Glimepiride-Teva 4mg 30 tablets — Made in Made in Israel — Free Delivery

(Glimepiride-Teva)

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Description Glimepiride-Teva 4mg 30 tablets — Made in Made in Israel — Free Delivery

Pharmacological properties

Glimepirid-teva - Hypoglycemic substance, active when taken orally, belongs to the group of sulfonylurea derivatives and can be used for non-insulin-dependent diabetes mellitus.

The preparation acts mainly by stimulating the release of insulin from the β-cells of the pancreas. As in the case of other sulfonylurea derivatives, this effect is based on an increase in the response of β-cells of the pancreas to physiological stimulation by glucose. In addition, Glimepiride-Teva has a pronounced effect not only on the pancreas, which is also characteristic of other sulfonylurea derivatives.

Release of insulin. Sulfonylurea derivatives regulate insulin secretion by closing the ATP-sensitive potassium channel in the β-cell membrane. Closure of the potassium channel induces β-cell depolarization and leads to the opening of calcium channels and an increased influx of calcium into the cell, which, in turn, leads to the release of insulin by exocytosis.

Glimepiride-Teva binds with a high rate of substitution to a β-cell membrane protein bound to the ATP-sensitive potassium channel, but the location of the binding site differs from the usual binding site for sulfonylurea derivatives.

The action of the preparation in places other than the pancreas is to improve the sensitivity of peripheral tissues to insulin and reduce the utilization of insulin by the liver.

Utilization of blood glucose by tissues of peripheral muscles and adipose tissue occurs with the help of special transport proteins located on the cell membrane. The transport of glucose to these tissues is an intermediate step in glucose metabolism. Glimepiride-Teva very quickly increases the number of active glucose transporting molecules on the plasma membranes of muscle and adipose tissue cells, which leads to the stimulation of glucose uptake.

General characteristics. In healthy individuals, the minimum effective oral dose is about 0.6 mg. The effect of the preparation Glimepiride-Teva is dose-dependent and reproducible. The physiological reaction to acute physical activity, that is, a decrease in insulin secretion, persists under the conditions of the action of glimepiride.

Pharmacokinetics. Bioavailability of Glimepiride-Teva after oral administration is 100%. Eating food does not significantly affect absorption, although it somewhat reduces its rate. Cmax in blood plasma is reached 2.5 hours after oral administration.

T1 / 2 with the introduction of multiple doses is about 5-8 hours.

Indications

Type II diabetes mellitus in cases where diet, exercise, and weight loss do not work.

Application

A proper diet, regular exercise, and regular blood and urine tests are essential to successful diabetes management. Preparations cannot provide an adequate level of glycemic control if the patient does not adhere to the recommended diet.

Doses of Glimepiride-Teva are determined based on the results of a metabolic study (measurement of glucose levels in blood and urine). In the first weeks of treatment, there may be an increased risk of hypoglycemia, therefore, it is necessary to carry out especially careful monitoring.

For adults. The initial dose is 1 mg of the preparation per day. If this dose achieves adequate glucose control, then it should be used for maintenance treatment.

If satisfactory glucose control is not achieved, the dose should be gradually increased based on glycemic control data, with an interval of about 1-2 weeks for each dose increase, 2 or 3 or 4 mg of Glimepirid-Teva per day.

A dose of the preparation above 4 mg / day gives better results only in exceptional cases. The maximum recommended dose is 6 mg / day.

If the use of the maximum daily dose of metformin does not achieve adequate glucose control, concomitant treatment with Glimepiride-Teva can be initiated. While maintaining the dose of metformin, treatment with Glimepirid-Teva should be started with a low dose, which is then gradually increased depending on the desired level of glycemic control up to the maximum daily dose. Combination therapy should be initiated under close medical supervision.

If the use of the maximum daily dose of Glimepiride-Teva does not achieve adequate glycemic control, concomitant insulin treatment can be initiated if necessary. While maintaining the dose of Glimepiride-Teva, insulin treatment should be started with a low dose, which should be gradually increased depending on the desired level of glycemic control up to the maximum daily dose. Combination therapy should be initiated under close medical supervision.

One dose of Glimepiride-Teva per day is usually sufficient. The preparation is recommended to be taken shortly before or during a hearty breakfast. Otherwise, shortly before or during the first main meal.

If the patient has forgotten to take the next dose of the preparation , the next dose should not be increased.

The tablets should be taken whole with a little water.

If a patient develops a hypoglycemic reaction after taking 1 mg of the preparation daily, this indicates that the patient's glucose level can only be controlled by diet.

During treatment with Glimepiride-Teva, the required dose can be reduced as a result of improved glycemic control due to increased sensitivity to the action of insulin. In order to avoid hypoglycemia, it is necessary to promptly reduce the dose or discontinue preparation treatment. The need to change the dose may also arise due to changes in body weight, lifestyle of the patient, or the action of other factors that increase the risk of hypo- or hyperglycemia.

Transfer of the patient from other oral antidiabetic agents to Glimepiride-Teva. In general, such a translation is possible. When transferring to Glimepirid-Teva, the dose and T½ of the preparation previously used should be taken into account. In some cases, especially if antidiabetic agents with a long T1 / 2 (eg chlorpropamide) were used, it is recommended to take the T1 / 2 into account for several days to minimize the risk of hypoglycemic reactions due to the additive effect. The recommended starting dose is 1 mg of the preparation per day. Based on data on the effect on blood glucose levels, the dose of Glimepiride-Teva can be increased as indicated above.

Transfer of the patient from insulin to Glimepirid-Teva. In exceptional cases, a transfer to Glimepirid-Teva of type II diabetes patients who used insulin may be indicated. Translation must be done under close medical supervision.

Contraindications

Insulin-dependent diabetes; diabetic coma; diabetic ketoacidosis; severe impairment of kidney or liver function; hypersensitivity to the preparation glimepiride-teva, other sulfonylurea derivatives or sulfonamides, or any component of the preparation. In case of severe impairment of kidney or liver function, it is necessary to transfer the patient to insulin.

Side effects

Based on the experience of using glimepiride-teva and other sulfonylurea derivatives, the following side effects have been identified.

From the immune system: leukocytoclastic vasculitis, mild sensitization reactions, which can turn into serious reactions with shortness of breath, a decrease in blood pressure and sometimes shock; allergic vasculitis.

Possible cross-allergy with sulfonylurea derivatives, sulfonamides or related substances.

Blood and lymphatic system disorders: thrombocytopenia, leukopenia, erythrocytopenia, granulocytopenia, agranulocytosis, hemolytic anemia and pancytopenia. Usually, these phenomena disappear after stopping treatment.

Metabolic and nutritional disorders: hypoglycemic reactions after taking Glimepiride-Teva.

Such reactions in most cases occur immediately, can be severe and are not always easy to correct. The occurrence of such reactions, as in the case of other antidiabetic agents, depends on individual factors, such as dietary habits and preparation dosage (see SPECIAL INSTRUCTIONS). The clinical picture of a severe attack of hypoglycemia may resemble the clinical picture of a stroke.

From the side of the organ of vision: temporary visual impairment due to changes in blood glucose levels, especially at the beginning of treatment.

From the digestive system: bloating, a feeling of discomfort in the stomach and abdominal pain, nausea, vomiting and diarrhea, in which sometimes it is necessary to stop using the preparation.

On the part of the hepatobiliary system: an increase in the level of liver enzymes, liver dysfunction (for example, with cholestasis and jaundice) are possible; hepatitis, which can progress to liver failure.

On the part of the skin and subcutaneous tissues: allergic and pseudo-allergic reactions may occur, including itching, rash, hives and sensitivity to light.

Others: a decrease in the concentration of sodium in the blood plasma.

special instructions

Glimepirid-teva must be taken immediately before or with a meal.

If the patient does not eat regularly or forgets to eat altogether, treatment with the preparation can lead to hypoglycemia. Possible symptoms of hypoglycemia include headache, severe hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, increased motor activity, aggressiveness, impaired concentration, anxiety and delayed reaction, depression, confusion, speech and visual disturbances, aphasia. tremors, paresis, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral cramps, and loss of consciousness, including coma, shallow breathing, and bradycardia.

In addition, signs of adrenergic counterregulation may be present, such as increased sweating, cold and damp skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris, and arrhythmias.

The clinical picture of a severe attack of hypoglycemia may be similar to the clinical picture of a stroke. Symptoms of hypoglycemia will almost always be adequately controlled by immediate intake of carbohydrates (sugar). Artificial sweeteners are ineffective.

From the experience of using other sulfonylurea derivatives, it is known that, despite the initial effectiveness of measures to eliminate hypoglycemia, it can reappear.

Severe or prolonged glycemia, which is only temporarily controlled by usual amounts of sugar, requires immediate treatment, sometimes hospitalization.

Factors that can cause the development of hypoglycemia:

unwillingness or (more often in elderly patients) inability of the patient to cooperate with the doctor;
inadequate nutrition, irregular food intake, fasting;
violation of the diet;
imbalance between exercise and carbohydrate intake;
drinking alcohol, especially in the absence of food;
impaired renal function;
severe liver dysfunction;
overdose of glimepiride;
uncompensated disorders of the endocrine system, affecting the metabolism of carbohydrates or counter-regulating hypoglycemia (for example, certain disorders of the thyroid gland, adenohypophysis or adrenal cortex);
concomitant use of other medicines (see INTERACTIONS).

Treatment with Glimepiride-Teva requires regular monitoring of blood and urine glucose levels. In addition, it is recommended to determine the content of glycosylated hemoglobin in the blood.

During treatment, it is necessary to regularly monitor the indicators of liver function and hematological parameters (especially the number of leukocytes and platelets).

In stressful situations (for example, accidents, unplanned surgery, febrile infections), a temporary transfer of the patient to insulin may be indicated.

There is no experience with the use of Glimepiride-Teva in patients with severe liver damage or patients on dialysis. Transfer to insulin is indicated for patients with severe kidney or liver damage.

The use of sulfonylurea preparations in patients with deficiency of the enzyme glucose-6-phosphate dehydrogenase can lead to hemolytic anemia. Since glimepiride belongs to the class of sulfonylurea derivatives, it should be used with caution in patients with glucose-6-phosphate dehydrogenase deficiency and consider switching to alternative therapy with preparations that are not sulfonylurea derivatives.

Patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use Glimepiride-Teva, since the preparation contains lactose.

Use during pregnancy or lactation

Pregnancy. Diabetes risk. Violation of normal blood glucose levels during pregnancy is highly likely to lead to congenital malformations and perinatal mortality. In this regard, in order to avoid teratogenic phenomena, you should carefully monitor the level of glucose in the blood during pregnancy. Under these circumstances, insulin administration is necessary. Patients planning a pregnancy should inform the doctor about this.

Risks associated with glimepiride. There is insufficient data on the use of glimepiride during pregnancy. Animal studies show reproductive toxicity, which is likely due to the pharmacological action (hypoglycemia) of glimepiride.

Thus, the preparation should not be used during pregnancy.

In cases of early pregnancy planning or pregnancy detection during treatment with glimepiride, you should switch to insulin therapy as soon as possible.

Lactation. It is not known whether glimepiride passes into breast milk. Since other sulfonylurea derivatives are excreted in breast milk and there is a risk of hypoglycemia in newborns, it is not recommended to use the preparation during breastfeeding.

Children. Do not use the preparation to treat children.

The ability to influence the reaction rate when driving or working with other mechanisms. The patient's ability to concentrate and respond quickly may be impaired as a result of hypo- or hyperglycemia, or as a result of visual impairment. This can pose a risk in situations where these qualities are especially important (for example, driving a car or machinery).

Patients should be advised to take steps to prevent the occurrence of hypoglycemia while driving. This is especially true for those people who poorly or completely cannot recognize the symptoms in themselves - the harbingers of hypoglycemia, and those who have frequent attacks of hypoglycemia. It is necessary to seriously weigh whether, under such circumstances, it is worth driving or working with mechanisms.

Interactions

If the preparation is taken simultaneously with certain other preparations, an undesirable increase or decrease in the severity of the hypoglycemic effect of the preparation glimepiride-teva may occur. therefore, other medicines should only be used as directed by a physician.

Glimepiride-Teva is metabolized by cytochrome P450 2C9 (CYP 2C9). It is known that the metabolism is affected by the concomitant administration of inducers (eg rifampicin) or CYP 2C9 inhibitors (eg fluconazole).

The results of an in vivo study showed that the AUC of glimepiride doubled with the simultaneous use of fluconazole (a CYP 2C9 inhibitor).

Hypoglycemia as a result of increased hypoglycemic action can occur if the preparation is taken simultaneously with such preparations: phenylbutazone, azaprozazone and oxyphenbutazone, insulin and oral antidiabetic agents, metformin, salicylates and n-aminosalicylic acid, anabolic steroids and male sex hormones, chloramine fenfluramine, fibrates, ACE inhibitors, fluoxetine, allopurinol, sympatholytics, cyclo-, tro-, and ifosfamides, sulfinpyrazone, some long-acting sulfonamide derivatives, tetracycline, clarithromycin, MAO inhibitors, quinoline antibiotics, probenecidant, paroxynifilin (high doses) tritochalin, fluconazole.

The hypoglycemic effect of Glimepiride-Teva may decrease, which leads to a deterioration in glycemic control, if the preparation is taken simultaneously with preparations that contain the following active ingredients: estrogens and gestagens, saluretics, thiazide diuretics, thyroid stimulants, GCS, phenothiazine derivatives, chlorpromazine , epinephrine and sympathomimetics, nicotinic acid (high doses) and nicotinic acid derivatives, laxatives (long-term use), phenytoin, diazoxide, glucagon, barbiturates and rifampicin, acetazolamide.

Antagonists of H2-receptors, blockers of β-adrenergic receptors, clonidine and reserpine can lead to potentiation or decrease in the hypoglycemic effect.

Under the influence of sympatholytic preparations such as β-adrenergic receptor blockers, clonidine and reserpine, signs of adrenergic counterregulation in hypoglycemia may be reduced or absent.

Alcohol consumption can increase or decrease the hypoglycemic effect of Glimepiride-Teva in an unpredictable manner.

The preparation can increase or decrease the severity of the action of coumarin derivatives.

Overdose

Hypoglycemia may develop, lasting 12–72 hours and may occur again after initial improvement. symptoms may persist for about a day after using glimepiride-teva. in general, hospitalization is recommended for medical supervision. nausea, vomiting, and epigastric pain may occur. usually hypoglycemia may be accompanied by neurological symptoms such as increased motor activity, tremors, anxiety, visual disturbances, poor coordination, drowsiness, coma, and seizures.

Treatment consists mainly of preventing absorption by inducing vomiting followed by water or lemonade with activated charcoal (adsorbent) and sodium sulfate (laxative). If the preparation was taken in a high dose, gastric lavage followed by the use of activated carbon and sodium sulfate is indicated. In case of a severe overdose, hospitalization in the intensive care unit is indicated. Glucose administration should be started as soon as possible. If necessary, use a bolus intravenous injection of 50 ml of 50% glucose, then 10% glucose solution with careful monitoring of blood glucose levels. Further treatment is symptomatic.

Glucose should be administered very carefully while monitoring blood glucose levels, as there is a risk of dangerous hyperglycemia.

Storage conditions

At a temperature not exceeding 25 ° c.

Tags: Glimepiride

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