Diabeton® MR (Gliclazide) 60 mg (30 tablets)

Structure

One tablet contains the active substance - gliclazide 60 mg*

Indications for use

Type 2 diabetes mellitus in adults when diet, exercise, and weight loss are insufficient to adequately control blood glucose levels

Uses

The drug is intended only for adult patients.

The tablet (s) are recommended to be taken with breakfast. If the next dose is missed, the dose cannot be increased the next day.

The daily dose of Diabeton®MR is from 30 to 120 mg (from ½ to 2 tablets). The dose of the drug is selected depending on the individual metabolic response of the patient.

The recommended starting dose is 30 mg per day (½ tablet of Diabeton® MR 60 mg). With effective glucose control, this dose can be used as maintenance therapy.

With inadequate glucose control, the daily dose of the drug can be gradually increased to 60, 90 or 120 mg. The interval between each dose increase should be at least 1 month, except for patients in whom the glucose level has not decreased after 2 weeks of administration.

The maximum recommended dose is 120 mg per day.

One tablet of Diabeton®MR 60 mg is equivalent to two tablets of Diabeton®MR 30 mg. Diabeton®MR 60 mg tablet is easily divided, allowing you to adapt the dosage of the drug.

Switching from gliclazide 80 mg tablets to modified-release tablets Diabeton® MR 60 mg:

One gliclazide 80 mg tablet is comparable to the modified release formulation Diabeton® MR 30 mg, i.e. with a half tablet Diabeton® MR 60 mg. The transition is carried out with strict glucose monitoring.

Switching from another hypoglycemic drug to Diabeton® MR 60 mg:

During the transition, the dosage and half-life of the previous drug should be taken into account. Reception of Diabeton® MR 60 mg should be started with 30 mg, followed by adjustment depending on the metabolic response.

When switching from hypoglycemic drugs of the sulfonylurea group with a prolonged half-life, in order to avoid the additive effect of the two drugs, a drug-free period of several days may be required.

In such cases, the transition to Diabeton® MR 60 mg tablets should be started with the recommended initial dose of 30 mg, followed by a gradual increase in the dose depending on the metabolic response.

Use in combination with other antidiabetic drugs:

Diabeton® MR 60 mg can be administered in combination with biguanides, alpha-glucosidase inhibitors or insulin.

Elderly patients (over 65 years old):

The drug is prescribed in the same dose as for patients under 65 years of age.

Renal failure:

For patients with mild or moderate renal impairment, the drug is prescribed in usual doses.

Patients with an increased risk of developing hypoglycemia: with insufficient or improper nutrition, with severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, lack of adrenocorticotropic hormone), after prolonged and / or high-dose corticosteroid therapy, severe cardiovascular diseases, it is recommended to start treatment with a minimum daily doses of 30 mg.

Side effects

- hypoglycemia (in case of irregular intake or missed meals): clammy sweat, anxiety, tachycardia, increased blood pressure, tremors, pain in the heart, arrhythmia, headache, acute hunger, nausea, vomiting, fatigue, sleep disturbances , agitation or lethargy, aggressiveness, poor concentration of attention, delayed reaction, visual and speech disorders, aphasia, paresis, decreased sensitivity, dizziness, loss of self-control, drowsiness, loss of consciousness, delirium, convulsions

- abdominal pain, nausea, vomiting, diarrhea, constipation, a reversible increase in the level of liver enzymes (ALT, AST, alkaline phosphatase), hepatitis

- skin rash, pruritus, urticaria, erythema, maculopapular rashes, bullous reactions

- anemia, leukopenia, thrombocytopenia, granulocytopenia, reversible after drug withdrawal

- transient visual impairment, especially at the beginning of treatment, due to changes in blood glucose levels

 

Contraindications

- known hypersensitivity to gliclazide or one of the auxiliary components of the drug, as well as to other drugs of the sulfonylurea group or sulfonamides

- type 1 diabetes mellitus

- diabetic ketoacidosis, pre-coma and diabetic coma

- severe renal or hepatic impairment

- miconazole therapy

- the period of pregnancy and lactation

Drug interactions

The combined use of Diabeton® MR and miconazole is contraindicated due to the risk of hypoglycemia, up to hypoglycemic coma.

Diabeton® MR is not recommended to be used simultaneously with phenylbutazone and alcohol due to the increased risk of hypoglycemia. During the period of drug treatment, it is necessary to refrain from drinking alcohol and taking medications containing alcohol in the composition.

Due to the risk of hypoglycemia, caution should be exercised while prescribing Diabeton® MR and antidiabetic drugs of other groups (insulins, acarbose, biguanides), beta-blockers, fluconazole, angiotensin-converting enzyme inhibitors (captopril, enalapril), antagonists, H2-receptors MAOIs, sulfonamides and non-steroidal anti-inflammatory drugs.

The simultaneous use of Diabeton® MR and Danazol is not recommended due to the risk of increased blood glucose levels. If it is necessary to prescribe such a combination, you should carefully monitor the level of glucose in the blood and urine, and in some cases adjust the dose of Diabeton® MR during and after danazol therapy.

Due to the risk of hyperglycemia, caution should be exercised when combining Diabeton® MR with chlorpromazine (at a dose> 100 mg per day, the latter causes a decrease in insulin secretion). During therapy with chlorpromazine, a dose adjustment of Diabeton® MR may be required.

Glucocorticosteroids (for systemic and local use: intra-articular, sub- or cutaneous, rectally) and tetracosactide, when taken simultaneously with Diabeton® MR, increase blood glucose levels and, due to a decrease in carbohydrate tolerance, can cause ketosis. During treatment and after glucocorticoid therapy, a dose adjustment of Diabeton® MR may be required.

Caution should be exercised when taking Diabeton® MR in combination with ritodrin, salbutamol and tertbutaline (intravenously) due to the risk of hyperglycemia. If necessary, you should switch to insulin therapy.

With the combined use of Diabeton® MR (sulfonylurea preparations) with anticoagulants (warfarin, etc.), an increase in the anticoagulant effect may be observed.

Special instructions

Hypoglycemia

The drug should be prescribed only if the patient has a regular meal (including breakfast).

The risk of hypoglycemia increases with a low-calorie diet, after prolonged or excessive physical exertion, alcohol consumption, or in the case of a combination of several hypoglycemic drugs.

The patient should be informed about the importance of adhering to diet, the need for regular exercise and regular monitoring of blood glucose levels. Patients and members of their families need to explain the danger of hypoglycemia, tell about its symptoms, methods of treatment and factors predisposing to the development of this complication.

Poor blood glucose control

The effectiveness of controlling blood glucose concentration in a patient receiving antidiabetic therapy may be reduced by the following factors: fever, injury, infection, or surgery.

The hypoglycemic efficacy of any oral antidiabetic drug, including Diabeton® MR, decreases over time in many patients due to the progression of diabetes or a decrease in response to the drug (secondary lack of effect of therapy). The conclusion about the secondary absence of the effect of therapy can be made only after an adequate dose adjustment and subject to the patient's diet.

Laboratory tests

Measurement of glycated hemoglobin (or fasting venous plasma glucose) is recommended when evaluating blood glucose control.

Prescribing sulfonylurea drugs to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency can lead to hemolytic anemia. Caution should be exercised when prescribing Diabeton® MR to patients with G6PD deficiency and consider alternative treatment with a drug of a different class.

The drug contains lactose, so it should not be used for congenital galactosemia, glucose-galactose malabsorption syndrome, as well as for lactase deficiency.

Features of the effect of the drug on the ability to drive vehicles or potentially dangerous mechanisms

Caution should be exercised when driving vehicles or other mechanisms, especially at the beginning of therapy.

Overdose

Symptoms are moderate to severe hypoglycemia.

Treatment: symptoms of hypoglycemia of moderate severity without loss of consciousness or signs of neurological disorders, eliminated by taking carbohydrates, adjusting the dose and / or changing the diet. Severe episodes of hypoglycemia accompanied by coma, seizures, or other neurological disorders require urgent care and immediate hospitalization. At the onset of hypoglycemic coma or suspicion of it, glucagon and 50 ml of concentrated glucose solution (20-30% intravenously) should be administered immediately, and then the infusion of 10% glucose solution should be continued at a rate that maintains the blood glucose concentration at a level of more than 1 g / L. Hemodialysis is ineffective.

Storage conditions

Store at a temperature not exceeding 30 ° C.
Keep out of the reach of children!

Shelf life - 3 years
Do not use after the expiration date indicated on the packaging.