Gliclazide MB, 30 mg 60 pcs

Gliclazide is a sulfonylurea derivative, an oral hypoglycemic drug that differs from similar drugs by the presence of an N-containing heterocyclic ring with an endocyclic bond. Gliclazide reduces blood glucose concentration by stimulating insulin secretion by β-cells of Langerhans islets. Increase of concentration of postprandial insulin and C-peptide is maintained after 2 years of therapy.

In addition to the effect on carbohydrate metabolism, gliclazide has hemovascular effects. In type 2 diabetes, gliclazide restores the early peak of insulin secretion in response to glucose intake and increases the second phase of insulin secretion. A significant increase in insulin secretion is observed in response to stimulation caused by food intake or glucose administration. Gliclazide reduces the risk of small vessel thrombosis by affecting the mechanisms that may contribute to the development of complications in diabetes: partial inhibition of platelet aggregation and adhesion and decrease of platelet-activating factors (beta thromboglobulin, thromboxane B2) and restoration of fibrinolytic activity of vascular endothelium and increase of tissue plasminogen activator activity.

Intensive glycemic control based on the use of gliclazide with modified release (target glycosylated hemoglobin (HbA1c) < 6.5%) significantly reduces the risk of micro- and macrovascular complications of type 2 diabetes compared to standard glycemic control (ADVANCE study).

Indications

Type 2 diabetes mellitus with insufficient effectiveness of diet therapy, physical activity and weight reduction.

Prevention of diabetes complications: reduction of risk of microvascular (nephropathy, retinopathy) and macrovascular complications (myocardial infarction, stroke) in patients with type 2 diabetes by intensive glycemic control.

Active ingredient

Composition

1 tablet contains the active ingredient:

gliclazid – 30.0 mg

How to take, the dosage

The drug is intended for adults only. The recommended dose of the drug should be taken orally, 1 time per day, preferably during breakfast. The daily dose is 30-120 mg (1-4 tablets) at once. It is recommended to swallow the tablet whole, without chewing or crushing.

If one or more doses of the drug are missed, the higher dose should be taken the next day. As with other hypoglycemic drugs, the dose of the drug in each case should be adjusted individually, depending on the blood glucose concentration and glycosylated hemoglobin (HbA1c). Initial recommended dose in adults who have not previously received treatment (including elderly patients aged ≥ 65 years) – 30 mg / day (1 tablet), then the dose is adjusted individually to achieve the desired result. No transition time is required when Gliclazide MB is replaced by another hypoglycemic agent. It is necessary to stop taking this drug first and only then take Gliclazide MB. The dose should be adjusted according to the blood glucose concentration after the start of treatment. Each subsequent dose adjustment can be made after a minimum of two weeks. The maintenance daily dose is 1 to 3 to 4 tablets and should not exceed 120 mg.

Glicliquid MB may be used in combination with biguanidines, alpha-glucosidase inhibitors, or insulin. The recommended doses of the drug for the elderly are identical to those for adults under 65 years of age. Recommended doses of the drug in mild to moderate renal insufficiency are identical to those in persons with normal renal function.

In patients at risk of hypoglycemia (insufficient or unbalanced diet; severe or poorly compensated endocrine disorders – pituitary and adrenal insufficiency, hypothyroidism; discontinuation of GCS after their long-term use and/or administration in high doses; severe cardiovascular diseases (severe coronary artery disease, severe carotid atherosclerosis, widespread atherosclerosis) a minimum dose (30 mg) of GliClazide MB is recommended.

To achieve intensive glycemic control, the dose of Gliclazide MB may be gradually increased to 120 mg/day in addition to diet and exercise until the target HbA1c level is achieved. The risk of hypoglycemia should be kept in mind. In addition, other hypoglycemic medications such as metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative, or insulin may be added to therapy.

Interaction

Gliclazide increases the effect of anticoagulants (warfarin), correction of anticoagulant dose may be required.
Miconazole (when administered systemically and when using gel on the oral mucosa) increases the hypoglycemic effect of the drug (possible development of hypoglycemia up to coma).
Phenylbutazone (systemic administration) increases the hypoglycemic effect of the drug (displaces it from binding to plasma proteins and/or slows excretion from the body), it is necessary to control blood glucose and adjust the dose of gliclazide, both during the administration of phenylbutazone and after its withdrawal.

Ethanol and ethanol-containing drugs increase hypoglycemia by inhibiting compensatory responses and may contribute to the development of hypoglycemic coma.

. When concomitantly administered with other hypoglycemic drugs (insulin, acarbose, biguanides), beta-adrenoblockers, fluconazole, angiotensin-converting enzyme inhibitors (captopril, enalapril), H2-histamine receptor blockers (cimetidine), monoamine oxidase inhibitors, sulfonamides and nonsteroidal anti-inflammatory drugs (NSAIDs) – increased hypoglycemic effect and risk of hypoglycemia.
Danazol – diabetogenic effect. Blood glucose levels should be controlled and the dose of gliclazide corrected, both during danazol administration and after its withdrawal.

Chlorpromazine in high doses (more than 100 mg/day) increases blood glucose levels, reducing insulin secretion. Blood glucose control and gliclazide dose adjustment is necessary, both during chlorpromazine administration and after its withdrawal
GCS (systemic, intraarticular, external, rectal use) increase blood glucose with possible development of ketoacidosis (reduced carbohydrate tolerance). Blood glucose control and gliclazide dose adjustment are necessary, both during GCS intake and after their withdrawal.

Ritodrine, salbutamol, terbutaline (intravenous administration) – increase blood glucose. It is recommended to control blood glucose and, if necessary, transfer the patient to insulin therapy.

Contraindications

Hypersensitivity to gliclazide or any of the excipients of the drug, other sulfonylurea derivatives, sulfonamides; type 1 diabetes mellitus; diabetic ketoacidosis, diabetic precoma, diabetic coma; severe renal or hepatic failure; taking miconazole; pregnancy and lactation; age under 18 years.

It is not recommended to use the drug simultaneously in combination with phenylbutazone or danazol.

Side effects

Hypoglycemia (in case of violation of the dosing regimen and inadequate diet): headache, increased fatigue, hunger, increased sweating, sudden weakness, palpitations, arrhythmia, increased blood pressure, drowsiness, insomnia, agitation, aggressiveness, anxiety, irritability, impaired concentration, inability to concentrate and slow reaction time, depression, visual disturbances, aphasia, tremors, paresis, sensory disturbances, dizziness, feelings of helplessness, loss of self-control, delirium, seizures, shallow breathing, bradycardia, loss of consciousness, coma.

Digestive system disorders: nausea, vomiting, diarrhea, abdominal pain, constipation (intensity of these symptoms decreases if taken with food); rarely – liver function disorders (hepatitis, cholestatic jaundice – requires discontinuation of the drug, increased activity of “liver” transaminases, alkaline phosphatase).

Hematopoietic organs: inhibition of medullary hematopoiesis (anemia, thrombocytopenia, leukopenia, granulocytopenia).

Allergic reactions: skin itching, urticaria, skin rash, including maculopapular and bullous), erythema.

Other: visual impairment.

General side effects of sulfonylurea derivatives: erythropenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis; life-threatening liver failure.

Overdose

Symptoms: hypoglycemia, impaired consciousness, hypoglycemic coma. Treatment: if the patient is conscious, take sugar by mouth.
Severe hypoglycemic states accompanied by coma, seizures or other neurological disorders may develop. If such symptoms occur, emergency medical assistance and immediate hospitalization is necessary.
If hypoglycemic coma is suspected or diagnosed, the patient is quickly injected intravenously with 50 ml of 40% dextrose (glucose) solution. Then a 5% solution of dextrose (glucose) is given intravenously by drip to maintain the necessary blood glucose level.

After recovery of consciousness, the patient should be given food rich in easily digestible carbohydrates (to avoid the recurrence of hypoglycemia). Close monitoring of blood glucose levels and observation of the patient should be carried out for at least 48 subsequent hours. After this period, depending on the condition of the patient, the attending physician will decide whether further observation is necessary. Dialysis is ineffective due to pronounced binding of gliclazide to plasma proteins.

Similarities