Treatment of type 2 diabetes when diet, exercise and weight loss are not effective enough.
Composition:
1 tabl contains 1 mg, 2 mg, 3 mg or 4 mg of glimepiride. The preparation contains lactose.
Action:
Oral hypoglycemic drug from the sulfonylurea group. The effect of Glimepiride is mainly to stimulate insulin secretion by pancreatic beta cells. In addition, it increases the sensitivity of peripheral tissues to insulin and reduces the uptake of insulin by the liver. The bioavailability of glimepiride administered orally is complete. The maximum concentration of the drug in the blood is reached within about 2.5 hours after administration. The degree of binding to plasma proteins is> 99%. Medium T0,5 is 5-8 h. The drug is excreted in 58% in the urine and in 35% in the faeces.
Contraindications:
Hypersensitivity to Glimepiride, other sulphonylurea derivatives or sulfonamides or to other components of the preparation. Type 1 diabetes (insulin dependent). Diabetic coma. Ketoacidosis. Severe renal or hepatic impairment (in this case, it is necessary to change the drug for insulin). Pregnancy and breastfeeding.
Precautions:
In the case of irregular meal intake or skipping, treatment with glimepiride may lead to hypoglycaemia. In addition, symptoms of adrenergic regulation may occur. In stressful situations (eg accident, major surgery, infections with a fever), a temporary change of the drug to insulin may be indicated. There are no data on the use of glimepiride in patients with severe hepatic impairment or on dialysis patients. In patients with severe renal or hepatic impairment a switch to insulin therapy is indicated. Due to the risk of haemolytic anemia, caution should be used in patients with G-6-PD deficiency and alternative treatment with non-sulphonylurea drugs should be considered. Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
The drug is contraindicated during pregnancy and breastfeeding. Insulin should be used during pregnancy.
Side effects:
Rare: changes in the blood picture (thrombocytopenia, leukopenia, erythropaenia, granulocytopenia, agranulocytosis, haemolytic anemia, pancytopenia) usually reversible after discontinuation of the drug; hypoglycemia. Very rare: hypersensitivity reactions (shortness of breath, low blood pressure, shock); leukocytoclastic vasculitis; nausea, vomiting, diarrhea, full stomach sensation, feeling of abdominal distension, abdominal discomfort and abdominal pain; liver dysfunction (eg cholestasis, jaundice), hepatitis, liver failure; decreased sodium concentration in the serum. Not known: cross-reactivity to sulfonylureas, sulfonamides or related chemical substances; transient visual disturbances, especially at the beginning of treatment, due to changes in blood glucose; increased levels of liver enzymes; skin hypersensitivity reactions (pruritus, rash, urticaria), hypersensitivity to light.
Dosage:
Orally, depending on the results of blood Glucose and urine tests. Initially, glimepiride is given at a dose of 1 mg a day. If this dose provides good glycemic control, it should be taken as a maintenance dose. In the absence of satisfactory control, the dose should be gradually increased based on the results of glycemic control, at intervals of 1 to 2 weeks to achieve a daily dose of 2 mg, 3 mg or 4 mg of glimepiride. Only in exceptional cases the dose of glimepiride greater than 4 mg per day gives better therapeutic results. The maximum recommended daily dose is 6 mg. Patients who do not achieve satisfactory efficacy after the maximum daily dose of Metformin can be combined with glimepiride.While maintaining the dose of Metformin, the administration of glimepiride from low doses should be initiated, which, depending on the effectiveness of glucose control, increases up to the maximum daily dose. Combination therapy should be started under close medical supervision. In patients who do not achieve satisfactory efficacy after the maximum daily dose of glimepiride, treatment with insulin may be initiated as necessary. While maintaining the dose of glimepiride, insulin should be started at low doses, which will gradually increase depending on the effectiveness of glucose control. Combination therapy should be started under close medical supervision. If the treatment is changed by replacing other oral antidiabetic agents with glimepiride, the dose and the half-life of the previously used medicine should be taken into account. For some medications, especially antidiabetic drugs with a long half-life (eg, chlorpropamide), it is recommended to keep a few days to remove the drug from the body, to minimize the risk of hypoglycaemic reactions caused by the combined effects of drugs. The recommended starting dose of glimepiride is 1 mg a day. Depending on the response to treatment, this dose may be gradually increased according to the above recommendations. Typically, a single daily dose of glimepiride is sufficient. It is recommended to take the drug shortly before or during breakfast, or - when breakfast is omitted - shortly before or during the first main meal. The tablets should be swallowed whole with a small amount of water. If you have hypoglycaemia after taking 1 mg of glimepiride per day, you can control your blood glucose only with a diet. During treatment, when insulin sensitivity is increased as a result of improved diabetes control, the need for glimepiride may be reduced. Therefore, to avoid hypoglycaemia, a dose reduction or discontinuation should be considered. The change in dosage should also be considered in the event of a change in the body weight or lifestyle and other factors that increase the risk of hypo- or hyperglycaemia.