Gliclazide Tablets (Ⅱ)

Sulfonylurea hypoglycemic oral diabetes drug. Gliclazide lowers blood glucose levels by stimulating insulin secretion from pancreatic islet cells. In type 2 diabetes, gliclazide can restore the first phase of insulin secretion in response to glucose and increase first phase insulin secretion. A significant increase in insulin secretion response induced by a meal or stimulated by glucose can be seen. Other properties: Blood biochemical properties. Gliclazide reduces the microthrombotic process through two mechanisms that may be involved in the formation of diabetic complications. (1) Partially inhibits platelet adhesion and aggregation, and reduces platelet activity markers (p-thromboglobulin, thromboxane B2). (2) Produces fibrinolytic activity on the vascular endothelium (increases tPA activity).

Its chemical name is: l_(3-azabicyclo【3.3.0】octyl)-3-p-toluenesulfonylurea.

This product is white tablets.

This product is used for type 2 diabetes, especially for those with vascular complications.

Oral administration, for adults only. As with all hypoglycemic drugs, the dosage should be adjusted according to the individual patient's condition. In cases of transient blood sugar control disorders, for patients whose blood sugar levels can be normalized through diet control, taking this drug for a short period of time is sufficient to achieve the therapeutic purpose. (1) Patients under 65 years old: ① Initial dose: The recommended initial dose is 1 tablet per day. ② Increased dose: Generally, the dose is increased by 1 tablet each time according to the patient's blood sugar metabolism. There should be an interval of at least 14 days between each increase in dose. ④ Maintenance treatment: The dose is 1 to 3 tablets per day, and 4 tablets per day in special cases. The standard dose is 2 tablets per day, taken twice. (2) High-risk patients: ① Patients over 65 years old: Start treatment once a day, 1/2 tablet each time. This dose can be gradually increased until the patient achieves satisfactory blood sugar control, but it must be ensured that there is a maintenance period of at least 14 days after each dose increase, and strict blood sugar monitoring is performed. ② In other high-risk patients, for patients with malnutrition or major changes in physical condition, or patients with irregular calorie intake or concomitant renal or hepatic dysfunction, treatment should be started at the lowest dose and the drug dose should be increased cautiously to avoid any hypoglycemic reaction (see [Precautions]). (3) Patients taking other U-type hypoglycemic drugs: Like all other sulfonylurea hypoglycemic drugs, this drug can directly replace other antidiabetic drugs without any transition period. When switching from sulfonylurea hypoglycemic drugs with a longer half-life (e.g., chlorpropamide) to this drug, patients should be strictly monitored (after a few weeks) to avoid the superposition of the effects of the two drugs and the subsequent risk of hypoglycemia.

Hypoglycemia (see [Precautions] and [Overdose]). (2) Gastrointestinal disturbances, including nausea, indigestion, diarrhea and constipation, have been reported; these two symptoms can be avoided or alleviated if gliclazide is taken with meals or in divided doses. (3) The following are less frequently reported adverse reactions: ① Mucosal and skin reactions: rash, pruritus, urticaria, maculopapular rash. ② Blood disorders: anemia, leukopenia, thrombocytopenia. ③ Increased liver enzyme levels (ASAT, ALAT, alkaline phosphatase), hepatitis (rare). If cholestatic jaundice occurs, stop taking this drug. Generally speaking, these symptoms will disappear after treatment is stopped.

The use of this drug is contraindicated in the following cases: (1) Patients who are allergic to gliclazide or any of the excipients used, or to other sulfonylureas or sulfonamides. (2) Patients with insulin-dependent diabetes, especially juvenile diabetes, diabetic patients with ketoacidosis or pre-diabetic coma. (3) Severe liver or kidney dysfunction. (4) Patients treated with miconazole (see [Drug Interactions]). (5) Lactation. (6) Porphyria: Pigments (porphyrins) accumulate in the body. In short, it is not recommended to use this drug with phenylbutazone, danazol (see [Drug Interactions]) or alcohol.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: 1. Pregnancy: (1) Risks associated with diabetes: Uncontrolled diabetes (gestational or permanent diabetes) is the cause of a high incidence of congenital malformations and perinatal mortality. In order to reduce the risk of congenital malformations, blood sugar must be best controlled during pregnancy. (2) Risks associated with gliclazide: Large doses of sulfonylurea hypoglycemic drugs have teratogenic effects on animals. There is currently insufficient clinical data to evaluate the possible teratogenic or fetotoxic effects of taking gliclazide during pregnancy. (3) Process of action: ① Maintaining blood sugar control can allow this type of patient to have a normal pregnancy. ② Whether it is type 1 or type 2 diabetes, gestational or permanent diabetes, insulin treatment is necessary. ③ In the latter case, it is recommended to start taking insulin when planning to become pregnant or taking it. Precautions for the elderly: Follow the doctor's advice and reduce the medication appropriately.

1. The following drugs may increase the risk of hypoglycemia. (1) Concomitant use is prohibited: Miconazole (umbrella route, oral gel): Increases the hypoglycemic effect and may cause hypoglycemic symptoms, even coma. (2) Concomitant use is not recommended: ① Phenylbutazone (systemic route): Increases the hypoglycemic effect of sulfonylurea drugs [replaces their binding to plasma proteins and (or) reduces their clearance]. It is best to use an anti-inflammatory drug with few interactions. Otherwise, the patient should be warned and the importance of self-monitoring should be emphasized; when used with anti-inflammatory drugs, it is necessary to adjust the drug dose during treatment and during the treatment interruption stage. ② Alcohol: Increases hypoglycemic reactions, especially chlorpropamide, glibenclamide, glipizide, and toluidine (by inhibiting compensatory reactions), and also has an increased risk of hypoglycemic coma. Avoid consuming alcohol or taking medications containing alcohol. (3) Caution is required in combined use: ① Szlig;； receptor blockers: All szlig;； receptor blockers can mask certain symptoms of hypoglycemia, such as palpitations and tachycardia. Most non-cardioselective szlig;； receptor blockers increase the suddenness and severity of hypoglycemia. Patients should be warned and the importance of self-monitoring of blood glucose should be emphasized, especially at the beginning of treatment. ② Fluconazole: Increases the half-life of sulfonylurea drugs and the risk of hypoglycemia symptoms. Patients should be warned and the importance of self-monitoring of blood glucose should be emphasized, and the dose of sulfonylurea drugs should be adjusted when necessary during fluconazole treatment. ④ Angiotensin-converting enzyme inhibitors (generally referring to captopril and enalapril): The use of angiotensin-converting enzyme inhibitors will aggravate the hypoglycemic effect of sulfonylurea hypoglycemic drugs. Symptomatic hypoglycemia is very rare. One theory is that improved glucose tolerance helps reduce the need for insulin. The importance of self-monitoring of blood glucose should be emphasized. 2. The following drugs may cause increased blood sugar levels: (1) It is recommended not to use them together: ① Danazol: Diabetogenic effect. If this drug cannot be avoided, patients should be warned and the importance of self-monitoring of urine sugar and blood sugar should be emphasized. When using and stopping ILdanazol treatment, the dose of diabetes treatment drugs needs to be adjusted. (2) Combined use requires caution: ① Chlorpromazine (psychotropic): Treatment with high-dose chlorpromazine (daily chlorpromazine dose of 100 mg) will increase blood sugar levels (reduce insulin release). Inform patients and emphasize the need for self-monitoring of IlIL sugar levels. If necessary, the dose of antidiabetic drugs should be adjusted during treatment with neuroleptic drugs and at the end of treatment. ② Glucocorticoids and teicosin (systemic and local routes: intra-articular, skin and rectal preparations): (with the exception of hydrocortisone as an alternative treatment in ADDISON's disease) Blood sugar levels will increase, sometimes accompanied by ketosis (decreased carbohydrate tolerance caused by glucocorticoids). Patients need to be warned and the importance of self-monitoring blood sugar needs to be emphasized, especially at the beginning of treatment. It is necessary to adjust the dose of drugs for treating diabetes during the use of glucocorticoids and after discontinuation of the drug. ③ Szlig;;2 Sympathomimetic drugs: Hydroxy ephedrine, salbutamol, and tributofol increase blood sugar levels due to their p2 agonist effects. The importance of self-monitoring blood sugar needs to be emphasized. Switch to insulin if necessary.

seal

80mg

24 months

Zhejiang Jingxin Pharmaceutical Co., Ltd.

• Founded in:

  1999-02-13

• Address:

  No. 800, Xinchang Avenue East Road, Yulin Street, Xinchang County, Zhejiang Province

• Tax NO.:

  91330000704503984N

• Registered Funds:

  861.02914 million yuan

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