Глидиаб®

General characteristics. Structure:

Active ingredient: 80 mg of gliclazide.

Excipients: sugar milk (lactose), cellulose microcrystallic, potato starch, hydroxypropyl-methyl cellulose (gipromelloza), magnesium stearate, talc (magnesium гидроксиликат), крахмалгликолат sodium.

Pharmacological properties:

Pharmacodynamics. ^{Глидиаб®} is the peroral hypoglycemic drug derivative of generation sulphonylurea II. Stimulates insulin secretion with pancreas β-cells, strengthens insulinsekretor-ny effect of glucose, increases sensitivity of peripheral fabrics to insulin. Stimulates activity of desmoenzymes - a muscular glikogensintetaza. Reduces an interval from the meal moment prior to insulin secretion. Recovers early peak of secretion of insulin (unlike other derivatives of sulphonylurea which make impact, mainly, during the second stage of secretion). Reduces postprandialny increase in level of glucose.

In addition to influence on carbohydrate metabolism, improves microcirculation: reduces adhesion and aggregation of thrombocytes, normalizes permeability of vessels, interferes with development of microthromboses and ateroskleroz, recovers process of a physiological pristenochny fibrinolysis. Reduces sensitivity of receptors of vessels to adrenaline. Slows down development of a diabetic retinopathy at not proliferative stage. At a diabetic nephropathy against the background of prolonged use causes reliable decrease in expressiveness of a proteinuria. Does not lead to increase in body weight as makes preferential impact on early peak of secretion of insulin and does not cause a giperinsulinemiya; promotes decrease in body weight at patients with obesity at observance of the corresponding diet.

Pharmacokinetics. After intake it is quickly soaked up in digestive tract. Absorption - high. After oral administration of 80 mg the maximum concentration in blood (2,2-8 mkg/ml) is reached approximately in 4 hours, after reception of 40 mg the maximum concentration in blood (2-3 mkg/ml) - in 2-3 h Svyazs by proteins of plasma - 85-97%, distribution volume - 0,35 l/kg. Equilibrium concentration in blood is reached in 2 days.

It is metabolized in a liver, at the same time 8 metabolites are formed. The quantity of the main metabolite which is found in blood makes 2-3% of all amount of the accepted drug, it has no hypoglycemic effect, however improves microcirculation. It is removed by kidneys - 70% in the form of metabolites, less than 1% in not changed look; with a fecal masses - 12% in the form of metabolites. The elimination half-life makes 8-20 hours.

Indications to use:

Diabetes mellitus of type 2 at adults in combination with a dietotherapy and a moderate exercise stress at inefficiency of the last.

Route of administration and doses:

The dose of drug is established individually, depending on age of the patient, clinical displays of a disease and level of a glycemia on an empty stomach and in 2 hours after food. An initial daily dose - 80 mg, an average daily dose - 160 mg, the maximum daily dose - 320 mg. ^{The drug Glidiab®} is accepted inside by 2 times a day (in the morning and in the evening) in 30-60 minutes prior to food.

Features of use:

Treatment ^{by the drug Glidiab®} is carried out in combination with a low-calorie diet with the small content of carbohydrates. It is regularly necessary to control the content of glucose in blood on an empty stomach and after meal. In case of surgical interventions or at a diabetes decompensation, it is necessary to consider a possibility of use of drugs of insulin. It is necessary to warn patients about the increased risk of emergence of a hypoglycemia in case of reception of ethanol, non-steroidal anti-inflammatory drugs and starvation.

In case of ethanol reception perhaps also development of a disulfiramopodobny syndrome (abdominal pains, nausea, vomiting, headache). Dose adjustment of drug at a physical or emotional overstrain, change of a diet is necessary.

Are especially sensitive to effect of hypoglycemic drugs of the elderly person; the patients who are not receiving the balanced food; the weakened patients; the patients suffering from pituitary and adrenal insufficiency. In an initiation of treatment, during selection of a dose sick, inclined to development of a hypoglycemia, it is not recommended to be engaged in the activity requiring special attention and speed of psychomotor reactions.

Side effects:

- A hypoglycemia (at disturbance of the mode of dosing and an inadequate diet); a headache, feeling of fatigue, feeling of hunger, perspiration, sharp weakness, aggression, uneasiness, irritability, a carelessness, impossibility to concentrate and the slowed-down reaction, a depression, a vision disorder, aphasia, a tremor, feeling of helplessness, touch frustration, dizziness, self-checking loss, a delirium, spasms, a hypersomnia, a loss of consciousness, shallow breathing, bradycardia.
- From system of digestive organs: dyspepsia (nausea, diarrhea, feeling of weight in epigastriums); anorexia - expressiveness decreases at inclusion in food time; abnormal liver functions (cholestatic jaundice, increase in activity of "hepatic" transaminases.
- Hemopoiesis disturbances: anemia, thrombocytopenia, leukopenia.
- Allergic reactions: itch, urticaria, makulopapulezny rash

Interaction with other medicines:

Inhibitors of an angiotensin-converting enzyme (captopril, enalapril), blockers of H2-histamine receptors (Cimetidinum), antifungal drugs (Miconazolum, флуконазол), non-steroidal anti-inflammatory drugs (phenylbutazone, indometacin, diclofenac), fibrata (Clofibratum, безафибрат), antitubercular drugs (Etioniamidum), salicylates, indirect anticoagulants of a coumarinic row, anabolic steroids, beta adrenoblockers, cyclophosphamide, chloramphenicol, monoaminooxidase inhibitors, streptocides of the prolonged action, фенфлурамин, fluoxetine, пентоксифиллин, гуанетидин, the theophylline, drugs blocking canalicular secretion, Reserpinum, Bromocriptinum, Disopyramidum, a pyridoxine, Allopyrinolum, ethanol and ethanol - the containing drugs, and also other hypoglycemic drugs (acarbose, guanyl guanidines, insulin) strengthen hypoglycemic effect ^{of the drug Glidiab®}.

Barbiturates, glucocorticosteroids, sympathomimetics (Epinephrinum, a clonidine, Ritodrinum, salbutamol, тербуталин), Phenytoinum, blockers of "slow" calcium channels, inhibitors of a karboangidraza (acetazoleamide), thiazide diuretics, Chlortalidonum, furosemide, триамтарен, asparaginase, Baclofenum, даназол, diazoxide, an isoniazid, morphine, a glucagon, rifampicin, hormones of a thyroid gland, lithium salt, in high doses weaken hypoglycemic effect ^{of the drug Glidiab®} - niacin, Chlorpromazinum, are oestrogenic also the oral contraceptives supporting them.

At interaction with ethanol development of disulfiramopodobny reaction is possible.

^{The drug Glidiab®} increases risk of emergence of ventricular premature ventricular contraction against the background of reception of cardiac glycosides.

Beta adrenoblockers, clonidine, Reserpinum, гуанетидин can mask clinical manifestations of a hypoglycemia.

Contraindications:

- hypersensitivity to drug;
- diabetes mellitus of type 1;
- diabetic ketoacidosis, diabetic prekoma, diabetic coma;
- giperosmolyarny coma;
- heavy liver and/or renal failure;
- the big surgical interventions, extensive burns, injuries and other states demanding performing insulin therapy;
- intestinal impassability, stomach paresis;
- the states which are followed by disturbance of absorption of food, development of a hypoglycemia (infectious diseases);
- leukopenia;
- pregnancy, breastfeeding period.

With care (need of more careful observation and selection of a dose)
appoint the drug Glidiab® at a feverish syndrome, alcoholism and diseases of a thyroid gland (with disturbance of its function).

Overdose:

At overdose the hypoglycemia is possible, up to development of a hypoglycemic coma.

Treatment: if the patient in consciousness - inside to accept digestible carbohydrates (sugar), at a loss of consciousness - intravenously to enter 40% solution of a dextrose (glucose), 1-2 mg of a glucagon intramusculary. After consciousness recovery the patient needs to give the food rich with the easily acquired carbohydrates (in order to avoid repeated development of a hypoglycemia).

Storage conditions:

List B. In the dry, protected from light place, at a temperature not above 25 °C. To store in the places unavailable to children. Not to apply after a period of validity. A period of validity - 4 years. 

Issue conditions:

According to the recipe

Packaging:

Tablets of 80 mg. On 10 tablets in a blister strip packaging. 2, 3, 4, 5 or 6 blister strip packagings together with the application instruction place in a pack from a cardboard.