Statiglin - Instructions For Use, Price, Tablets 5 And 3.5 Mg, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Statiglin

Statiglin: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Statiglin

ATX code: A10BB01

Active ingredient: glibenclamide (Glibenclamide)

Manufacturer: Pharmasintez JSC (Russia); LLC "Pharmasintez-Tyumen" (Russia)

Description and photo update: 2020-08-01

Prices in pharmacies: from 70 rubles.

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Statiglin is an oral hypoglycemic agent.

Release form and composition

Dosage form of release - tablets: round, white or white with a yellow tint; dosage 1.75 mg: - biconvex, dosage 3.5 mg - flat-cylindrical with a chamfer, dosage 5 mg - flat-cylindrical with a chamfer and a dividing line on one side (7 pcs. in a blister strip, in a cardboard box 2, 6, 8 or 10 packs; 10 pcs. In a blister, in a cardboard bundle 2, 5 or 10 packs; 25, 30, 50, 60, 75, 80, 84, 90, 100, 112, 120, 150, 180 or 240 pcs in a polymer can, sealed with a lid with a first opening control, in a cardboard box of 1 can. Each box also contains instructions for the use of Statiglin).

1 tablet contains:

• active substance: glibenclamide - 1.75; 3.5 or 5 mg;
• additional components: povidone K30, lactose monohydrate, microcrystalline cellulose, low-substituted hyprolose, colloidal silicon dioxide, sodium carboxymethyl starch, sodium stearyl fumarate.

Pharmacological properties

Pharmacodynamics

Glibenclamide is a second-generation sulfonylurea derivative that exhibits pancreatic and extra-pancreatic effects. By lowering the glucose irritation threshold in β-cells of the pancreas, the drug activates insulin production, increases sensitivity to the latter, and increases the degree of its interaction with target cells. The active substance helps to increase the release of insulin, and to enhance its effect on the absorption of glucose by the liver and muscles, and also slows down the course of lipolysis in adipose tissue (extra-pancreatic effects).

Glibenclamide is active mainly in the second phase of insulin secretion. Weakens the thrombogenic properties of blood, demonstrates a hypolipidemic effect. After oral administration, the hypoglycemic effect is observed after 2 hours, reaches a maximum after 7–8 hours and lasts 12 hours. Taking Statiglin leads to a gradual increase in insulin content and a gradual decrease in plasma glucose levels in the blood, which reduces the risk of hypoglycemic conditions. The action of the drug is observed against the background of the preserved endocrine function of the pancreas.

Pharmacokinetics

Absorption from the gastrointestinal tract (GIT) with oral administration of glibenclamide is 48–84%, bioavailability is 100%. The period of reaching the maximum blood level (T _max) is 1–2 hours. Simultaneous food intake does not significantly affect the absorption of glibenclamide.

The agent binds to plasma proteins by 95–99%. Its volume of distribution (V _d) is from 9 to 10 liters. Glibenclamide passes the placental barrier to an insignificant extent. It is almost completely biotransformed in the liver, resulting in the formation of two inactive metabolites, one of which is excreted by the kidneys, and the second through the intestines, in approximately the same ratio. The half-life (T _1/2) of Statiglin varies from 3 to 16 hours.

Indications for use

The use of Statiglin is recommended for type 2 diabetes mellitus, as an adjunct to diet therapy and exercise. The drug is used as monotherapy or as part of a complex treatment with metformin and other oral hypoglycemic agents, with the exception of glinides and sulfonylurea derivatives.

Contraindications

Absolute:

• type 1 diabetes mellitus;
• severe liver dysfunction;
• renal failure, severe, with creatinine clearance (CC) <30 ml / min;
• condition after resection of the pancreas;
• diabetic precoma and coma, diabetic ketoacidosis;
• severe form of adrenal insufficiency;
• paresis of the stomach, intestinal obstruction;
• decompensation of carbohydrate metabolism against the background of infectious diseases, burns, trauma or after major surgical operations, if insulin therapy is indicated;
• porphyria;
• syndrome of glucose and lactose malabsorption, lactase deficiency, hereditary lactose intolerance;
• age up to 18 years;
• pregnancy and lactation;
• combined use with bosentan;
• hypersensitivity to any component of the drug, to sulfonamides, other sulfonylurea derivatives; diuretics containing a sulfonamide group in the molecule; probenecid, due to the increased risk of cross-reactions.

Relative (use Statiglin tablets with extreme caution):

• damage to the thyroid gland with a decrease in its function;
• cerebral atherosclerosis;
• insufficient function of the adrenal cortex or the anterior pituitary gland;
• febrile syndrome;
• renal and / or hepatic impairment of mild to moderate severity;
• chronic alcoholism, acute alcohol intoxication;
• insufficiency of glucose-6-dehydrogenase (taking sulfonylurea derivatives can cause the development of hemolytic anemia);
• conditions accompanied by impaired absorption of food and the risk of hypoglycemia (prolonged fasting, insufficient intake of carbohydrates from food, heavy physical activity, vomiting / diarrhea);
• age over 65.

Statiglin, instructions for use: method and dosage

Statiglin tablets should be taken orally before meals, regularly at the same time of day. It is recommended to swallow them without chewing, drinking a sufficient amount of liquid.

The dose of the drug is selected individually, taking into account the age, the severity of diabetes mellitus, fasting blood glucose and 2 hours after eating. In case of changes in body weight and lifestyle, a dose adjustment is required. It is necessary to regularly monitor the level of glucose in the blood and urine, the content of glycated hemoglobin, as well as indicators of lipid metabolism.

The use of the drug, depending on the dosage:

• Statiglin tablets 5 mg: may be divided into 2 equal parts. The dose can vary from 2.5 to 15 mg per day (½ – 3 tablets), the initial daily dose is 2.5–5 mg (½ – 1 tablet), the maximum is 15 mg (3 tablets of Statiglin 5 mg);
• Statiglin tablets 1.75 mg and 3.5 mg: prescribed once a day at an initial dose of 1.75-3.5 mg (1-2 tablets of 1.75 mg or ½ – 1 tablets of Statiglin 3.5 mg), the average daily dose is 3.5 mg (2 tablets of 1.75 mg or 1 of 3.5 mg). To achieve effective glycemic control, the dose can be gradually increased, the maximum dose is 10.5 mg per day (6 tablets of 1.75 or 3 tablets of Statiglin 3.5 mg). If you need to take more than 3 tablets of 1.75 mg, you need to switch to using the drug at a dosage of 3.5 mg.

The dose should be increased at intervals of 2-7 days until the required daily therapeutic dose is reached, not exceeding the maximum.

If the daily dose of Statiglin is 1-2 tablets, as a rule, they are taken in the morning 1 time per day. Higher doses should be divided into 2 doses, using in a ratio of 2 ÷ 1 in the morning and evening.

When you miss the next dose of Statiglin, it is recommended to take the next dose at the usual time, while increasing the dose in order to compensate for the missed dose is not allowed.

Weakened, elderly or malnourished patients are recommended to reduce both the initial and maintenance dose to prevent the development of hypoglycemia.

When transferring a patient who has used other hypoglycemic drugs with a similar type of action to receive Statiglin, the latter is prescribed according to the above scheme, and the previous agent is immediately canceled.

Statiglin can also be used in combination with metformin and other oral antidiabetic agents such as guar gum or acarbose, which do not increase insulin secretion. With metformin intolerance, it is possible to use glibenclamide in combination with thiazolidinediones (pioglitazone, rosiglitazone), at the initial stage of the development of secondary resistance to glibenclamide - with insulin. In the case of complete secondary resistance to glibenclamide, the use of insulin in monotherapy is recommended.

Side effects

When taking Statiglin inside, the following negative side reactions from the systems and organs may develop:

• blood and lymphatic system: rarely - thrombocytopenia, leukocytopenia, thrombocytopenic purpura; extremely rare - erythropenia, leukopenia, agranulocytosis, bone marrow aplasia, aplastic anemia, eosinophilia, pancytopenia or hemolytic anemia, bleeding disorders;
• hepatobiliary system: extremely rarely - cholestasis, bilirubinemia, cholestatic hepatitis, granulomatous hepatitis, increased activity of alanine aminotransferase (ALT) and aspartate aminotransferase (ACT); in some cases, these side effects can provoke life-threatening liver failure, but they can also regress after stopping the use of Statiglin;
• Gastrointestinal tract: infrequently - belching, metallic taste in the mouth, a feeling of heaviness and fullness in the stomach, nausea, vomiting, anorexia, heartburn, diarrhea and abdominal pain; rarely - pancreatitis;
• metabolism and nutrition: often - weight gain, hypoglycemia;
• kidneys and urinary tract: extremely rare - increased diuresis, transient proteinuria;
• organ of vision: extremely rarely - disorders of the accommodating ability of the eye and visual impairment;
• immune system: extremely rarely - hypersensitivity reactions in the form of urticaria, which can lead to the development of severe conditions, accompanied by shortness of breath and a decrease in blood pressure (BP), up to the onset of life-threatening shock; isolated cases - severe generalized allergic reactions with joint pain, skin rash, fever, proteinuria and jaundice (if urticaria symptoms develop, an urgent need to consult a doctor), allergic vasculitis, sometimes life-threatening; cross-allergy to sulfonamides and other sulfonylurea derivatives may occur;
• skin and subcutaneous tissues: rarely - itching of the skin, urticaria, erythema nodosum, psoriasis-like skin reactions, erythematous / maculopapular / bullous rash.

In isolated cases, such side effects of Statiglin were recorded as hyponatremia, photosensitization, pellagra-like symptoms, and tardive cutaneous porphyria. There may be an acute reaction of intolerance to ethanol-containing drinks after drinking them - a disulfiram-like reaction, manifested by vomiting, a feeling of heat in the face and in the upper body, headache, dizziness, tachycardia. During the period of therapy, it is required to refrain from drinking alcohol.

Overdose

With an overdose of Statiglin, hypoglycemia may occur. This complication is often inherent in a protracted nature and a high probability of the appearance of severe conditions, up to coma, which ends in death. The characteristic precursors of hypoglycemia against the background of diabetic polyneuropathy or concomitant treatment with sympatholytic agents may be weak or absent.

Symptoms of hypoglycemia include: sudden excessive sweating, severe hunger, a decrease in temperature and pallor of the skin, general anxiety, palpitations, tremors, headache, paresthesias of the oral mucosa, sleep disorders, pathological drowsiness, impaired coordination of movements, a sense of fear, transient neurological disorders (disorders of vision and speech, altered perception of sensations or manifestations of paresis and paralysis). In case of progression of hypoglycemia, there may be a loss of self-control and consciousness, and a predisposition to seizures may appear.

With the development of hypoglycemia of mild to moderate severity, it is required to take an oral sugar solution or dextrose (glucose). In severe hypoglycemia, leading to loss of consciousness, intravenous dextrose solution 40% or glucagon is administered intramuscularly, intravenously, subcutaneously. After the recovery of consciousness, it is necessary to eat food rich in carbohydrates in order to avoid the recurrence of hypoglycemia.

special instructions

The recommended dosage regimen and food regimen should be carefully observed. The physician should scrupulously assess the benefit-risk ratio of the drug when it is prescribed to patients with liver and / or kidney pathology or hypofunction of the thyroid gland, adrenal glands or the anterior pituitary gland. An adjustment of the dose of Statiglin is required when changing the diet, physical / emotional overstrain.

Factors that increase the risk of hypoglycemia include:

• imbalance between exercise level and carbohydrate intake;
• unwillingness / inability (most often observed in the elderly) to cooperate with a doctor;
• irregular meals or skipping meals, malnutrition;
• diet change;
• severe renal and / or liver dysfunction;
• drinking alcohol, especially if you skip meals;
• diarrhea, vomiting;
• glibenclamide overdose;
• separate decompensated endocrine disorders, causing disorders of carbohydrate metabolism or adrenergic counterregulation as a result of hypoglycemia;
• combined use with certain drugs.

Medicines affecting the central nervous system, lowering blood pressure (including β-blockers), as well as autonomic neuropathy, can mask the signs of hypoglycemia.

It is not recommended to stay in the sun for a long time during therapy.

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

Influence on the ability to drive vehicles and complex mechanisms

During treatment with Statiglin, there is a risk of hypoglycemia, which entails a worsening of reactions and a weakening of concentration, as a result of which patients who drive vehicles and other complex mechanisms should be careful.

Application during pregnancy and lactation

Use of Statiglin is contraindicated in pregnant women. In case of pregnancy during drug therapy, it must be canceled. When planning a pregnancy, treatment with oral hypoglycemic agents should be replaced with insulin therapy.

Whether Statiglin is excreted in breast milk has not been established, but since other sulfonylurea derivatives are detected in breast milk, it is contraindicated to take glibenclamide during lactation.

Pediatric use

For children and adolescents under 18 years of age, Statiglin therapy is contraindicated, since there is no data on the effectiveness and safety of its implementation in this age group.

With impaired renal function

Against the background of renal failure, the excretion of metabolites in the feces increases compensatory. If CC is ≥ 30 ml / min, the total rate of elimination of glibenclamide from the body remains unchanged; in severe renal failure (CC <30 ml / min), cumulation may occur.

Patients with severe renal impairment are contraindicated in patients with mild and moderate impairments (CC ≥ 30 ml / min) - the minimum effective initial and maintenance dose should be taken, due to the possible development of hypoglycemia.

For violations of liver function

In the presence of functional disorders of the liver, the excretion of the active substance from the blood plasma slows down. Patients with severe hepatic impairment are contraindicated to take Statiglin, with mild and moderate severity - it is recommended to reduce the initial and maintenance doses due to the risk of hypoglycemia.

Use in the elderly

Persons over 65 years of age should use a lower starting and maintenance dose of Statiglin to avoid hypoglycemia. Elderly patients also need regular monitoring of fasting blood glucose and after meals, especially at the beginning of the course.

Drug interactions

• acarbose, biguanides and other oral hypoglycemic agents, insulin, non-steroidal anti-inflammatory drugs (NSAIDs), anabolic agents and male sex hormones, angiotensin-converting enzyme (ACE) inhibitors, β-adrenergic blockers, azapropazone, quininetidolone derivatives, gininopathiramine, fenfluramine, coumarin derivatives, monoamine oxidase (MAO) inhibitors, antifungal agents (fluconazole, miconazole), feniramidol, fluoxetine, para-aminosalicylic acid, pentoxifylline (administered parenterally in high doses), pyrazolone derivatives, phenylgenosulfamides, cyclophosphamide), salicylates, sulfinpyrazone, probenecid, tetracyclines, sulfonamides, clarithromycin, tritoqualin: increase the hypoglycemic effect of glibenclamide;
• diazoxide, isoniazid, cyclosporin, barbiturates, glucocorticosteroids, epinephrine, glucagon, nicotinate (in large doses), rifampicin, phenytoin, phenothiazines, thiazide diuretics, ritodrin, clonidine, acetazolamide, estrogens (hormonal hormone blockers). calcium channels, preparations of iodine-containing thyroid hormones, lithium salts, sympathomimetic agents: reduce the hypoglycemic effect of glibenclamide;
• calcium chloride, ammonium chloride (urine acidifying agents): increase the efficiency of glibenclamide as a result of a decrease in the degree of its dissociation and an increase in reabsorption;
• alcohol (with single / chronic use), reserpine, clonidine, blockers of H ₂ -histamine receptors: these substances can both enhance and weaken the hypoglycemic effect of glibenclamide;
• reserpine, clonidine, guanethidine, β-blockers: in response to hypoglycemia, signs of adrenergic counterregulation decrease or are absent;
• cyclosporine: the plasma concentration of this substance increases and the risk of increasing its toxicity is aggravated; it is recommended to control the level of cyclosporine and, if necessary, adjust its dose;
• pentamidine (in isolated cases): there is a pronounced decrease / increase in blood glucose levels;
• coumarin derivatives: the effect of these agents may be weakened / enhanced;
• drugs that suppress bone marrow hematopoiesis: the risk of myelosuppression is aggravated;
• bosentan: there is an increase in the cases of an increase in the activity of liver enzymes, since this substance and glibenclamide block the transport of bile acids from liver cells, thereby leading to their intracellular accumulation and aggravation of the cytotoxic effect; this combination is contraindicated.

Analogs

Statiglin analogs are Bagomet Plus, Glibeks, Glibenfazh, Glibenclamide + Metformin, Glibenclamide, Glimidstad, Glukovans, Gluconorm, Maninil, Metglib Force, etc.

Terms and conditions of storage

Store in a place protected from moisture and light, out of reach of children, at a temperature not exceeding 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Statiglin

Since the drug began to be released only two years ago, there are currently no patient reviews about Statiglin on specialized sites. It is not possible to objectively assess the disadvantages and effectiveness of this hypoglycemic agent.

Analogs of the drug containing glibenclamide as an active component, which is included in Statiglin, according to users, as part of complex therapy for type 2 diabetes mellitus, can effectively control blood glucose levels. However, often, especially at the beginning of the course, lead to the appearance of undesirable effects, mainly in the form of lack of appetite, nausea and diarrhea.

The price of Statiglin in pharmacies

On average, the price of Statiglin in the form of tablets is (per package containing 120 pcs.): Dosage 1.75 mg - 90 rubles; dosage 3.5 mg - 100 rubles; dosage 5 mg - 80 rubles.

Statiglin: prices in online pharmacies

Drug name Price Pharmacy

Statiglin 1.75 mg tablets 120 pcs. RUB 70 Buy

Statiglin tab. 1.75 mg 120 pcs. RUB 72 Buy

Statiglin 5 mg tablets 120 pcs. RUB 76 Buy

Statiglin 3.5 mg tablets 120 pcs. 77 RUB Buy

Statiglin tab. 5 mg 120 pcs. RUB 78 Buy

Statiglin tab. 3.5 mg 120 pcs. 110 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!