Glimepiride Tablets

Glimepiride is an oral sulfonylurea hypoglycemic drug that mainly works by stimulating pancreatic beta cells to release insulin. This effect is mainly based on increasing the responsiveness of pancreatic beta cells to physiological concentrations of glucose. In addition, glimepiride also has an extrapancreatic hypoglycemic effect. 1. Insulin release: Glimepiride, like other sulfonylurea drugs, regulates insulin secretion by closing the ATP-sensitive potassium ion channel of the pancreatic beta cell membrane. Glimepiride closes the potassium ion channel to induce beta cell membrane depolarization, opens the calcium ion channel to cause calcium ion influx, and promotes insulin release. 2. Extrapancreatic activity: The extrapancreatic effect is to improve the sensitivity of peripheral tissues to insulin and reduce the output of glucose by the liver. Peripheral muscle and adipose tissue take up glucose in the blood, and glimepiride increases the number of glucose transfer molecules in the plasma membrane of muscle and fat cells, thereby stimulating glucose uptake. The increase in glucose uptake activates the activity of glycosyl-phosphatidylinositol-specific phospholipase C, thereby further stimulating glucose metabolism. Glimepiride inhibits the output of glucose from the liver by increasing the concentration of intracellular fructose 2,6-bisphosphate. 3. Pharmacodynamic characteristics: The minimum effective oral dose for healthy people is about 0.6 mg. The effect of glimepiride is dose-dependent and reproducible. When taking glimepiride, the physiological response of reduced insulin secretion during intense exercise still exists. There is no significant difference in the therapeutic effect whether the drug is taken 30 minutes before or immediately before a meal. Once a day, the metabolism of diabetic patients can be well controlled for 24 hours. Although the hydroxy metabolites of glimepiride cause a small decrease in serum glucose in healthy subjects (statistically significant), this is only a small part of the overall effect of the drug. 4. Combination therapy with insulin: There is limited data on combination therapy with insulin. When patients still cannot effectively control blood sugar with the maximum dose of glimepiride, combined insulin therapy can be started. Two studies have confirmed that combined therapy can achieve the same metabolic control as insulin alone; however, the average dose of insulin required for combined therapy is lower.

The main ingredient of this product is glimepiride.

Green shaped tablets.

It is suitable for type 2 diabetes mellitus in which diet control, exercise therapy and weight loss cannot satisfactorily control blood sugar.

Take the medication orally as directed by your doctor. For patients with diabetes, there is no fixed dose for glimepiride or any other hypoglycemic drug. Fasting blood sugar and glycosylated hemoglobin must be measured regularly to determine the minimum effective dose of the patient's medication; Measure glycosylated hemoglobin levels to monitor the patient's treatment effect. Usual starting dose: In the initial treatment stage, the starting dose of glimepiride is 1-2 mg once a day, administered at breakfast or the first main meal. Those patients who are sensitive to hypoglycemic drugs should start with 1 mg once a day, and the dose should be adjusted with caution. There is no precise dosage relationship between glimepiride and other oral hypoglycemic drugs. The maximum initial dose of glimepiride does not exceed 2 mg. Usual maintenance dose: The usual maintenance dose is 1-4 mg once a day, and the recommended maximum maintenance dose is 6 mg once a day.

Based on the experience with glimepiride tablets and other sulfonylurea drugs, the following adverse reactions should be considered: 1. Immune system: In individual cases, mild allergic reactions can develop into life-threatening serious conditions, such as dyspnea, hypotension, and sometimes shock. In very rare cases, allergic vasculitis may occur. There may be cross-allergy with other sulfonylureas, sulfonamides or related substances. 2. Blood and lymphatic system: Hematological changes are rare during the treatment of glimepiride tablets. Moderate to severe thrombocytopenia, leukopenia, erythropenia, granulocytopenia, agranulocytosis, hemolytic anemia and pancytopenia have been reported. Usually they can be recovered after stopping the drug. 3. Metabolic system: In very rare cases, hypoglycemia has been observed after taking glimepiride tablets. Hypoglycemia reactions usually occur immediately, can be very severe, and are sometimes difficult to correct. As with other hypoglycemic therapies, hypoglycemia reactions are based on individual factors, such as eating habits and dosage (see [Precautions]). 4. Eyes: Especially at the beginning of treatment, temporary effects on vision may occur due to changes in blood sugar. 5. Gastrointestinal tract: Gastrointestinal complaints such as nausea, vomiting and diarrhea, gastric pressure or fullness and abdominal pain are very rare and rarely lead to interruption of treatment. 6. Hepatobiliary system: Elevated liver enzymes may occur, and very rare cases of liver damage (such as cholestasis and jaundice) may progress, such as hepatitis, and may develop into liver failure. Skin and subcutaneous tissue: Skin allergic reactions such as itching, rash and urticaria may occur. In very rare cases, photosensitivity may occur. 7. Laboratory indicators: Decreased blood sodium concentration was observed in individual cases.

1. Those who are allergic to any ingredient of this product. 2. Those with type 1 diabetes, diabetic coma, ketoacidosis, severe renal or liver damage, allergic to glimepiride, other sulfonylureas, sulfonamides or excipients. 3. For patients with severe renal or liver damage, insulin treatment should be used instead. 4. Glimepiride tablets are contraindicated for pregnant and breastfeeding patients.

Precautions for children: There is no research data on the safety and effectiveness of this product for children. Precautions for pregnancy and lactation: 1. Pregnancy: Glimepiride tablets are contraindicated during pregnancy. Pregnant patients should switch to insulin. Patients planning to become pregnant should notify their doctors. 2. Lactation: Sulfonylurea derivatives, such as glimepiride, can be excreted from breast milk and are contraindicated for lactating women. Precautions for the elderly: No special instructions, or follow the doctor's advice.

1. If glimepiride tablets are taken at the same time as certain other drugs, the hypoglycemic effect of glimepiride may be enhanced or weakened. Therefore, other drugs should be taken with the knowledge or guidance of a doctor. 2. Glimepiride is metabolized by cytochrome P450 (CYP2C9). Its metabolism is known to be affected by the simultaneous use of CYP2C9 agonists (rifampicin) or inhibitors (fluconazole). 3. The results of in vivo drug-drug interaction studies showed that the simultaneous use of fluconazole (one of the strongest CYP2C9 inhibitors) can increase the AUC of glimepiride by about 2 times. 4. Based on the experience of using glimepiride tablets and other sulfonylurea drugs, the following drug interactions should be noted: Taking one of the following drugs that potentially cause a decrease in blood sugar may lead to hypoglycemia in some cases, such as: phenylbutazone, azapropazone, oxybutazone, insulin and oral hypoglycemic drugs, metformin, salicylic acid, para-aminosalicylic acid, steroids and androgens, chloramphenicol, coumarin anticoagulants, fenfluramine, clofibrate, ACE inhibitors, fluoxetine, allopurinol, sympathetic nerve drugs, cyclophosphamide, ifosfamide, sulfinpyrazone, long-acting sulfonamides, tetracyclines, monoamine oxidase inhibitors, quinolone antibiotics, probenecid, miconazole, pentoxifylline (high-dose parenteral administration), tritoquine, and fluconazole. Taking one of the following drugs that weaken the hypoglycemic effect may increase blood glucose levels, such as: estrogen and progesterone, thiazide diuretics, thyroid stimulating hormone, glucocorticoids, phenothiazine and its derivatives, chlorpromazine, epinephrine and other sympathomimetics, niacin (high doses) and its derivatives, laxatives (when used for a long time), phenytoin, diazoxide, glucagon, barbiturates, rifampicin, acetazolamide. 5. H2 receptor antagonists, beta-blockers, clonidine and reserpine may enhance or weaken the hypoglycemic effect. 6. Under the influence of sympathetic drugs such as beta-blockers, clonidine, guanethidine and reserpine, the adrenergic counter-regulation signs of hypoglycemia may be weakened or even disappear. 7. Alcohol consumption may enhance or weaken the hypoglycemic effect of glimepiride tablets, but it is unpredictable. 8. Glimepiride may enhance or weaken the effect of coumarin derivatives.

Keep sealed.

1mg

24 months

Shandong Xinhua Pharmaceutical Company Limited

• Founded in:

  1998-11-20

• Address:

  Chemical Industry Zone, Zibo High-tech Industrial Development Zone

• Tax NO.:

  91370300164103727C

• Registered Funds:

  682,407,635 yuan

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