Diabeton MV (60 mg): instructions for use. Diabeton MB (60 mg): instructions for use Diabeton as part of combination therapy

Patients with the second type of diabetes do not need insulin injections for a long time, compensation for the disease in most of them can be achieved exclusively with tableted antidiabetic drugs. Diabeton MB 60 mg is one of these drugs, its action is based on the stimulation of its own production of insulin. In addition to the effect on carbohydrate metabolism, Diabeton has a protective and regenerating effect on blood vessels, improves the elasticity of their walls, and prevents atherosclerosis.

The drug is easy to take and has a minimum of contraindications, so it is widely used in the treatment of diabetes. Despite the apparent safety, you should not drink it without the approval of a doctor or exceed the dose. A prerequisite for the appointment of Diabeton is a proven lack of own insulin. While the pancreas is working normally, preference should be given to other hypoglycemic agents.

How the drug works

Diabeton has a medicinal effect on the body in diabetes due to the presence of gliclazide in its composition. All other components of the drug are auxiliary, thanks to them the structure of the tablet and its timely absorption are ensured. Gliclazide belongs to the group of sulfonylurea derivatives. It includes several substances with similar properties; in Russia, in addition to gliclazide, glibenclamide, glimeperide, and gliquidone are common.

The hypoglycemic effect of these drugs is based on their effect on beta cells. These are structures in the pancreas that synthesize insulin. After taking Diabeton, the release of insulin into the blood increases, and sugar decreases at the same time.

Diabeton is only effective if the beta cells are alive and still partially performing their functions. Therefore, the drug do not use in type 1 diabetes. Its appointment is also undesirable for the first time after the debut of type 2 disease. This type of diabetes is characterized by high production of insulin at the onset of carbohydrate disorders, and then a gradual fading of secretion after a few years.

High sugar at first is caused for the most part, that is, poor perception of the available insulin by the tissues. The main symptom of insulin resistance is excess weight in a patient. Therefore, if obesity is observed, Diabeton is not prescribed. At this time, drugs that reduce resistance are needed, such as Metformin (dose from 850 mg). Diabeton is included in the treatment regimen when deterioration in beta-cell function is established. It can be detected by analyzing the c-peptide. If the result is below 0.26 mmol / l, the appointment of Diabeton is justified.

Thanks to this tool, the production of insulin in diabetes approaches the physiological one: the peak of secretion returns in response to glucose that enters the blood from carbohydrate foods, and the production of the hormone in phase 2 increases.

In addition to stimulating beta cells, Diabeton and other gliclazide-based tablets have a significant effect on the rate of development of atherosclerotic changes in the vessels:

1. Act as an antioxidant. Diabetes is characterized by an increased production of free radicals and a weakening of the cells' protection from their effects. Due to the presence of an aminoazobicyclooctane group in the gliclazide molecule, dangerous free radicals are partially neutralized. The antioxidant effect is especially noticeable in small capillaries, therefore, when taking Diabeton, smoothing of symptoms is noted in patients with retinopathy and nephropathy.
2. Restore the properties of the vascular endothelium. This happens due to increased synthesis of nitric oxide in their walls.
3. Reduce the risk of thrombosis, as they reduce the ability of platelets to stick together.

The effectiveness of Diabeton is confirmed by research. When using it at a dose of 120 mg, a decrease in the frequency of vascular complications of diabetes by 10% was noted. The drug showed the best results in the protective effect on the kidneys, the risk of progress decreased by 21%, proteinuria - by 30%.

It has long been believed that sulfonylurea derivatives accelerate the destruction of beta cells, and hence the progression of diabetes. It has now been established that this is not the case. When you start taking Diabeton MB 60 mg, there is an increase in insulin secretion by an average of 30%, then every year this figure decreases by 5%. In patients who control sugar only with diet or diet and metformin, there is no decrease in synthesis for the first 2 years, then about 4% per year.

Application instruction of Diabeton MV

The letters MB in the name of the drug indicate that this is a modified release agent (English version MR - modified release). In a tablet, the active substance is placed between the fibers of hypromellose, which forms a gel in the gastrointestinal tract. Due to this structure, the drug is released longer, its action lasts for a day. Diabeton MB is produced in the form of tablets; when the tablet is divided into parts, the drug does not lose its prolonged effect.

On sale there are dosages of 30 and 60 mg. Take them once a day, best of all during breakfast. The tablet may be broken in half to reduce dosage, but should not be chewed or crushed into powder.

Normal, not MB, Diabeton is available with an increased dose of gliclazide - 80 mg, they drink it twice a day. Currently, it is considered obsolete and is practically not used, since the prolonged drug gives a more pronounced and stable effect.

Diabeton goes well with other hypoglycemic agents. Most often it is prescribed in combination with Metformin. If stimulating insulin production is not enough, in type 2 diabetes, tablets can be used along with insulin injections.

The initial dosage of Diabeton, regardless of the age and stage of diabetes in a patient, is 30 mg. At this dose, the remedy will have to be drunk for the entire first month of admission. If 30 mg is not enough for normal glycemic control, the dosage is increased to 60, after another month - up to 90, then - up to 120. Two tablets, or 120 mg - the maximum dose, should not be consumed more per day. If Diabeton in combination with other hypoglycemic drugs cannot provide normal sugar in type 2 diabetes, the patient is prescribed insulin.

If the patient used Diabeton 80 mg and wants to switch to a modern drug, the dose is calculated as follows: 1 tablet of the old drug is replaced by 30 mg of Diabeton MB. After the transition within a week, glycemia should be monitored more often than usual.

Admission during pregnancy and lactation

The potential effect of drugs on the fetus during pregnancy is investigated without fail. To determine the degree of risk, the FDA classification is most often used. In it, the active substances are grouped into classes according to the level of impact on the embryo. Almost all sulfonylurea drugs are class C. Animal studies have shown that they lead to impaired development of the child or toxic effects on him. Moreover, most of the changes are reversible, congenital anomalies did not occur. Due to the high risk, human studies have not been conducted.

Diabeton MB at any dose during pregnancy is prohibited, as are other oral remedies for diabetes. Instead, insulin preparations are prescribed. Switching to insulin should preferably be done during the planning period. If pregnancy occurs while taking Diabeton, the tablets must be immediately canceled.

Studies on the penetration of gliclazide into breast milk and through it into the child's body have not been conducted, therefore, Diabeton is not prescribed during breastfeeding.

Contraindications

The list of contraindications for taking Diabeton and its analogues:

1. Absolute lack of insulin due to damage to beta cells in type 1 diabetes or severe type 2 diabetes.
2. Childhood. The second type of diabetes in children is an extremely rare disease, so the effect of gliclazide on a growing body has not been studied.
3. The presence of skin reactions due to hypersensitivity to tablets: rash, itching.
4. Individual reactions in the form of proteinuria and joint pain.
5. Low sensitivity to the drug, which can be observed both from the beginning of the reception, and after a while. To overcome the threshold of sensitivity, you can try to increase its dose.
6. Acute complications of diabetes: and. At this time, a transition to insulin is required. After treatment, the intake of Diabeton is resumed.
7. Diabeton is broken down in the liver, so you can not drink it in case of liver failure.
8. After splitting, the drug is mostly excreted by the kidneys, so it is not used for nephropathy complicated by renal failure. The use of Diabeton is allowed if the GFR does not fall below 30.
9. Alcohol in combination with Diabeton increases the risk, so alcoholic beverages and drugs with ethanol are prohibited.
10. The use of miconazole, an antifungal agent, greatly increases insulin production and contributes to the development of severe. Miconazole should not be taken in tablets, administered intravenously and used as a gel for the oral mucosa. Miconazole shampoos and skin creams are allowed. If it is necessary to use miconazole, the dose of Diabeton should be temporarily reduced.

Side effects of the drug

The most common undesirable effect of Diabeton on the body is hypoglycemia caused by a lack of carbohydrates or an incorrectly determined dose of the drug. This is a condition in which sugar drops below a safe level. Hypoglycemia is accompanied by symptoms: internal trembling, headache, hunger. If sugar is not increased in time, the patient's nervous system may suffer. The risk of hypoglycemia after taking the drug is classified as frequent and is less than 5%. Due to the most natural effect of Diabeton on insulin synthesis, the likelihood of a dangerous decrease in sugar is lower than that of other drugs from the group. If the maximum dosage of 120 mg is exceeded, severe hypoglycemia may develop, up to coma and death.

A patient in this condition needs urgent hospitalization and intravenous glucose.

More rare side effects:

If diabetes has had high sugar for a long time, after the start of taking Diabeton, a temporary deterioration in vision may be observed. Most often, patients complain of a veil before their eyes or cloudiness. A similar effect is common with rapid normalization of glycemia and does not depend on the type of tablets. After a couple of weeks, the eyes will adjust to the new conditions, and vision will return. To reduce the drop in vision, the dose of the drug should be increased slowly, starting from the minimum.

Some drugs in combination with Diabeton can enhance its effect:

• all anti-inflammatory drugs, especially phenylbutazone;
• fluconazole, an antifungal drug from the same group as miconazole;
• ACE inhibitors - drugs to reduce pressure, often prescribed for diabetes (enalapril, Kapoten, Captopril, etc.);
• means for reducing acidity in the gastrointestinal tract - famotidine, nizatidine and others with an ending - tidine;
• streptocide, antibacterial agent;
• clarithromycin, an antibiotic;
• antidepressants related to monoamine oxidase inhibitors - moclobemide, selegiline.

It is desirable to replace these drugs with others with a similar effect. If replacement is not possible, the dose of Diabeton should be reduced during co-administration and sugar should be measured more often.

What can replace

Diabeton is the original preparation of gliclazide, the rights to the trade name belong to the French company Servier. In other countries it is sold under the name Diamicron MR. Diabeton is supplied to Russia directly from France or produced in a company owned by Servier (in this case, the manufacturer of Serdiks LLC is indicated on the package, such tablets are also original).

Other drugs with the same active ingredient and similar dosage are generics. It is believed that generics are not always as effective as the original. Despite this, home-made products with gliclazide have good patient reviews and are widely used in the treatment of diabetes. By prescription, patients most often receive drugs produced in Russia.

Analogues of Diabeton MV:

What do patients ask?

Question: I started taking Diabeton 5 years ago, gradually the dose increased from 60 mg to 120. For the last 2 months, sugar after eating, instead of the usual 7-8 mmol / l, has been about 10, sometimes even higher. What is the reason for the bad action of the remedy? How to return sugar to normal?

Answer: when taking Diabeton, it can be caused by several reasons. First, sensitivity to this drug may decrease. In this case, you can try other drugs from this group or limit yourself to other hypoglycemic agents. Secondly, with a long history of diabetes, the cells that produce insulin die. In this case, the only way out is insulin therapy. Thirdly, you need to review your diet. Perhaps the amount of carbohydrates in it has gradually increased.

Question: Two months ago I was diagnosed with type 2 diabetes. They prescribed Glucophage 850 in the morning, 1 tablet, there was no result. A month later, Glibenclamide 2.5 mg was added, sugar practically did not decrease. I'm going to the doctor soon. Whether it is necessary to ask to write out to me Diabeton?

Answer: Perhaps the prescribed dosage is insufficient. Glucophage per day needs 1500-2000 mg, 2-3 times a day. Glibenclamide can also be safely increased to 5 mg. There is a suspicion that you have been incorrectly diagnosed with the type of diabetes. It is necessary to undergo an additional examination and find out if the secretion of your own insulin is present and in what volume. If not, you will have to inject insulin.

Question: I have type 2 diabetes, overweight, I need to lose at least 15 kg. Are Diabeton and Reduxin normally combined? Will I need to reduce the dose of Diabeton after losing weight?

Answer: There are no contraindications to the simultaneous use of these drugs. But Reduxin can be unsafe. This remedy is prohibited for cardiovascular diseases and. If you are obese and have a significant history of diabetes, these contraindications are either present or expected in the near future. The best way to lose weight in this case is with restriction (but not cutting to a minimum!) Calories. Simultaneously with the loss of kilograms, insulin resistance will also decrease, the dose of Diabeton can be reduced.

Question: I have been drinking Diabeton for 2 years, fasting glucose is almost always normal. I recently noticed that when I sit for a long time, my feet go numb. At the appointment with a neurologist, they found a decrease in sensitivity. The doctor said that this symptom means the beginning of neuropathy. I always thought that complications arise only with high sugar. What's the matter? How to avoid neuropathy?

Answer: The main cause of complications is indeed hyperglycemia. At the same time, not only fasting glucose damages the nerves, but also any increase during the day. In order to find out now whether your diabetes is sufficiently compensated, you need to donate blood for. If the result is higher than normal, you need to contact your doctor to adjust the dose of Diabeton or prescribe other drugs. In the future, sugar should be measured not only in the morning, but also during the day, preferably 2 hours after each meal.

Question: My grandmother is 78, she has diabetes for over 10 years, she drinks Maninil and Siofor. For a long time, sugar remained close to normal, with a minimum of complications. Gradually, the pills began to help worse, increased the dose, anyway, sugar is more than 10. Recently, up to 15-17 mmol / l, my grandmother has a lot of bad symptoms, lies for half a day, has lost weight by size. Will there be any sense if Maninil is replaced with Diabeton? I heard that this drug is better.

Answer: If there is a decrease in the effect of hypoglycemic tablets at the same time as losing weight, then your own insulin is not enough. It's time for insulin therapy. Elderly people who cannot cope with the administration of the drug on their own are prescribed the traditional scheme - injections twice a day.

Gliclazide is a sulfonylurea derivative, an oral hypoglycemic drug that differs from similar drugs in 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 the islets of Langerhans. The increase in postprandial insulin and C-peptide levels persisted after 2 years of therapy. In addition to influencing carbohydrate metabolism, gliclazide has hemovascular effects. Influence on insulin secretion In type 2 diabetes, the drug restores an early peak of insulin secretion in response to glucose intake and enhances the second phase of insulin secretion. A significant increase in insulin secretion is observed in response to stimulation caused by food intake and glucose administration. Hemovascular effects Gliclazide reduces the risk of small vessel thrombosis by influencing the mechanisms that can cause the development of complications in diabetes mellitus: partial inhibition of platelet aggregation and adhesion and a decrease in the concentration of platelet activating factors (beta-thromboglobulin, thromboxane B2), as well as to restore the fibrinolytic activity of the vascular endothelium and increase the activity of tissue plasminogen activator. Intensive glycemic control based on the use of the drug Diabeton MB (glycosylated hemoglobin (HbA1c

Pharmacokinetics

Absorption After oral administration, gliclazide is completely absorbed. The concentration of gliclazide in plasma increases gradually over the first 6 hours, the plateau level is maintained from 6 to 12 hours. Individual variability is low. Food intake does not affect the rate or extent of absorption of gliclazide. Distribution Plasma protein binding is approximately 95% of gliclazide. Vd - about 30 liters. Taking the drug Diabeton MB at a dose of 60 mg 1 time / day ensures the maintenance of an effective concentration of gliclazide in the blood plasma for more than 24 hours. Metabolism Gliclazide is metabolized mainly in the liver. There are no active metabolites in plasma. Excretion T1 / 2 averages from 12 to 20 hours. Gliclazide is excreted mainly by the kidneys, excretion is carried out in the form of metabolites, less than 1% is excreted by the kidneys unchanged. Linearity The relationship between the dose taken (up to 120 mg) and AUC is linear. Pharmacokinetics in special clinical situations In the elderly, there are no significant changes in pharmacokinetic parameters.

Contraindications

The recommended dose of the drug should be taken orally, 1 time per day, preferably during breakfast. The daily dose can be 30-120 mg (1/2-2 tablets) at one time. It is recommended to swallow a tablet or half a tablet whole, without chewing or crushing. If you miss one or more doses of the drug, you should not take a higher dose on the next dose, the missed dose should be taken the next day. As with other hypoglycemic drugs, the dose of the drug in each case must be selected individually, depending on the concentration of blood glucose and HbA1c.

Precautionary measures

type 1 diabetes; diabetic ketoacidosis, precoma, coma; concomitant use of miconazole; for slender and thin people, these pills are especially harmful, read the article LADA-diabetes for more details; severe kidney and liver failure (in these cases, you need to inject insulin, and not take diabetes pills); concomitant use of miconazole; pregnancy and breastfeeding period; age up to 18 years; hypersensitivity to gliclazide, other sulfonylurea derivatives, excipients in tablets. Assign with caution: severe diseases of the cardiovascular system (heart failure, myocardial infarction, etc.); hypothyroidism - reduced function of the thyroid gland; adrenal or pituitary insufficiency; diseases of the liver or kidneys, including diabetic nephropathy; irregular or unbalanced diet, alcoholism; elderly people.

Use during pregnancy and lactation

Hypoglycemia When taking sulfonylurea derivatives, incl. and gliclazide, hypoglycemia may develop, and in some cases - in a severe and prolonged form, requiring hospitalization and intravenous administration of dextrose for several days (see section Side effects). The drug can only be prescribed to those patients whose meals are regular and includes breakfast. It is very important to maintain a sufficient intake of carbohydrates from food, because. the risk of developing hypoglycemia increases with irregular or insufficient nutrition, as well as with the consumption of food poor in carbohydrates. Hypoglycemia often develops with a low-calorie diet, after prolonged or vigorous exercise, after drinking alcohol, or when taking several hypoglycemic drugs at the same time. As a rule, the symptoms of hypoglycemia disappear after eating foods rich in carbohydrates (for example, sugar). It should be borne in mind that taking sweeteners does not help eliminate hypoglycemic symptoms. Experience with other sulfonylurea derivatives suggests that hypoglycemia may recur despite effective initial relief of this condition. In the event that hypoglycemic symptoms are pronounced or prolonged, even in the case of a temporary improvement in the condition after eating a meal rich in carbohydrates, it is necessary to provide emergency medical care, up to hospitalization. In order to avoid the development of hypoglycemia, careful individual selection of drugs and dosing regimen is necessary, and also providing the patient with complete information about the ongoing treatment. An increased risk of developing hypoglycemia can occur in the following cases: - refusal or inability of the patient (especially the elderly) to follow the doctor's prescriptions and control their condition; - insufficient and irregular nutrition, skipping meals, fasting and changing diet; - imbalance between physical activity and the amount of carbohydrates taken; - renal failure; - severe liver failure; - overdose of the drug Diabeton MB; - some endocrine disorders (thyroid diseases, pituitary and on renal insufficiency); - simultaneous administration of certain drugs. Hepatic / renal insufficiency In patients with hepatic insufficiency and / or severe renal insufficiency, the pharmacokinetic and / or pharmacodynamic properties of gliclazide may change. The hypoglycemia that develops in such patients can be quite prolonged, in such cases, immediate appropriate therapy is necessary. Information for patients It is necessary to inform the patient and his family about the risk of developing hypoglycemia, its symptoms and conditions that contribute to its development. The patient must be informed of the potential risks and benefits of the proposed treatment. The importance of diet, the need for regular exercise and blood glucose control should be explained to the patient. Inadequate glycemic control Glycemic control in patients receiving hypoglycemic therapy may be weakened in the following cases: fever, trauma, infectious diseases or major surgery. Under these conditions, it may be necessary to stop therapy with Diabeton MB and prescribe insulin therapy. In many patients, the effectiveness of oral hypoglycemic agents, incl. gliclazide, tends to decrease after an extended period of treatment. This effect may be due to both the progression of the disease and a decrease in the therapeutic response to the drug. This phenomenon is known as secondary drug resistance, which must be distinguished from primary, in which the drug does not give the expected clinical effect already at the first appointment. Before diagnosing secondary drug resistance in a patient, it is necessary to assess the adequacy of the dose selection and the patient's compliance with the prescribed diet. Control of laboratory parameters To assess glycemic control, regular determination of fasting blood glucose and glycated hemoglobin HbA1c levels is recommended. In addition, it is advisable to regularly carry out self-monitoring of blood glucose concentrations. Sulfonylureas can cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency. Since gliclazide is a sulfonylurea derivative, care must be taken when prescribing it to patients with glucose-6-phosphate dehydrogenase deficiency. The possibility of prescribing a hypoglycemic drug of another group should be evaluated. high speed of physical and mental reactions, especially at the beginning of therapy.

Dosage and administration

Indications for use Type 2 diabetes mellitus, if diet and exercise do not help enough. Prevention of complications of diabetes mellitus: reducing the risk of microvascular (nephropathy, retinopathy) and macrovascular complications (myocardial infarction, stroke) through intensive control of blood sugar.

Side effects

Drugs and substances that increase the risk of developing hypoglycemia (increasing the effect of gliclazide) Combinations are contraindicated introduction) enhances the hypoglycemic effect of sulfonylurea derivatives, tk. displaces them from their association with plasma proteins and / or slows down their excretion from the body. It is preferable to use another anti-inflammatory drug. If phenylbutazone is necessary, the patient should be warned about the need for glycemic control. If necessary, the dose of Diabeton MB should be adjusted while taking phenylbutazone and after it has ended. When used simultaneously with gliclazide, ethanol increases hypoglycemia, inhibiting compensatory reactions, and may contribute to the development of hypoglycemic coma. It is necessary to stop taking medicines containing ethanol and drinking alcohol. GPP-1); beta-blockers, fluconazole; ACE inhibitors - captopril, enalapril; blockers of histamine H2 receptors; MAO inhibitors; sulfonamides, clarithromycin, NSAIDs) is accompanied by an increase in the hypoglycemic effect and the risk of hypoglycemia. Drugs that increase blood glucose (weaken the effect of gliclazide) Combinations are not recommended Danazol has a diabetogenic effect. If taking this drug is necessary, the patient is advised to carefully monitor blood glucose. If it is necessary to take drugs together, it is recommended to select a dose of a hypoglycemic agent both during danazol administration and after its withdrawal. in the blood by decreasing insulin secretion. Careful glycemic control is recommended. If it is necessary to take drugs together, it is recommended to select a dose of a hypoglycemic agent both during the administration of an antipsychotic and after its withdrawal. With the simultaneous use of GCS (for systemic and local use - intraarticular, cutaneous, rectal administration) and tetracosactide increase the concentration of glucose in the blood with the possible development of ketoacidosis (decrease in carbohydrate tolerance). Careful glycemic control is recommended, especially at the start of treatment. If it is necessary to take drugs together, it may be necessary to adjust the dose of the hypoglycemic agent both during the administration of corticosteroids and after their withdrawal. special attention to the importance of self-glycemic control. If necessary, it is recommended to transfer the patient to insulin therapy. Combinations that should be taken into account Sulfonylureas may increase the effect of anticoagulants (eg warfarin) when taken together. Dose adjustment of the anticoagulant may be required.

Overdose

The most dangerous side effect is low blood sugar, hypoglycemia. Its symptoms: headache, fatigue, irritability, nightmares, palpitations. In severe cases, the patient may lose consciousness. Read the article "Hypoglycemia - symptoms, treatment and prevention" for more details. Diabeton MB causes severe hypoglycemia less frequently than other sulfonylurea drugs. Other side effects - abdominal pain, nausea, vomiting, diarrhea, constipation, rash, itchy skin, increased activity of liver enzymes (AST, ALT, alkaline phosphatase). At the beginning of taking Diabeton, there may be temporary visual disturbances - due to the fact that blood sugar quickly drops. Hepatitis and jaundice are also possible, but rarely. Adverse changes in blood composition are extremely rare.

Interaction with other drugs

special instructions

In case of an overdose of sulfonylurea derivatives, hypoglycemia may develop. Treatment: if moderate symptoms of hypoglycemia occur, increase carbohydrate intake with food, reduce the dose of the drug and / or change the diet. Careful monitoring of the patient's condition should be continued until the attending physician is sure that nothing threatens the patient's health. Severe hypoglycemic conditions may develop, accompanied by coma, convulsions or other neurological disorders. If such symptoms appear, it is necessary to provide emergency medical care and immediate hospitalization. In the case of a hypoglycemic coma or suspicion of it, the patient is injected intravenously with 50 ml of a 20-30% dextrose (glucose) solution. Then in / in drip 10% dextrose solution to maintain the concentration of glucose in the blood above 1 g / l. Careful monitoring of blood glucose levels and monitoring of the patient should be carried out for at least the next 48 hours. Then, depending on the patient's condition, the need for further monitoring should be decided. Dialysis is ineffective due to the pronounced binding of gliclazide to plasma proteins.

Last update of the description by the manufacturer 16.09.2015

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Description of the dosage form

White, biconvex, oval tablets, scored and debossed "DIA" "60" on both sides.

pharmachologic effect

Pharmacodynamics

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 lowers blood glucose levels by stimulating insulin secretion from the beta cells of the islets of Langerhans. The increase in the concentration of postprandial insulin and C-peptide persists after 2 years of therapy.

In addition to the effect on carbohydrate metabolism, gliclazide has hemovascular effects.

Influence on insulin secretion

In type 2 diabetes, the drug restores the early peak of insulin secretion in response to glucose intake and enhances 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.

Hemovascular effects

Gliclazide reduces the risk of thrombosis of small vessels, affecting the mechanisms that can cause the development of complications in diabetes mellitus: it partially inhibits platelet aggregation and adhesion and reduces the concentration of platelet activating factors (beta-thromboglobulin, thromboxane B 2), and also restores the fibrinolytic activity of the vascular endothelium and increases the activity of tissue plasminogen activator.

Intensive glycemic control based on the use of Diabeton ® MB (HbA1c<6,5%), достоверно снижает микро- и макрососудистые осложнения сахарного диабета типа 2 в сравнении со стандартным гликемическим контролем (исследование ADVANCE).

The strategy of intensive glycemic control included the appointment of Diabeton ® MB and an increase in its dose on the background of (or instead of) standard therapy before adding another hypoglycemic drug (for example, metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative, or insulin) to it. The average daily dose of the drug Diabeton ® MB in patients in the intensive control group was 103 mg, the maximum daily dose was 120 mg.

Against the background of the use of the drug Diabeton ® MB in the intensive glycemic control group (mean follow-up 4.8 years, mean HbA1c level - 6.5%) compared with the standard control group (mean HbA1c level - 7.3%), a significant decrease in 10% relative risk of combined macro- and microvascular complications.

The advantage was achieved by significantly reducing the relative risk of major microvascular complications by 14%, the occurrence and progression of nephropathy by 21%, the occurrence of microalbuminuria by 9%, macroalbuminuria by 30% and the development of renal complications by 11%.

The benefits of intensive glycemic control while taking the drug Diabeton ® MB did not depend on the benefits achieved against the background of antihypertensive therapy.

Pharmacokinetics

Suction

After oral administration, gliclazide is completely absorbed. The concentration of gliclazide in plasma increases gradually, during the first 6 hours, the plateau level is maintained from 6 to 12 hours. Individual variability is low.

Eating does not affect the degree of absorption of gliclazide.

Distribution

Approximately 95% of gliclazide binds to plasma proteins. V d - about 30 liters. Taking the drug Diabeton ® MB at a dose of 60 mg 1 time per day ensures the maintenance of an effective concentration of gliclazide in the blood plasma for more than 24 hours.

Metabolism

Gliclazide is metabolized primarily in the liver. There are no active metabolites in plasma.

breeding

Gliclazide is excreted mainly by the kidneys: excretion is carried out in the form of metabolites, less than 1% is excreted by the kidneys unchanged. T 1/2 gliclazide averages from 12 to 20 hours.

Linearity

The relationship between the dose taken (up to 120 mg) and AUC is linear.

Special populations

Elderly people. In the elderly, there are no significant changes in pharmacokinetic parameters.

Indications for Diabeton ® MB

type 2 diabetes mellitus with insufficient effectiveness of diet therapy, physical activity and weight loss;

prevention of complications of diabetes mellitus: reducing the risk of microvascular (nephropathy, retinopathy) and macrovascular complications (myocardial infarction, stroke) in patients with type 2 diabetes mellitus through intensive glycemic control.

Contraindications

hypersensitivity to gliclazide, other sulfonylurea derivatives, sulfonamides or excipients that make up the drug;

diabetes mellitus type 1;

diabetic ketoacidosis, diabetic precoma, diabetic coma;

severe renal or hepatic insufficiency (in these cases it is recommended to use insulin);

taking miconazole (see "Interaction");

pregnancy and lactation (see "Use during pregnancy and lactation");

age up to 18 years.

Due to the fact that the drug contains lactose, Diabeton ® MB is not recommended for patients with congenital lactose intolerance, galactosemia, glucose-galactose malabsorption.

Carefully: old age, irregular and / or unbalanced diet, glucose-6-phosphate dehydrogenase deficiency, severe cardiovascular disease, hypothyroidism, adrenal or pituitary insufficiency, renal and / or liver failure, long-term corticosteroid therapy, alcoholism.

Use during pregnancy and lactation

Pregnancy

There is no experience with the use of gliclazide during pregnancy. Data on the use of other sulfonylurea derivatives during pregnancy are limited.

In studies on laboratory animals, teratogenic effects of gliclazide have not been identified.

To reduce the risk of congenital malformations, optimal control (appropriate therapy) of diabetes mellitus is necessary.

Oral hypoglycemic drugs are not used during pregnancy. Insulin is the drug of choice for the treatment of diabetes in pregnant women. It is recommended to replace the intake of oral hypoglycemic drugs with insulin therapy both in the case of a planned pregnancy and if the pregnancy occurred while taking the drug.

Lactation

Taking into account the lack of data on the intake of gliclazide in breast milk and the risk of developing neonatal hypoglycemia, breastfeeding is contraindicated during drug therapy.

Side effects

Given the experience of using gliclazide, one should be aware of the possibility of developing the following side effects.

hypoglycemia

Like other drugs of the sulfonylurea group, Diabeton ® MB can cause hypoglycemia in case of irregular meals and especially if meals are skipped. Possible symptoms of hypoglycemia: headache, severe hunger, nausea, vomiting, fatigue, sleep disturbance, irritability, agitation, decreased concentration, slow reaction, depression, confusion, impaired vision and speech, aphasia, tremor, paresis, loss of self-control , a feeling of helplessness, impaired perception, dizziness, weakness, convulsions, bradycardia, delirium, shallow breathing, drowsiness, loss of consciousness with the possible development of coma, up to death.

Adrenergic reactions may also be noted: increased sweating, clammy skin, anxiety, tachycardia, increased blood pressure, palpitations, arrhythmia and angina pectoris.

As a rule, the symptoms of hypoglycemia are stopped by the intake of carbohydrates (sugar). Sweeteners are ineffective. Against the background of other sulfonylurea derivatives, relapses of hypoglycemia were noted after its successful relief.

In severe or prolonged hypoglycemia, emergency medical attention is indicated, possibly with hospitalization, even if there is an effect from carbohydrate intake.

Other side effects

From the gastrointestinal tract: abdominal pain, nausea, vomiting, diarrhea, constipation. Taking the drug during breakfast avoids or minimizes these symptoms.

The following side effects are less common.

From the skin and subcutaneous tissue: rash, pruritus, urticaria, angioedema, erythema, maculopapular rash, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis).

From the circulatory and lymphatic system: hematological disorders (anemia, leukopenia, thrombocytopenia, granulocytopenia) rarely develop. As a rule, these phenomena are reversible in the event of discontinuation of therapy.

From the side of the liver and biliary tract: increased activity of liver enzymes (AST, ALT, alkaline phosphatase), hepatitis (isolated cases). If cholestatic jaundice occurs, therapy should be discontinued.

These effects are usually reversible upon discontinuation of therapy.

From the side of the organ of vision: transient visual disturbances may occur due to changes in blood glucose concentration, especially at the beginning of therapy.

Side effects inherent in sulfonylurea derivatives: as well as against the background of taking other sulfonylurea derivatives, the following side effects were noted: erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis, hyponatremia. There was an increase in the activity of liver enzymes, impaired liver function (for example, with the development of cholestasis and jaundice) and hepatitis; manifestations decreased over time after discontinuation of sulfonylurea drugs, but in some cases led to life-threatening liver failure.

Side effects reported in clinical studies

In the study ADVANCE there was a slight difference in the frequency of various serious adverse events between the two groups of patients. No new safety data has been received. A small number of patients experienced severe hypoglycemia, but the overall incidence of hypoglycemia was low. The incidence of hypoglycemia in the intensive glycemic control group was higher than in the standard glycemic control group. Most episodes of hypoglycemia in the intensive glycemic control group occurred during concomitant insulin therapy.

Interaction

1. Drugs and substances that increase the risk of developing hypoglycemia (enhancing the effect of gliclazide)

Contraindicated combinations

Miconazole (with systemic administration and when using the gel on the oral mucosa): enhances the hypoglycemic effect of gliclazide (hypoglycemia may develop up to a coma).

Phenylbutazone (systemic administration): enhances the hypoglycemic effect of sulfonylurea derivatives (displaces them from the connection with plasma proteins and / or slows down their excretion from the body).

It is preferable to use another anti-inflammatory drug. If phenylbutazone is necessary, the patient should be warned about the need for glycemic control. If necessary, the dose of the drug Diabeton ® MB should be adjusted during the administration of phenylbutazone and after its completion.

Ethanol: enhances hypoglycemia, inhibiting compensatory reactions, may contribute to the development of hypoglycemic coma. It is necessary to stop taking drugs, which include ethanol, and drinking alcohol.

Taking gliclazide in combination with certain drugs: other hypoglycemic agents (insulin, acarbose, metformin, thiazolidinidiones, dipeptidyl peptidase-4 inhibitors, GLP-1 agonists); beta-blockers, fluconazole; ACE inhibitors - captopril, enalapril; blockers of histamine H 2 receptors; MAO inhibitors; sulfonamides; clarithromycin and NSAIDs is accompanied by an increase in the hypoglycemic effect and the risk of hypoglycemia.

2. Drugs that increase blood glucose (weaken the effect of gliclazide)

Danazol: has a diabetic effect. In the event that taking this drug is necessary, the patient is advised to carefully monitor blood glucose. If it is necessary to take drugs together, it is recommended to select a dose of a hypoglycemic agent both during the administration of danazol and after its withdrawal.

Combinations requiring precautions

Chlorpromazine (neuroleptic): in high doses (> 100 mg / day) increases the concentration of glucose in the blood, reducing insulin secretion. Careful glycemic control is recommended. If it is necessary to take drugs together, it is recommended to select a dose of a hypoglycemic agent, both during the administration of an antipsychotic and after its withdrawal.

GCS (systemic and local use - intraarticular, cutaneous, rectal administration) and tetracosactide: increase the concentration of blood glucose with the possible development of ketoacidosis (decrease in carbohydrate tolerance). Careful glycemic control is recommended, especially at the start of treatment. If it is necessary to take drugs together, it may be necessary to adjust the dose of the hypoglycemic agent, both during the administration of GCS and after their withdrawal.

Ritodrine, salbutamol, terbutaline (in / in the introduction): beta 2-adrenergic agonists increase the concentration of blood glucose.

Emphasis should be placed on the importance of self-glycemic control. If necessary, it is recommended to transfer the patient to insulin therapy.

3. Combinations to be taken into account

Anticoagulants (eg warfarin). Sulfonylureas may enhance the effect of anticoagulants when taken together. Dose adjustment of the anticoagulant may be required.

Dosage and administration

The drug is intended only for the treatment of adults.

The daily dose can be 30-120 mg (1/2-2 tablets) at one time.

If you miss one or more doses of the drug, you should not take a higher dose on the next dose, the missed dose should be taken the next day.

As with other hypoglycemic drugs, the dose of the drug in each case must be selected individually, depending on the concentration of blood glucose and the level of HbA1c.

In the case of adequate control, the drug at this dose can be used for maintenance therapy. With inadequate glycemic control, the daily dose of the drug can be sequentially increased to 60, 90 or 120 mg.

Increasing the dose is possible not earlier than after 1 month of drug therapy at the previously prescribed dose. The exception is patients in whom the concentration of blood glucose has not decreased after 2 weeks of therapy. In such cases, the dose of the drug may be increased 2 weeks after the start of treatment.

1 tab. drug Diabeton ® MB tablets with a modified release of 60 mg is equivalent to 2 tables. Diabeton ® MB modified release tablets 30 mg. The presence of a notch on 60 mg tablets allows you to divide the tablet and take a daily dose of both 30 mg (1/2 tab. 60 mg) and, if necessary, 90 mg (1 and 1/2 tab. 60 mg).

Switching from taking the drug Diabeton ® tablets 80 mg to the drug Diabeton ® MB tablets with modified release 60 mg

1 tab. drug Diabeton ® 80 mg can be replaced by 1/2 tab. drug Diabeton ® MB modified release 60 mg. When transferring patients from the drug Diabeton ® 80 mg to the drug Diabeton ® MB, careful glycemic control is recommended.

Switching from taking another hypoglycemic drug to Diabeton ® MB modified release tablets 60 mg

The drug Diabeton ® MB tablets with a modified release of 60 mg can be used instead of other hypoglycemic drugs for oral administration. When transferring to Diabeton ® MB in patients receiving other hypoglycemic drugs for oral administration, their dose and T 1/2 should be taken into account. As a rule, no transition period is required. The initial dose should be 30 mg and then should be titrated depending on the concentration of blood glucose.

When replacing sulfonylurea derivatives with a long T 1/2 with Diabeton ® MB, to avoid hypoglycemia caused by the additive effect of two hypoglycemic agents, you can stop taking them for several days. The initial dose of the drug Diabeton ® MB in this case is also 30 mg (1/2 tab. 60 mg) and, if necessary, can be increased further, as described above.

Combined reception with other hypoglycemic drugs

Diabeton ® MB can be used in combination with biguanidines, alpha-glucosidase inhibitors or insulin.

In case of inadequate glycemic control, additional insulin therapy should be prescribed with careful medical monitoring.

Elderly patients

Dose adjustment for patients over 65 years of age is not required.

Patients with renal insufficiency

The results of clinical studies have shown that dose adjustment of the drug in patients with mild to moderate renal insufficiency is not required. Careful 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 corticosteroids after their long-term use and / or high doses; severe cardiovascular disease - severe coronary artery disease, severe atherosclerosis of the carotid arteries, widespread atherosclerosis), it is recommended to use the minimum dose (30 mg) of Diabeton ® MB.

Prevention of complications of diabetes

To achieve intensive glycemic control, you can gradually increase the dose of Diabeton ® MB to 120 mg / day in addition to diet and exercise until the target HbA1c level is reached. Be aware of the risk of hypoglycemia. In addition, other hypoglycemic drugs can be added to therapy, for example, metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative, or insulin.

Children and adolescents under the age of 18

Data on the efficacy and safety of the drug in children and adolescents under the age of 18 are not available.

Overdose

In case of an overdose of sulfonylurea derivatives, hypoglycemia may develop.

If moderate symptoms of hypoglycemia occur without impaired consciousness or neurological symptoms, you should increase the intake of carbohydrates with food, reduce the dose of the drug and / or change the diet. Close medical monitoring of the patient's condition should continue until there is confidence that nothing threatens his health.

Perhaps the development of severe hypoglycemic conditions, accompanied by coma, convulsions or other neurological disorders. When such symptoms appear, emergency medical care and immediate hospitalization are necessary.

In the case of hypoglycemic coma or if it is suspected, the patient is injected intravenously with 50 ml of a 20-30% dextrose (glucose) solution. Then, a 10% dextrose solution is injected intravenously to maintain the concentration of glucose in the blood above 1 g / l. Careful monitoring of blood glucose levels and observation of the patient must be carried out for at least 48 subsequent hours. After this period of time, depending on the condition of the patient, the attending physician decides on the need for further observation.

Dialysis is ineffective due to the pronounced binding of gliclazide to plasma proteins.

special instructions

hypoglycemia

When taking sulfonylurea derivatives, incl. and gliclazide, hypoglycemia may develop, in some cases - in a severe and prolonged form, requiring hospitalization and intravenous administration of a dextrose solution for several days (see "Side Effects").

The drug can be prescribed only to those patients whose meals are regular and include breakfast. It is very important to maintain a sufficient intake of carbohydrates from food, because. the risk of developing hypoglycemia increases with irregular or insufficient nutrition, as well as with the consumption of food poor in carbohydrates. Hypoglycemia often develops with a low-calorie diet, after prolonged or vigorous exercise, after drinking alcohol, or when taking several hypoglycemic drugs at the same time.

As a rule, the symptoms of hypoglycemia disappear after eating a meal rich in carbohydrates (such as sugar). It should be borne in mind that taking sweeteners does not help eliminate hypoglycemic symptoms. Experience with other sulfonylurea derivatives suggests that hypoglycemia may recur despite effective initial relief of this condition. If hypoglycemic symptoms are pronounced or prolonged, even in the case of a temporary improvement in the condition after eating a meal rich in carbohydrates, it is necessary to provide emergency medical care, up to hospitalization.

In order to avoid the development of hypoglycemia, careful individual selection of drugs and dosing regimen is necessary, as well as providing the patient with complete information about the treatment being carried out.

An increased risk of developing hypoglycemia may occur in the following cases:

Refusal or inability of the patient (especially the elderly) to follow the doctor's prescriptions and control their condition;

Insufficient and irregular nutrition, skipping meals, fasting and changing diet;

Imbalance between physical activity and the amount of carbohydrates taken;

kidney failure;

severe liver failure;

Overdose of the drug Diabeton ® MB;

Some endocrine disorders: thyroid disease, pituitary and adrenal insufficiency;

Simultaneous reception of some drugs (see "Interaction").

Renal and liver failure

In patients with hepatic and / or severe renal insufficiency, the pharmacokinetic and / or pharmacodynamic properties of gliclazide may change. The state of hypoglycemia that develops in such patients can be quite long, in such cases, immediate appropriate therapy is necessary.

Information for patients

It is necessary to inform the patient, as well as his family members, about the risk of developing hypoglycemia, the symptoms and conditions that contribute to its development. The patient should be informed of the potential risks and benefits of the proposed treatment.

The patient should be explained the importance of diet, the need for regular exercise and control of blood glucose levels.

Poor glycemic control

Glycemic control in patients receiving therapy with hypoglycemic agents may be impaired in the following cases: fever, trauma, infectious diseases, or major surgery. Under these conditions, it may be necessary to stop therapy with Diabeton ® MB and prescribe insulin therapy.

In many patients, the effectiveness of oral hypoglycemic agents, incl. gliclazide, tends to decrease after an extended period of treatment. This effect may be due to both the progression of the disease and a decrease in the therapeutic response to the drug. This phenomenon is known as secondary drug resistance, which must be distinguished from primary, in which the drug does not give the expected clinical effect already at the first appointment. Before diagnosing secondary drug resistance in a patient, it is necessary to assess the adequacy of dose selection and patient compliance with the prescribed diet.

Laboratory tests

Sulfonylureas can cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency. Since gliclazide is a sulfonylurea derivative, care must be taken when prescribing it to patients with glucose-6-phosphate dehydrogenase deficiency. The possibility of prescribing a hypoglycemic drug of another group should be evaluated.

Influence on the ability to drive vehicles and mechanisms

In connection with the possible development of hypoglycemia when using the drug Diabeton ® MB, patients should be aware of the symptoms of hypoglycemia and be careful while driving vehicles or performing work that requires a high rate of physical and mental reactions, especially at the beginning of therapy.

Release form

Modified release tablets, 60 mg.

Diabeton MB is a drug designed to treat type 2 diabetes mellitus.

The active ingredient of the drug is gliclazide, which stimulates the beta cells of the pancreas to produce more insulin, which causes a decrease in blood sugar. MB designation for modified release tablets. Gliclazide is a sulfonylurea derivative. From the tablets, gliclazide is released for 24 hours in uniform proportions, which is a plus in the treatment of diabetes.

On this page you will find all the information about Diabeton MB: full instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Diabeton MB. Want to leave your opinion? Please write in the comments.

Clinical and pharmacological group

Oral hypoglycemic drug.

Terms of dispensing from pharmacies

Released by prescription.

Prices

How much does Diabeton MV cost? The average price in pharmacies is at the level of 350 rubles.

Release form and composition

"Diabeton" is produced in the following forms:

• Tablets 80 mg.
• Tablets with modified release "Diabeton MV" 60 mg.

The active substance of the drug is gliclazide - 80 mg (60 mg). The composition includes excipients: maltodextrin, magnesium stearate, hypromellose 100 cP, lactose monohydrate, anhydrous colloidal silicon dioxide.

Pharmacological effect

The active component of Diabeton (gliclazide) has a pronounced hypoglycemic effect, effectively reducing the concentration of glucose in the blood and stimulating the secretion of insulin by β-cells of the islets of Langerhans.

Diabeton against the background of type 2 diabetes mellitus in response to the intake of glucose contributes to the restoration of the early peak of insulin secretion and at the same time enhances the second phase of its secretion. In addition, Diabeton, according to the instructions, reduces the risk of developing thrombosis of small vessels, influencing the mechanisms that are the main factors in the development of complications of diabetes mellitus.

Indications for use

According to the instructions, Diabeton is prescribed:

1. When treating against the background of insufficient effectiveness from physical exertion and diet therapy;
2. For the prevention of complications of diabetes mellitus - reducing the risk of development, retinopathy, and nephropathy.

Contraindications

This medicinal product can only be used on the prescription of a doctor after a thorough examination and determination of the type of diabetes mellitus. Diabeton MV tablets have the following limitations and contraindications:

1. Age less than 18 years;
2. Ketoacidosis against the background of diabetes mellitus;
3. Lactase deficiency or galactosemia;
4. The period of pregnancy and breastfeeding;
5. severe renal or hepatic insufficiency;
6. Individual intolerance to the components of the drug;
7. Diabetic coma in a patient - the introduction of this drug can only aggravate the patient's condition.

With special care, the drug Diabeton MB is prescribed to patients with abnormalities in the work of the heart, hypothyroidism, chronic alcoholism, against the background of glucocorticosteroid therapy, and elderly patients.

Use during pregnancy and lactation

Diabeton MB at any dose during pregnancy is prohibited, as are other oral remedies for diabetes. Instead, insulin preparations are prescribed. Switching to insulin should preferably be done during the planning period. If pregnancy occurs while taking Diabeton, the tablets must be immediately canceled.

Studies on the penetration of gliclazide into breast milk and through it into the child's body have not been conducted, therefore, Diabeton is not prescribed during breastfeeding.

Instructions for use

The instructions for use indicate that Diabeton MB is intended only for the treatment of adults. The recommended dose of the drug should be taken orally, 1 time / day, preferably during breakfast.

• The daily dose is 30-120 mg (1/2-2 tab.) in 1 dose. It is recommended to swallow a tablet or half a tablet whole, without chewing or crushing.

If you miss one or more doses of the drug, you should not take a higher dose on the next dose, the missed dose should be taken the next day. As with other hypoglycemic drugs, the dose of the drug in each case must be selected individually, depending on the concentration of blood glucose and HbA1c.

• The initial recommended dose for adults (including for elderly patients ≥ 65 years) is 30 mg (1/2 tab.) / day.

In the case of adequate control, the drug at this dose can be used for maintenance therapy. With inadequate glycemic control, the daily dose of the drug can be sequentially increased to 60 mg, 90 mg or 120 mg. Increasing the dose is possible not earlier than after 1 month of drug therapy at the previously prescribed dose. The exception is patients in whom the concentration of blood glucose has not decreased after 2 weeks of therapy. In such cases, the dose of the drug may be increased 2 weeks after the start of treatment.

• The maximum recommended daily dose of the drug is 120 mg.

One tablet of the drug Diabeton MB tablets with a modified release of 60 mg is equivalent to 2 tab. of the drug Diabeton MV tablets with a modified release of 30 mg. The presence of a notch on 60 mg tablets allows you to divide the tablet and take a daily dose of both 30 mg (1/2 tab. 60 mg) and, if necessary, 90 mg (1 tab. 60 mg and 1/2 tab. 60 mg).

Side effects

The most dangerous side effect is low blood sugar, hypoglycemia. Its symptoms: headache, fatigue, irritability, nightmares, palpitations. In severe cases, the patient may lose consciousness.

Diabeton MB causes severe hypoglycemia less frequently than other sulfonylurea drugs. Other side effects - abdominal pain, nausea, vomiting, diarrhea, constipation, rash, itchy skin, increased activity of liver enzymes (AST, ALT, alkaline phosphatase). At the beginning of taking Diabeton, there may be temporary visual disturbances - due to the fact that blood sugar quickly drops. Hepatitis and jaundice are also possible, but rarely.

Adverse changes in blood composition are extremely rare.

Overdose

In case of an overdose of sulfonylurea derivatives, hypoglycemia may develop. Your blood sugar will drop below normal, which is dangerous. Mild hypoglycemia can be managed on its own, but in severe cases, emergency medical attention is required.

special instructions

After a long period of treatment, the effectiveness of Diabeton MB may decrease. This may be due to the progression of the disease or a decrease in the therapeutic response to the action of the drug - secondary drug resistance. Before diagnosing this disorder, it is necessary to assess the adequacy of dose selection and patient compliance with the prescribed diet.

During therapy, hypoglycemia may develop, and in some cases - in a prolonged / severe form, which requires hospitalization and intravenous administration of dextrose for several days. To avoid the development of hypoglycemia, careful individual selection of drugs and dosing regimen is required.

The likelihood of developing hypoglycemia increases in the following cases:

• kidney failure;
• severe liver failure;
• overdose of Diabeton MB;
• combined use with certain drugs;
• imbalance between the amount of carbohydrates taken and physical activity;
• skipping meals, irregular/malnutrition, dietary changes and fasting;
• refusal / inability of the patient to control his condition and follow the doctor's prescriptions (especially for elderly patients);
• some endocrine disorders (thyroid disease, adrenal and pituitary insufficiency).

The weakening of glycemic control while taking Diabeton MB is possible with fever, trauma, infectious diseases or major surgical interventions. In these cases, it may be necessary to discontinue the drug and prescribe insulin therapy.

drug interaction

Many medicines increase the risk of hypoglycemia when taken with Diabeton. This should be taken into account by the doctor when prescribing combined treatment of diabetes with acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 agonists, and insulin.

The effect of Diabeton MB is enhanced by drugs for hypertension - beta-blockers and ACE inhibitors, as well as fluconazole, histamine H2 receptor blockers, MAO inhibitors, sulfonamides, clarithromycin. Other drugs may weaken the effect of gliclazide. Read the official instructions for use for more details.

Tell your doctor about all medications, supplements, and herbs you are taking before you are prescribed diabetes pills. Learn how to control your blood sugar on your own. Know what to do if it goes up or down too low.