Diabeton - instructions for use, reviews, analogs and forms of release (tablets 80 mg, 60 mg MB with modified release) of the drug for the treatment of type 2 diabetes in adults, children and pregnancy

In this article, you can read the instructions for using the drug Diabeton. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Diabeton in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Diabeton in the presence of existing structural analogues. Use for the treatment of type 2 diabetes in adults, children, as well as during pregnancy and lactation.

Diabeton - oral hypoglycemic agent, derivative of sulfonylureas of the 2nd generation.Stimulates the secretion of insulin by beta cells of the pancreas. Increases the sensitivity of peripheral tissues to insulin. Apparently, it stimulates the activity of intracellular enzymes (in particular, muscle glycogen synthetase). Reduces the time interval from the time of food intake to the onset of insulin secretion. Restores the early peak of insulin secretion, reduces the postprandial peak of hyperglycemia.

Gliclazide (active ingredient of the drug Diabeton) reduces adhesion and aggregation of platelets, slows the development of the wall clot, increases vascular fibrinolytic activity. Normalizes vascular permeability. It has anti-atherogenic properties: lowers the concentration in the blood of total cholesterol (Xs) and Xc-LDL, increases the concentration of Xc-HDL, and also reduces the amount of free radicals. Prevents the development of microthrombosis and atherosclerosis. Improves microcirculation. Reduces the sensitivity of blood vessels to adrenaline.

With diabetic nephropathy against a background of long-term use of glycazide, there is a significant decrease in proteinuria.

Composition

Gliklazid + auxiliary substances.

Pharmacokinetics

After oral administration, Diabetonum is completely absorbed. The concentration of glycazide in the blood 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 rate or degree of absorption of the glycazide. Gliklazid is metabolized primarily in the liver. There are no active metabolites in the plasma. It is excreted mainly by kidneys in the form of metabolites, less than 1% - with urine in unchanged form.

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

Indications

• 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 by intensive glycemic control.

Forms of release

Tablets 80 mg.

Modified release tablets 60 mg (Diabetes MB).

Instructions for use and dosing regimen

Diabeton

The initial daily dose is 80 mg, the average daily dose of 160-320 mg, the frequency of reception - 2 times a day before meals.Dosing individually depending on fasting glycemia and 2 hours after eating, as well as from clinical manifestations of the disease.

Diabetes MW

The drug is intended only for adults.

The recommended dose of the drug should be taken orally, once a day, preferably during breakfast.

The daily dose is 30-120 mg (1 / 2-2 tablets) in 1 dose. It is recommended to swallow a pill or half of the whole tablet without chewing or grinding.

If you skip one or more doses of the drug, you can not take a higher dose to 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 for adults (including for the elderly ≥65 years) is 30 mg (1/2 tablet) per day.

In case of adequate control, the drug in 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. Increase in the dose is possible not earlier than after 1 month of therapy with the drug in the previously prescribed dose.Exception is made by 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 the treatment.

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

1 modified-release tablet 60 mg is equivalent to 2 tablets with a modified release of 30 mg. The presence of a notch on the tablets of 60 mg allows you to divide the pill and take the daily dose as 30 mg (1/2 tablet 60 mg) and, if necessary, 90 mg (1 tablet 60 mg and 1/2 tablet 60 mg).

Transition from the administration of the drug Diabetes tablets 80 mg per drug Diabeton MB tablets with modified release of 60 mg

1 tablet of the drug Diabetes 80 mg can be replaced with 1/2 modified-release tablet Diabetes MB 60 mg. When transferring patients from the drug Diabetes 80 mg to the drug Diabetes MB recommended careful glycemic control.

Transition from taking another hypoglycemic drug to the drug Diabetes MB tablets with a modified release of 60 mg

The drug Diabetes Mint MB tablets with a modified release of 60 mg can be used in place of another hypoglycemic agent for oral administration.When transferring to MB of patients receiving other hypoglycemic drugs for oral administration, their dose and half-life period should be considered. As a rule, a transition period is not required. The initial dose should be 30 mg and then should be titrated depending on the concentration of blood glucose.

When Diabeton MB is replaced with derivatives of sulfonylureas 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 Diabetes MB is also 30 mg (1/2 tablet 60 mg) and, if necessary, can be further increased as described above.

Combination with another hypoglycemic drug

Diabetes MB can be used in combination with biguanides, alpha-glucosidase inhibitors or insulin.

With inadequate glycemic control, additional insulin therapy should be prescribed with careful medical supervision.

Special patient groups

Correction of the dose of the drug for patients over 65 years is not required.

The results of clinical studies showed that correction of the dose of the drug in patients with mild and moderate renal insufficiency is not required. It is recommended that a thorough medical check is carried out.

In patients who are at risk for developing hypoglycemia (insufficient or unbalanced diet, severe or poorly compensated endocrine disorders - pituitary and adrenal insufficiency, hypothyroidism, elimination of glucocorticosteroids after long-term administration and / or intake in high doses, severe cardiovascular disease, cardiovascular system - severe IHD, severe atherosclerosis of the carotid arteries, widespread atherosclerosis), it is recommended to use the minimal dose (30 mg) of the drug Diabetes MB.

To achieve intensive glycemic control in order to prevent complications of diabetes mellitus, you can gradually increase the dose of Diabeton MB to 120 mg per day in addition to diet and exercise until the target level of HbA1c is reached. It should be remembered about the risk of developing hypoglycemia. In addition, other hypoglycemic drugs may be added to therapy, for example,metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative or insulin.

Side effect

• hypoglycemia;
• headache;
• a strong sense of hunger;
• nausea, vomiting;
• constipation;
• increased fatigue;
• sleep disturbance;
• irritability;
• excitation;
• decreased concentration of attention;
• delayed reaction;
• depression;
• confusion of consciousness;
• impaired vision and speech;
• tremor;
• loss of self-control;
• feeling helpless;
• dizziness;
• weakness;
• convulsions;
• bradycardia;
• rave;
• shallow breathing;
• drowsiness;
• loss of consciousness with possible development of coma, up to a lethal outcome;
• increased sweating;
• "sticky" skin;
• anxiety;
• tachycardia;
• increased blood pressure;
• a feeling of palpitations;
• arrhythmia;
• angina pectoris;
• rash;
• itching;
• erythema;
• maculopapular rash;
• bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis);
• hives;
• angioedema;
• hematological disorders (anemia, leukopenia, thrombocytopenia, granulocytopenia, agranulocytosis);
• transient visual disorders.

Contraindications

• type 1 diabetes mellitus;
• Diabetic ketoacidosis, diabetic precoma, diabetic coma;
• severe renal or hepatic insufficiency (in these cases it is recommended to use insulin);
• simultaneous administration of miconazole;
• pregnancy;
• lactation period (breastfeeding);
• age to 18 years;
• hypersensitivity to gliclazide or any of the excipients of the drug, other derivatives of sulfonylurea, sulfonamides.

Application in pregnancy and lactation

Experience in the use of Diabeton in pregnancy is absent. Data on the use of other derivatives of sulfonylurea in pregnancy are limited.

In studies on laboratory animals teratogenic effects of glycazide were not revealed.

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

Oral hypoglycemic drugs during pregnancy are not applied. Insulin is the drug of choice for the therapy 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 if the pregnancy has occurred while taking the drug.

Given the lack of data on the intake of Diabetone in breast milk and the risk of developing neonatal hypoglycemia, it is contraindicated during treatment with the drug.

Use in children

Contraindicated in children and adolescents under the age of 18 (there is no data on the efficacy and safety of the drug in this age group.)

special instructions

Hypoglycaemia

When prescribing Diabetes MB, it should be borne in mind that hypoglycemia may develop, due to the administration of sulfonylurea derivatives, and in some cases severe and prolonged, requiring hospitalization and Dextrose (glucose) administration for several days.

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

Typically, the symptoms of hypoglycemia go away after eating a meal rich in carbohydrates (such as sugar). It should be borne in mind that the use of sugar substitutes does not help to eliminate hypoglycemic symptoms. The experience of using other sulfonylurea derivatives suggests that hypoglycemia can recur despite effective initial arrest of this condition. In the event that hypoglycemic symptoms have a pronounced character or are prolonged, even in the case of temporary improvement after 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 regimens is required, as well as providing the patient with complete information about the proposed treatment.

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

• refusal or inability of the patient (especially the elderly) to follow the prescriptions of the doctor and monitor their condition;
• insufficient and irregular meals, skipping meals, fasting and changing diets;
• an imbalance between exercise and the amount of carbohydrates taken;
• kidney failure;
• severe hepatic impairment;
• drug overdose Diabetes MB;
• Some endocrine disorders (thyroid gland diseases, pituitary and adrenal insufficiency);
• simultaneous reception of certain medicines.

Hepatic / Renal Failure

In patients with hepatic and / or renal insufficiency of a severe degree, the pharmacokinetic and / or pharmacodynamic properties of the glycazide are possible. Hypoglycemia, developing in these patients, can be quite long, in such cases, immediate appropriate therapy is needed.

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 should be informed about the potential risks and benefits of the proposed treatment. The patient needs to explain the importance of dieting, the need for regular exercise and regular monitoring of blood glucose levels.

Insufficient glycemic control

Glycemic control in patients receiving therapy with hypoglycemic agents may be weakened in the following cases: fever, trauma, infectious diseases or major surgical interventions. With 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. glyclazide, tends to decline after a long treatment period. This effect can be due to both the progression of the disease and the decrease in the therapeutic response to the drug. This phenomenon is known as secondary drug resistance, which must be distinguished from the primary, in which the drug already at the first appointment does not give the expected clinical effect. Before diagnosing the patient for secondary drug resistance, it is necessary to evaluate the adequacy of dose selection and adherence to prescribed diet.

Control of laboratory indicators

To assess the glycemic control is recommended to determine the fasting blood glucose level and the level of glycosylated hemoglobin.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 glycazide is a derivative of sulfonylureas, caution should be exercised when it is administered to patients with deficiency of glucose-6-phosphate dehydrogenase. One should evaluate the possibility of prescribing a hypoglycemic drug of another group.

Impact on the ability to drive vehicles and manage mechanisms

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

Drug Interactions

Preparations and substances that enhance the effect of gliclazide (contribute to an increased risk of hypoglycemia)

Combinations are contraindicated

The simultaneous use with miconazole (for systemic use and when using the gel on the oral mucosa) leads to an increasehypoglycemic action of gliclazide (hypoglycemia is possible up to the state of coma).

Combinations are not recommended

Phenylbutazone (for systemic use) enhances the hypoglycemic effect of sulfonylurea derivatives, displaces them from the bond with plasma proteins and / or slows their excretion from the body. Preferably, another anti-inflammatory drug is used. If the reception of 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.

When used simultaneously with glycazide, ethanol (alcohol) increases hypoglycemia, inhibiting compensatory reactions, and may contribute to the development of hypoglycemic coma. It is necessary to refuse to take medicines containing ethanol, and from drinking alcohol.

Combinations that require precautions

Reception of Diabeton in combination with certain drugs (for example, other hypoglycemic agents - insulin, acarbose, metformin, thiazolidinediones, inhibitors of dipeptidipeptidase-4,agonists of GLP-1); beta-adrenoblockers, fluconazole; ACE inhibitors - captopril, enalapril; blockers of histamine H2 receptors; MAO inhibitors; sulfonamides, clarithromycin, NSAIDs) is accompanied by increased hypoglycemic effect and risk of hypoglycemia.

Preparations, weakening the effect of glycazide (contribute to an increase in blood glucose)

Combinations are not recommended

Danazol has a diabetic effect. If the drug is needed, the patient should be carefully monitored for blood glucose. If it is necessary to take joint medications, it is recommended that a dose of a hypoglycemic agent be selected at the time of taking danazol and after its withdrawal.

Combinations that require precautions

Joint use of Diabeton with chlorpromazine in high doses (more than 100 mg per day) can lead to an increase in the concentration of glucose in the blood by reducing the secretion of insulin. Careful glycemic control is recommended. If it is necessary to take joint medications, it is recommended that a dose of a hypoglycemic agent be chosen at the time of taking the neuroleptic, and after its withdrawal.

With the simultaneous use of glucocorticosteroids (for systemic and topical application - intraarticular, cutaneous, rectal administration) and tetracosactide increase the concentration of glucose in the blood with the possible development of ketoacidosis (reduced tolerance to carbohydrates). Careful glycemic control is recommended, especially at the beginning of treatment. If it is necessary to take medications together, it may be necessary to correct the dose of the hypoglycemic agent both during administration of the GCS and after their withdrawal.

With the combined use of beta2-adrenomimetics (ritodrin, salbutamol, terbutaline intravenous administration) contribute to an increase in the concentration of glucose in the blood.

It is necessary to pay special attention to the importance of independent glycemic control. If necessary, it is recommended to transfer the patient to insulin therapy.

Combinations that should be taken into account

Derivatives of sulfonylureas can enhance the action of anticoagulants (eg, warfarin) when taken together. You may need to adjust the dose of anticoagulant.

Analogues of the drug Diabetes

Structural analogs for the active substance:

• Glidiab;
• Glidiab MB;
• Glyclad;
• Gliclazide;
• Gliklazid MB;
• Glukostabil;
• Diabetolong;
• Diabetes MB;
• Diabetes;
• Diabetes FM;
• Diabinax;
• Diabrazide;
• Diatics;
• Predian;
• Reclild.

Analogues on the pharmacological group (hypoglycemic agents):

• Avandamet;
• Avandia;
• Adebit;
• Amalvia;
• Amaryl;
• Antidiab;
• Arfazetine;
• Astroson;
• Bagomet Plus;
• Bagomet;
• Baeta;
• Bethanase;
• Bukarban;
• Butamide;
• Victoria;
• Galvus;
• Hillemal;
• Glemaz;
• Glybenez retard;
• Glibenclamide;
• Glidiab;
• Glyclad;
• Gliclazide;
• Glicon;
• Glucobene;
• Glucovans;
• Gluconorm;
• Glukostabil;
• Glucotrol HL;
• Glucophage;
• Glucophage Long;
• Glumex;
• Diabetolong;
• Diabetes;
• Diaglinide;
• Diatics;
• Langerin;
• Maninil;
• Meglymide;
• Metogamma;
• Metformin;
• Minidiab;
• Movoglecken;
• Novoformin;
• OngliSa;
• Pioglar;
• Pioglit;
• Reclild;
• Roglit;
• Siofor;
• Sofamet;
• Formethine;
• Formina Pliva;
• Chloropropamide;
• Januvia.

Similar medicines:

Other medicines: