Glimepirid-Teva
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Glimepiride-Teva is a hypoglycemic drug.
Release form and composition
Dosage form - tablets: oblong, with beveled edges: 1 mg - white; 2 mg - white, dividing risk on one side; 3 mg - a marble surface of light yellow color with a brownish tint, on one side there is a dividing line; 4 mg - yellow with light marbling, on one side of the dividing line (10 pcs. In blisters; at a dose of 1, 2 or 3 mg - in a cardboard box of 3 or 6 blisters; at a dose of 4 mg - in a cardboard box 3, 6 or 10 blisters).
One tablet contains:
- active substance: glimepiride - 1, 2, 3 or 4 mg;
- auxiliary ingredients: magnesium stearate, corn starch, lactose monohydrate, povidone, sodium carboxymethyl starch, polysorbate 80, iron dye yellow oxide (E 172), talc.
Indications for use
Glimepirid-Teva is used for the treatment of type 2 diabetes mellitus in the absence of results from physical activity and adherence to a previously prescribed diet. If monotherapy with the drug is ineffective, it is recommended to use it in combination with metformin or insulin.
Contraindications
Absolute:
- type 1 diabetes mellitus;
- diabetic ketoacidosis, diabetic precoma and coma (including hyperosmolar);
- severe renal failure (including the need for hemodialysis);
- severe liver failure;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- insufficiency of G-6-PD (glucose-6-phosphate dehydrogenase) - for a dose of 1, 2 or 3 mg;
- leukopenia - for a dose of 4 mg;
- the period of pregnancy and breastfeeding (lactation);
- children and adolescents up to 18 years old;
- individual hypersensitivity to glimepiride, other components of the drug and other sulfonylurea derivatives / sulfonamide drugs (the likelihood of developing allergic reactions increases).
Tablets are taken with caution in case of alcoholism, infectious fever, conditions requiring the transfer of the patient to insulin therapy, such as severe multiple trauma, extensive burns / surgery, adrenal insufficiency, thyroid diseases (thyrotoxicosis, hypothyroidism), impaired absorption of food and drugs in Gastrointestinal tract (gastrointestinal tract), including intestinal obstruction and intestinal paresis, at the initial stage of therapy, when the risk of hypoglycemia is increased, with intercurrent diseases or changes in lifestyle (diet and diet, decrease / increase in physical activity) - for a dose 1, 2 or 3 mg, G-6-PD deficiency - for a dose of 4 mg.
Method of administration and dosage
Tablets are inside, entire liquid squeezed liquid in sufficient quantity (1 / 2 cups). The daily dose is taken 1 time during a hearty breakfast or the first main meal (or immediately before them). You should not skip a meal after taking Glimepirid-Teva.
The dosage regimen is set individually, taking into account the indicators of the concentration of glucose in the blood and the patient's lifestyle. The initial dose of glimepiride is 1 mg once a day. Upon reaching the optimal therapeutic effect, it is recommended to take this dose as a maintenance dose.
If there is no glycemic control, the daily dose is increased in stages, by 1 mg in 1-2 weeks (2-3-4-6 mg), carrying out regular monitoring of the blood glucose concentration. The maximum daily dose is 6 mg; higher daily doses are effective in exceptional cases. The course of therapy is long, blood sugar control should be carried out constantly.
Glimepiride with metformin
In the absence of glycemic control in patients taking metformin, concomitant therapy with glimepiride is allowed, provided that the metformin dose is maintained. Start taking Glimepirid-Teva with a minimum daily dose, which is gradually increased depending on the required concentration of glucose in the blood, up to the maximum. Combination therapy is performed under close medical supervision.
Glimepiride with insulin
If glycemic control cannot be achieved by taking the maximum dose of glimepiride alone or in combination with the maximum dose of metformin, it is possible to use glimepiride in combination with insulin. In this case, the last dose of glimepiride assigned to the patient remains unchanged, and concomitant insulin therapy begins with a minimum dose with a possible gradual increase in the future (under the control of blood sugar concentration). Combination therapy is performed under close medical supervision.
Switching to glimepiride from other oral hypoglycemic drugs
Glimepiride is taken in an initial daily dose of 1 mg, even if the patient has taken the maximum dose of another oral hypoglycemic drug before changing therapy. Any increase in the dose of Glimepiride-Teva is carried out in stages, by 1 mg in 1-2 weeks, taking into account the effectiveness, dose and duration of action of the oral hypoglycemic drug used. Sometimes, especially for antidiabetic drugs with a long half-life, a temporary (up to several days) discontinuation of the course of administration may be required in order to avoid an additive effect that increases the likelihood of hypoglycemia.
Switching to glimepiride from insulin
When insulin therapy of patients with type 2 diabetes mellitus, in exceptional cases, when compensating for the disease and intact secretory function of β-cells of the pancreas, insulin can be replaced with glimepiride. Translation should be done under close medical supervision. In this case, taking Glimepirid-Teva begins with a minimum daily dose of 1 mg.
Side effects
- metabolism: rarely - a hypoglycemic reaction, which occurs mainly soon after taking glimepiride, can have a severe form and course and is not always amenable to relief, depends on the diet and diet, as well as the dosage of the drug;
- organ of vision: with an unknown frequency - transient visual impairments associated with changes in blood glucose (especially at the beginning of therapy);
- digestive system: very rarely - nausea / vomiting, abdominal pain, diarrhea (in exceptional cases, interruption of the course may be required), a feeling of discomfort and heaviness in the epigastric region, jaundice, cholestasis, hepatitis (including liver failure); with an unknown frequency - an increase in the activity of liver enzymes;
- blood and lymphatic system: rarely - leukopenia, thrombocytopenia (moderate to severe), hemolytic / aplastic anemia, granulocytopenia, erythrocytopenia, agranulocytosis, pancytopenia;
- hypersensitivity reactions: very rarely - itching, urticaria and skin rash, usually moderately pronounced, but may worsen, aggravated by shortness of breath and a decrease in blood pressure (blood pressure) up to the development of anaphylaxis; with an unknown frequency - cross-allergy with sulfonamides, sulfonylurea derivatives, other sulfonamides; allergic vasculitis may also develop;
- other reactions: very rarely - hyponatremia; isolated cases - headache, asthenia; with an unknown frequency - late cutaneous porphyria, photosensitization.
Overdose due to ingestion of a large dose of Glimepiride-Teva threatens the development of hypoglycemia. Symptoms of the condition are: increased sweating, increased anxiety, rise in blood pressure, tachycardia, palpitations, arrhythmia, pain in the heart, dizziness, headache, a sharp increase in appetite, nausea / vomiting, drowsiness, apathy, anxiety, aggressiveness, depression, confusion, paresis, tremor, impaired sensitivity, impaired concentration, convulsions of central origin. Symptoms of hypoglycemia may be similar to the clinical picture of ischemic stroke. Coma may develop. The condition can last 12–72 hours and recur after the initial restoration of blood glucose concentration.
For the treatment of an overdose, gastric lavage is recommended, after which the patient must be given activated carbon and sodium picosulfate. As soon as possible, it is required to start the introduction of dextrose, if necessary, intravenously 50 ml of a 40% solution, then infusion of a 10% solution. All procedures are performed under close monitoring of blood glucose concentration. In the future, symptomatic therapy may be needed, mainly carried out under the supervision of specialists in a hospital setting.
special instructions
The hypoglycemic agent is taken strictly at the appointed time, in doses determined by the doctor. A higher dose should not be taken after the missed dose. The doctor should discuss with the patient the situation when the drug is missed, food intake or it is not possible to take the next dose of glimepiride at the set time, and give recommendations for adjusting the dosage regimen. The patient should immediately inform the doctor about taking the drug in a dose exceeding the prescribed dose.
It is necessary to immediately inform the doctor about the appearance of hives or skin rashes, since such hypersensitivity reactions can quickly develop to anaphylactic shock.
When hypoglycemia develops after taking glimepiride at a dose of 1 mg per day, glycemic control is carried out exclusively through dietary regulation.
Upon reaching the state of compensation for type 2 diabetes mellitus, the patient's insulin sensitivity increases, which may require a decrease in the dose of glimepiride or its temporary withdrawal in order to avoid the development of hypoglycemia. Dose adjustment is also necessary when changing the patient's lifestyle, his weight, or in the event of the appearance of other factors affecting the development of hyper- or hypoglycemia.
A balanced diet, regular adequate exercise and weight loss, if necessary, are just as important to achieving optimal blood glucose control as adherence to dosing with hypoglycemic drugs.
The risk of developing hypoglycemia is increased in the first weeks of glimepiride therapy, which requires more careful monitoring of the patient's condition, especially in case of non-compliance with the regimen and diet.
Factors contributing to the development of hypoglycemia:
- non-compliance with medical prescriptions, especially by elderly patients, due to insufficient ability to cooperate with a doctor;
- irregular, malnutrition, forced skipping meals, fasting, changing the usual diet;
- the discrepancy between the amount of physical activity and the amount of carbohydrates consumed;
- drinking alcoholic beverages, especially while skipping meals;
- glimepiride overdose;
- renal failure;
- severe liver failure;
- some uncompensated diseases of the endocrine system that affect carbohydrate metabolism (pituitary insufficiency, adrenal insufficiency, thyroid dysfunction);
- complex use with other drugs that can enhance or weaken the hypoglycemic effect of Glimepirid-Teva.
The above factors, as well as previous episodes of hypoglycemia, should be notified to the attending physician, who, based on such data, will adjust the dose of glimepiride or the entire therapy regimen. Dose adjustment is also required when changing the usual lifestyle or the presence of an intercurrent disease.
Symptoms of hypoglycemia may be smoothed out or absent altogether in elderly patients, with autonomic neuropathy, or with simultaneous therapy with β-blockers, reserpine, clonidine, guanethidine. Hypoglycemia can almost always be quickly relieved by taking carbohydrates (sugar / glucose, for example, in the form of a sweet fruit drink or sugar cube) immediately. Therefore, the patient must have ≥ 20 g glucose (4 sugar cubes) with him at all times. Sugar substitutes are ineffective in the treatment of hypoglycemia.
From the experience of using other sulfonylurea derivatives, it is known that, despite the success of hypoglycemia relief, a relapse of the disease is possible at the initial stage, and therefore the patient should be monitored continuously and carefully. In the event of an attack of severe hypoglycemia, immediate medical measures are required under the supervision of medical staff, and in certain circumstances, hospitalization.
When a patient with diabetes mellitus seeks another doctor (for example, after being injured in an ambulance or when sick on weekends), he must inform the medical staff about the presence of hypoglycemia and about previous therapy.
When taking glimepiride, it is necessary to regularly monitor the picture of peripheral blood (especially the indicator of leukocytes, platelets) and liver function, blood glucose levels, as well as the concentration of HbA1c (glycosylated hemoglobin).
Stressful situations, such as trauma, surgery, and infectious diseases complicated by fever, may require temporary transfer of the patient to insulin therapy.
There is no experience with the use of glimepiride in patients with severe hepatic insufficiency, renal insufficiency, in patients on hemodialysis, and therefore, they are shown to switch to insulin therapy.
Treatment of patients with G-6-PD deficiency with sulfonylurea derivatives, including glimepiride, may cause hemolytic anemia. In such patients, the possibility of using hypoglycemic substances of other groups should be considered.
Certain side effects of glimepiride, such as serious changes in the blood picture, severe hypoglycemia, hypersensitivity reactions, hepatic failure, can be life-threatening under certain circumstances. The patient is required to be warned about the need to immediately consult a doctor and inform him about the development of side effects.
At the initial stage of therapy, in the case of a transition from one hypoglycemic agent to another, or with irregular intake of glimepiride, a decrease in the speed of psychomotor reactions and concentration of attention is possible due to hyper- or hypoglycemia. This condition can negatively affect the ability to drive vehicles or perform other difficult jobs.
Drug interactions
- metformin or other oral hypoglycemic drugs, insulin, angiotensin-converting enzyme (ATP) inhibitors, anabolic steroids and male sex hormones, allopurinol, coumarin derivatives, chloramphenicol, fluoxetine, cyclophosphamide, trophosphamide phen and disfiraphosphamidin, gfuramidine monoamine oxidases (MAO), fluconazole, miconazole, pentoxifylline for parenteral administration in high doses, azapropazone, oxyphenbutazone, phenylbutazone, probenecid, salicylates (including aminosalicylic acid), antimicrobial agents (some sulfanilamine derivatives) tetracyclines, tritoqualin: enhance the hypoglycemic effect of glimepiride and increase the likelihood of hypoglycemia;
- acetazolamide, barbiturates, glucocorticosteroids (GCS), diazoxide, saluretics, thiazide diuretics, epinephrine and other sympathomimetic drugs, glucagon, laxatives (with long-term use), nicotinic acid (in high doses) and its derivatives, estrogens and progestogens, phenothiazine derivatives including chlorpromazine), phenytoin, rifampicin, iodine-containing thyroid hormones, lithium salts: weaken the hypoglycemic effect of Glimepiride-Teva and reduce the concentration of glucose in the blood;
- blockers of H 2 -histamine receptors, reserpine and clonidine: can both enhance and weaken the hypoglycemic effect of the drug;
- β-blockers, guanethidine, clonidine and reserpine: a decrease or absence of clinical symptoms of hypoglycemia is possible;
- coumarin derivatives: glimepiride can enhance or weaken their effect;
- drugs that inhibit bone marrow hematopoiesis: glimepiride increases the risk of myelosuppression;
- alcohol (both with chronic and single use): can increase or decrease the hypoglycemic effect.
If necessary, the simultaneous use of glimepiride with other drugs, their choice should be agreed with the doctor.
Analogs
Analogs of the drug Glimepirid-Teva are: Amaryl, Glime, Glemaz, Glemuno, Glimepirid Canon, Glimepirid, Meglimid, Glyumedex, Diamerid, etc.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life is 4 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
