Statiglin, tablets 5 mg 120 pcs

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Indications

Active ingredient

Composition

Composition per tablet:

The active ingredient:

glibenclamide 5 mg

Auxiliary substance:

Lactose monohydrate – 50.0 mg;

povidone K30 – 5.0 mg;

Hyprolose low-substituted – 23.0 mg;

Microcrystalline cellulose – 47.0 mg;

sodium carboxymethyl starch – 8.0 mg;

colloidal silica – 1.0 mg;

sodium stearyl fumarate – 1.0 mg.

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 reached, 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

In combination therapy with other hypoglycemic drugs

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.

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

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 concentration control and dose adjustment of cyclosporine is recommended when used simultaneously with glibenclamide.
When using glibenclamide concomitantly with bosentan an increase in the activity of “hepatic” enzymes has been noted because glibenclamide and bosentan suppress the transport of bile acids from liver cells, which leads to their intracellular accumulation and increase their cytotoxic effect. Therefore, concomitant use of glibenclamide and bozentan is contraindicated.

Drugs that depress medullary hematopoiesis increase the risk of myelosuppression.

Special Instructions

The drug should be taken regularly and, if possible, at the same time. It is necessary to carefully observe the regimen of taking the drug and the dietary regime. The physician should carefully consider the prescription of glibenclamide in patients with impaired hepatic and renal function, as well as in hypothyroidism, anterior pituitary gland or adrenal cortex. It is necessary to adjust the dose of glibenclamide in case of physical and emotional overexertion, changes in diet.

Factors contributing to the risk of hypoglycemia include:

– patient reluctance or inability (more often seen in elderly patients) to cooperate with the physician;

– malnutrition, irregular meal intake, or skipping meals;

– An imbalance between exercise and carbohydrate intake;

– dietary changes;

– alcohol consumption, especially when combined with skipping meals;

-serious renal impairment;

– severe hepatic impairment;

– glibenclamide overdose;

– diarrhea, vomiting;

– Certain decompensated endocrine disorders that impair carbohydrate metabolism or adrenergic counter-regulation in response to hypoglycemia (e.g., some thyroid and anterior pituitary gland dysfunction, insufficiency of the adrenal cortex);

– concurrent administration of certain medications.

Major surgical interventions and trauma, extensive burns, infectious diseases with febrile syndrome may require withdrawal of oral hypoglycemic drugs and prescription of insulin.

A long stay in the sun is not recommended during treatment.

The use of sulfonylurea derivatives, which include glibenclamide, in patients with glucose-6-phosphate dehydrogenase deficiency may lead to hemolytic anemia; therefore, hypoglycemic agents other than sulfonylurea derivatives should be used.

Concomitant use of drugs that have an effect on the central nervous system, lowering blood pressure (including beta-adrenoblockers), as well as autonomic neuropathy may mask the symptoms of hypoglycemia.

The risk of hypoglycemia is slightly higher in elderly patients, therefore, more careful selection of drug dose and regular monitoring of blood glucose concentration on an empty stomach and after meals is necessary, especially at the beginning of treatment.

Alcohol can induce hypoglycemia and also disulfiram-like reactions (nausea, vomiting, abdominal pain, fever in face and upper trunk, tachycardia, dizziness, headache), therefore, it is necessary to abstain from alcohol during treatment with glibenclamide.

Whenever you change doctors (e.g., hospitalization, sick leave), the patient should always tell the attending physician that he or she has diabetes.

Fertility

There are no data on the effect of glibenclamide on fertility.

Hypoglycemia may occur while taking glibenclamide and, as a consequence, decreased reaction and ability to concentrate; therefore, during treatment with the drug, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require concentration and quick psychomotor reactions.

Contraindications

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

– Hypersensitivity to other sulfonylurea derivatives; sulfonamides; diuretics containing a sulfonamide group in the molecule; probenecid, since 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.

Glibenclamide should be used with caution in febrile syndrome; thyroid disease (with decreased function); insufficiency of anterior pituitary or adrenal cortex function; glucose-6-dehydrogenase deficiency; chronic alcoholism, acute alcohol intoxication; conditions accompanied with food absorption disorders and risk of hypoglycemia (long-term fasting, insufficient intake of carbohydrates with food, excessive physical activity, diarrhea or vomiting); renal insufficiency of mild to moderate degree of severity (creatinine clearance ≥ 30 ml/min); hepatic insufficiency of mild to moderate degree of severity; cerebral atherosclerosis; in elderly patients aged over 65 years due to risk of hypoglycemia.

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; pellagro-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, feeling of heat 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.

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