle toxicity of both drugs.

Keep sealed.

0.25g

24 months

Shandong Lukang Group Saite Co., Ltd.

• Founded in:

  1999-09-21

• Address:

  No. 518 Lianhuashan Road, Xintai City, Shandong Province

• Tax NO.:

  91370982863087914N

• Registered Funds:

  49.548 million yuan

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