Gemfibrozil Capsules

This product is a lipid-regulating drug of the clofibric acid derivative class. Its mechanism of action in lowering blood lipids is not yet fully understood. It may involve peripheral fat decomposition, reduce the liver's uptake of free fatty acids and reduce the formation of triglycerides in the liver, inhibit the synthesis of very low-density lipoprotein apolipoproteins and reduce the production of very low-density lipoproteins. This product reduces blood triglycerides and increases blood high-density lipoprotein concentrations. Although it can slightly reduce blood low-density lipoprotein cholesterol blood concentrations, it may increase low-density lipoprotein in type IV hyperlipoproteinemia. A 5-year placebo-controlled study showed that this product can reduce the occurrence of severe coronary heart disease sudden death and myocardial infarction. Long-term administration of 10 times the human dose to rats increased the incidence of liver malignancies and benign testicular tumors.

The chemical name of this product is: 2,2-dimethyl-5-(2,5-dimethylphenyloxy)-pentanoic acid. Its molecular formula is: C15H22O3, and its molecular weight is: 250.34.

This product is in the form of capsules.

Suitable for primary hyperlipidemia.

Usual oral dose for adults: 0.3-0.6 g at a time, twice a day, 30 minutes before breakfast and dinner.

1The most common adverse reactions are gastrointestinal discomfort, such as indigestion, anorexia, nausea, vomiting, fullness, stomach discomfort, etc. Other less common adverse reactions include headache, dizziness, fatigue, rash, itching, impotence, etc. 2Occasionally, there is cholelithiasis or myositis (myalgia, fatigue). This product is a derivative of clofibric acid, which may cause myositis, myopathy and rhabdomyolysis syndrome, leading to increased blood creatine phosphokinase. Rhabdomyolysis occurs, mainly manifested by myalgia combined with increased blood creatine phosphokinase, myoglobinuria, and can lead to renal failure, but it is rare. In patients with nephrotic syndrome and other renal damage that lead to decreased blood albumin or patients with hyperthyroidism, the risk of myopathy increases. 3Occasionally, liver function tests (increased blood aminotransferase, lactate dehydrogenase, bilirubin, and alkaline phosphatase) are abnormal, but they can return to normal after stopping the drug. 4 Occasionally, mild anemia and decreased white blood cell count may occur, but long-term use can stabilize the condition. Some patients may experience severe anemia, leukopenia, thrombocytopenia, and bone marrow suppression.

1. Patients who are allergic to Gemfibrozil are contraindicated. 2. Patients with gallbladder disease or cholelithiasis are contraindicated, as this product may aggravate the symptoms of gallbladder disease. Patients with liver dysfunction or primary biliary cirrhosis are contraindicated, as this product may promote increased cholesterol excretion and increase the already high cholesterol level. 3. Patients with severe renal insufficiency are contraindicated, as taking this product may cause rhabdomyolysis and severe hyperkalemia in patients with renal insufficiency; patients with nephrotic syndrome causing serum protein reduction are contraindicated, as they have an increased risk of myopathy.

Precautions for children: There is insufficient research on the use of this product in children, so the pros and cons must be weighed when using it. Precautions for pregnancy and lactation: High doses of this product can cause fetal death in animals, but no human studies have been reported. It is unknown whether this product enters breast milk, so pregnant and lactating women should not take this product. Precautions for the elderly: If the elderly have poor renal function, the dosage of this product should be appropriately reduced.

1. This product can significantly enhance the effect of oral anticoagulants. When used with it, attention should be paid to reducing the dose of oral anticoagulants and frequently monitoring the prothrombin time to adjust the dose of anticoagulants. Its mechanism of action is still uncertain. It may be because this product can replace warfarin and other drugs from their protein binding sites, thereby enhancing their effects. 2. When this product is used in combination with other drugs with high protein binding rates, it can also replace them from the protein binding sites, leading to enhanced effects, such as tolbutamide and other sulfonylurea hypoglycemic drugs, phenytoin, furosemide, etc. When taking the above drugs during lipid-lowering treatment, the doses of hypoglycemic drugs and other drugs should be adjusted. 3. The combined use of clofibric acid derivatives and HMG-CoA reductase inhibitors, such as lovastatin, for the treatment of hyperlipidemia will increase the risk of severe muscle toxicity of both, which can cause myalgia, rhabdomyolysis, increased blood creatine phosphokinase and other myopathy, and should be avoided as much as possible. 4. When this product is used in combination with bile acid binding resins, such as colestipol, gemfibrozil should be taken at least 2 hours before or 2 hours after taking these drugs. Bile acid binding drugs can bind to other drugs taken at the same time, thereby affecting the absorption of other drugs. 5. This product is mainly excreted through the kidneys. When used in combination with immunosuppressants, such as cyclosporine, it can increase the latter's blood concentration and nephrotoxicity, and there is a risk of worsening renal function. The dose should be reduced or the drug should be discontinued. Caution should also be exercised when this product is used in combination with other nephrotoxic drugs.

Keep in a dark, sealed container. Store in a cool and dark place.

0.3g

36 months

Changzhou Pharmaceutical Factory Co., Ltd.

• Founded in:

  2001-12-14

• Address:

  No. 518, Laodong East Road, Changzhou

• Tax NO.:

  91320400137158490L

• Registered Funds:

  108 million yuan

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