Index of drugs

Non-insulin-dependent diabetes (type 2) in adults when dietary compliance, exercise and weight loss are not sufficient to maintain normal blood Glucose levels.

1 tabl modified release contains 30 mg or 60 mg gliclazide. Table. about modifications. release 60 mg contain lactose.

Oral hypoglycemic drug from the sulfonylurea group. Gliclazide reduces the amount of glucose in the blood, stimulating the release of insulin by the beta cells of the Langerhans Islands. Increased postprandial insulin secretion and protein C in the pancreas persists even after 2 years of treatment. In type 2 diabetes, gliclazide restores the early growth of insulin secretion in the presence of glucose and increases the second phase of insulin secretion. Gliclazide reduces the formation of micro-thrombi in two mechanisms that may underlie complications of diabetes: partial inhibition of platelet aggregation and adhesion by reducing the activity of platelet markers (β-thromboglobulin, thromboxane B₂); effect on fibrinolytic activity of the vascular endothelium by increasing the activity of tissue plasminogen activator (tPA). After oral administration, the plasma concentration of the drug increases gradually for 6 h, and then remains unchanged between 6 and 12 h. Absorption is complete. Plasma protein binding is approximately 95%. A single daily dose makes it possible to maintain gliclazide plasma concentrations for over 24 hours. Gliclazide is metabolised mainly in the liver and excreted in the urine (1% unchanged). No active metabolite was detected in the plasma. T_0,5 in the elimination phase is 12-20 h.

Hypersensitivity to gliclazide or other components of the preparation and to other sulfonylurea and sulfonamide derivatives. Type 1 diabetes. Pre-coma or diabetic coma. Ketosis and diabetic acidosis. Severe renal or hepatic failure. Miconazole treatment. Breast-feeding.

Due to the increased risk of hypoglycaemia, the preparation should be used with caution in patients with the following risk factors: lack of cooperation on the part of the patient; malnutrition, irregular meal times, leaving meals, periods of fasting or changes in diet; imbalance between physical effort and the supply of carbohydrates; renal failure; severe liver failure; some endocrine disorders (thyroid dysfunction, hypopituitarism and adrenal insufficiency); overdose of the drug and simultaneous administration of other preparations that affect glycaemia. The control of glycaemia in patients receiving antidiabetic treatment may be influenced by fever, injury, infection or surgery, and insulin therapy may be required. The effectiveness of the hypoglycaemic effect of antidiabetic drugs decreases over time, this may be due to the gradual increase in diabetes or a reduction in response to treatment. Before the patient is diagnosed with secondary therapeutic failure, appropriate dose adjustment and diet planning should be considered. Caution should be exercised and consideration should be given to the treatment of other groups of patients in G-6-PD deficiency due to the risk of hemolytic anemia. The safety and efficacy of the preparation in children and adolescents has not been established. Table. about modifications. 60 mg release contain lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose and galactose.

The use of oral hypoglycemic agents during pregnancy is inappropriate. Insulin is the drug of first choice. It is recommended to discontinue oral hypoglycemic agents and initiate insulin therapy before attempting to become pregnant or immediately after its finding. The drug is contraindicated in women who are breastfeeding.

May occur: hypoglycaemia (possible symptoms: headache, severe hunger, nausea, vomiting, tiredness, drowsiness, sleep disturbances, agitation, aggression, impaired concentration, impaired consciousness, slowing of reactions, depression, feeling of confusion,vision and speech disorders, dementia, tremor, paresis, sensation, dizziness, feelings of powerlessness, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, drowsiness and loss of consciousness, which can lead to coma or death and signs of adrenergic stimulation: sweating skin moisture, anxiety, tachycardia, palpitations, hypertension, chest pain, arrhythmias); gastrointestinal disorders (abdominal pain, nausea, vomiting, indigestion, diarrhea, constipation); skin and subcutaneous tissue disorders (rash, pruritus, urticaria, angioneurotic edema, erythema, maculopapular eruptions, bullous reactions - Stevens-Johnson syndrome and toxic epidermal necrolysis); blood disorders (anemia, leukopenia, thrombocytopenia, granulocytopenia) transient after discontinuation of treatment; liver disorders (increased liver enzymes, hepatitis (isolated cases), cholestatic jaundice - should be discontinued if it occurs); eye disorders (transient visual disturbances). Adverse reactions of sulfonylureas: erythrocytopenia, agranulocytosis, haemolytic anemia, pancytopenia, allergic vasculitis, hyponatraemia, increased liver enzymes, hepatic impairment (cholestasis and jaundice), hepatitis, transient withdrawal of a sulphonylurea, or in isolated cases leading to to life-threatening liver failure.

Orally. Adults: 30-120 mg in a single daily dose, for breakfast. The dose should be adjusted individually depending on the patient's response (blood Glucose, HbA1c). The recommended starting dose is 30 mg a day. If the blood glucose concentration is controlled effectively, this dose can be used as maintenance treatment. If the blood glucose is not adequately controlled, the dose may be gradually increased to 60, 90 or 120 mg per day. The dose should not be increased more frequently than at least after 1 month, except in patients whose blood glucose level has not decreased after 2 weeks of treatment; in such cases, the dose may be increased at the end of the 2nd week of treatment. The maximum daily recommended dose is 120 mg. The product can be used with biguanides, alpha-glucosidase inhibitors or insulin; in patients with blood glucose insufficiently controlled with the preparation, combination therapy with insulin should be introduced under close medical care. In elderly patients and in patients with mild to moderate renal impairment, no dose adjustment is necessary. In patients at risk of hypoglycaemia (malnourished or poorly fed patients with severe or insufficiently compensated endocrine disorders - hypopituitarism, hypothyroidism, adrenal insufficiency); after discontinuation of long-term treatment and / or treatment with high doses of corticosteroids; with severe arterial diseases - severe coronary heart disease, severe carotid insufficiency, peripheral vascular disease), a minimum daily starting dose of 30 mg is recommended.
Replacement of a preparation containing 80 mg gliclazide with a modified preparation. release: 1 tabl. a preparation containing 80 mg of gliclazide is comparable to 30 mg of the preparation in the form of a modified tablet. release (ie 1 Diaprel MR 30 mg tablet or half Diaprel MR 60 mg tablet). The change can be made on the condition that blood parameters are monitored.Replacement of another oral anti-diabetic drug with Diaprel MR: the dose and T should be taken into account when replacing_0,5 previously used antidiabetic drug. It is not necessary to apply a transitional period. An initial dose of 30 mg should be used and adjusted so that it is adapted to the patient's blood glucose response as described above. In the event of a change from other hypoglycemic sulfonylureas with an extended T_0,5 it may be necessary to stop treatment for several days to prevent an additive effect. The dosing regimen in such situations should be the same as at the beginning of the treatment, i.e. treatment should start at a dose of 30 mg per day and then increase depending on the patient's metabolic response.
1 tabl about modifications. release 60 mg is equivalent to 2 tablets. about modifications. release of 30 mg; Table. 60 mg can be divided into halves.The dose of the drug should be swallowed without crushing or chewing.