Details

Approved date: January 29, 2007
 
Gliclazide sheet
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Generic name: gliclazide tablets
 
English name: Gliclazide Tablets
 
Pinyin: Gelieqite Pian
 
[Ingredients] The main ingredients of this product are: gliclazide. Its chemical name is: 1-(3-azabicyclo[3.3.0]octyl)-3-p-toluenesulfonylurea.
 
Molecular formula: C15H21N3O3S
 
Molecular weight: 323.41
 
【Properties】 This product is a white film.
 
[Indications] for type 2 diabetes.
 
【Specification】80mg
 
[Usage and Dosage] Oral starting dose of 40 ~ 80mg (1/2 ~ 1 tablet), 1 or 2 times a day, after the adjustment according to blood sugar level to 80mg ~ 240mg (1 ~ 3 tablets), 2 to 3 times After the blood sugar control, change the maintenance amount daily. Older patients should be reduced.
 
[Adverse reactions] Occasionally mild nausea, vomiting, upper abdominal pain, constipation, diarrhea, erythema, urticaria, thrombocytopenia, granulocytopenia, anemia, etc., most disappeared after stopping the drug.
 
[taboo]
 
1. Liver and kidney dysfunction are prohibited.
 
2. Allergic to sulfonylurea drugs is prohibited.
 
【Precautions】
 
Patients with type 1.2 diabetes should be treated with insulin when they develop stress, trauma, surgery and other stress conditions and ketoacidosis and non-ketotic hyperosmolar diabetes coma.
 
2. Not for patients with type 1 diabetes.
 
3. When combined with anticoagulants, coagulation tests should be performed regularly.
 
4. When the dose is too large, too little food or strenuous exercise, attention should be paid to prevent hypoglycemia.
 
5. Should be taken under the guidance of a physician. The patient's blood sugar and urine sugar must be checked regularly.
 
[Pregnant women and lactating women] Animal experiments and clinical observations prove that sulfonylurea hypoglycemic drugs can be teratogenic and discharged from milk, so pregnant women and lactating mothers should not be used.
 
[Child medication] is not clear.
 
[Geriatric Use] The dosage is appropriately reduced.
 
[Drug interactions] and non-steroidal anti-inflammatory drugs (especially salicylates), sulfonamides, dicoumarin anticoagulants, monoamine oxidase inhibitors, beta-blockers, benzodiazepines When combined with drugs such as Zhuo, tetracycline, chloramphenicol, dicyclohexylethylpiperidine, clofibrate, and ethanol, the dosage should be reduced to avoid hypoglycemia.
 
[Drug overdose] is not clear.
 
[Pharmacology and Toxicology] This product is a second-generation sulfonylurea hypoglycemic agent with a strong effect. The mechanism is to selectively act on islet β cells, promote insulin secretion, and increase insulin release after eating glucose. The generation and output are suppressed. This product has been proven to reduce platelet aggregation and adhesion through animal experiments and clinical use, and is helpful in the prevention and treatment of diabetic microangiopathy.
 
[Pharmacokinetics] This product is taken orally, absorbed rapidly in the gastrointestinal tract, reaches plasma peak in 3 to 4 hours, plasma protein binding rate is 92%, half-life is 10 to 12 hours, mainly metabolized in the liver after oral administration. discharge.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Packing] Aluminum-plastic packaging, 60 pieces per box.
 
[Validity Period] 48 months
 
[Executive Standards] National Food and Drug Administration National Drug Standard WS1-(X-103)-95Z-2011
 
[Approval No.] National Drug Standard H44021592
 
【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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