DIABETON MV PILLS 60MG

Modified Release Tablets

Composition

1 pill contains:
Active substance: Gliclazide - 60 mg.
Excipients: Calcium phosphate dihydrate, maltodextrin, hypromellosis, Magnesium stearate, anhydrous colloidal silicon dioxide.

Packing

30 pieces

Mechanism of action

Oral hypoglycemic drug from the group of sulfonylurea derivatives of the II generation, which differs from similar preparations by the presence of an N-containing heterocyclic ring with an endocyclic bond.
Diabetes MB lowers blood glucose by stimulating insulin secretion by b-cells of the islets of Langerhans. After 2 years of treatment, most patients do not develop addiction to the drug (there is still an increase in postprandial insulin and C-peptide secretion).
In type 2 diabetes mellitus (non-insulin-dependent), 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.
Gliclazide has a pronounced extrapancreatic effect, i.e.increases the sensitivity of peripheral tissues to insulin.
In muscle tissue, the effect of insulin on glucose absorption, due to the improved sensitivity of peripheral tissues to insulin, is significantly increased (+ 35%). This effect of gliclazide is mainly due to the fact that it promotes the action of insulin on muscle glycogen synthetase and causes post-transcriptional changes in GLUT4 relative to glucose.
Diabetes MB reduces glucose formation in the liver, normalizing fasting glucose levels.
In addition to the effect on carbohydrate metabolism, gliclazide improves microcirculation. The drug reduces the risk of thrombosis of small vessels, affecting 2 mechanisms that may be involved in 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.
Gliclazide has antioxidant properties: reduces the level of lipid peroxides in plasma, increases the activity of erythrocyte superoxide dismutase.

Indications and usage

Type 2 diabetes mellitus (non-insulin-dependent) in combination with diet therapy with the lack of the latter.

Contraindications

- diabetes mellitus type 1 (insulin-dependent);
- diabetic ketoacidosis;
- diabetic precoma and coma;
- conditions requiring insulin therapy (surgery, high body temperature, infectious diseases, injuries);
- renal failure severe;
- severe liver failure;
- simultaneous reception of miconazole;
- pregnancy;
- breast-feeding;
- children's and teenage age up to 18 years.
- Hypersensitivity to the components of the drug and other sulfonylurea derivatives.

Pregnancy and Breastfeeding

There is not enough clinical data to assess the risk of possible defects and fetotoksicheskih effects caused by the use of gliclazide during pregnancy. Therefore, the use of Diabeton MV in this category of patients is contraindicated.
When the pregnancy came on the background of the drug, there is no specific reason for its termination. In such cases, as well as in the case of a planned pregnancy, the drug should be discontinued and therapy should be continued only with insulin preparations under the careful control of all laboratory parameters of carbohydrate metabolism. Neonatal blood glucose monitoring is also recommended.
It is not known whether gliclazide is excreted in breast milk; data on the risk of developing neonatal hypoglycemia are not available. In this regard, gliclazide therapy during breastfeeding is contraindicated.
ATexperimental studies in animals it has been shown that sulfonylurea derivatives in high doses have a teratogenic effect.

Dosage and administration

The drug is intended only for adults (including for patients 65 years and older). The recommended starting dose is 30 mg.
Selection of the dose should be carried out in accordance with the level of glucose in the blood after the start of treatment. Each subsequent dose change may be undertaken after at least a 2-week period.
With maintenance therapy, the daily intake of a single dose provides effective control of blood glucose levels. The daily dose of the drug can vary from 30 mg (1 tab.) To 90-120 mg (3-4 tab.). The maximum daily dose is 120 mg.
The drug is taken orally 1 time / day during breakfast.
When you skip one or more doses of the drug should not take a higher dose in the next dose.
For patients who have not previously received treatment, the initial dose is 30 mg. Then the dose is selected individually to achieve the desired therapeutic effect.
Diabeton MB can replace Diabeton in doses from 1 to 4 tab./day.
Switching from another hypoglycemic drug to Diabeton MB does not require any transitional period of time. You must first stop taking a hypoglycemic drug, and only then appoint Diabeton MB.
Diabeton MB can be used in combination with biguanides, alpha glucosidase inhibitors or insulin.
For elderly patients, the recommended doses are the same as for patients under 65 years of age.
If a patient has previously received sulfonylurea therapy with a long T1/2 (for example, chlorpropamid), then for 1-2 weeks it is necessary to conduct careful observation (control of glycemia level) in order to avoid the development of hypoglycemia as a consequence of the residual effects of previous therapy.
In patients with mild to moderate severity of renal failure (CC from 15 to 80 ml / min), the drug is prescribed in the same doses as in patients with normal renal function.

Adverse reactions

On the part of the endocrine system: hypoglycemia is possible.
Gastrointestinal: nausea, diarrhea, or constipation are possible (less common when prescribing the drug during meals); rarely - increased activity of AST, ALT, ALP; in some cases - jaundice.
Hemic and lymphatic: rarely - anemia, leukopenia, thrombocytopenia.
Allergic reactions: rarely - itching, urticaria, maculo-papular rash.

When prescribing Diabeton MB, it should be borne in mind that hypoglycemia may develop due to the administration of sulfonylurea derivatives, and in some cases in severe and prolonged form requiring hospitalization and glucose administration for several days.
In order to avoid the development of hypoglycemia, careful selection of patients and individual selection of doses, as well as providing the patient with complete information about the proposed treatment are necessary.
With the use of hypoglycemic drugs in elderly patients, those who are not constantly receiving sufficient nutrition, with a weakened general condition, in patients with adrenal or pituitary insufficiency, the risk of hypoglycemia is increased.
Symptoms of hypoglycemia are difficult to recognize in the elderly and in patients receiving beta-blocker therapy.
In the appointment of Diabeton MV patients of advanced age, it is necessary to carefully monitor the level of glucose in the blood. Treatment should begin gradually and during the first days of therapy, fasting glucose levels should be monitored and after meals.
Diabetes MB can only be prescribed to patients who receive regular meals, necessarily including breakfast and ensuring sufficient intake of carbohydrates. Hypoglycemia often develops with a low-calorie diet, after prolonged or vigorous exercise, after drinking alcohol, or while taking several hypoglycemic drugs at the same time.
If symptoms of cholestatic jaundice occur, treatment should be interrupted. After the cancellation of Diabeton MB, these symptoms usually disappear.
In patients with severe hepatic and / or renal insufficiency, the pharmacokinetic and / or pharmacodynamic properties of gliclazide may be altered. In particular, severe hepatic or renal failure may affect the distribution of gliclazide in the body. Hepatic failure can also reduce glucogenesis. These effects increase the risk of developing hypoglycemic conditions. Hypoglycemia that develops in these patients can be quite long, in such cases it is necessary to immediately conduct appropriate therapy.
Control of blood glucose levels in patients receiving hypoglycemic agents may be impaired in the following cases: fever, trauma, infectious diseases, or surgery. In such situations, it may be necessary to discontinue treatment with Diabeton MB and prescribe insulin therapy.
The effectiveness of Diabeton MB (as well as other oral hypoglycemic drugs) in some patients tends to decrease after a long period of time. This may be due to the progression of diabetes mellitus or a decrease in the response to the drug. This phenomenon is known as secondary drug resistance, which must be distinguished from the primary when the drug is prescribed for the first time and does not give the expected effect. Before diagnosing a patient's secondary failure of drug therapy, it is necessary to assess the adequacy of the dose selection and patient compliance with the prescribed diet.
During therapy with Diabeton MB, phenylbutazone and danazol are not recommended. It is preferable to use another NSAID.
During therapy with Diabeton MB, it is necessary to abandon the use of alcohol or drugs, which include ethanol.
It is necessary to inform the patient and his family members about the risk of hypoglycemia, its symptoms and conditions conducive to its development. It is also necessary to explain what primary and secondary drug resistance is.The patient must be informed about the potential risk and benefits of the proposed treatment, it is also necessary to tell him about other therapies. The patient needs to explain the importance of consistent dieting, the need for regular exercise and regular monitoring of blood glucose and urine levels.
Control of laboratory parameters
It is necessary to regularly determine the levels of glucose and glycolized hemoglobin in the blood, the content of glucose in the urine.
Influence on ability to drive motor transport and control mechanisms
Patients should be aware of the symptoms of hypoglycemia and use caution when driving or doing work that requires a high rate of psychomotor reactions.

Drugs that enhance the effect of Diabeton MB
Combinations are contraindicated
The simultaneous use of Diabeton MB with miconazole (for systemic use) enhances the possible development of hypoglycemia up to a coma.
Combinations are not recommended.
Phenylbutazone (for systemic use) enhances the hypoglycemic effect of sulfonylurea derivatives, since replaces their connection with plasma proteins and / or slows their elimination from the body.
When used simultaneously with Diabeton MB, ethanol and ethanol-containing drugs enhance hypoglycemia, inhibiting compensatory reactions, and may contribute to the development of hypoglycemic coma.
Combinations requiring special precautions
The simultaneous use of beta-blockers masks some of the symptoms of hypoglycemia, such as palpitations and tachycardia. Most non-selective beta-blockers increase the frequency and severity of hypoglycemia.
Fluconazole increases the duration of T1/2 sulfonylurea derivatives and increases the risk of hypoglycemia.
The simultaneous use of ACE inhibitors (captopril, enalapril) may aggravate the hypoglycemic effect of sulfonylurea derivatives (according to one of the hypotheses, glucose tolerance improves and the insulin requirements decrease). Hypoglycemic reactions are rare.
The preparations weakening action of Diabeton of MV
Combinations are not recommended.
With simultaneous use with danazol, the effectiveness of Diabeton MB may decrease.
Combinations requiring special precautions
The combined use of Diabeton MB with chlorpromazine in high doses (more than 100 mg / day) can lead to an increase in plasma glucose levels due to a decrease in insulin secretion.
With simultaneous use of corticosteroids (for systemic, external and local use) and tetrakozaktid increase the level of glucose in the blood with the possible development of ketoacidosis (decrease in glucose tolerance under the influence of corticosteroids).
With the simultaneous use of Diabeton MB with progestogens, the diabetogenic effect of progestogens in high doses should be taken into account.
When used together, stimulants b2-adrenoreceptors (for systemic use) - ritodrin, Salbutamol , terbutaline increase the blood glucose level (self-monitoring of blood glucose should be ensured; if necessary, the patient may need to be transferred to insulin).
If necessary, the use of the above combinations should provide control of blood glucose levels. It may be necessary to further adjust the dose of Diabeton MB both during the period of combination therapy and after discontinuation of the additional drug.

Symptoms: hypoglycemia, in severe cases - accompanied by coma, convulsions and other neurological disorders.
Treatment: moderate symptoms of hypoglycemia are corrected by carbohydrate intake, dose adjustment and / or diet change. Careful monitoring of the patient’s condition should be continued until the attending physician is certain that nothing threatens the patient’s health. In severe conditions it is necessary to provide emergency medical care and immediate hospitalization.
If a hypoglycemic coma is suspected or diagnosed, 50 ml of a concentrated glucose solution (40%) is quickly injected into the patient. Then, a more diluted glucose solution (5%) is injected into / into the drip to maintain the required level of glucose in the blood. Careful monitoring should be carried out at least for the next 48 hours. Further, depending on the condition of the patient, the question of the need for further monitoring of the patient’s vital functions should be resolved.
In patients with liver disease, plasma clearance of gliclazide may be slow.Dialysis in such patients is usually not performed due to the pronounced binding of gliclazide to plasma proteins.

The drug should be stored under normal conditions.

3 years.

Diabeton mv