GliDiab - instructions for use, doses, side effects, contraindications

Excipients: lactose monohydrate 23.44 mg, microcrystalline cellulose 32 mg, potato starch. 13.43 mg, hypromellose 2.33 mg, magnesium stearate 1.6 mg, talc 0.8 mg, sodium carboxymethyl starch 6.4 mg.

Description:

Tablets white or white with a yellowish or kremovatymi shade of color, flat-cylindrical, with a facet.

Pharmacotherapeutic group:Hypoglycemic agent for oral use of the second-generation sulfonylurea group

ATX: & nbsp

A.10.B.B.09 Gliclazide

Pharmacodynamics:

Oral hypoglycemic agent, derivative of sulfonylureas of the second generation. It stimulates the secretion of insulin by the pancreas, increases the insulin secretion effect of glucose and the sensitivity of peripheral tissues to insulin. Stimulates the activity of intracellular enzymes of muscle glycogen synthase. Reduces the time interval from the time of food intake to the onset of insulin secretion. It restores the early peak of insulin secretion (unlike other sulfonylurea derivatives, for example, glibenclamide, which mainly affect the second stage of secretion).In addition to the effect on carbohydrate metabolism, it affects microcirculation. Reduces postprandial hyperglycemia, reduces adhesion and aggregation of platelets, delays the development of parietal thrombosis, normalizes vascular permeability and prevents the development of microthrombosis and atherosclerosis, restores the process of physiological parietal fibrinolysis, counteracts increased reaction to epinephrine vessels with microangiopathy. Slows the development of diabetic retinopathy at the non-proliferative stage; with diabetic nephropathy against a background of prolonged use, there is a significant decrease in proteinuria. Does not lead to an increase in body weight, since it has a predominant effect on the early peak of insulin secretion and does not cause hyperinsulinemia; helps to reduce body weight in obese patients while observing an appropriate diet. It has anti-atherogenic properties, lowers the concentration in the blood of total cholesterol.

Pharmacokinetics:

Absorption is high. After oral administration of 80 mg the period of reaching the maximum concentration is 4 hours, the maximum concentration in the blood plasma is 2.2-8 μg / ml.The connection with plasma proteins is 85-97%, the volume of distribution is 0.35 l / kg. The equilibrium concentration in the blood plasma is reached after 2 days. Half-life - 8-20 hours Metabolised in the liver, with the formation of 8 metabolites. The amount of the main metabolite found in the blood - 2-3% of the total amount of the drug taken, it has no hypoglycemic properties, but has an effect on microcirculation. It is excreted by the kidneys - 70 % in the form of metabolites, less than 1% unchanged, intestine-12% in the form of metabolites.

Indications:

Diabetes mellitus type 2 in adults (with ineffectiveness of diet and exercise).

Contraindications:

Hypersensitivity, diabetes mellitus type 1, diabetic ketoacidosis, diabetic precoma and coma, severe hepatic and / or renal failure, concomitant miconazole therapy, pregnancy, lactation, age 18 years, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Elderly age, irregular and / or unbalanced nutrition, severe diseases of the cardiovascular system (including coronary heart disease, atherosclerosis), hypothyroidism,adrenal or pituitary insufficiency, hypopituitarism, renal and / or hepatic insufficiency, long-term glucocorticosteroid therapy, alcoholism, insufficiency of glucose-6-phosphate dehydrogenase, concomitant therapy with phenylbutazone and danazol.

Dosing and Administration:

Inside, with meals, the initial daily dose - 80 mg, the average daily dose - 160 320 mg (for 2 hours - in the morning and in the evening). The dose depends on the age, severity of diabetes, fasting blood glucose, and 2 hours after eating.

Patients elderly or with chronic renal failure of mild and moderate severity (creatinine clearance - 15-80 ml / min) the drug is prescribed in the same doses.

Side effects:

Hypoglycaemia (with a dysregulation and an inadequate diet): headache, fatigue, hunger, increased sweating, severe weakness, palpitations, arrhythmia, increased blood pressure, drowsiness, insomnia, agitation, aggressiveness, anxiety, irritability, decreased concentration, inability focus and delayed response, depression, visual impairment, aphasia,tremor, paresis, sensory disturbances, dizziness, feelings of helplessness, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, loss of consciousness, coma.

Disorders from the gastrointestinal tract: dyspepsia (nausea, vomiting, diarrhea, abdominal pain, constipation)

- severity decreases with admission during meals; rarely - violations of the liver (hepatitis, cholestatic jaundice

- requires withdrawal of the drug, increased activity of "liver" transaminases, alkaline phosphatase).

Violations from the blood and lymphatic system: oppression of bone marrow hematopoiesis (anemia, thrombocytopenia, leukopenia, granulocytopenia).

Disturbances from the skin and subcutaneous tissues: skin itching, urticaria, maculopapular rash, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis), angioedema (Quincke's edema), erythema.

Disorders from the side of the organ of vision: transient visual impairment caused by changes in blood glucose concentration, especially at the beginning of therapy.

Common side effects of sulfonylurea derivatives: erythropenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis; life-threatening liver failure.

Overdose:

Symptoms: hypoglycemia, impaired consciousness, hypoglycemic coma.

Treatment: if the patient is conscious, take sugar inside; in case of a consciousness disorder, intravenous administration of a 40% dextrose solution, then dropping 5% dextrose solution intravenously, to reach a blood glucose concentration of 5.55 mol / l, 1-2 mg glucagon in / m, 15 min, as well as the determination of pH, urea, creatinine and electrolytes in the blood. After the restoration of consciousness it is necessary to give the patient food that is rich in easily assimilated carbohydrates (in order to avoid the re-development of hypoglycemia). With edema of the brain - mannitol and dexamethasone. Dialysis is ineffective.

Interaction:

Enhances the effect of anticoagulants (warfarin), an anticoagulant dose adjustment may be required.

Miconazole (with systemic administration and with the use of gel on the oral mucosa) enhances the hypoglycemic effect of the drug (hypoglycemia may develop up to the state of coma).

Phenylbutazone (systemic administration) enhances the hypoglycemic effect of the drug (displaces plasma from plasma binding and / or slows the elimination from the body), blood glucose control and correction of the dose of gliclazide are necessary, both during the administration of phenylbutazone and after its withdrawal.

Ethanol and ethanol-containing drugs, increase hypoglycemia, inhibiting compensatory reactions, may contribute to the development of hypoglycemic coma. With simultaneous administration with other hypoglycemic drugs (insulin, acarbose, biguanides), beta-adrenoblockers, fluconazole, angiotensin-converting enzyme (ACE) inhibitors (captopril, enalapril), blockers of H2-histamine receptors (cimetidine), monoamine oxidase (MAO) inhibitors, sulfonamides and non-steroidal anti-inflammatory drugs - increased hypoglycemic effect and risk of hypoglycemia.

Danazol - Diabetogenic effect. It is necessary to monitor blood glucose and dose correction of gliclazide, both during danazol administration and after its cancellation.

Chlorpromazine in high doses (more than 100 mg / day) increases the glucose level in the blood, reducing the secretion of insulin.It is necessary to monitor blood glucose and dose correction of gliclazide, both during the intake of chlorpromazine, and after its withdrawal.

Glucocorticosteroids (systemic, intraarticular, external / rectal administration) - increase the blood glucose level with possible development of ketoacidosis (decrease - tolerance to carbohydrates). It is necessary to monitor blood glucose and dose correction of gliclazide, both during the intake of glucocorticosteroids, and after their withdrawal.

Ritodrin, salbutamol, terbutaline (iv) - increase blood glucose, it is recommended to monitor blood glucose and, if necessary, transfer the patient to insulin therapy.

Special instructions:

During the administration of the drug, a regular determination of fasting blood glucose and glycosylated hemoglobin is necessary.

Large surgical interventions and injuries, extensive burns, infectious diseasesTreatment with febrile syndrome may require the abolition of oral hypoglycemic drugs and the administration of insulin.

Patients should be warned about the increased risk of hypoglycemia in cases of taking ethanol and ethanol-containing medicines (incl.possibly the development of disulfiram-like reactions: abdominal pain, nausea, vomiting, headache), non-steroidal anti-inflammatory drugs, with starvation.

Dose correction is necessary in case of physical and emotional overstrain, changes in diet.

Typically, the symptoms of hypoglycemia occur after eating a meal rich in carbohydrates (such as sugar), taking sugar substitutes does not help to eliminate hypoglycemic symptoms. Hypoglycemia can recur, despite effective initial cupping. If hypoglycemic symptoms are severe or prolonged, even in the case of temporary improvement after a meal rich in carbohydrates, emergency medical care is necessary, up to hospitalization.

Particularly sensitive to the effects of hypoglycemic, medicines, the elderly, patients who do not receive a balanced diet, with a general weakened condition, patients suffering from pituitary-adrenal insufficiency. Clinical manifestations of hypoglycemia can be masked when taking beta-blockers, clonidine, reserpine, guanetidine.It is possible to develop secondary drug resistance (it is necessary to distinguish from the primary drug, at which the drug already at the first appointment does not give the expected clinical effect).

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Tablets 80 mg.

Packaging:

For 10 tablets in a planar cell package.

6 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

4 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000001 / 01

Date of registration:16.05.2011 / 28.03.2017

Expiration Date:Unlimited

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp29.04.2017

Illustrated instructions

Instructions

Glidiab® (Glidiab)