pharmachologic effect
Hypoglycemic agent for oral use of the sulfonylurea group of the second generation
Diabepharm® MB is an oral hypoglycemic drug, a sulfonylurea derivative of the second generation. Stimulates insulin secretion (3-cells of the pancreas, enhances the insulin secretory effect of glucose, increases the sensitivity of peripheral tissues to insulin. Stimulates the activity of intracellular enzymes - muscle glycogen synthetase. Reduces the interval from the moment of food intake to the onset of insulin secretion. Restores the early peak of insulin secretion (unlike other sulfonylureas, which act primarily during the second stage of secretion) Reduces the postprandial increase in glucose levels.
In addition to influencing carbohydrate metabolism, it improves microcirculation: reduces platelet adhesion and aggregation, normalizes vascular permeability, prevents the development of microthrombosis and atherosclerosis, and restores the process of physiological parietal fibrinolysis. Reduces the sensitivity of vascular receptors to adrenaline. Slows down the development of diabetic retinopathy at the non-proliferative stage. In diabetic nephropathy, long-term use causes a significant decrease in the severity of proteinuria. Does not lead to weight gain, since it has a predominant effect on the early peak of insulin secretion and does not cause hyperinsulinemia; helps reduce body weight in obese patients when following an appropriate diet.
Directions for use and doses
The dose of the drug should be selected individually depending on the clinical manifestations of the disease, fasting glucose levels and 2 hours after meals. Typically, the initial daily dose (including for elderly people over 65 years of age) is 30 mg (1 tablet), then, if necessary, the dose of the drug is increased at intervals of at least 2 weeks. The maximum daily dose is 120 mg (4 tablets). The drug is taken orally 1 time per day in the morning, during breakfast.
Diabepharm® MB can replace Diabepharm in doses of 1 to 4 tablets per day.
Can be used in combination with other hypoglycemic agents: biguanides, alpha-glucosidase inhibitors or insulin.
Diabefarm® MV (Diabefarm MR)
GLICLAZIDE IS INTENDED FOR TREATMENT OF ADULT PATIENTS ONLY.
The recommended dose of gliclazide should be taken orally, 1 time per day (p/day), preferably during breakfast.
The daily dose can be 30 - 120 mg (in terms of the required number of tablets) per dose.
It is recommended to swallow the tablet or half of the tablet whole, without chewing or crushing.
If you miss one or more doses of the drug, you should not take a higher dose at the next dose; the missed dose should be taken the next day at the usual time.
As with other hypoglycemic drugs, the dose of gliclazide in each case must be adjusted depending on the concentration of glucose in the blood and HbAlc.
Initial dose
The initial recommended dose (including for elderly patients ≥ 65 years) is 30 mg 1 time / day.
If adequately controlled, gliclazide at this dose can be used for maintenance therapy. In case of inadequate glycemic control, the daily dose of gliclazide can be sequentially increased to 60, 90 or 120 mg (in terms of the required number of tablets).
An increase in dose is possible no earlier than after 1 month of therapy with gliclazide at the previously prescribed dose. The exception is patients whose blood glucose concentrations have not decreased after 2 weeks of therapy. In such cases, the dose of gliclazide can be increased 2 weeks after starting treatment.
The maximum recommended daily dose of gliclazide is 120 mg (in terms of the required number of tablets).
1 tablet of gliclazide extended release 60 mg is equivalent to 2 tablets of gliclazide extended release 30 mg.
The presence of a risk on 60 mg tablets allows you to divide the tablet and take a daily dose of both 30 mg (1/2 60 mg tablet) and, if necessary, 90 mg (1 and 1/2 60 mg tablets).
Switching from gliclazide regular-release tablets to gliclazide extended-release tablets
Gliclazide, tablets, 80 mg (regular release), can be replaced by gliclazide, extended-release tablets, at a dose of 30 mg (based on the required number of tablets). Careful glycemic control is recommended when switching patients from regular-release gliclazide to extended-release gliclazide.
Switching from another hypoglycemic drug to gliclazide
Gliclazide can be used instead of another PGGP. When switching to gliclazide in patients receiving other GGGPs, their dose and half-life should be taken into account. As a rule, no transition period is required. The initial dose of extended-release gliclazide should be 30 mg per day and then titrated according to blood glucose concentrations.
When replacing gliclazide with sulfonylurea derivatives with a long half-life, to avoid hypoglycemia caused by the additive effect of two hypoglycemic agents, you can stop taking them for several days. The initial dose of extended-release gliclazide is also 30 mg 1 time / day and, if necessary, can be increased further, as described above.
Combined use with another hypoglycemic drug
Gliclazide can be used in combination with biguanidines, α-glucosidase inhibitors or insulin.
If glycemic control is inadequate, additional insulin therapy should be prescribed with close medical supervision.
Elderly patients
No dose adjustment of gliclazide is required for patients over 65 years of age.
Patients with kidney failure
The results of clinical studies have shown that no dose adjustment of gliclazide is required in patients with mild to moderate renal failure. Close medical monitoring is recommended.
Patients at risk of developing hypoglycemia
In patients at risk of developing hypoglycemia (insufficient or unbalanced nutrition; severe or poorly compensated endocrine disorders (pituitary and adrenal insufficiency, hypothyroidism); withdrawal of GCS after their long-term use and/or use in high doses; severe diseases of the cardiovascular system - severe coronary heart disease, severe atherosclerosis of the carotid arteries, widespread atherosclerosis), it is recommended to use a minimum dose of gliclazide - 30 mg of the drug per day.
Prevention of complications of diabetes mellitus
To achieve intensive glycemic control, the dose of gliclazide can be gradually increased to 120 mg once a day in addition to diet and exercise until the target HbAlc value is achieved. The risk of hypoglycemia should be remembered. In addition, other hypoglycemic drugs, such as metformin, an α-glucosidase inhibitor, a thiazolidinedione drug, or insulin, can be added to therapy.
Children and adolescents under 18 years of age
There are no data on the effectiveness and safety of gliclazide in children and adolescents under 18 years of age.
Contraindications
- Hypersensitivity to the drug;
- diabetes mellitus type 1;
- diabetic ketoacidosis, diabetic precoma, diabetic coma;
- hyperosmolar coma;
- severe liver and/or kidney failure;
- major surgical interventions, extensive burns, injuries and other conditions requiring insulin therapy; intestinal obstruction, gastric paresis;
- conditions accompanied by impaired absorption of food, the development of hypoglycemia (infectious diseases);
- leukopenia;
- pregnancy,
- breastfeeding period;
- children under 18 years of age.
special instructions
Treatment with Diabepharm® MB is carried out in combination with a low-calorie, low-carbohydrate diet. It is necessary to regularly monitor blood glucose levels on an empty stomach and after meals.
In case of surgical interventions or in case of decompensation of diabetes, it is necessary to consider the possibility of using insulin preparations.
Patients should be warned about the increased risk of hypoglycemia when taking ethanol, nonsteroidal anti-inflammatory drugs, and fasting. If you take ethanol, it is also possible to develop disulfiram-like syndrome (abdominal pain, nausea, vomiting, headache).
It is necessary to adjust the dose of the drug in case of physical or emotional stress or changes in diet.
Elderly people are especially sensitive to the effects of hypoglycemic drugs; patients who do not receive a balanced diet; weakened patients; patients suffering from pituitary-adrenal insufficiency.
At the beginning of treatment, during dose selection, patients prone to developing hypoglycemia are not recommended to engage in activities that require increased attention and speed of psychomotor reactions.
Diabepharm MV, 30 pcs., 60 mg, extended-release tablets
The recommended dose of gliclazide should be taken orally, 1 time per day (p/day), preferably during breakfast.
The daily dose can be 30 - 120 mg (in terms of the required number of tablets) per dose.
It is recommended to swallow the tablet or half of the tablet whole, without chewing or crushing.
If you miss one or more doses of the drug, you should not take a higher dose at the next dose; the missed dose should be taken the next day at the usual time.
As with other hypoglycemic drugs, the dose of gliclazide in each case must be adjusted depending on the concentration of glucose in the blood and HbAlc.
Initial dose
The initial recommended dose (including for elderly patients ≥ 65 years) is 30 mg 1 time / day.
If adequately controlled, gliclazide at this dose can be used for maintenance therapy. In case of inadequate glycemic control, the daily dose of gliclazide can be sequentially increased to 60, 90 or 120 mg (in terms of the required number of tablets).
An increase in dose is possible no earlier than after 1 month of therapy with gliclazide at the previously prescribed dose. The exception is patients whose blood glucose concentrations have not decreased after 2 weeks of therapy. In such cases, the dose of gliclazide can be increased 2 weeks after starting treatment.
The maximum recommended daily dose of gliclazide is 120 mg (in terms of the required number of tablets).
1 tablet of gliclazide extended release 60 mg is equivalent to 2 tablets of gliclazide extended release 30 mg.
The presence of a risk on 60 mg tablets allows you to divide the tablet and take a daily dose of both 30 mg (1/2 60 mg tablet) and, if necessary, 90 mg (1 and 1/2 60 mg tablets).
Switching from gliclazide regular-release tablets to gliclazide extended-release tablets
Gliclazide, tablets, 80 mg (regular release), can be replaced by gliclazide, extended-release tablets, at a dose of 30 mg (based on the required number of tablets). Careful glycemic control is recommended when switching patients from regular-release gliclazide to extended-release gliclazide.
Switching from another hypoglycemic drug to gliclazide
Gliclazide can be used instead of another PGGP. When switching to gliclazide in patients receiving other GGGPs, their dose and half-life should be taken into account. As a rule, no transition period is required. The initial dose of extended-release gliclazide should be 30 mg per day and then titrated according to blood glucose concentrations.
When replacing gliclazide with sulfonylurea derivatives with a long half-life, to avoid hypoglycemia caused by the additive effect of two hypoglycemic agents, you can stop taking them for several days. The initial dose of extended-release gliclazide is also 30 mg 1 time / day and, if necessary, can be increased further, as described above.
Combined use with another hypoglycemic drug
Gliclazide can be used in combination with biguanidines, α-glucosidase inhibitors or insulin.
If glycemic control is inadequate, additional insulin therapy should be prescribed with close medical supervision.
Elderly patients
No dose adjustment of gliclazide is required for patients over 65 years of age.
Patients with kidney failure
The results of clinical studies have shown that no dose adjustment of gliclazide is required in patients with mild to moderate renal failure. Close medical monitoring is recommended.
Patients at risk of developing hypoglycemia
In patients at risk of developing hypoglycemia (insufficient or unbalanced nutrition; severe or poorly compensated endocrine disorders (pituitary and adrenal insufficiency, hypothyroidism); withdrawal of GCS after their long-term use and/or use in high doses; severe diseases of the cardiovascular system - severe coronary heart disease, severe atherosclerosis of the carotid arteries, widespread atherosclerosis), it is recommended to use a minimum dose of gliclazide - 30 mg of the drug per day.
Prevention of complications of diabetes mellitus
To achieve intensive glycemic control, the dose of gliclazide can be gradually increased to 120 mg once a day in addition to diet and exercise until the target HbAlc value is achieved. The risk of hypoglycemia should be remembered. In addition, other hypoglycemic drugs, such as metformin, an α-glucosidase inhibitor, a thiazolidinedione drug, or insulin, can be added to therapy.
Children and adolescents under 18 years of age
There are no data on the effectiveness and safety of gliclazide in children and adolescents under 18 years of age.
