Glimepiride pills 4mg №30

Indications

- treatment of diabetes mellitus type 2 with the ineffectiveness of the previously prescribed diet and exercise.

With the ineffectiveness of monotherapy with Glimepiride, it may be used in combination therapy with Metformin or insulin.

Dosage and administration

The drug is used inside. The initial and maintenance doses of glimepiride are set individually based on the results of regular monitoring of glucose concentrations in the blood.

Initial dose and dose selection

At the beginning of treatment, the drug is prescribed 1 mg 1 time / day. When an optimal therapeutic effect is achieved, it is recommended to take this dose as a maintenance dose.

In the absence of glycemic control, the daily dose should be gradually increased under regular control of the concentration of glucose in the blood (at intervals of 1-2 weeks) to 2 mg, 3 mg or 4 mg per day. Doses above 4 mg / day are effective only in exceptional cases. The maximum recommended daily dose is 6 mg.

The time and frequency of receiving the daily dose is determined by the doctor taking into account the lifestyle of the patient. The daily dose is prescribed in 1 reception immediately before or during a hearty breakfast, or the first main meal.

The pills are taken whole, without chewing, with a sufficient amount of liquid (about 0.5 cups).It is not recommended to skip meals after consuming glimepiride.

Duration of treatment

Treatment with glimepiride is long-term, under the control of glucose in the blood and urine.

Use in combination with metformin

In the absence of glycemic control in patients taking metformin, concomitant glimepiride therapy may be initiated. While maintaining the dose of metformin at the same level, treatment with glimepiride begins with a minimum dose, and then the dose gradually increases depending on the desired level of glycemic control, up to the maximum daily dose. Combination therapy should be carried out under close medical supervision.

Use in combination with insulin

In cases where the glycemic control cannot be achieved by taking the maximum dose of glimepiride in monotherapy or in combination with the maximum dose of metformin, a combination of glimepiride with insulin is possible. In this case, the last dose of glimepiride assigned to the patient remains unchanged. In this case, insulin treatment begins with a minimum dose, with the possible subsequent gradual increase in its dose under the control of glucose concentration in the blood. Combined treatment requires mandatory medical supervision.

Transfer of a patient from another oral hypoglycemic drug to glimepiride

When transferring a patient from another oral hypoglycemic drug to glimepiride, the initial daily dose of the latter shouldbe 1 mg (even if the patient is transferred to glimepiride from the maximum dose of another oral hypoglycemic drug). Any increase in the dose of glimepiride should be carried out in stages in accordance with the above recommendations. The efficacy, dose and duration of action of the hypoglycemic agent used must be taken into account. In some cases, especially when taking hypoglycemic drugs with a long half-life (for example, chlorpropamid), it may be necessary to temporarily (within a few days) stop treatment in order to avoid an additive effect that increases the risk of hypoglycemia.

Transfer of the patient from insulin to glimepiride

In exceptional cases, when insulin therapy is performed in patients with type 2 diabetes mellitus, when compensating for the disease and when the β-cells of the pancreas are maintained secretly, insulin can be replaced with glimepiride. Translation must be carried out under the close supervision of a physician. In this case, the transfer of the patient to glimepiride begins with a minimum dose of 1 mg.

Adverse effects

Metabolism: in rare cases, hypoglycemic reactions may develop. These reactions mainly occur shortly after taking the drug, can have a severe form and over and they are not always easy to stop. The onset of these symptoms depends on individual factors, such as dietary patterns and dosing.

Special senses: during treatment (especially at its onset) transient visual disturbances due to a change in glucose concentration in the blood may occur.

On the part of the digestive system: sometimes nausea, vomiting, feeling of heaviness or discomfort in the epigastrium, abdominal pain, diarrhea, very rarely leading to cessation of treatment; in rare cases - increased activity of liver enzymes, cholestasis, jaundice, hepatitis (up to the development of liver failure).

Hemic and lymphatic: thrombocytopenia (moderate to severe), leukopenia, hemolytic or aplastic anemia, erythrocytopenia, granulocytopenia, agranulocytosis and pancytopenia are rarely possible.

Allergic reactions: sometimes urticaria may appear (itching, skin rash). Such reactions are, as a rule, moderately pronounced, but can progress, accompanied by a fall in blood pressure, dyspnea, up to the development of anaphylactic shock. If urticaria appears, consult a doctor immediately. Possible cross-allergy with other sulfonylurea derivatives, sulfonamides, it is also possible the development of allergic vasculitis.

Other: in exceptional cases, headaches, asthenia, hyponatremia, photosensitivity, late skin porphyria may develop.

Individual side effects (severe hypoglycemia, serious changes in the blood picture, severe allergic reactions, liver failure) may, under certain circumstances, pose a threat to the patient's life.In case of undesirable or severe reactions, the patient should immediately inform the attending physician about them and not continue taking the drug without his recommendation.

Contraindications

— type 1 diabetes;

— diabetic ketoacidosis, diabetic precoma and coma;

— conditions involving a violation of food intake and the development of hypoglycemia (infectious diseases);

— leukopenia;

— severe abnormal liver function;

— severe renal dysfunction (including patients on hemodialysis);

— lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

— pregnancy;

— lactation;

— children up to 18 years;

— hypersensitivity to glimepiride or to any inactive component of the drug, to other sulfonylurea derivatives or to sulfanilamide drugs (risk of developing hypersensitivity reactions).

WITH caution: conditions requiring the transfer of the patient to insulin therapy (extensive burns, severe multiple injuries, major surgical interventions, as well as violations of the absorption of food and drugs in the gastrointestinal tract - intestinal obstruction, paresis of the stomach).

Use during pregnancy and lactation

Glimepiride is contraindicated for use in pregnant women. In the case of a planned pregnancy or pregnancy, a woman should be transferred to insulin therapy.

Since Since glimepiride seems to penetrate into breast milk, it should not be given to women during lactation. In this case, it is necessary to switch to insulin therapy or stop breastfeeding.

Application for violations of the liver

Contraindicated in severe violations of the liver.

Application for violations of kidney function

Contraindicated in severe renal dysfunction (including in patients on hemodialysis).

Use in children

Contraindicated in children and adolescents under 18 years of age.

Special notes

Glimepiride should be taken in recommended doses and at the scheduled time. Errors in the use of the drug, for example, skipping a dose, can never be eliminated by the subsequent intake of a higher dose. The doctor and the patient should discuss in advance the measures to be taken in case of such errors (for example, skipping the drug or eating) or in situations where it is impossible to take the next dose of the drug at the scheduled time. The patient should immediately inform the doctor in case of receiving too high a dose of the drug.

The development of hypoglycemia in a patient after taking 1 mg / day means the ability to control glycemia solely by diet.

When compensation for type 2 diabetes is achieved, insulin sensitivity is increased. In this regard, the need for glimepiride may decrease during the treatment process. In order to avoid the development of hypoglycemia, it is necessary to temporarily reduce the dose or cancel glimepiride. Dose adjustment should also be carried out with a change in the patient’s body weight, lifestyle, or other factors that increase the risk of developing hypo- or hyperglycemia.

Adequate diet, regular and sufficient exercise and, if necessary, weight loss are just as important for achieving optimal control of blood glucose levels as regular glimepiride intake. The clinical symptoms of hyperglycemia are: increased urinary frequency, severe thirst, dry mouth and dry skin.

In the first weeks of treatment, the risk of hypoglycemia may increase, which requires particularly careful monitoring of the patient. During treatment with glimepiride, with irregular eating or skipping meals, hypoglycemia may develop. Its possible symptoms are: headache, hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, anxiety, aggressiveness, concentration disorders and reactions, depression, confusion, speech and visual disturbances, aphasia, tremor, paresis, sensory disturbances, dizziness, loss of self-control, delirium, cerebral seizures, confusion or loss of consciousness, including coma, shallow breathing, bradycardia. In addition, as a result of the adrenergic feedback mechanism, symptoms such as cold, sticky sweat, anxiety, tachycardia, increased blood pressure, angina, and heart rhythm disturbances can occur. Factors contributing to the development of hypoglycemia include:

— unwillingness or (especially in old age) insufficient ability of the patient to cooperate with the doctor;

— Inadequate, irregular meals, skipping meals, fasting, changing the usual diet;

— an imbalance between exercise and carbohydrate intake;

— drinking alcohol, especially when combined with skipping meals;

— impaired renal function;

— severe abnormal liver function;

— overdose of glimepiride;

— some uncompensated diseases of the endocrine system that affect carbohydrate metabolism (for example, dysfunction of the thyroid gland, pituitary or adrenal insufficiency);

— simultaneous use of some other drugs.

The physician should be informed of the above factors and episodes of hypoglycemia, since they require particularly strict monitoring of the patient. If there are such factors that increase the risk of developing hypoglycemia, the dose of glimepiride or the entire treatment regimen should be adjusted. This must also be done in the case of an intercurrent disease or a change in the lifestyle of the patient.

Symptoms of hypoglycemia may be smoothed out or completely absent in the elderly, in patients with autonomic neuropathy, or receiving simultaneous treatment with beta-blockers, clonidine, reserpine, guanethidine, or other sympatholytic agents. Hypoglycemia can almost always be quickly stopped by taking carbohydrates immediately (glucose or sugar, for example, in the form of a piece of sugar, sweet fruit juice or tea). In this regard, the patient should always carry at least 20 g of glucose (4 pieces of sugar).Sweeteners are ineffective in the treatment of hypoglycemia.

From the experience of using other sulfonylurea drugs, it is known that, despite the initial success in stopping hypoglycemia, it is possible to relapse. In this regard, continuous and careful observation of the patient is necessary. Severe hypoglycemia requires immediate treatment under the supervision of a physician, and under certain circumstances, hospitalization of the patient.

If a patient with diabetes is treated by different doctors (for example, during his stay in hospital after an accident, with illness on weekends), he must inform them of his illness and prior treatment.

During treatment with glimepiride, regular monitoring of liver function and a picture of peripheral blood (especially the number of leukocytes and platelets) is required.

In stressful situations (for example, in case of injury, surgery, infectious diseases involving fever), it may be necessary to temporarily transfer the patient to insulin therapy.

There is no experience with glimepiride in patients with severe impaired liver and kidney function or patients on hemodialysis. Patients with severe impaired renal function and liver are shown to be transferred to insulin therapy.

During treatment with glimepiride, regular monitoring of the glucose concentration in the blood, as well as the concentration of glycated hemoglobin is necessary.

Influence on ability to drive motor transport and control mechanisms

At the beginning of treatment, when switching from one drug to another, or when taking glimepiride on an irregular basis, it may occur due to hypo- or hyperglycemia, a decrease in the concentration of attention and speed of the psychomotor reactions of the patient. This may adversely affect the ability to drive vehicles or to control various machines and mechanisms.

Overdose

After ingestion of a large dose of glimepiride, hypoglycemia may develop, lasting from 12 to 72 hours, which may recur after the initial recovery of the glucose concentration in the blood. In most cases, it is recommended observation in the hospital. There may be: increased sweating, anxiety, tachycardia, increased blood pressure, palpitations, pain in the heart, arrhythmia, headache, dizziness, a sharp increase in appetite, nausea, vomiting, apathy, drowsiness, anxiety, aggressiveness, impaired concentration, depression, confusion, tremor, paresis, impaired sensitivity, convulsions of central genesis. Sometimes the clinical picture of hypoglycemia may resemble a stroke. Perhaps the development of coma.

Treatment includes induction of vomiting, plentiful drink with Activated carbon (adsorbent) and sodium picosulfate (laxative). When taking a large amount of the drug is indicated gastric lavage, followed by the introduction of sodium picosulfate and activated carbon.The introduction of dextrose is started as soon as possible, if necessary in the form of IV injection of 50 ml of 40% solution, followed by an infusion of 10% solution, with careful monitoring of the concentration of glucose in the blood. Further treatment should be symptomatic.

In the treatment of hypoglycemia, which developed as a result of the accidental intake of glimepiride by infants or young children, in order to avoid hyperglycemia, the dose of dextrose (50 ml of 40% solution) should be monitored and the glucose concentration in the blood should be continuously monitored.

Drug interaction

The simultaneous use of glimepiride with some drugs can cause both strengthening and weakening of the hypoglycemic effect of the drug. Therefore, other drugs can be taken only after consultation with the doctor.

Strengthening hypoglycemic action and, consequently, the possible development of hypoglycemia, can be observed with the simultaneous use of glimepiride with insulin, metformin or other oral hypoglycemic drugs, ACE inhibitors, Allopurinol, anabolic steroids and anapolic steroids, as well as in the case, by going to ifosfamide, fenfluramine, fibrates, Fluoxetine, sympatholytic (guanethidine), MAO inhibitors, miconazole, Pentoxifylline (with pa enteralnom administered in high doses), phenylbutazone, azapropazone,oxyphenbutazone, probenecid, quinolone antibiotics, salicylates and aminosalicylic acid, sulfinpyrazone, some long-acting sulfonamides, tetracyclines, tritoqualine, Fluconazole.

The weakening of the hypoglycemic action, and the associated increase in the concentration of glucose in the blood, can be observed with simultaneous use of glimepiride with acetazole amide, barbiturates, GCS, diazoxide, saluretics, thiazide diuretics, epinephrine and other sympathomimetic drugs, glucagon, laxatives (with long-term use), nicotinic acid (in high doses) and derivatives of nicotinic acid, estrogens and progestogens, phenothiazines, chlorpromazine, phenytoin, rifampicin, hormone E thyroid, lithium salts.

Histamine H blockers₂-receptors, clonidine and reserpine are able to both potentiate and weaken the hypoglycemic effect of glimepiride.

Under the influence of such sympatholytic agents as beta-blockers. clonidine, guanethidine, and reserpine, it is possible that there is a reduction or absence of clinical signs of hypoglycemia

Against the background of glimepiride intake, the effect of coumarin derivatives may be enhanced or weakened.

With simultaneous use with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.

Single or chronic drinking can both strengthen and weaken the hypoglycemic effect of glimepiride.

Pharmacy sales terms

The drug is available on prescription.

Terms and conditions of storage

List B. The drug should be kept out of the reach of children at a temperature not exceeding 25 ° C.