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Gemfibrozil capsule

Product description
Approved date: March 16, 2007
 
Date of revision: October 1, 2010
 
         November 30, 2015
 
Gemfibrozil capsule instruction manual
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Generic Name: Gemfibrozil Capsules
 
English name: Gemfibrozil Capsules
 
Pinyin: Jifeiluoqi Jiaonang
 
[Ingredients] The main ingredients of this product are: Gemfibrozil. Its chemical name is: 2,2-dimethyl-5-(2,5-dimethylphenyloxy)-pentanoic acid.
 
 
 
    Molecular formula: C15H22O3
 
    Molecular weight: 250.34
 
【Properties】
 
     This product is a capsule and the content is white powder.
 
[indications]
 
    For hyperlipidemia. It is suitable for patients with severe IV or V hyperlipoproteinemia, high risk of coronary heart disease, diet control, and weight loss. It is also suitable for patients with type IIb hyperlipoproteinemia, high risk of coronary heart disease, diet control, weight loss, and other drugs for the treatment of blood lipids.
 
    In view of the potential carcinogenicity of this product to humans, it should be strictly limited to the specified indications, and should be stopped in time if the effect is not obvious.
 
[Specification] 0.3g
 
【Dosage】
 
    Oral dosage for adults Oral: 0.3 to 0.6 g (1 to 2 capsules) once a day, 2 times a day, 30 minutes before breakfast and dinner.
 
【Adverse reactions】
 
    1. The most common adverse reactions are gastrointestinal discomfort, such as dyspepsia, anorexia, nausea, vomiting, feeling of fullness, etc. Other rare side effects include headache, dizziness, fatigue, rash, itching, impotence and so on.
 
    2. Occasionally cholelithiasis or myositis (myalgia, fatigue). This product is a derivative of clofibrate, which may cause myositis, myopathy and rhabdomyolysis syndrome, leading to an increase in serum creatine phosphokinase. Rhabdomyolysis occurs, mainly manifested as myalgia with elevated serum creatine phosphokinase, myoglobinuria, and can lead to renal failure, but rare. In patients with nephrotic syndrome and other kidney damage leading to a decrease in albumin or hyperthyroidism, the risk of developing myopathy is increased.
 
     3. Occasionally, the liver function test (blood aminotransferase, lactate dehydrogenase, bilirubin, alkaline phosphatase increased) is abnormal, but it can return to normal after stopping the drug.
 
     4. Occasionally mild anemia and decreased white blood cell count, but long-term application can be stable, individual severe anemia, leukopenia, thrombocytopenia and myelosuppression.
 
[taboo]
 
1. It is forbidden to allergic to gemfibrozil and its similar drugs.
 
2. Patients with gallbladder disease, cholelithiasis are banned, this product may increase the symptoms of gallbladder disease. In patients with liver dysfunction or primary biliary cirrhosis, this product can promote the increase of cholesterol excretion and increase the already high cholesterol level.
 
     3. Patients with severe renal insufficiency are banned because taking this product in patients with renal insufficiency may cause rhabdomyolysis and severe hyperkalemia; patients with nephrotic syndrome causing a decrease in serum protein are banned because of the increased risk of developing myopathy.
 
【Precautions】
 
1. This product may interfere with the diagnosis, hemoglobin, hematocrit, white blood cell count may be reduced; blood creatine phosphokinase, alkaline phosphatase, aminotransferase, lactate dehydrogenase may increase.
 
2. Regular inspection during medication:
 
1 whole blood and platelet count;
 
2 liver function test;
 
3 blood lipids;
 
4 blood creatine phosphokinase.
 
   3. If it is invalid after 3 months of treatment, it should be discontinued. If cholelithiasis, abnormal liver function, suspected myopathy symptoms (such as myalgia, tenderness, fatigue, etc.) or blood creatine phosphokinase are significantly elevated after administration, the drug should also be discontinued.
 
   4. After the product is stopped, blood cholesterol and triglycerides may rebound more than the original level, so it is advisable to give a low-fat diet and monitor blood lipids to normal.
 
   5. In the treatment of high blood lipids, it is also 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 stopping the drug, the corresponding antihyperlipidemic treatment is no longer needed.
 
   6. Dietary therapy is always the primary method of treating hyperlipidemia, plus exercise and weight loss are superior to any form of medication.
 
[Pregnant women and lactating women]
 
    Large doses of this product in animals can cause fetal death, and human studies have not been reported. Whether this product enters the milk is unknown, so pregnant women and lactating women should not take this product.
 
[Children's medication]
 
    Children's research on taking this product is not sufficient, and the advantages and disadvantages must be weighed when applied.
 
[Geriatric Use]
 
    If the elderly have renal dysfunction, the dosage of this product should be appropriately reduced.
 
【medicine interactions】
 
   1. This product can significantly enhance the role of oral anticoagulant, and should be used to reduce the dose of oral anticoagulant, often monitoring prothrombin time to adjust the amount of anticoagulant. The mechanism of action is still uncertain, probably because this product can replace warfarin and other proteins from its protein binding site, thereby enhancing its role.
 
      2. When used in combination with other drugs with high protein binding rate, they can also be replaced by protein binding sites, resulting in enhanced action, such as tolbutamide and other sulfonylureas, phenytoin, furosemide. Etc., taking the above drugs during the treatment of hypolipidemic, the dose of hypoglycemic agents and other drugs should be adjusted.
 
    3. The combination of clofibrate derivatives and hydroxymethylglutaryl coenzyme reductase inhibitors, such as lovastatin, in the treatment of hyperlipidemia will increase the risk of serious muscle toxicity, causing myalgia, rhabdomyolysis, blood Muscle disease such as increased creatine phosphokinase should be avoided as much as possible.
 
      4. This product should be combined with bile acid-binding resin, such as colestipol, at least 2 hours or 2 hours before taking these drugs. Because bile acid-binding drugs can be combined with other drugs taken at the same time, which affects the absorption of other drugs.
 
      5. 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, and may cause the deterioration of renal function. It should be reduced or discontinued. This product should also be used in conjunction with other drugs with nephrotoxicity.
 
【Drug overdose】
 
    At present, there is no report on the drug overdose of this product. If there is a drug overdose, the corresponding supportive therapy should be taken for the symptoms of poisoning.
 
【Pharmacology and Toxicology】
 
    This product is a clofibrate acid lipid regulating drug, its mechanism of action is not fully understood, may involve the decomposition of peripheral fat, reduce liver uptake of free fatty acids and reduce the formation of triglyceride in the liver, inhibit the synthesis of very low density lipoprotein apolipoprotein And reduce the production of very low density lipoproteins. This product lowers blood triglyceride and increases blood high-density lipoprotein concentration. Although it can slightly reduce blood low-density lipoprotein cholesterol blood concentration, type IV hyperlipoproteinemia may increase low-density lipoprotein. A 5-year placebo-controlled study showed that this product can reduce the occurrence of sudden death or myocardial infarction in coronary heart disease.
 
    Long-term administration to rats in 10 times human dose showed an increase in the incidence of hepatic malignancy and benign testicular tumors.
 
【Pharmacokinetics】
 
    The product is completely absorbed from the gastrointestinal tract, and the peak plasma concentration occurs 1 to 2 hours after oral administration; the T1/2 is 1.5 hours, and the plasma protein binding rate is about 98%. The hypolipidemic effect began to appear 2 to 5 days after treatment, and the peak effect appeared at the 4th week. Metabolized in the liver, about 70% of the drugs are excreted by the kidneys, mainly in the original form. 6% is excreted by feces.
 
[Storage] Sealed and stored in a cool place (not more than 20 ° C).
 
[Package] medicinal plastic bottles, 30 capsules per bottle.
 
[Validity Period] 36 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44021201
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348
 
400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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