Diameride, tablets 2 mg 30 pcs

Diameride acts primarily by stimulating the secretion and release of insulin from pancreatic beta cells (pancreatic action). As with other sulfonylurea derivatives, this effect is based on the increased response of pancreatic beta cells to physiological glucose stimulation, with much less insulin secreted than with traditional sulfonylurea derivatives. The smallest stimulating effect of glimepiride on insulin secretion also reduces the risk of hypoglycemia. In addition, glimepiride has extrapancreatic action – the ability to improve the sensitivity of peripheral tissues (muscle, fat) to the action of its own insulin, reduce insulin uptake by the liver; it inhibits the production of glucose in the liver. Glimepiride selectively inhibits cyclooxygenase and reduces the conversion of arachidonic acid to thromboxane A2, which promotes platelet aggregation, thus having an antiplatelet effect. Glimepiride promotes normalization of lipids, reduces the concentration of malonic aldehyde in blood, which leads to a significant reduction in lipid peroxidation, it contributes to the antiatherogenic action of the drug. Glimepiride increases the level of endogenous a-tocopherol, catalase activity, glutathione peroxidase and superoxide dismutase that promotes reduction of oxidative stress in patient’s organism, which is constantly present at type 2 diabetes.

Indications

Type 2 diabetes mellitus with ineffectiveness of previously prescribed diet and exercise. If monotherapy with glimepiride is ineffective, its use in combination therapy with metformin or insulin is possible.

Active ingredient

Composition

One tablet contains:

the active substance: glimepiride in terms of 100% substance – 2 mg;

excipients: lactose monohydrate 77.67 mg; povidone 2.5 mg, poloxamer 0.5 mg, croscarmellose sodium 4.7 mg; microcrystalline cellulose 12 mg; magnesium stearate 0.6 mg, iron oxide yellow dye 0.03 mg.

How to take, the dosage

The drug Diameride is administered orally. Initial and maintenance doses of glimepiride are established individually on the basis of the results of regular monitoring of blood glucose concentration. Initial dose and dose selection
At the beginning of treatment, 1 mg of glimepiride is prescribed once daily. When the 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 blood glucose concentration (at intervals of 1-2 weeks) to 2 mg, 3 mg or 4 mg daily. Doses above 4 mg daily are effective only in exceptional cases. The maximum recommended daily dose is 6 mg.
The time and frequency of the daily dose is determined by the physician, taking into account the lifestyle of the patient. The daily dose is prescribed in one dose immediately before or during a solid breakfast or the first main meal. Glimepiride tablets are taken whole, without chewing, with enough liquid (about 0.5 cup). It is not recommended to skip meals after taking glimepiride.
Treatment duration
Treatment with glimepiride is long, under control of blood glucose content.
Use in combination with metmorphine
In the absence of glycemic control in patients taking metmorphine, concomitant therapy with glimepiride may be initiated. If the dose of metformin is maintained at the same level, treatment with glimepiride begins with the minimum dose, and then the dose is gradually increased depending on the desired level of glycemic control, up to the maximum daily dose. Combination therapy should be conducted under close medical supervision.
Combination with insulin
In cases when it is not possible to achieve glycemic control 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 prescribed to the patient remains unchanged. In this case, treatment with insulin begins with a minimum dose, with a possible subsequent gradual increase in its dose under the control of blood glucose concentrations. 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 should be 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 made in stages in accordance with the above recommendations. It is necessary to take into account the effectiveness, dose and duration of action of the used hypoglycemic agent. In some cases, especially when taking hypoglycemic drugs with a long half-life, it may be necessary to temporarily (for several days) stop treatment to avoid the additive effect, increasing the risk of hypoglycemia.
Transfer of a patient from insulin to glimepiride
In exceptional cases, when performing insulin therapy in patients with type 2 diabetes, with compensation of the disease and with preserved secretory function of b-cells of the pancreas, insulin may be replaced with glimepiride. The transfer should be carried out under the close supervision of a doctor. In this case, transfer of the patient to glimepiride is started with a minimum dose of 1 mg.

Interaction

Simultaneous use of glimepiride with some drugs may cause both strengthening and weakening of the hypoglycemic effect of the drug. Therefore, other drugs may be taken only after agreement with the doctor.
Increased hypoglycemic action and the associated possible development of hypoglycemia may be observed when concomitant use of glimepiride with insulin, metformin or other oral hypoglycemic drugs, angiotensin-converting enzyme (ACE) inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, trophosphamide and isophosphamide, phenflouramine, fibrates, fluoxetine, sympatholytic drugs (guanethidine), monoamine oxidase inhibitors (MAOIs), miconazole, pentoxifylline (when given parenterally in high doses), phenylbutazone, azapropazone oxyphenbutazone, probenecid, quinolone antibiotics, salicylates and aminosalicylic acid, sulfinpyrazone, some prolonged sulfonamides, tetracyclines, tritoqualine, fluconazole.
Weakening of hypoglycemic action, and the associated increase in blood glucose concentrations may be observed with the simultaneous use of glimepiride with acetazolamide, barbiturates, glucocorticosteroids, diazoxide, saluretics, thiazide diuretics, epinephrine and other sympathomimetic agents, glucagon, laxatives (long-term use), nicotinic acid (high dose) and nicotinic acid derivatives, estrogens and progestogens, phenothiazine derivatives, including chlorpromazine, phenytoin, rifampicin, thyroid hormones, lithium salts. H2-histamine receptor blockers, clonidine and reserpine can both potentiate and attenuate the hypoglycemic effects of glimepiride. Under the influence of b-adrenoblockers, clonidine, guanethidine, and reserpine, clinical signs of hypoglycemia may be weakened or absent. Against the background of glimepiride administration, enhancement or weakening of the effect of coumarin derivatives may be observed. When concomitant use with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases. Single or chronic use of alcohol may both enhance and weaken the hypoglycemic effect of glimepiride.

Special Instructions

Diameride should be taken in the recommended doses and at the prescribed times. Mistakes in the use of the drug, such as skipping a dose, should never be corrected by taking a higher dose at a later time. The physician and the patient must agree in advance on the measures to be taken in case of such errors (e.g. skipping a dose or eating) or in situations in which the next dose cannot be taken at the prescribed time. The patient should inform the physician immediately in case of taking too high a dose of the drug. The development of hypoglycemia in the patient after taking 1 mg of glimepiride per day means that it is possible to control glycemia solely by means of diet. When compensation for type 2 diabetes mellitus is achieved, insulin sensitivity increases. Due to this, the need for glimepiride may decrease during treatment. In order to avoid the development of hypoglycemia, it is necessary to temporarily reduce the dose or cancel glimepiride. Dose adjustment should also be made in case of changes in the patient’s body weight, lifestyle, or other factors contributing to the risk of hypo- or hyperglycemia. An adequate diet, regular and sufficient exercise, and, if necessary, weight reduction are as important in achieving optimal blood glucose control as regular glimepiride administration. The clinical symptoms of hyperglycemia are: increased frequency of urination, intense thirst, dry mouth and dry skin. This should also be done in case of an intercurrent disease or a change in the patient’s lifestyle. Symptoms of hypoglycemia may be subdued or absent at all in the elderly, in patients with autonomic neuropathy or receiving simultaneous treatment with b-adrenoblockers, clonidine, reserpine, guanethidine. Hypoglycemia can almost always be quickly controlled by immediate intake of carbohydrates (glucose or sugar, for example, in the form of a piece of sugar, sweet fruit juice or tea). The patient should therefore always carry at least 20 glucose (4 sugars). Sugar substitutes are ineffective in the treatment of hypoglycemia. It is known from the experience of using other sulfonylurea drugs that despite the initial success in stopping hypoglycemia, its recurrence is possible. In this connection, continuous and careful observation of the patient is necessary. Severe hypoglycemia requires immediate treatment under medical supervision, and in certain circumstances, hospitalization of the patient. If a patient with diabetes mellitus is treated by different doctors (e.g. during a hospital stay after an accident, when he gets sick on weekends), he must necessarily inform them about his illness and the previous treatment. During treatment with glimepiride, regular monitoring of liver function and peripheral blood counts (especially leukocyte and platelet counts) is required. In stressful situations (e.g., trauma, surgery, infectious diseases accompanied by fever) it may be necessary to temporarily transfer the patient to insulin therapy. There is no experience in the use of glimepiride in patients with severe hepatic and renal dysfunction or patients on hemodialysis. Patients with severe renal and hepatic dysfunction should be transferred to insulin therapy. During treatment with glimepiride, regular monitoring of blood glucose concentration, as well as concentration of glycosylated hemoglobin, is necessary. Certain side effects (severe hypoglycemia, serious changes in the blood picture, severe allergic reactions, liver failure) may in certain circumstances be life-threatening for the patient. In case of any undesirable or serious reactions the patient should immediately inform the attending physician, and under no circumstances should the patient continue taking the drug without his or her recommendation.

Contraindications

Side effects

Metabolic reactions: hypoglycemic reactions may occur. These reactions mainly occur shortly after taking the drug, may have a severe form and course and they are not always easy to stop. The onset of these symptoms depends on individual factors, such as diet and dosing.

Visual side effects: during treatment (especially at the beginning) transient visual disturbances due to changes in blood glucose concentration may be observed.

Digestive system disorders: nausea, vomiting, sensation of heaviness or discomfort in epigastrium, abdominal pain, diarrhea, very rarely leading to discontinuation of treatment; increased activity of “liver” enzymes, cholestasis, jaundice, hepatitis (up to liver failure).

Blood system disorders: thrombocytopenia (moderate to severe), leukopenia, hemolytic or aplastic anemia, erythrocytopenia, granulocytopenia, agranulocytosis and pancytopenia.

Allergic reactions: possible urticaria (itching, skin rash). These reactions are usually moderately expressed, but may progress, accompanied by a drop in blood pressure, shortness of breath, up to the development of anaphylactic shock. If hives occur, seek medical attention immediately. Cross-allergy with other sulfonylurea derivatives, sulfonamides or other sulfonamides is possible, allergic vasculitis may develop.

Other side effects: in exceptional cases development of headache, asthenia, hyponatremia, photosensitization, late cutaneous porphyria are possible.

Overdose

After an oral large dose of glimepiride, hypoglycemia may develop, lasting from 12 to 72 hours, which may recur after the initial recovery of blood glucose concentrations. In most cases, observation in a hospital setting is recommended.

The symptoms of hypoglycemia: increased sweating, anxiety, tachycardia, increased blood pressure, palpitations, heart pain, arrhythmia, headache, dizziness, sudden increase in appetite, nausea, vomiting, apathy, drowsiness, restlessness, aggressiveness, impaired concentration, depression, confusion, tremors, paresis, sensory disturbances, convulsions of central genesis. Sometimes the clinical picture of hypoglycemia may resemble a stroke. Coma development is possible.

The treatment includes induction of vomiting, copious drinking with activated carbon (adsorbent) and sodium picosulfate (laxative). If large amounts of the drug are taken, gastric lavage is indicated, followed by administration of sodium picosulfate and activated charcoal. As soon as possible begin administration of dextrose, if necessary by intravenous injection of 50 ml of 40% solution, followed by infusion of 10% solution, with careful monitoring of blood glucose concentration. Further treatment should be symptomatic.

Pregnancy use

Glimepiride is contraindicated in pregnant women. In case of a planned pregnancy or if pregnancy occurs, the woman should be transferred to insulin therapy. Since glimepiride penetrates into breast milk, it should not be prescribed to women during lactation. In this case, it is necessary to switch to insulin therapy or stop breastfeeding.

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