Глидиаб® MV

General characteristics. Structure:

Active ingredient: 30 mg of gliclazide.

Excipients: gidroksipropilmetiltsellyuloza, cellulose microcrystallic, aerosil, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. ^{Глидиаб®МВ} is the peroral hypoglycemic drug derivative of generation sulphonylurea II. Stimulates insulin secretion with pancreas β-cells, strengthens insulinosekretorny 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 atherosclerosis, 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 an insulinaa does not cause a giperinsulinemiya; promotes decrease in body weight at patients with obesity at observance of the corresponding diet.

Pharmacokinetics. It is almost completely soaked up from a GIT after intake. Concentration of active ingredient increases in plasma gradually, reaching a maximum in 6-12 h after administration of drug. Meal does not influence absorption. Communication with proteins of plasma makes about 95%. It is metabolized in a liver with formation of inactive metabolites. The elimination half-life makes about 16 h. It is removed preferential by kidneys in the form of metabolites and about 1% of drug is removed with urine in an invariable look. At elderly people any essential clinical changes of pharmacokinetics are not observed.

Thanks to features of a dosage form, daily reception of a single dose of drug provides effective therapeutic concentration of gliclazide in plasma for 24 hours.

Indications to use:

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

Route of administration and doses:

The dose of drug should be selected individually depending on clinical displays of a disease, glucose level on an empty stomach and in 2 hours after food. Usually initial daily dose (including for people of advanced age 65 years are more senior) makes 30 mg (1 tablet), further if necessary the dose of drug is raised with an interval by not less than 2 weeks.

The maximum daily dose - 120 mg (4 tablets). Drug is accepted inside once a day in the morning, during a breakfast.

Glidiab can replace Glidiab in doses from 1 to 4 tablets in days.

It is possible to apply in combination with other hypoglycemic means: guanyl guanidines, inhibitors of alpha glucosidases or insulin.

To patients with a renal failure from weak to moderate degree of manifestation (clearance of creatinine from 15 to 80 ml/min.) drug is appointed in the same doses.

Features of use:

Treatment by 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 decompensation of diabetes 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, a 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, 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:

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 тяжестив 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, makulo-papular 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 this-nolsoderzhashchiye drugs, and also other hypoglycemic drugs (acarbose, guanyl guanidines, insulin) strengthen hypoglycemic action of 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 action of Glidiab - niacin, Chlorpromazinum, are oestrogenic also the oral contraceptives supporting them.

At interaction with ethanol development of disulfiramopodobny reaction is possible.

Gliclazide 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 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 digestible carbohydrates in order to avoid repeated development of a hypoglycemia.

Storage conditions:

List B. In dry, protected from light and the place, unavailable to children, at a temperature not above 25 °C. Not to use after the term specified on packaging. A period of validity - 2 years. 

Issue conditions:

According to the recipe

Packaging:

Tablets with the modified release of 30 mg. On 10 tablets in a blister strip packaging. On 3 or 6 blister strip packagings together with the application instruction place in a pack from a cardboard.