Gliclazide extended-release tablets

1. This drug is a hypoglycemic sulfonylurea-oral diabetes treatment drug. 2. Gliclazide lowers blood sugar levels by stimulating pancreatic β cells to secrete insulin. For type 2 diabetes, gliclazide can restore the first-phase insulin secretion peak in response to glucose and increase the second-phase insulin secretion. It can be seen that the insulin secretion response induced or stimulated by glucose after a meal is significantly increased.

Gliclazide, its chemical name is: 1-(3-azabicyclo[3.3.0]oct-3-yl)-3-toluenesulfonylurea.

This product is a white tablet.

Adults with non-insulin-dependent diabetes mellitus (type 2) when diet, exercise, and weight loss alone are insufficient to control blood glucose levels.

1. Oral, for adults only. Once a day, the dose is 1 to 4 tablets, 30 to 120 mg. It is recommended to take it at breakfast. 2. If you forget to take the medicine on a certain day, the dose should not be increased on the next day. As with all hypoglycemic drugs, the dose should be adjusted according to the patient's metabolic response (blood sugar, HbAlc). 3. Initial dose: The recommended initial dose is 30 mg per day. * If the blood sugar level is satisfactory, this dose can be used as maintenance therapy: * If the blood sugar level is not good, the dose can be gradually increased to 60, 90 or 120 mg per day, with an interval of at least 1 month between each increase, except when the blood sugar level has not decreased after 2 weeks of treatment. In this case, it is recommended to increase the dose after 2 weeks of treatment. The maximum recommended dose must not exceed 120 mg per day. 4. Replace gliclazide 80 mg with gliclazide extended-release tablets: One gliclazide 80 mg tablet is equivalent to one gliclazide extended-release tablet. When replacing, blood sugar monitoring must be provided. 5. Replace other oral hypoglycemic drugs with gliclazide sustained-release tablets: gliclazide sustained-release tablets can replace other oral diabetes treatment drugs. In this case, the dose and half-life of the previously used hypoglycemic drugs must be considered. 6. Generally, there is no need for a transition period when switching to gliclazide sustained-release tablets. It is better to start with a dose of 30 mg. Then adjust according to the patient's blood sugar situation as mentioned above. If the patient switches from sulfonylurea drugs with a long half-life to gliclazide sustained-release tablets, in order to avoid the superposition of the effects of the two drugs and the subsequent risk of hypoglycemia, a few days of adjustment of the treatment window may prove necessary. 7. When switching to this drug, it is recommended to follow the steps used for the first treatment of gliclazide sustained-release tablets, that is, the first treatment dose is 30 mg per day, and then gradually increase according to the metabolic situation. 8. Combined use with other oral diabetes drugs: gliclazide sustained-release tablets can be used in combination with biguanides, alpha-glucosidase inhibitors or insulin. 9. Patients who cannot be adequately controlled by gliclazide extended-release tablets should be treated with insulin at the beginning of treatment under close medical supervision. 10. For patients with mild or moderate renal insufficiency: The treatment plan is the same as that for patients with normal renal function, but careful monitoring is required. These data have been confirmed by clinical trials. 11. For patients at high risk of hypoglycemia: (1) malnutrition or malnutrition; (2) severe or poorly compensated endocrine diseases (anterior pituitary insufficiency, hypothyroidism, adrenal insufficiency); (3) withdrawal of long-term and/or high-dose corticosteroid treatment; (4) severe vascular diseases (severe coronary heart disease, severe carotid artery damage, diffuse vascular disease), it is recommended to start treatment with a minimum dose of 30 mg/day, or follow the doctor's advice.

1. Common adverse reactions: (1) Hypoglycemia: Like other sulfonylurea drugs, treatment with gliclazide extended-release tablets may cause hypoglycemia, especially when meal intervals are irregular or one or more meals are skipped. Hypoglycemia may have the following symptoms: headache, extreme hunger, nausea, vomiting, fatigue, drowsiness, sleep disorders, agitation, aggressive behavior, decreased concentration and attention, slow reaction, depression, mental confusion, visual and language disorders, aphasia, tremor, partial paralysis, sensory impairment, dizziness, fatigue, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, drowsiness and loss of consciousness and even coma to death. In addition, adrenergic counter-regulatory symptoms have been observed: sweating, moist skin, anxiety, tachycardia, hypertension, palpitations, angina and arrhythmia. These symptoms usually disappear after the intake of carbohydrates (sugar). However, artificial sugar substitutes are ineffective. For cases of long-term severe hypoglycemia, even if it is temporarily controlled by the absorption of glycosides, immediate drug treatment or even hospitalization may be required. (2) Gastrointestinal dysfunction: For example, abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation have been reported less frequently, but if gliclazide is taken at breakfast, these symptoms can be avoided or the risk can be minimized. 2. Rare adverse reactions: (1) Skin and subcutaneous tissue reactions: rash, itching, urticaria, erythema, maculopapular rash, and blistering. For other sulfonylurea drugs, there are very few cases of allergic nodular vasculitis. (2) Blood disorders: extremely rare, including anemia, leukopenia, thrombocytopenia, granulocytopenia, etc. These abnormalities are usually reversible and disappear when treatment is stopped. For other sulfonylurea drugs, a few cases of erythropenia, granulocytopenia, anemia and various blood cell reductions can be seen. (3) Hepatobiliary diseases: increased liver enzyme levels (AST, ALT, alkaline phosphatase), hepatitis (rare). If cholestatic jaundice occurs, discontinue treatment. Other sulfonylurea drugs may cause rare cases of elevated liver enzyme levels, liver dysfunction (cholestasis and jaundice), and even hepatitis. Symptoms subside after treatment is discontinued. Only a few cases have life-threatening liver failure. Usually these symptoms disappear after treatment is discontinued. (4) Visual impairment: Temporary visual impairment may be due to changes in blood sugar levels when treatment is started.

1. Known allergy to gliclazide or one of its excipients, other sulfonylureas, or sulfonamides; 2. Type 1 diabetes; 3. Pre-diabetic coma, diabetic ketoacidosis; 4. Severe renal or hepatic insufficiency: Insulin is recommended for these cases; 5. Patients treated with miconazole (see [Drug Interactions]); 6. Lactating period (see [Use in Pregnant and Lactating Women]).

Precautions for children: There is a lack of clinical studies or data in children. Precautions for pregnancy and lactation: 1. Pregnancy: There is a lack of clinical data on the use of gliclazide in pregnant women, and there is little data on other sulfonylurea drugs. In animals, gliclazide is non-teratogenic. In order to reduce the risk of congenital malformations in uncontrolled diabetes, diabetes must be controlled before pregnancy. Oral hypoglycemic drugs are not applicable during pregnancy, so insulin is used as a continued treatment for diabetes. It is recommended to switch from oral hypoglycemic drugs to insulin treatment when planning to become pregnant or when pregnancy is discovered. 2. Lactation: There is a lack of data on the entry of gliclazide and its metabolites into breast milk. Considering the risk of neonatal hypoglycemia, gliclazide is prohibited for lactating women. Precautions for the elderly: For patients over 65 years old, the administration of gliclazide extended-release tablets should follow the same treatment plan for patients under 65 years old, or follow the doctor's advice.

1. The following drugs may increase the risk of hypoglycemia. (1) Concomitant use is prohibited - Diclofenac (systemic route, oral gel): Increases the hypoglycemic effect and may cause hypoglycemic symptoms and even coma. (2) Concomitant use is not recommended - Phenylbutazone (systemic route): Increases the hypoglycemic effect of sulfonylurea drugs (replaces their binding to plasma proteins, or reduces their excretion). It is best to use a different anti-inflammatory agent, otherwise, warn the patient and emphasize the importance of self-monitoring: When used with anti-inflammatory agents, it is necessary to adjust the drug dosage during and after anti-inflammatory treatment. - Alcohol: Increases hypoglycemic reactions (by inhibiting compensatory reactions) and has the potential risk of hypoglycemic coma. Avoid alcohol or drugs containing alcohol. (3) Use with caution in combination The hypoglycemic effect may be enhanced. Hypoglycemia may occur in some cases when used with the following drugs. Other hypoglycemic drugs (insulin, acarbose, biguanides), beta-receptor blockers, fluconazole, angiotensin-converting enzyme inhibitors (captopril, enalapril), H2-receptor antagonists, MAOls, sulfonamides, nonsteroidal anti-inflammatory drugs. 2. The following drugs may cause blood sugar levels to increase (1) It is recommended not to use them together - Danazol: Diabetogenic effect. If the use of this drug cannot be avoided, the patient needs to be warned and the importance of self-monitoring urine sugar and blood sugar needs to be emphasized. The dose of diabetes medication needs to be adjusted when using and stopping danazol treatment. (2) Use with caution - Chlorpromazine (antipsychotic drug): Treatment with high doses of chlorpromazine (daily chlorpromazine dose of 100 mg) will increase blood sugar levels (reduce insulin release). The patient needs to be informed and the importance of self-monitoring blood sugar needs to be emphasized. The dose of diabetes medication needs to be adjusted during and after antipsychotic treatment. -Glucocorticoids (systemic and local routes: intra-articular, cutaneous and rectal preparations) and tebuconazole (corticotropin): Possible ketosis and increased blood glucose levels (decreased carbohydrate tolerance caused by adrenocortical hormones). Patients need to be informed and the importance of self-monitoring of blood glucose needs to be emphasized. The dose of diabetes medications needs to be adjusted during and after treatment with adrenocortical hormones. -Benzyl hydroxyephedrine, salbutamol, tributofol: (intravenous injection) Due to the beta-2 agonist effect, blood glucose levels are increased. The importance of self-monitoring of blood glucose needs to be emphasized. If necessary, switch to insulin. 3. Other issues to consider for combined medications -Anticoagulants (warfarin) In general use, sulfonylureas may cause potential anticoagulant effects. It may be necessary to consider adjusting the dose of the anticoagulant.

Sealed, store below 30℃.

30mg

36 months.

Zhongmao Bencao Pharmaceutical Co., Ltd.

• Founded in:

  2004-04-28

• Address:

  Economic Development Zone, Shizi Town, Langxi County, Xuancheng City, Anhui Province

• Tax NO.:

  913418217608460685

• Registered Funds:

  25.51 million yuan

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