Glimecomb
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
Glimecomb is an oral combined hypoglycemic agent with pancreatic and extra-pancreatic effects.
Release form and composition
Dosage form - tablets: flat-cylindrical, from white to white with a creamy or yellowish shade of color (marbling of color is possible), with a risk and bevel (10 pcs. In blister strip packs, in a cardboard box 6 packs; 20 pcs. In packs contour cell, in a cardboard box 5 packs; 30, 60 and 120 pcs. in plastic bottles, in a cardboard box 1 bottle).
Active ingredients in 1 tablet:
- metformin hydrochloride - 500 mg;
- gliclazide - 40 mg.
Additional components: croscarmellose sodium, povidone, magnesium stearate, sorbitol.
Indications for use
- type 2 diabetes mellitus in case of ineffectiveness of diet therapy, physical activity and previous monotherapy with gliclazide or metformin;
- type 2 diabetes mellitus with stable and well-controlled blood glucose levels - to replace the previous combination therapy with two drugs (gliclazide and metformin).
Contraindications
Absolute:
- hypoglycemia;
- diabetic ketoacidosis, diabetic precoma and coma;
- type 1 diabetes mellitus;
- liver failure;
- acute and chronic diseases accompanied by tissue hypoxia: recent myocardial infarction, respiratory and heart failure, shock;
- acute conditions that can lead to changes in kidney function: severe infection, dehydration, shock;
- severe renal dysfunction;
- lactic acidosis, in history including;
- infectious diseases, extensive burns, trauma, major surgical interventions and other conditions requiring insulin therapy;
- porphyria;
- acute alcohol intoxication, chronic alcoholism;
- adherence to a hypocaloric diet (less than 1000 cal / day);
- the period of pregnancy and breastfeeding;
- carrying out a radioisotope or X-ray examination with the introduction of an iodine-containing contrast agent (48 hours before and 48 hours after);
- simultaneous administration of miconazole;
- hypersensitivity to any active or auxiliary component of the drug or other sulfonylurea derivatives.
It is not recommended to prescribe Glimecomb to patients over the age of 60 who perform heavy physical work (due to the high risk of lactic acidosis).
Carefully:
- diseases of the thyroid gland with a violation of its function;
- adrenal insufficiency;
- febrile syndrome;
- hypofunction of the anterior pituitary gland.
Method of administration and dosage
Glimecomb should be taken orally during or immediately after a meal.
The doctor determines the dose individually, depending on the level of glucose in the blood.
The initial daily dose, as a rule, is 1–3 tablets, then it is gradually increased, if necessary, until it is possible to achieve a stable compensation of the disease.
The maximum daily dose is 5 tablets.
The daily dose is usually divided into 2 doses - morning and evening.
Side effects
- allergic reactions: maculopapular rash, itching, urticaria;
- on the part of metabolism: with an inadequate diet and violation of the dosage regimen - hypoglycemia (hunger, headache, fatigue, severe weakness, dizziness, increased sweating, temporary neurological disorders, impaired coordination of movements, palpitations; with the progression of hypoglycemia - loss of self-control and consciousness); in some cases - lactic acidosis (abdominal pain, respiratory disorders, decreased blood pressure, drowsiness, myalgia, weakness, hypothermia, reflex bradyarrhythmia);
- on the part of the hematopoietic organs: rarely - inhibition of bone marrow hematopoiesis (thrombocytopenia, anemia, leukopenia);
- from the digestive system: decreased appetite, dyspeptic disorders (metallic taste in the mouth, diarrhea, nausea, feeling of heaviness in the epigastrium); rarely - liver damage (increased activity of hepatic transaminases and alkaline phosphatase, cholestatic jaundice, hepatitis);
- others: visual impairment.
Sulfonylurea derivatives, which include one of the active ingredients of Glymecomba (gliclazide), can cause the following side effects: allergic vasculitis, hemolytic anemia, agranulocytosis, pancytopenia, erythropenia, and life-threatening liver failure.
In case of an overdose and in the presence of risk factors due to the metformin, which is part of the drug, the development of lactic acidosis is possible - a condition requiring urgent medical care (its signs are described above). Treatment should be carried out in a hospital. The most effective treatment for this complication is hemodialysis.
Also, an overdose can lead to the development of hypoglycemia, since the drug contains gliclazide. With mild to moderate hypoglycemia, it is necessary to introduce glucose (dextrose) or take a sugar solution inside. In severe hypoglycemia (manifested by loss of consciousness), a 40% solution of glucose (dextrose) is administered intravenously, or glucagon is administered intravenously, subcutaneously or intramuscularly. After the patient's consciousness is restored, he needs to be given food rich in carbohydrates in order to prevent the re-development of hypoglycemia.
special instructions
Glimecomb is prescribed only to patients who receive regular low-carb meals, which include breakfast without fail.
During treatment, fasting blood glucose levels and after meals should be regularly monitored, especially in the first days of taking the drug.
Stop taking Glimecomb 48 hours before intravenous administration of an iodine-containing radiopaque contrast agent or surgery. Reception can be resumed no earlier than 48 hours later.
It must be borne in mind that sulfonylurea derivatives (in this case, gliclazide) can cause hypoglycemia, in some cases in severe and prolonged form. Most often, this condition develops with a low-calorie diet, after vigorous or prolonged physical activity, after drinking alcoholic beverages, and also while taking several hypoglycemic agents. To avoid the development of hypoglycemia, it is necessary to carefully and individually select the dose for each patient and provide him with full information about the upcoming treatment.
The dose of Glimecomb should be adjusted when changing the diet, with emotional and physical overstrain.
The following groups of patients are especially sensitive to the action of hypoglycemic drugs:
- patients with pituitary-adrenal insufficiency;
- elderly people;
- persons who do not receive a balanced diet;
- patients with a general weakened condition.
Fasting, drinking alcohol, and taking nonsteroidal anti-inflammatory drugs increase the risk of hypoglycemia.
Guanethidine, reserpine, clonidine, and beta-blockers may mask clinical signs of hypoglycemia.
For infectious diseases with febrile syndrome, extensive burns, trauma and major surgical interventions, it may be necessary to discontinue Glymecomb and prescribe insulin therapy. During the period of therapy, it is necessary to monitor renal function and periodically (at least 2 times a year) determine lactate in plasma. If lactic acidosis develops, the drug should be discontinued.
When planning pregnancy and in case of its occurrence during the use of the drug, it is necessary to stop taking it and prescribe insulin therapy.
During the period of treatment, alcohol is prohibited. Care should be taken when driving a car and performing potentially hazardous types of work that require increased attention, speed of mental and motor reactions.
Drug interactions
Hypoglycemic action Glimekomba reinforce other hypoglycemic agents (e.g., insulin, acarbose, biguanides), tubular secretion blockers, sulfonamides long-acting blockers are H 2-histamine receptors (for example, cimetidine), coumarin anticoagulants, antifungal agents (fluconazole, miconazole), angiotensin-converting enzyme inhibitors (enalapril, captopril), beta-adrenergic blockers, salicylates, nonsteroidal butoxyphenylamines, anti-tuberculosis drugs (ethionamide), fibrates (clofibrate, bezafibrate), anabolic steroids, oxytetracycline, fenfluramine, disopyramide, tetracycline, guanetidine, fluoxetine, cyclophosphamide, allopurinol, reserpine, chloramphene, theoxidine.
The hypoglycemic effect of Glymecomb is weakened by carbonic anhydrase inhibitors (acetazolamide), thiazide diuretics, lithium salts, antiepileptic drugs (phenytoin), thyroid hormones, slow calcium channel blockers, glucocorticosteroids, barbiturates, adrenomimetics, corticosteroids, corticosteroids, chyloxidine, chyloxidinum furosemide, glucagon, isoniazid, triamterene, terbutaline, morphine, asparaginase, salbutamol, danazol, ritodrin, in high doses - oral contraceptives, estrogens, chlorpromazine, nicotinic acid.
Drugs that inhibit bone marrow hematopoiesis increase the likelihood of myelosuppression, ethanol - the development of lactic acidosis.
In the case of a combination with cardiac glycosides, Glimecomb increases the risk of developing ventricular premature beats.
Nifedipine enhances absorption and slows down the elimination of metformin.
With prolonged use, cationic agents secreted in the tubules (procainamide, amiloride, vancomycin, quinine, quinidine, digoxin, triamterene, morphine, ranitidine) increase the maximum blood concentration of metformin by 60%, furosemide by 22%.
Metformin reduces the maximum concentration and half-life of furosemide by 31 and 42.3%, respectively.
Analogs
No information available.
Terms and conditions of storage
Store in a dry, dark place, out of the reach of children, at a temperature not exceeding 25 ° C.
Shelf life is 2 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!
