Catad_pgroup Oral hypoglycemic drugs

Diabeton MV 30 - instructions for use

INSTRUCTIONS
FOR MEDICAL APPLICATION OF THE PREPARATION

Registration number:

Tradename: Diabeton ® MV

International non-proprietary name:

Gliclazide.

Dosage form:

modified release tablets.

Composition:
One tablet contains:
Active substance: gliclazide - 30.0 mg.
Excipients: calcium hydrogen phosphate dihydrate 83.64 mg, hypromellose 100 cP 18.0 mg, hypromellose 4000 cP 16.0 mg, magnesium stearate 0.8 mg, maltodextrin 11.24 mg, anhydrous colloidal silicon dioxide 0.32 mg.

Description
White, biconvex oval tablets with "DIA 30" engraving on one side and company logo on the other.

Pharmacotherapeutic group:

hypoglycemic agent for oral administration of the II generation sulfonylurea group.
ATX code: A10ВВ09

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Gliclazide is a sulfonylurea derivative, a hypoglycemic drug for oral administration, which 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 b-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 mellitus, 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, 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 restoration of fibrinolytic activity of the vascular endothelium and increased activity of tissue plasminogen activator.
Intensive glycemic control based on the use of Diabeton® MB (HbA1c The strategy of intensive glycemic control included the appointment of Diabeton® MB and an increase in its dose against the background (or instead of) standard therapy before adding another hypoglycemic drug to it (for example, metformin, an alpha-glucosidase inhibitor , a thiazolidinedione derivative or insulin) The average daily dose of 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 group of intensive glycemic control (average follow-up 4.8 years, average HbA1c level 6.5%) compared with the standard control group (average HbA1c level 7.3%), a significant decrease of 10% was shown relative risk of combined incidence of macro- and microvascular complications
The advantage was achieved due to a significant reduction in the relative risk: major microvascular complications by 14%, the onset and progression of nephropathy by 21%, the onset of microalbuminuria by 9%, macroalbuminuria by 30% and the development of renal complications by 11%.
The advantages of intensive glycemic control while taking the drug Diabeton® MV did not depend on the advantages achieved against the background of antihypertensive therapy.

Pharmacokinetics
After oral administration, gliclazide is completely absorbed. The concentration of gliclazide in plasma increases gradually, reaching a plateau after 6-12 hours. Individual variability is low.
Food intake does not affect the degree of absorption of the drug. The relationship between the dose taken (up to 120 mg) and the area under the concentration-time pharmacokinetic curve is linear. About 95% of the drug binds to plasma proteins. Gliclazide is metabolized mainly in the liver and is excreted mainly by the kidneys: excretion is carried out in the form of metabolites, less than 1% is excreted by the kidneys unchanged. There are no active metabolites in plasma.
The half-life of gliclazide averages 12 to 20 hours. The volume of distribution is about 30 liters.
In the elderly, no significant changes in pharmacokinetic parameters are observed.
Taking the drug Diabeton® MV at a dose of 30 mg once a day ensures the maintenance of the effective concentration of gliclazide in the blood plasma for more than 24 hours.

INDICATIONS FOR USE
Diabetes mellitus type 2 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 by intensive glycemic control.

CONTRAINDICATIONS

• hypersensitivity to gliclazide, other sulfonylurea derivatives, sulfonamides or to excipients that make up the drug;
• type 1 diabetes mellitus;
• diabetic ketoacidosis, diabetic precoma, diabetic coma;
• severe renal or hepatic impairment (insulin is recommended in these cases)
• concomitant therapy with miconazole (see section "Interaction with other medicinal products");
• pregnancy and lactation (see section "Pregnancy and lactation");
• age up to 18 years.

It is not recommended to use in combination with phenylbutazone and danazol (see section "Interaction with other medicinal products").
Carefully:
Elderly age, irregular and / or unbalanced nutrition, deficiency of glucose-6-phosphate dehydrogenase, severe diseases of the cardiovascular system, hypothyroidism, adrenal or pituitary insufficiency, renal and / or hepatic failure, long-term glucocorticosteroid therapy (GCS), alcoholism.

PREGNANCY AND BREASTFEEDING
Pregnancy
There is no experience with gliclazide during pregnancy. Data on the use of other sulfonylurea derivatives during pregnancy are limited.
In studies on laboratory animals, the teratogenic effects of gliclazide have not been identified.
To reduce the risk of congenital malformations, optimal control (appropriate therapy) of diabetes mellitus is required.
Oral hypoglycemic drugs are not used during pregnancy.
Insulin is the drug of choice for the treatment of diabetes mellitus 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 in the event that 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 hypoglycemia in a breastfed baby, breastfeeding is contraindicated during therapy with this drug.

DOSAGE AND APPLICATION
THE PREPARATION IS INTENDED FOR ADULTS ONLY.
The recommended dose of the drug (1-4 tablets, 30-120 mg) should be taken orally, once a day, preferably during breakfast.
It is recommended to swallow the tablet whole without chewing or crushing.
If you miss one or more doses of the drug, you should not take a higher dose in 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 glycosylated hemoglobin (HbA1c).
Initial dose
The initial recommended dose (including for elderly patients, ≥ 65 years) is 30 mg per day.
In 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 no earlier than after 1 month of drug therapy in the previously prescribed dose. The exception is patients in whom the blood glucose concentration did not decrease after 2 weeks of therapy. In such cases, the dose of the drug may be increased 2 weeks after the start of administration.
The maximum recommended daily dose of the drug is 120 mg.

Switching from taking the drug Diabeton ® tablets 80 mg for the drug Diabeton ®
1 tablet of the drug Diabeton® 80 mg can be replaced by 1 tablet with a modified release of Diabeton® MB 30 mg. When transferring patients from Diabeton® 80 mg to Diabeton® MB, careful glycemic control is recommended.
Switching from another hypoglycemic drug to Diabeton ® MV modified release tablets 30 mg
The drug Diabeton® MB tablets with modified release 30 mg can be used instead of another hypoglycemic drug for oral administration. When transferring to Diabeton® MB patients receiving other hypoglycemic drugs for oral administration, their dose and half-life should be taken into account. As a rule, there is no need for a transition period.
The initial dose should be 30 mg and then titrated against the blood glucose concentration.
When the drug Diabeton® MB replaces sulfonylurea derivatives with a long half-life, in order 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 is also 30 mg and, if necessary, can be further increased, as described above.
Combined use with another hypoglycemic drug
Diabeton® MB can be used in combination with biguanides, alpha-glucosidase inhibitors or insulin.
In case of inadequate glycemic control, additional insulin therapy should be prescribed with careful medical monitoring.

Elderly patients
No dose adjustment is required for patients over 65 years of age.

Patients with renal impairment 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 (inadequate or unbalanced nutrition; severe or poorly compensated endocrine disorders - pituitary and adrenal insufficiency, hypothyroidism; withdrawal of glucocorticosteroids (GCS) after their long-term use and / or taking in high doses; severe cardiovascular diseases vascular system - severe ischemic heart 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 mellitus
To achieve intensive glycemic control, the dose of Diabeton® MB can be gradually increased to 120 mg / day in addition to diet and exercise until the target HbA1c level is reached. It should be remembered about the risk of developing hypoglycemia. In addition, other hypoglycemic drugs can be added to the therapy, for example, metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative, or insulin.

Children and adolescents under the age of 18.
There are no data on the efficacy and safety of the drug in children and adolescents under the age of 18 years.

SIDE EFFECT
Taking into account the experience of using gliclazide and other sulfonylurea derivatives, 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 missed. Possible symptoms of hypoglycemia: headache, severe hunger, nausea, vomiting, increased fatigue, sleep disturbance, irritability, agitation, decreased concentration, delayed reaction, depression, confusion, impaired vision and speech, aphasia, tremor, paresis, impaired perception , dizziness, weakness, convulsions, bradycardia, delirium, respiratory failure, drowsiness, loss of consciousness with the possible development of coma, up to death.
Andrenergic reactions may also occur: increased sweating, "clammy" skin, anxiety, tachycardia, increased blood pressure, palpitations, arrhythmias and angina pectoris.
As a rule, the symptoms of hypoglycemia are relieved by the intake of carbohydrates (sugar).
Taking sweeteners is ineffective. Against the background of other sulfonylurea derivatives, recurrences of hypoglycemia were noted after successful relief.
For severe or prolonged hypoglycemia, urgent medical attention is indicated, possibly with hospitalization, even if there is an effect of carbohydrate intake.

Other side effects

• From the gastrointestinal tract: abdominal pain, nausea, vomiting, diarrhea, constipation. Taking the drug with breakfast helps to avoid or minimize these symptoms.

Less commonly, the following side effects are noted:

• On the part of the skin and subcutaneous tissue: rash, pruritus, urticaria, erythema, maculopapular rash, bullous rash.
• On the part of the circulatory and lymphatic system: hematological disorders (anemia, leukopenia, thrombocytopenia, granulocytopenia) are rare. As a rule, these phenomena are reversible in the event of discontinuation of therapy.
• From the liver and biliary tract: increased activity of "liver" enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase), hepatitis (isolated cases). If cholestatic jaundice develops, therapy should be discontinued.

The following side effects are usually reversible if therapy is discontinued.

• On the part of the organ of vision: there may be transient visual disturbances caused by changes in the concentration of blood glucose, especially at the beginning of therapy.
• Side effects inherent in sulfonylurea derivatives: while taking other sulfonylurea derivatives, the following side effects were noted: erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis and 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, the manifestations decreased over time after the withdrawal of sulfonylurea drugs, but in some cases led to life-threatening liver failure.

Side effects reported in clinical trials
In the ADVANCE study, there was little difference in the incidence of various serious adverse events between the two patient groups. No new safety data were received. A small number of patients had 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 were observed with concomitant insulin therapy.

OVERDOSE
In case of an overdose with sulfonylurea derivatives, hypoglycemia may develop.
If moderate symptoms of hypoglycemia occur without impaired consciousness or neurological symptoms, increase the intake of carbohydrates with food, reduce the dose of the drug and / or change the diet. Close medical observation of the patient's condition should continue until there is confidence that nothing threatens his health.
The development of severe hypoglycemic conditions, accompanied by coma, seizures, or other neurological disorders, is possible. If 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 blood glucose concentration above 1 g / l. Careful monitoring of blood glucose concentration and monitoring of the patient should be carried out for at least 48 subsequent hours.
After this period of time, depending on the patient's condition, the attending physician decides on the need for further observation. Dialysis is ineffective due to the pronounced binding of gliclazide to plasma proteins.

INTERACTION WITH OTHER DRUGS
1) Drugs that increase the risk of hypoglycemia:
(enhancing the action 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 coma).
Combinations not recommended
- 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 taking phenylbutazone is necessary, the patient should be warned about the need for glycemic control. If necessary, the dose of Diabeton® MB should be adjusted during and after taking phenylbutazone.
- Ethanol: enhances hypoglycemia, inhibiting compensatory reactions, may contribute to the development of hypoglycemic coma. It is necessary to stop taking medications that include ethanol and alcohol.

Taking gliclazide in combination with certain drugs (for example, other hypoglycemic agents - insulin, an alpha-glucosidase inhibitor, biguanides; beta-blockers, fluconazole; angiotensin-converting enzyme inhibitors - captopril, enalapril; blockers of H2-receptor mono-histaminoidaminoidamines; inhibitors of H2-histaminoidaminoidamide receptors; anti-inflammatory drugs) is accompanied by an increase in the hypoglycemic effect and the risk of hypoglycemia.
2) Drugs that increase blood glucose levels:
(weakening the effect of gliclazide)
Combinations not recommended
- Danazol: has a diabetogenic effect. If taking this drug is necessary, careful glycemic control is recommended to the patient. If it is necessary to take drugs together, it is recommended to select a dose of a hypoglycemic agent both while taking danazol and after its cancellation.
Combinations requiring precautions
- Chlorpromazine (neuroleptic): in high doses (more than 100 mg per day) increases the concentration of glucose in the blood, reducing the secretion of insulin.
Close 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 the antipsychotic and after its withdrawal.
- GKS(systemic and local application: intra-articular, skin, rectal administration): increase the concentration of blood glucose with the possible development of ketoacidosis (decreased tolerance to carbohydrates). Close glycemic control is recommended, especially at the beginning 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 intake of GCS and after their cancellation.
- Ritodrin, salbutamol, terbutaline(intravenous): beta-2 adrenomimetics 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(e.g. warfarin)
Sulfonylurea derivatives can enhance the effect of anticoagulants when taken together. Dose adjustment of the anticoagulant may be required.

SPECIAL INSTRUCTIONS
Hypoglycemia
When taking sulfonylurea derivatives, including 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 the "Side Effects" section).
The drug can be prescribed only to those patients whose meals are regular and include breakfast. It is very important to maintain an adequate intake of carbohydrates from the diet, as the risk of hypoglycemia increases with irregular or insufficient nutrition, as well as with the consumption of foods that are low in carbohydrates.
Hypoglycemia often develops with a low-calorie diet, after prolonged or vigorous exercise, after taking ethanol or ethanol-containing drugs, or when taking several hypoglycemic drugs at the same time.
Typically, symptoms of hypoglycemia resolve after eating foods rich in carbohydrates (such as sugar). It should be borne in mind that taking sweeteners does not help to eliminate hypoglycemic symptoms. Experience with other sulfonylurea derivatives suggests that hypoglycemia can recur despite effective initial relief of this condition. If the hypoglycemic symptoms are pronounced or prolonged, even in the case of a temporary improvement in the condition after eating a meal rich in carbohydrates, emergency medical care is necessary, up to hospitalization.
To avoid the development of hypoglycemia, careful individual selection of drugs and dosage regimen is required, as well as providing the patient with complete information about the treatment being performed.
An increased risk of hypoglycemia may occur in the following cases:

• refusal or inability of the patient (especially the elderly) to follow the doctor's prescriptions and control his condition;
• inadequate and irregular nutrition, skipping meals, starvation and dietary changes;
• 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 disease, pituitary and adrenal insufficiency;
• concomitant use of certain medications (see section "Interaction with other medicinal products"). Clinical manifestations of hypoglycemia can be masked when taking beta-blockers, clonidine, reserpine, guanethidine.

Renal and hepatic impairment
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 prolonged, in such cases, immediate appropriate therapy is necessary.

Patient information
It is necessary to inform the patient and his family members about the risk of developing hypoglycemia, its symptoms and conditions conducive to its development. The patient needs to be educated about the potential risks and benefits of the proposed treatment.
The patient needs to be educated about the importance of diet, the need for regular exercise and blood glucose monitoring.
Poor blood glucose control
Glycemic control in patients receiving hypoglycemic therapy can be weakened in the following cases: major surgical interventions and injuries, extensive burns, infectious diseases with febrile syndrome. In these conditions, it may be necessary to discontinue therapy with Diabeton® MB and prescribe insulin therapy.
In some patients, the effectiveness of oral hypoglycemic agents, including 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 effect is known as secondary drug resistance, which must be distinguished from primary drug resistance, in which the drug does not give the expected clinical effect even after the first administration. Before diagnosing a patient with secondary drug resistance, it is necessary to assess the adequacy of dose selection and patient compliance with the prescribed diet.

Laboratory tests
To assess glycemic control, it is recommended to regularly measure fasting blood glucose and glycosylated hemoglobin HbA1c levels. In addition, it is advisable to regularly self-monitor the blood glucose concentration.
Sulfonylurea derivatives 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 assessed.

INFLUENCE ON THE ABILITY TO DRIVE A CAR AND PERFORMANCE OF WORKS REQUIRING HIGH SPEED OF MENTAL AND PHYSICAL REACTIONS
Patients should be aware of the symptoms of hypoglycemia and should be careful when driving or performing work that requires a high rate of physical and mental reactions, especially at the beginning of therapy.

RELEASE FORM
Modified release tablets 30 mg.
30 tablets in a blister (PVC / Al), 1 or 2 blisters with instructions for medical use in a cardboard box.
When packing (packing) at the Russian enterprise Serdiks LLC: 30 tablets in a blister (PVC / Al), 2 blisters with instructions for use in a cardboard box.

STORAGE CONDITIONS
No special storage conditions are required.
Keep out of the reach of children.
List B.

BEST BEFORE DATE
3 years. Do not use after the expiration date printed on the package.

TERMS OF HOLIDAY
On prescription.

Registration certificate issued to Servier Laboratories, France

Produced by "Laboratories Servier Industry", France
Servier Industry Laboratories:
905, Highway Saran, 45520 Gidy, France
905, route de Saran, 45520 Gidy, France

LLC "Serdix":

Registration certificate issued to Servier Laboratories, France
Produced by: LLC "Serdiks", Russia
LLC "Serdix":
142150, Russia, Moscow region,
Podolsk district, Sofyino village, bldg. 1/1
For all questions, contact the Representative Office of Servier Laboratories JSC.

Representative office of Servier Laboratories JSC:
115054, Moscow, Paveletskaya sq. 2, building 3

The last updated description by the manufacturer 16.09.2015

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Description of the dosage form

White, biconvex, oval tablets, notched and engraved with "DIA" "60" on both sides.

pharmachologic effect

pharmachologic effect- hypoglycemic.

Pharmacodynamics

Gliclazide is a sulfonylurea derivative, a hypoglycemic drug for oral administration, which differs from similar drugs by the presence of an N-containing heterocyclic ring with an endocyclic bond.

Gliclazide reduces the concentration of blood glucose by stimulating the secretion of insulin by 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 mellitus, 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 small vessel thrombosis, influencing 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 activation factors (beta-thromboglobulin, thromboxane B2), 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 against the background (or instead of) standard therapy before adding another hypoglycemic drug to it (for example, metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative or insulin). The average daily dose of 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 group of intensive glycemic control (average follow-up time 4.8 years, average HbA1c level - 6.5%) compared with the standard control group (average HbA1c level - 7.3%), a significant decrease in 10% relative risk of combined incidence of macro- and microvascular complications.

The advantage was achieved due to a significant reduction in the relative risk of major microvascular complications by 14%, the onset and progression of nephropathy by 21%, the onset of microalbuminuria by 9%, macroalbuminuria by 30%, and the development of renal complications by 11%.

The advantages of intensive glycemic control while taking Diabeton® MB did not depend on the advantages achieved during antihypertensive therapy.

Pharmacokinetics

Suction

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

Food intake does not affect the degree of absorption of gliclazide.

Distribution

About 95% of gliclazide binds to plasma proteins. V d - about 30 liters. Taking the drug Diabeton® MB at a dose of 60 mg once a day ensures the maintenance of the 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.

Withdrawal

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 of gliclazide averages from 12 to 20 hours.

Linearity

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

Special populations

Aged people. In the elderly, no significant changes in pharmacokinetic parameters are observed.

Indications of the drug 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 to excipients that make up the drug;

type 1 diabetes mellitus;

diabetic ketoacidosis, diabetic precoma, diabetic coma;

severe renal or hepatic impairment (insulin is recommended in these cases);

taking miconazole (see "Interaction");

pregnancy and lactation (see "Application 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 nutrition, glucose-6-phosphate dehydrogenase deficiency, severe CVS diseases, hypothyroidism, adrenal or pituitary insufficiency, renal and / or hepatic failure, long-term GCS therapy, alcoholism.

Application during pregnancy and lactation

Pregnancy

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

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

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

Oral hypoglycemic drugs are not used during pregnancy. Insulin is the drug of choice for the treatment of diabetes mellitus 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 in the event that 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

Taking into account the experience of using gliclazide, one should remember about 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, increased fatigue, sleep disturbance, irritability, agitation, decreased concentration, delayed reaction, depression, confusion, impaired vision and speech, aphasia, tremor, paresis, loss of self-control , 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 occur: increased sweating, clammy skin, anxiety, tachycardia, increased blood pressure, palpitations, arrhythmia and angina pectoris.

As a rule, the symptoms of hypoglycemia are relieved by the intake of carbohydrates (sugar). Taking sweeteners is ineffective. Against the background of other sulfonylurea derivatives, recurrences of hypoglycemia were noted after successful relief.

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

Other side effects

From the gastrointestinal tract: abdominal pain, nausea, vomiting, diarrhea, constipation. Taking the drug with breakfast helps to avoid or minimize these symptoms.

The following side effects are less common.

On the part of the skin and subcutaneous tissue: rash, pruritus, urticaria, Quincke's edema, erythema, maculopapular rash, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis).

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

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

These phenomena are usually reversible in the event of discontinuation of therapy.

On the part of the organ of vision: there may be transient visual disturbances caused by changes in the concentration of blood glucose, especially at the beginning of therapy.

Side effects inherent in sulfonylurea derivatives: as well as while 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 the withdrawal of sulfonylurea drugs, but in some cases led to life-threatening liver failure.

Side effects reported in clinical trials

In research ADVANCE there was little difference in the incidence of various serious adverse events between the two patient groups. No new safety data were received. A small number of patients had 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 were observed with concomitant insulin therapy.

Interaction

1. Drugs and substances that increase the risk of 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 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 taking phenylbutazone is necessary, the patient should be warned about the need for glycemic control. If necessary, the dose of Diabeton® MB should be adjusted during and after taking phenylbutazone.

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

Taking gliclazide in combination with some 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 are accompanied by an increase in the hypoglycemic effect and the risk of hypoglycemia.

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

Danazol: has a diabetogenic effect. If taking this drug is necessary, the patient is advised to closely monitor blood glucose. If it is necessary to take drugs together, it is recommended to select a dose of a hypoglycemic agent both while taking danazol and after its cancellation.

Combinations requiring precautions

Chlorpromazine (neuroleptic): in high doses (> 100 mg / day) increases the concentration of glucose in the blood, decreasing the secretion of insulin. Close 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 the antipsychotic and after its cancellation.

GCS (systemic and local application - intra-articular, cutaneous, rectal administration) and tetracosactide: increase the concentration of blood glucose with the possible development of ketoacidosis (decreased tolerance to carbohydrates). Close glycemic control is recommended, especially at the beginning 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 intake of GCS and after their cancellation.

Ritodrin, salbutamol, terbutaline (i.v. administration): beta 2 -adrenomimetics 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 (such as warfarin). Sulfonylurea derivatives can enhance the effect of anticoagulants when taken together. Dose adjustment of the anticoagulant may be required.

Method of administration and dosage

The drug is intended only for the treatment of adults.

The daily dose can be 30-120 mg (1 / 2-2 table.) In one dose.

If you miss one or more doses of the drug, you should not take a higher dose in 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 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 therapy with the drug in the previously prescribed dose. The exception is patients in whom the blood glucose concentration did not decrease after 2 weeks of therapy. In such cases, the dose of the drug can be increased 2 weeks after the start of administration.

1 tab. the drug Diabeton® MB tablets with modified release 60 mg is equivalent to 2 tablets. Diabeton® MB tablets with modified release 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 Diabeton® tablets 80 mg to Diabeton® MB tablets with modified release 60 mg

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

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

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

When the drug Diabeton® MB replaces sulfonylurea derivatives with a long T 1/2, in order 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 table. 60 mg) and, if necessary, can be further increased, as described above.

Combined intake 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

No dose adjustment is required for patients over 65 years of age.

Patients with renal impairment

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 (inadequate or unbalanced nutrition; severe or poorly compensated endocrine disorders - pituitary and adrenal insufficiency, hypothyroidism; cancellation of GCS after long-term use and / or administration of high doses; severe CVS diseases - severe coronary artery disease, severe atherosclerosis of the carotid arteries, widespread atherosclerosis), it is recommended to use the minimum dose (30 mg) of the drug Diabeton® MB.

Prevention of complications of diabetes mellitus

To achieve intensive glycemic control, the dose of Diabeton® MB can be gradually increased to 120 mg / day in addition to diet and exercise until the target HbA1c level is reached. It should be remembered about the risk of developing 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

There are no data on the efficacy and safety of the drug in children and adolescents under the age of 18 years.

Overdose

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

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

The development of severe hypoglycemic conditions, accompanied by coma, seizures, or other neurological disorders, is possible. If 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 blood glucose concentration above 1 g / l. Close monitoring of blood glucose levels and monitoring of the patient should be carried out for at least 48 subsequent hours. After this period of time, depending on the patient's condition, 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 an adequate intake of carbohydrates in the diet, because the risk of developing hypoglycemia increases with irregular or inadequate nutrition, as well as with the consumption of foods 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.

Typically, symptoms of hypoglycemia resolve after eating foods rich in carbohydrates (such as sugar). It should be borne in mind that taking sugar substitutes does not help to eliminate hypoglycemic symptoms. Experience with other sulfonylurea derivatives suggests that hypoglycemia can 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, emergency medical care is necessary, up to hospitalization.

To avoid the development of hypoglycemia, careful individual selection of drugs and dosage regimen is required, as well as providing the patient with complete information about the treatment being performed.

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

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

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

An 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 disease, pituitary and adrenal insufficiency;

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

Renal and hepatic impairment

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 prolonged, in such cases, immediate appropriate therapy is necessary.

Patient information

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 needs to be educated about the potential risks and benefits of the proposed treatment.

The patient needs to be educated about the importance of diet, the need for regular exercise and blood glucose monitoring.

Insufficient glycemic control

Glycemic control in patients receiving hypoglycemic therapy may be impaired in the following cases: fever, injury, infectious disease, or major surgery. In these conditions, it may be necessary to discontinue therapy with Diabeton® MB and prescribe insulin therapy.

In many patients, the effectiveness of oral hypoglycemic agents, incl. gliclazide tends to decline 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 drug resistance, in which the drug does not give the expected clinical effect even after the first administration. Before diagnosing a patient with secondary drug resistance, it is necessary to assess the adequacy of dose selection and patient compliance with the prescribed diet.

Laboratory tests

Sulfonylurea derivatives 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 assessed.

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 or performing work that requires a high speed of physical and mental reactions, especially at the beginning of therapy.

Release form

Modified release tablets, 60 mg.

Diabetes mellitus type 2 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 by intensive glycemic control.

Contraindications Diabeton MV tablets 30mg

Hypersensitivity to gliclazide, other sulfonylurea derivatives, sulfonamides or to excipients that are part of the drug; type 1 diabetes mellitus; diabetic ketoacidosis, diabetic precoma, diabetic coma; severe renal or hepatic impairment (insulin is recommended in these cases); concomitant therapy with miconazole; pregnancy and lactation; age up to 18 years. It is not recommended to use in combination with phenylbutazone and danazol. With care: old age, irregular and / or unbalanced nutrition, deficiency of glucose-6-phosphate dehydrogenase, severe diseases of the cardiovascular system, hypothyroidism, adrenal or pituitary insufficiency, renal and / or hepatic insufficiency, long-term therapy with glucocorticosteroids (GCS), alcoholism Pregnancy: There is no experience with gliclazide during pregnancy. Data on the use of other sulfonylurea derivatives during pregnancy are limited. In studies on laboratory animals, the teratogenic effects of gliclazide have not been identified. To reduce the risk of congenital malformations, optimal control (appropriate therapy) of diabetes mellitus is required. Oral hypoglycemic drugs are not used during pregnancy. Insulin is the drug of choice for the treatment of diabetes mellitus 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 in the event that the pregnancy occurred while taking the drug. Breastfeeding: given the lack of data on the intake of gliclazide in breast milk and the risk of hypoglycemia in a breastfed baby, breastfeeding is contraindicated during therapy with this drug.

Method of application and dosage Diabeton MV tablets 30mg

The drug is intended only for the treatment of adults. The recommended dose of the drug (1-4 tablets, 30-120mg) should be taken orally, once a day, preferably during breakfast. It is recommended to swallow the tablet whole without chewing or crushing. If you miss one or more doses of the drug, you should not take a higher dose in 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 glycosylated hemoglobin (HbA1c). The initial recommended dose (including for elderly patients over 65 years old) is 30 mg per day. In 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 no earlier than after 1 month of drug therapy in the previously prescribed dose. The exception is patients in whom the blood glucose concentration did not decrease after 2 weeks of therapy. In such cases, the dose of the drug may be increased 2 weeks after the start of administration. The maximum recommended daily dose of the drug is 120 mg. Switching from taking the drug Diabeton tablets 80 mg to the drug Diabeton MV 30mg modified-release tablets: one tablet of Diabeton 80mg can be replaced with one modified-release tablet Diabeton MB 30mg. When transferring patients from Diabeton 80mg to Diabeton MV, careful glycemic control is recommended. Switching from another hypoglycemic drug to Diabeton MV 30mg modified-release tablets. The drug Diabeton MV 30mg modified-release tablets can be used instead of another hypoglycemic drug for oral administration. When transferring to Diabeton MB patients receiving other hypoglycemic drugs for oral administration, their dose and half-life should be taken into account. As a rule, there is no need for a transition period. The starting dose should be 30mg and then titrated against the blood glucose concentration. When the drug Diabeton MV replaces sulfonylurea derivatives with a long half-life in order 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 MV is also 30 mg and, if necessary, can be further increased, as described above. Combined administration with another hypoglycemic drug. Diabetes mellitus CF can be used in combination with biguanides, alpha-glucosidase inhibitors, or insulin. In case of inadequate glycemic control, additional insulin therapy should be prescribed with careful medical monitoring. Elderly patients: No dose adjustment is required for patients over 65 years of age. 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 (inadequate or unbalanced nutrition; severe or poorly compensated endocrine disorders - pituitary and adrenal insufficiency, hypothyroidism; withdrawal of glucocorticosteroids (GCS) after their long-term use and / or taking in high doses; severe cardiovascular diseases vascular system - severe ischemic heart disease, severe atherosclerosis of the carotid arteries, widespread atherosclerosis), it is recommended to use the minimum dose (30 mg) of the drug Diabeton MB. Prevention of complications of diabetes mellitus. To achieve intensive glycemic control, the dose of Diabeton MB can be gradually increased to 120 mg / day in addition to diet and exercise until the target HbA1c level is reached. It should be remembered about the risk of developing hypoglycemia. In addition, other hypoglycemic drugs such as metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative or insulin can be added to the therapy. Children and adolescents under the age of 18. There are no data on the efficacy and safety of the drug in children and adolescents under the age of 18 years.

Diabeton is a medicine that helps people with type 2 diabetes. It promotes the secretion of insulin, and increases the sensitivity of tissues to it. In this article, we will take a closer look at why a drug is needed and how to use it.

Diabeton tablets stimulate the secretion of insulin with the help of beta cells formed by the pancreas. They increase the sensitivity of tissues to insulin. They also reduce the amount of time that elapses between a meal and the onset of insulin secretion.

Diabeton contains an active substance called gliclazide. With the help of it, the adhesion of platelets decreases, which prevents the formation of blood clots at an early stage. It helps to normalize the penetrating ability of blood vessels. It lowers the amount of cholesterol in the circulatory system and interferes with the development of atherosclerosis. Also, gliclazide is needed to reduce the sensitivity of blood vessels to adrenaline.

With long-term use of Diabeton in patients, a decrease in the protein content in urine analysis is observed. This has been proven through research carried out.

Diabeton contains gliclazide, as well as other substances that have an auxiliary character.

Instructions for use Diabeton MV indicates the following situations in which the drug is needed:

• Diabetes mellitus type 2. It is needed in situations where physical activity, proper nutrition and a decrease in total body weight have not shown their effectiveness.
• In order to prevent diseases such as nephropathy, heart attack, etc.

After administration, the drug is completely absorbed. This increases the content of gliclazide in the human circulatory system. This happens gradually. Food does not in any way affect the process or rate of absorption of the drug by the body. The active substance is broken down by the kidneys, and then excreted from the body. Its content in urine is less than 1%.

Diabetone is not used by women during pregnancy. This is indicated by other drugs similar in active substance to Diabeton. Studies have been carried out on some species of animals, which revealed that gliclazide does not carry any disturbance of embryonic development in the fetus. To reduce the likelihood of having a child with various diseases, you need competent specialist control over the course of diabetes mellitus.

For women during pregnancy, diabetes is often replaced with insulin. It is recommended to do this not only during the period of bearing the fetus, but also before the planned conception.

No studies related to taking the drug during lactation have been conducted. Therefore, it is necessary either to refuse to take Diabeton, or to stop feeding the baby with breast milk.

Forms of issue

Diabeton is available in cardboard boxes. Each of them contains 30 tablets of Diabeton MB 60 mg of an oblong type.

Contraindications

Consider the absolute contraindications for taking Diabetone:

• Diabetes mellitus type 1.
• A small amount of insulin in the human body with diabetes.
• Violation of carbohydrate metabolism due to insulin deficiency.
• Serious kidney disease. In such situations, insulin should be used.
• The period of carrying the fetus and lactation.
• Children under the age of 18.
• Allergic reactions to active and additional substances contained in the medicine.

One of the components of the drug is lactose. People suffering from lactose intolerance should refrain from taking Diabetone or regularly undergo medical examinations, during which the doctor will identify the current state of health.

Also, the drug should be abstained from in case of improper diet, diseases associated with the heart, liver failure, alcohol intoxication, hangover syndrome.

Consider contraindications based on incompatibility with other drugs:

• Miconazole or Diabeton lead to the rapid development of hypoglycemia, increasing the properties of gliclazide. Ultimately, this can lead to a coma.
• Phenylbutazone, in combination with the drug, may increase the likelihood of developing hypoklycemia. For a joint admission, constant monitoring of medical examinations is needed. If necessary, the dose of Diabeton must be adjusted.
• It is worth refraining from taking medication with other drugs containing ethanol. This increases the risk of hypoglycemic disease. It is also worth giving up any kind of alcoholic beverages.
• Diabetone should be taken with caution with insulin if needed.
• Chlorpromazine, together with the drug, can cause an increase in glucose in the circulatory system, while insulin production is greatly reduced.

With possible receptions of Diabeton with other drugs, it is worth taking glycemic control seriously. In some situations, it will be necessary to transfer the patient to insulin.

Dosage

Diabetone dosages should be started at 80 mg. Then they increase to 320 mg. All doses are prescribed individually for each patient. It depends on his daily routine, general health, age and body weight.

Diabeton MB 30 mg is prescribed exclusively for adults. It should be taken once a day, each time before meals. It is not allowed to take food before the medicine.

The daily dosage for patients is 20-120 mg taken at a time.

If the patient misses taking the medication, then it is not allowed to increase the dosage next time. It is necessary to return to the dosage that should have been used. It is selected on an individual basis, depending on the clinical research conducted.

People who are over 65 years old should start taking the medication with a dose of 30 mg. This is half of one tablet.

If the patient is successfully treated, the drug may be supportive. If there is a reverse trend, then the dosage can increase several times up to 120 mg. They need to be increased smoothly: the next dose is possible if the previous one was drunk for a month. There is an exception here: the dose can be increased more quickly if the glucose content in the human circulatory system does not decrease after several weeks of treatment.

There is a maximum dose of the drug, the excess of which is not allowed at all - 120 mg.

CF is modified release. One tablet having this function is equivalent to two of the same, but with a lower active substance content. When taking Diabeton MV, it should be understood that it is necessary to reduce the daily rate of conventional funds by 1.5-2 times.

Let's consider an example of switching from regular Diabeton to modified one. 1 tablet of 80 mg can be replaced with a modified 60 mg. With this kind of transition, it is necessary to observe careful medical supervision based on hypoglycemic indicators.

If the patient switches from a conventional medication to Diabeton MB, then a short period of abstinence from taking the drug can be observed, which lasts for several days. This is necessary in order for the adaptive effect to pass in a calmer form. At the same time, the doses of the modified form of Diabeton will have to start with a minimum - 30 mg. It can go up every month. In the absence of visible results of treatment, the dosage may change after a faster time.

Based on the studies carried out, a special dosage change for people suffering from mild renal failure is not required.

If a patient has an increased likelihood of developing hypoglycemia due to a poor lifestyle (unhealthy diet, lack or excess of physical activity, heart disease, etc.), then a minimum dosage of the drug, equal to 30 mg, must be taken.

To increase control over the likelihood of developing diabetes mellitus, you need to gradually increase the dosage of the drug. This needs to be in addition to regular physical activity and a normal lifestyle. The maximum daily dose of Diabeton is 120 mg, the minimum is 30 mg.

Instructions for use

Diabeton MV 60 mg, instructions for use:

Depending on the doses prescribed by the doctor, it is necessary to take a Diabeton tablet before eating. It is not advisable to chew or grind it.

If the patient misses taking the drug, then it is forbidden to increase the dosage the next day. Be sure to use the missed dose.

Side effects

The drug can cause a number of different side effects. You should start with the most basic and popular - hypoglycemia.

Most often, hypoglycemia is caused by irregular food intake after taking the drug. It is especially dangerous not to eat at all. The main symptoms of this disease:

• Headache.
• Increased feeling of hunger.
• Vomiting urge.
• Increased excitability and irritability.
• Depressive and nervous conditions.
• Deteriorated reaction.
• Feverish feelings.
• Excessive sweating.
• A sharp change in blood pressure.
• Arrhythmia.
• Problems with heart.

There may also be other side effects associated with the use of the drug. Let's consider them, dividing them into groups:

• Human skin. Rash, itching, rashes.
• Circulatory system. Decreased platelet count, anemia, leukopenia. These diseases develop in rare cases and most often go away after the completion of the course.
• Urinary system. Hepatitis, jaundice. With the manifestation of the latter disease, it is necessary to urgently refuse to take the drug.
• Dysfunction of vision.
• Liver problems.

Studies were conducted in which 2 groups of patients participated. Both members took the drug for a long time. Some people with diabetes developed hypoglycemia. Most often this arose due to the use of the drug along with insulin. The other part of the subjects did not have any side effects or they were insignificant.

Price

Diabeton MV will cost 299 rubles for 30 tablets containing 60 mg of the active substance.

Analogs

Consider the analogs of the drug, similar to it in the pharmacological group:

• Avandamet. Contains the active ingredient metformin. Used for type 2 diabetes. Reduces the amount of glucose in the circulatory system. Price - 1526 rubles.
• Adebit. Can be used to treat type 1 diabetes when combined with insulin. Prices vary greatly and the drug is not always available in pharmacies.
• Amaryl. It is used when it is necessary to increase blood glucose, and exercise does not bring the desired effect. Price in pharmacies - 326 rubles. for 30 tablets with 1 mg of active ingredient. It is a good alternative to Diabeton.
• Arfazetin. Used for supportive therapy. For more serious forms of the disease, it is not applied. The price in the pharmacy is 55 rubles. Arfazetin wins in cost over all other analogues, but this remedy is not suitable for full-fledged treatment.
• Maninil. Stimulates insulin production. Maninil or Diabeton - there is practically no difference. It all depends on the dosages. The average price in a pharmacy is 119 rubles.
• Gluconorm. It is necessary to increase the level of insulin in the blood when the normalization of the lifestyle does not help. The price in a pharmacy is 245 rubles.
• Novoformin. Needed for type 2 diabetes. Suitable for obese patients. Data on availability in pharmacies is not available.
• Gliclazide. Reduces glucose in the circulatory system. Contains the same active ingredient as Diabeton. Price - 149 rubles.
• Glucophage. Does not increase the secretion of insulin, but increases the sensitivity of tissues to it. It is mainly used for preventive therapy. This is a good analogue of Diabeton, but it is used in specific cases. Price - 121 rubles.
• Glucovance. Contributes to the normalization of glucose levels in the human body. Increases tissue sensitivity to insulin. Average price - 279 rubles.
• Diabetharm. Stimulates insulin secretion. It is rapidly absorbed in the body. Price - 131 rubles.

These were the main analogues of Diabeton. It is often asked which is the best of them. There is no answer here. All of these drugs are prescribed on an individual basis.

Overdose

If you take an excessive amount of Diabetone, hypoglycemia may develop. When the first symptoms appear, it is necessary to increase the amount of carbohydrates in food, reduce the dosage of the medication and normalize physical activity.

In case of an overdose, severe convulsions, coma, or other neurological disorders may occur. In such situations, it is necessary to urgently call an ambulance, followed by hospitalization of the patient.

The following overdose symptoms may also occur:

• Intense desire to eat.
• Nausea.
• Feeling weak.
• Sleep problems.
• Increased excitability.
• Prostration.

Treatment depends on the symptoms. In hypoglycemic coma, a glucose solution must be injected into the patient's body. Then the patient should be under the supervision of a doctor in a hospital for several days.

Gliclazide is a sulfonylurea derivative, a hypoglycemic drug for oral administration, which differs from similar drugs by the presence of an N-containing heterocyclic ring with an endocyclic bond. Gliclazide reduces the concentration of glucose in the blood, stimulating the secretion of insulin by β-cells of the islets of Langerhans. Increases in postprandial insulin and C-peptide levels persist 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 mellitus, 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 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 blood 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 the 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 of 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 Relationship between the dose taken (up to 120 mg) and AUC is linear. Pharmacokinetics in special clinical situations In the elderly, no significant changes in pharmacokinetic parameters are observed.

Contraindications

The recommended dose of the drug should be taken orally, once a day, preferably during breakfast. The daily dose may be 30–120 mg (1/2 –2 tablets) in one 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 in 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 mellitus; diabetic ketoacidosis, precoma, coma; simultaneous administration of miconazole; these pills are especially harmful for slender and thin people, for more details read the article LADA-diabetes; severe renal and hepatic impairment (in these cases, you need to inject insulin, and not take pills for diabetes); simultaneous administration of miconazole; pregnancy and the period of breastfeeding; age under 18; hypersensitivity to gliclazide, other sulfonylurea derivatives, excipients in tablets. Prescribe with caution: severe diseases of the cardiovascular system (heart failure, heart attack, etc.); hypothyroidism - decreased function of the thyroid gland; insufficiency of the adrenal glands or pituitary gland; liver or kidney disease, including diabetic nephropathy; irregular or unbalanced diet, alcoholism; elderly people.

Application 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 the Side Effects section). The drug can be prescribed only to those patients whose meals are regularly and includes breakfast. It is very important to maintain an adequate intake of carbohydrates from the diet, because the risk of developing hypoglycemia increases with irregular or inadequate nutrition, as well as with the consumption of foods poor in carbohydrates. Hypoglycemia is more likely to develop with a low-calorie diet, after prolonged or vigorous exercise, after drinking alcohol, or taking several hypoglycemic drugs at the same time. Typically, symptoms of hypoglycemia resolve after eating foods rich in carbohydrates (such as sugar). It should be borne in mind that taking sugar substitutes does not help to eliminate hypoglycemic symptoms. Experience with other sulfonylurea derivatives suggests that hypoglycemia can 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 dosage regimen is required, and also providing the patient with complete information about the treatment. An increased risk of developing hypoglycemia may be noted in the following cases: - refusal or inability of the patient (especially the elderly) to follow the doctor's prescriptions and control his condition; diet; - imbalance between physical activity and the amount of carbohydrates taken; - renal failure; - severe hepatic failure; - overdose of the drug Diabeton MB; - some endocrine disorders (diseases of the thyroid gland, pituitary and hepatic / renal insufficiency In patients with hepatic insufficiency and / or severe renal insufficiency, the pharmacokinetic and / or pharmacodynamic properties of gliclazide may change. Hypoglycemia that develops in these patients can be long enough, in such cases, it is necessary to immediately conduct appropriate therapy. Information for patients It is necessary to inform the patient and his family members about the risk of hypoglycemia, its symptoms and conditions conducive to its development. The patient should be educated about the potential risks and benefits of the proposed treatment. The patient should be educated about the importance of diet, the need for regular exercise and control of blood glucose concentration. Insufficient glycemic control Glycemic control in patients receiving hypoglycemic therapy may be weakened in the following cases: fever, injury, infectious disease or major surgery. In these conditions, it may be necessary to discontinue therapy with Diabeton MB and prescribe insulin therapy. In many patients, the effectiveness of oral hypoglycemic agents, incl. gliclazide tends to decline 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 drug resistance, in which the drug does not give the expected clinical effect even after the first administration. Before diagnosing a patient with secondary drug resistance, it is necessary to assess the adequacy of the dose selection and the patient's compliance with the prescribed diet. Monitoring of laboratory parameters To assess glycemic control, it is recommended to regularly determine the level of fasting blood glucose and the level of glycosylated hemoglobin HbA1c. In addition, it is advisable to regularly conduct self-monitoring of blood glucose concentration. Derivatives of sulfonylureas can cause hemolytic anemia in patients with deficiency of glucose-6-phosphate dehydrogenase. 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 assessed.Effect on the ability to drive vehicles and control 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 should be careful while driving or performing work requiring high speed of physical and mental reactions, especially at the beginning of therapy.

Method of administration and dosage

Indications for use Type 2 diabetes if diet and exercise are not helpful. 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 hypoglycemia (enhancing the effect of gliclazide) Combinations are contraindicated Miconazole (with systemic administration and when using a gel on the oral mucosa): enhances the hypoglycemic effect of gliclazide (hypoglycemia may develop up to coma) Combinations are not recommended (systemic butazone). introduction) enhances the hypoglycemic effect of sulfonylurea derivatives, because displaces them from connection with plasma proteins and / or slows down their excretion from the body. Another anti-inflammatory drug is preferred. If taking 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 while taking phenylbutazone and after its end.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 medications that contain ethanol and drinking alcohol. Combinations requiring precautions Taking gliclazide in combination with certain medications (for example, other hypoglycemic agents - insulin, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, agonists) GLP-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 (weakening the effect of gliclazide) Combinations are not recommended Danazol has a diabetogenic effect. If taking this drug is necessary, the patient is advised to closely monitor blood glucose. If it is necessary to take drugs together, it is recommended to select a dose of a hypoglycemic agent both while taking danazol and after its cancellation. in the blood by reducing the secretion of insulin. Close 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 the antipsychotic and after its cancellation. With the simultaneous use of GCS (for systemic and local use - intra-articular, cutaneous, rectal administration) and tetracosactide increase the concentration of glucose in the blood with the possible development of ketoacidosis (decreased tolerance to carbohydrates). Close glycemic control is recommended, especially at the beginning of treatment. If it is necessary to take the drugs together, it may be necessary to adjust the dose of the hypoglycemic agent both during the intake of GCS and after their cancellation. emphasizing the importance of self-glycemic control. If necessary, it is recommended to transfer the patient to insulin therapy. Combinations to be taken into account Derivatives of sulfonylureas can enhance 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 are: headache, increased fatigue, irritability, nightmares, palpitations. In severe cases, the patient may lose consciousness. Read more in the article "Hypoglycemia - Symptoms, Treatment and Prevention". Diabeton MV causes severe hypoglycemia less frequently than other sulfonylurea derivatives. Other side effects are abdominal pain, nausea, vomiting, diarrhea, constipation, rash, itchy skin, increased activity of liver enzymes (AST, ALT, ALP). At the beginning of taking Diabeton, there may be temporary visual impairments - due to the fact that blood sugar is rapidly decreasing. 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 the intake of carbohydrates 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. Development of severe hypoglycemic conditions, accompanied by coma, convulsions or other neurological disorders, is possible. If such symptoms appear, emergency medical care and immediate hospitalization are necessary. In case of hypoglycemic coma or suspicion of it, the patient is injected intravenously with 50 ml of a 20-30% dextrose (glucose) solution. Then intravenous drip of 10% dextrose solution to maintain blood glucose concentration above 1 g / l. Careful monitoring of blood glucose levels and observation of the patient should be carried out at least for 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.