Statiglin, tablets 3.5mg 120 pcs

How to take, the dosage

Ingestion. The drug should be taken before meals, without chewing and with plenty of liquid. The drug should be taken at the same time of the day.

The dose of the drug is adjusted individually depending on the age, severity of diabetes, blood glucose concentration at baseline and 2 hours after meals. Dose adjustment is necessary in case of changes in the patient’s body weight and lifestyle. Regular monitoring of blood and urine glucose concentrations, glycated hemoglobin, and lipid metabolism parameters is also necessary.

The tablets are 5 mg. The tablet can be divided into 2 equal parts. The daily dose range is ½ to 3 tablets (2.5 mg to 15 mg). The starting dose is 2.5 to 5 mg (½ to 1 tablet) per day. The maximum daily dose is 15 mg (3 tablets).

The dose should be increased at intervals of several days to 1 week until the desired therapeutic dose is reached, which should not exceed the maximum dose.

The tablets are 1.75 mg. The initial dose is usually 1-2 tablets (1.75 mg to 3.5 mg) once daily. The average daily dose is 3.5 mg (2 tablets). If necessary, the dose is gradually increased until adequate glycemic control is achieved. The maximum daily dose is 6 tablets (10.5 mg). If it is necessary to take more than three tablets, the dose is switched to 3.5 mg tablets.

The dose should be increased at intervals of a few days to a week until the desired therapeutic dose is achieved, which should not exceed the maximum dose.

Tablets 3.5 mg. The initial dose is usually ½ to 1 tablet once daily. The average daily dose is 3.5 mg (1 tablet). If necessary, the dose is gradually increased until adequate glycemic control is achieved. The maximum daily dose is 10.5 mg (3 tablets).

Daily doses of up to 2 tablets are usually taken once a day – in the morning. Higher doses are divided into 2 doses, 2:1 in the morning and 2:1 in the evening.

If one dose is missed, the next dose should be taken at the usual time; the higher dose should not be taken.

Transition from other hypoglycemic drugs

When transitioning from other hypoglycemic drugs with a similar type of action, glibenclamide is administered according to the scheme above, and the preceding drug is immediately withdrawn.

Use in combination therapy with other hypoglycemic drugs

Glibenclamide may be used in combination therapy with metformin and other oral hypoglycemic drugs that do not stimulate insulin secretion (guar gum or acarbose). In case of intolerance to metformin, a combination of glibenclamide with thiazolidinediones (rosiglitazone, pioglitazone) may be recommended, in the initial stage of secondary resistance to glibenkamide – with insulin. In case of complete secondary resistance to glibenkamide – insulin monotherapy.

Use in elderly, frail and malnourished patients

In elderly, frail or malnourished patients, the initial and maintenance doses should be reduced because of the risk of hypoglycemia.

Children and adolescents

There are no data on the efficacy and safety of glibenclamide in this age group.

The use in patients with renal and hepatic impairment

The use of glibenclamide in patients with severe renal and hepatic impairment is contraindicated. In patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min) and mild to moderate hepatic impairment, the initial and maintenance doses should be reduced because of the risk of hypoglycemia.

Interaction

Glibenclamide is metabolized by CYP2C9 cytochrome, which should be considered when using it simultaneously with inducers or inhibitors of CYP2C9.

Augmentation of the hypoglycemic effects of glibenclamide is observed with concomitant use of angiotensin-converting enzyme inhibitors, anabolic agents and male sex hormones, other oral hypoglycemic agents (e.g., acarbose, biguanides) and insulin, nonsteroidal anti-inflammatory drugs (NSAIDs), azapropasone. beta-adrenoblockers, guanethidine, quinine, quinolone derivatives, chloramphenicol, clofibrate, coumarin derivatives, disopyramide, fenfluramine, pheniramidol, fluoxetine, monoamine oxidase inhibitors. antifungal agents (miconazole, fluconazole), para-aminosalicylic acid, pentoxifylline (in high doses given parenterally), perhexiline, pyrazolone derivatives, phenylbutazones, phosphamides (e.g., cyclophosphamide, ifosfamide, trophosphamide), probenecid, salicylates, sulfinpyrazone, sulfonamides, tetracyclines, clarithromycin and tritoqualine.

Urine acidifying agents (ammonium chloride, calcium chloride) enhance the effect of glibenclamide by reducing its degree of dissociation and increasing its reabsorption. Hypoglycemic effect of glibenclamide may be reduced with concomitant use of barbiturates, isoniazid, cyclosporine, diazoxide, glucocorticosteroids, glucagon, epinephrine, nicotinate (in high doses), phenytoin, phenothiazines, rifampicin, rithoridine, clonidine, thiazide diuretics, acetazol amide, estrogens (e.g., oral hormonal contraceptives), iodine-containing thyroid hormone preparations, “slow” calcium channel blockers, sympathomimetic agents and lithium salts.

In concomitant use with pentamidine in single cases a marked decrease or increase in blood glucose concentration may occur.

H2-histamine receptor blockers, clonidine and reserpine can both potentiate and attenuate the hypoglycemic effects of glibenclamide.
Under the influence of sympatholytic agents such as beta-adrenoblockers, clonidine, guanethidine and reserpine, signs of adrenergic counter-regulation in response to hypoglycemia may be reduced or absent.

Single or chronic alcohol consumption may either enhance or weaken the hypoglycemic effects of glibenclamide.

Glibenclamide may potentiate or attenuate the effects of coumarin derivatives. Glibenclamide may increase the plasma concentration of cyclosporine and potentially lead to increased toxicity, so it is recommended to control the concentration and adjust the dose of cyclosporine during concomitant use with glibenclamide.
When using glibenclamide concomitantly with bozentan an increase in the activity of “hepatic” enzymes has been noted because glibenclamide and bozentan inhibit the transport of bile acids from liver cells, which leads to their intracellular accumulation and enhance their cytotoxic effect. In this regard, concomitant use of glibenclamide and bozentan is contraindicated.

Drugs that depress medullary hematopoiesis increase the risk of myelosuppression.

Special Instructions

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Contraindications

– Hypersensitivity to glibenclamide and/or any excipient of the drug;

– Hypersensitivity to other sulfonylurea derivatives; sulfonamides; diuretics with a sulfonamide group in the molecule; probenecid, because cross reactions may occur;

– Diabetic ketocidosis. cross reactions may occur;

– type 1 diabetes mellitus;

– diabetic ketoacidosis, diabetic precoma and coma;

– condition after pancreatic resection;

p> – severe hepatic insufficiency;

– severe renal insufficiency (creatinine clearance < 30 ml/min);

– severe adrenal insufficiency;

– Decompensation of carbohydrate metabolism in infectious diseases, burns, trauma, or after major surgery when insulin therapy is indicated;

– intestinal obstruction, paresis of the stomach;

– hereditary lactose intolerance, lactase deficiency or glucose and lactose malabsorption syndrome;

– pregnancy and breastfeeding;

– childhood under 18 years of age (efficacy and safety not studied);

– porphyria;

– concomitant use with bosentan.

Side effects

Classification of adverse reactions by frequency of development: frequently (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, < 1/1000), very rarely (< 1/10000), including individual reports.

Metabolic and nutritional disorders: often: hypoglycemia, weight gain.

Visual organ disorders: very rare: visual impairment and accommodation disorders.

Blood and lymphatic system disorders: rare: thrombocytopenia, thrombocytopenic purpura, leukocytopenia; very rare: leukopenia, agranulocytosis, erythropenia, hemolytic anemia or pancytopenia, aplastic anemia, bone marrow aplasia, eosinophilia and blood clotting disorders.

Gastrointestinal disorders: infrequent: nausea, heartburn, anorexia, belching, vomiting, “metallic” taste in the mouth, a feeling of heaviness and overflow in the stomach, abdominal pain and diarrhea; rarely – pancreatitis.

Liver and biliary tract disorders: very rarely: increased activity of “liver” enzymes (ACT, ALT), cholestasis, cholestatic hepatitis, granulomatous hepatitis and bilirubinemia. In individual cases, hepatitis, increased activity of “liver” enzymes and/or cholestasis and jaundice may lead to life-threatening liver failure, but may regress after discontinuation of glibenclamide.

Renal and urinary tract disorders: very rare: increased diuresis, transient proteinuria.

Skin and subcutaneous tissue disorders: rare: skin itching; urticaria; erythema nodosa; erythematous, maculopapular or bullous rash; psoriasis-like skin reactions.

Immune system disorders: very rare reactions in the form of urticaria may trigger severe states accompanied by shortness of breath and decrease in blood pressure up to the onset of life-threatening shock. There are individual cases of severe generalized allergic reactions with skin rash, joint pain, fever, protein in the urine and jaundice. If symptoms of urticaria occur, seek medical attention immediately. Cross-allergy with other sulfonylurea derivatives and sulfonamides is possible.

In individual cases, allergic vasculitis may develop, in some cases – life-threatening.

Other side effects observed in isolated cases include photosensitization; hyponatremia; late cutaneous porphyria; pellagra-like symptoms. It is possible to develop an acute reaction of intolerance to alcohol after its use, manifested by complications of the circulatory and respiratory organs (disulfiram-like reaction: vomiting, fever in the face and upper torso, tachycardia, dizziness, headache).

Overdose

In case of overdose, hypoglycemia may develop. This condition may be prolonged and contribute to the development of severe states up to comatose, life-threatening or lethal. In diabetic polyneuropathy or with concomitant treatment with sympatholytic drugs (see section “Interaction with other drugs”) the typical precursors of hypoglycemia may be mild or absent.

Symptoms of hypoglycemia: Severe feelings of hunger, sudden profuse sweating, palpitations, pallor and decreased skin temperature, oral mucous membrane paresthesias, trembling, general restlessness, headache, abnormal sleepiness, sleep disorders, feelings of fear, impaired movement coordination, temporary neurological disorders (such as visual and speech disorders, paresis and paralysis or altered sensation perception). With progression of hypoglycemia, loss of self-control and consciousness is possible, a predisposition to seizures develops.

Treatment: In mild or moderate hypoglycemia it is necessary to take dextrose (glucose) or sugar solution.

In severe hypoglycemia accompanied by loss of consciousness, intravenous administration of 40% dextrose solution or glucagon intravenously, intramuscularly, subcutaneously. After recovery of consciousness, the patient should be given food rich in carbohydrates to avoid the recurrence of hypoglycemia.

Similarities

Maninil, Glibenclamide