Diabeton MV
Diabeton MV: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Instructions for the use of Diabeton method and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Diabeton mr
ATX code: A10BB09
Active ingredient: Gliclazid (Gliclazide)
Producer: Les Laboratoires Servier (France)
Description and photo updated: 12.12.2018
Diabeton MV is an oral hypoglycemic drug with modified release.
Release form and composition
Dosage form - modified release tablets: oval, white, biconvex; Diabeton MV 30 mg - engraving “DIA 30” on one side, the company logo on the other; Diabeton MV 60 mg - with a notch, “DIA 60” engraving on both sides (15 pcs. In blisters, in a cardboard box 2 or 4 blisters; 30 pcs. In blisters, in a cardboard box 1 or 2 blisters).
Composition of 1 tablet:
- active substance: gliclazide - 30 or 60 mg;
- auxiliary components: calcium hydrogen phosphate dihydrate - 83.64 / 0 mg; hypromellose 100 cP - 18/160 mg; hypromellose 4000 cP - 16/0 mg; magnesium stearate - 0.8 / 1.6 mg; maltodextrin - 11.24 / 22 mg; anhydrous colloidal silicon dioxide - 0.32 / 5.04 mg; lactose monohydrate - 0 / 71.36 mg.
Pharmacological properties
Pharmacodynamics
Gliclazide is a sulfonylurea derivative, an oral hypoglycemic drug, which is distinguished from similar drugs by the presence of an N-containing heterocyclic ring with an endocyclic bond.
Gliclazide helps to reduce the concentration of glucose in the blood, stimulates the secretion of insulin by β-cells of the islets of Langerhans. An increase in postprandial insulin and C-peptide levels persists after 2 years of drug use. In addition to affecting carbohydrate metabolism, the substance has hematovascular effects.
In type 2 diabetes mellitus, Diabeton MB restores the early peak of insulin secretion in response to glucose intake, and also enhances the second phase of insulin secretion. A significant increase in secretion is observed in response to stimulation, which is due to the introduction of glucose and food intake.
Gliclazide reduces the likelihood of small vessel thrombosis, influencing the mechanisms that can cause complications in diabetes mellitus: partial inhibition of platelet adhesion / aggregation and a decrease in the concentration of platelet activation factors (thromboxane B2, β-thromboglobulin), as well as an increase in the activity of tissue plasminogen activator and restoration of fibrinolytic activity of the vascular endothelium.
Intensive glycemic control, which is based on the use of Diabeton MB, in comparison with standard glycemic control significantly reduces the macro- and microvascular complications of type 2 diabetes mellitus.
The advantage is due to a significant decrease in the relative risk of major microvascular complications, the appearance and progression of nephropathy, the occurrence of macroalbuminuria, microalbuminuria, and the development of renal complications.
The benefits of intensive glycemic control during use of Diabeton MV did not depend on the benefits achieved during antihypertensive therapy.
Pharmacokinetics
- absorption: after oral administration, complete absorption occurs. Plasma concentration of gliclazide in the blood increases gradually over the first 6 hours, the plateau level is maintained in the range of 6-12 hours. Individual variability is low. Food intake does not affect the degree / rate of absorption of gliclazide;
- distribution: binding to plasma proteins - approximately 95%. Vd is approximately 30 liters. Reception of Diabeton MB 60 mg once a day ensures the maintenance of an effective plasma concentration of gliclazide in the blood for longer than 24 hours;
- metabolism: metabolism occurs primarily in the liver. Active metabolites are not present in plasma;
- Excretion: the half-life averages 12–20 hours. Excretion occurs mainly by the kidneys in the form of metabolites, less than 1% is excreted unchanged.
The relationship between the dose taken and the AUC (area under the concentration / time curve) is linear.
Indications for use
- type 2 diabetes mellitus in cases where other measures (diet therapy, exercise and weight loss) are not effective enough;
- complications of diabetes mellitus (prevention by intensive glycemic control): reducing the likelihood of micro- and macrovascular complications (nephropathy, retinopathy, stroke, myocardial infarction) in patients with type 2 diabetes mellitus.
Contraindications
Absolute:
- type 1 diabetes mellitus;
- diabetic precoma, diabetic ketoacidosis, diabetic coma;
- hepatic / renal failure in severe course (in such cases, the use of insulin is recommended);
- combined use with miconazole, phenylbutazone or danazol;
- congenital lactose intolerance, galactosemia, galactose / glucose malabsorption syndrome;
- age up to 18 years;
- pregnancy and lactation;
- individual intolerance to the components of the drug, as well as other sulfonylurea derivatives, sulfonamides.
Relative (diseases / conditions in the presence of which the appointment of Diabeton CF requires caution):
- alcoholism;
- irregular / unbalanced diet;
- severe diseases of the cardiovascular system;
- insufficiency of glucose-6-phosphate dehydrogenase;
- adrenal / pituitary insufficiency;
- hypothyroidism;
- long-term therapy with glucocorticosteroids;
- renal / hepatic impairment;
- elderly age.
Instructions for the use of Diabeton MV: method and dosage
Diabeton MV tablets are taken orally, without crushing or chewing, preferably during breakfast, once a day.
The daily dose can vary from 30 to 120 mg (maximum). It is determined by the concentration of blood glucose and HbA1c.
In cases of missing a single dose, it is impossible to increase the next one.
The initial recommended daily dose is 30 mg. In the case of adequate control, Diabeton MB at this dose can be used for maintenance therapy. In case of inadequate glycemic control (not earlier than 30 days after the start of drug use), the daily dose can be sequentially increased to 60, 90 or 120 mg. A faster dose increase (after 14 days) is possible in cases where the blood glucose concentration has not decreased during the therapy period.
1 tablet Diabeton 80 mg can be replaced with Diabeton MB 30 mg (under close glycemic control). It is also possible to switch from other oral hypoglycemic agents, while taking into account their dose and half-life. A transition period is usually not required. The initial dose in these cases is 30 mg, after which it must be titrated depending on the concentration of blood glucose.
When switching from sulfonylurea derivatives with a long half-life, in order to avoid the development of hypoglycemia, which is associated with the additive effect of drugs, you can stop taking them for several days. The initial dose in such cases is also 30 mg with a possible subsequent increase according to the scheme described above.
Possible combined use with biguanidines, insulin or α-glucosidase inhibitors. In cases of inadequate glycemic control, additional insulin therapy should be prescribed with careful medical supervision.
With mild / moderate renal impairment, therapy should be carried out under close medical supervision.
Diabeton MV is recommended to be taken at 30 mg per day for patients who are at risk of hypoglycemia due to such conditions / diseases:
- unbalanced / insufficient nutrition;
- poorly compensated / severe endocrine disorders, including pituitary and adrenal insufficiency, hypothyroidism;
- cancellation of glucocorticosteroids after their prolonged use and / or taking in high doses; severe diseases of the cardiovascular system, including severe atherosclerosis of the carotid arteries, severe ischemic heart disease, widespread atherosclerosis.
To achieve intensive glycemic control, it is possible to gradually increase the dose to the maximum as an adjunct to diet and exercise until the target HbA1c level is reached. It is necessary to remember about the likelihood of hypoglycemia. Also, other hypoglycemic drugs can be added to Diabeton MB, in particular, α-glucosidase inhibitors, metformin, insulin or thiazolidinedione derivatives.
Side effects
Like other drugs of the sulfonylurea group, Diabeton MB in cases of irregular meals and, especially if meals were missed, can cause hypoglycemia. Possible symptoms: decreased concentration, agitation, nausea, headache, shallow breathing, severe hunger, vomiting, increased fatigue, sleep disturbance, irritability, delayed reaction, depression, loss of self-control, confusion, speech and visual impairment, aphasia, paresis, tremor, impaired perception, feeling of helplessness, dizziness, weakness, convulsions, bradycardia, delirium, drowsiness, loss of consciousness with the possible development of coma, up to death.
Adrenergic reactions are also possible: increased sweating, clammy skin, tachycardia, anxiety, increased blood pressure, palpitations, angina pectoris and arrhythmia.
In most cases, these symptoms can be stopped with carbohydrates (sugar). Taking sweeteners in such cases is ineffective. Against the background of therapy with other sulfonylurea derivatives, relapses of hypoglycemia were noted after its successful relief.
In cases of prolonged / severe hypoglycemia, emergency medical care is indicated, up to hospitalization, even if there is an effect of carbohydrate intake.
Possible disorders of the digestive system: nausea, abdominal pain, vomiting, constipation, diarrhea (the intake of Diabeton CF during breakfast helps to minimize the likelihood of developing these disorders).
Less commonly, the following adverse reactions are noted:
- lymphatic system and hematopoietic organs: rarely - hematological disorders (manifested in the form of anemia, leukopenia, thrombocytopenia, granulocytopenia; are, as a rule, reversible);
- skin / subcutaneous tissue: rash, urticaria, pruritus, erythema, Quincke's edema, maculopapular rash, bullous reactions;
- organ of vision: transient visual disturbances (associated with changes in blood glucose levels, especially at the beginning of the use of Diabeton MV);
- biliary tract / liver: increased activity of liver enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase); in isolated cases - hepatitis, cholestatic jaundice (requires discontinuation of therapy), disorders are usually reversible.
Adverse reactions inherent in sulfonylurea derivatives: allergic vasculitis, erythrocytopenia, hyponatremia, agranulocytosis, hemolytic anemia, pancytopenia. There is information about the development of an increase in the activity of liver enzymes, liver dysfunction (for example, with the development of jaundice and cholestasis) and hepatitis. The severity of these reactions decreases with time after drug withdrawal, but in some cases, life-threatening liver failure may develop.
Overdose
In cases of overdose with Diabeton MB, hypoglycemia may develop.
Therapy: moderate symptoms - an increase in carbohydrate intake with food, a decrease in the dose of the drug and / or a change in diet; careful monitoring is required until the health threat disappears; severe hypoglycemic conditions, accompanied by convulsions, coma or other neurological disorders - immediate hospitalization and emergency medical care are required.
In hypoglycemic coma / suspicion of it, an intravenous jet injection of 20-30% dextrose solution (50 ml) is indicated, after which a 10% dextrose solution is injected intravenously (in order to maintain a blood glucose concentration above 1000 mg / l). Careful monitoring of blood glucose levels and monitoring of the patient's condition should be carried out for at least the next 48 hours. The need for further monitoring is determined by the patient's condition.
Due to the pronounced binding of gliclazide to plasma proteins, dialysis is ineffective.
special instructions
During therapy, hypoglycemia may develop, and in some cases - in a prolonged / severe form, which requires hospitalization and intravenous dextrose for several days.
Diabeton MV can be prescribed only if the patient's meals are regular and includes breakfast. Maintaining an adequate intake of carbohydrate from food is very important, since the likelihood of hypoglycemia with irregular / insufficient nutrition, as well as with the consumption of low carbohydrate foods, increases. Most often, the appearance of hypoglycemia is observed with a low-calorie diet, after vigorous / prolonged physical exercise, drinking alcohol, or with the simultaneous use of several hypoglycemic drugs.
To avoid the development of hypoglycemia, a careful individual selection of drugs and a dosage regimen is required.
The likelihood of developing hypoglycemia increases in the following cases:
- refusal / inability of the patient to control his condition and follow the doctor's prescriptions (in particular, this applies to elderly patients);
- imbalance between the amount of carbohydrates taken and physical activity;
- skipping meals, irregular / inadequate nutrition, dietary changes and fasting;
- renal failure;
- severe liver failure;
- overdose of Diabeton MB;
- combined use with certain drugs;
- some endocrine disorders (thyroid disease, adrenal and pituitary insufficiency).
The weakening of glycemic control while taking Diabeton CF is possible with fever, trauma, infectious diseases, or major surgical interventions. In these cases, it may be necessary to discontinue the drug and prescribe insulin therapy.
After a long period of treatment, the effectiveness of Diabeton CF may decrease. This may be due to the progression of the disease or a decrease in the therapeutic response to the drug - secondary drug resistance. Before diagnosing this disorder, it is necessary to assess the adequacy of the dose selection and patient compliance with the prescribed diet.
In order to assess glycemic control, regular monitoring of fasting blood glucose and glycosylated hemoglobin HbA1c is recommended. It is also advisable to conduct regular self-monitoring of blood glucose concentration.
Sulfonylurea derivatives can lead to hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency (the appointment of Diabeton MV with this disorder requires caution); it is also necessary to assess the possibility of prescribing a hypoglycemic drug of another group.
Influence on the ability to drive vehicles and complex mechanisms
When driving vehicles, patients should be careful, which is associated with the likelihood of developing hypoglycemia.
Application during pregnancy and lactation
Diabetone MV is not prescribed to nursing and pregnant women (due to limited data confirming the safety / effectiveness of therapy).
Pediatric use
In children and adolescents under 18 years of age, the use of Diabeton MV is contraindicated, which is associated with the limited data confirming the safety / effectiveness of treatment.
With impaired renal function
Reception of Diabeton CF in severe renal failure is contraindicated.
For violations of liver function
According to the instructions, Diabeton MV is contraindicated in severe liver failure.
Use in the elderly
Prescribing the drug requires caution. In elderly patients, dose adjustment of Diabeton MV is not required, but constant monitoring of the condition is necessary.
Drug interactions
Substances / medicines that increase the likelihood of hypoglycemia (the effect of gliclazide is enhanced):
- miconazole: hypoglycemia may develop up to coma (the combination is contraindicated);
- phenylbutazone: if a combined use is required, glycemic control is required (the combination is not recommended; a dose adjustment of Diabeton MB may be required);
- ethanol: the likelihood of developing a hypoglycemic coma (it is recommended to refuse alcohol consumption and the use of drugs containing ethanol);
- other hypoglycemic agents, including insulin, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 agonists; β-blockers; fluconazole; angiotensin-converting enzyme inhibitors, including captopril, enalapril; blockers of histamine H2-receptors; monoamine oxidase inhibitors; non-steroidal anti-inflammatory drugs; sulfonamides; clarithromycin and some other drugs / substances: increased hypoglycemic effect (combination requires caution).
Substances / medicines that increase blood glucose levels (the effect of gliclazide is weakened):
- Danazol: has a diabetogenic effect (the combination is not recommended); if necessary, combined use, it is recommended to carefully monitor blood glucose and adjust the dose of Diabeton MB;
- chlorpromazine (in high doses): decreased insulin secretion (the combination requires caution); close glycemic control is shown, dose adjustment of Diabeton MB may be required;
- salbutamol, ritodrin, terbutaline and other β 2 -adrenomimetics: increased blood glucose concentration (the combination requires caution);
- glucocorticosteroids, tetracosactide: the likelihood of developing ketoacidosis - a decrease in carbohydrate tolerance (the combination requires caution), careful glycemic control is recommended, especially at the beginning of therapy; dose adjustment of Diabeton MB may be required.
During the use of the drug, special attention should be paid to the importance of self-glycemic control. If necessary, it is recommended to transfer the patient to insulin therapy.
When combined with anticoagulants, their effect may be enhanced, which may require dose adjustment.
Analogs
Analogs of Diabeton MV are: Gliclazid Canon, Gliclada, Glidiab, Diabetalong, Diabinaks, Diabefarm and others.
Terms and conditions of storage
No special storage conditions are required. Keep out of the reach of children.
Shelf life: dosage 30 mg - 3 years; dosage of 60 mg - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Diabetone MV
According to reviews, Diabeton MV is an effective drug that helps lower blood sugar levels. The development of side effects is reported only in rare cases. Of the shortcomings, they usually indicate a fairly high cost of the drug.
Price for Diabeton MB in pharmacies
The approximate price for Diabeton MV (30 tablets of 60 mg each) is 180-315 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
