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, glimepiride increases the sensitivity of peripheral tissues to insulin and reduces insulin uptake in 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 in the blood is 5-8 h. At high doses, a slight increase in half-life was observed. The drug is excreted in 58% with urine and in 35% with faeces. Both urine and faeces were identified by two metabolites - probably derived from changes in the liver (mainly by the CYP2C9 enzyme): a hydroxyl derivative and a carboxylic acid derivative. Final T0,5 these metabolites were 3-6 h and 5-6 h, respectively.
Contraindications:
Hypersensitivity to Glimepiride, other sulphonylurea or sulfonamide derivatives or to other components of the preparation. Type 1 diabetes (insulin dependent). Diabetic coma. Ketoacidosis. Severe kidney or liver problems. Pregnancy and breastfeeding.
Precautions:
If you have irregular meals or skipped meals, treatment with glimepiride may lead to hypoglycaemia. 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, it is recommended to change the drug for insulin. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
The drug is contraindicated during pregnancy and breastfeeding. Insulin should be used during pregnancy.
Side effects:
Uncommon: transient visual disturbances (usually at the beginning of treatment). Rare: changes in the blood picture (thrombocytopenia, leukopenia, pancytopenia) - usually disappearing after discontinuation of the drug; hypoglycaemia, increased liver enzymes. Very rare: mild hypersensitivity reactions (which may increase to severe reactions with dyspnoea, low blood pressure and sometimes shock), allergic vasculitis, hypersensitivity to sulphonylureas, sulfonamides or related substances, nausea, vomiting, diarrhea, pressure or stomach fullness, abdominal pain, abnormal liver function (eg cholestasis, jaundice), hepatitis (which may lead to liver failure), allergic skin reactions (pruritus, rash, urticaria), hypersensitivity to light, hyponatremia.
Dosage:
Orally. Dosage depends 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 treatment with other oral antidiabetic agents is changed to glimepiride, the dose and half-life of the previously used medicine should be taken into account. 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. 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.