Глюкованс

Глюкованс – peroral hypoglycemic means.

Form of release and structure

Dosage form – tablets: a kapsulovidny biconvex form in a film cover of light orange color with an engraving on one of the parties "2,5" or yellow color with an engraving "5" (on 15 pieces in blisters, in a cardboard pack 2 blisters).

The maintenance of the operating components in 1 tablet:

• Glibenclamidum – 2,5 mg or 5 mg;
• Metforminum a hydrochloride – 500 mg.

Excipients: K30 povidone, croscarmellose sodium, magnesium stearate, cellulose microcrystallic.

Structure of a cover of light orange/yellow color: опадрай OY-L-24808 pink / опадрай 31-F-22700 yellow (a gipromelloza 15cP, lactoses monohydrate, titanium dioxide, ferrous oxide red, ferrous oxide black / dye quinoline yellow, a macrogoal, ferrous oxide yellow), the water purified.

Indications to use

Glyukovans's use is shown by an adult, sick diabetes mellitus of the 2nd type if:

• The previous monotherapy by derivatives of sulphonylurea or metformin, the dietotherapy and physical exercises were inefficient;
• The combined treatment by Metforminum and derivatives of sulphonylurea at patients with well controlled and stable level of a glycemia should be replaced with monotherapy.

Contraindications

• Diabetes mellitus of the 1st type;
• Diabetic prekoma and coma;
• Diabetic ketoacidosis;
• Laktatsidoz, including in the anamnesis;
• Renal and/or liver failure;
• Functional disturbances of kidneys (clearance of creatinine (CC) <60 мл/мин);
• The acute states causing changes of function of kidneys: heavy infection, organism dehydration, shock, introduction of intravascular iodinated contrast means;
• Porphyria;
• Hypoxia of fabrics against the background of acute or chronic forms of respiratory or heart failure, shock, recently postponed myocardial infarction;
• Period of pregnancy and breastfeeding;
• Concomitant use of Miconazolum;
• Extensive surgical interventions;
• Acute drunkenness, alcoholism;
• Observance of a hypocaloric diet (less than 1000 kcal a day);
• Syndrome of glyukozo-galaktozny malabsorption, intolerance of a galactose, deficit of lactase;
• Age up to 18 years;
• The age is more senior than 60 years, when performing heavy exercise stresses (risk of development of a laktatsidoz);
• Hypersensitivity to components of drug or other derivatives of sulphonylurea.

With care it is recommended to appoint at: diseases of a thyroid gland with noncompensated disturbance of its function; adrenal insufficiency; feverish syndrome; hypofunctions of a front share of a hypophysis.

Route of administration and dosage

Pill is recommended to be taken during food, the diet at the same time has to contain a large amount of carbohydrates.

The doctor makes purpose of a dose individually taking into account glycemia level.

Initial dose – 1 tablet of 2,5 mg / 500мг or 5 mg / 500 mg of 1 times a day.

At transfer of the patient with combined or monotherapies by drugs of sulphonylurea and Metforminum on treatment by Glyukovans not to allow a hypoglycemia, purpose of an initial dose should not exceed an equivalent daily dose of earlier accepted drugs. For achievement of the corresponding control of content of glucose in blood the dose should be increased gradually, it is no more than on 5 mg / 500 than mg a day every two weeks or more rare. Dose adjustment has to be carried out always depending on glycemia level.

The maximum daily dose – 4 tablets on 5 mg / 500 mg or 6 tablets of 2,5 mg / 500 mg. The mode of reception of tablets is defined individually, it depends on a daily dose of drug:

• 1 tablet (any dosage) – 1 time a day, in the morning;
• 2 or 4 tablets (any dosage) – 2 times a day, in the morning and in the evening;
• 3, 5 or 6 tablets on 2,5 mg / 500 mg or 3 tablets on 5 mg / 500 mg – 3 times a day, it is necessary to accept in the morning, during the lunchtime and in the evening.

For patients of advanced age the initial dose should not exceed 1 tablet of 2,5 mg / 500 mg. Purpose of a dose and use of drug has to take place under regular control of a condition of function of kidneys.

Side effects

• From the alimentary system: very often – lack of appetite, nausea, abdominal pains, vomiting, diarrhea. Symptoms are, as a rule, shown at the beginning of therapy and have temporality. Very seldom – functional disturbances of a liver, hepatitis;
• From sense bodys: often – smack of metal in a mouth. At the beginning of therapy perhaps temporary vision disorder;
• From a metabolism: hypoglycemia; seldom – attacks of a skin porphyria and a hepatic porphyria; very seldom – лактацидоз. At long therapy – decrease in level of concentration of B12 vitamin in blood serum (can become the reason of megaloblastny anemia). Against the background of alcohol intake – disulfiramopodobny reaction;
• From bodies of a hemopoiesis: seldom – thrombocytopenia and a leukopenia; very seldom – a pancytopenia, hemolitic anemia, a marrow aplasia, an agranulocytosis;
• From integuments: seldom – an itch, korepodobny rash; very seldom – exfoliative dermatitis, a mnogoformny erythema, a photosensitization;
• Allergic reactions: seldom – a small tortoiseshell; very seldom – a visceral or skin allergic vasculitis, an acute anaphylaxis. At a concomitant use manifestations of cross hypersensitivity to sulfonamides and their derivatives are possible;
• Laboratory indicators: infrequently – increase in level of concentration of creatinine and urea in blood serum to moderate degree; very seldom – a hyponatremia.

Special instructions

Treatment is recommended to be accompanied with regular control of level of glucose in blood on an empty stomach and after meal.

During administration of drug it is necessary to consider a possibility of development of a laktatsidoz, emergence of abdominal pains, a strong indisposition, muscular spasms and dispeptic frustration can become symptoms of a disease.

At Glyukovans's use there is a risk of development of a hypoglycemia, its emergence at the patients who are on a diet with the low content of the carbohydrates which are not observing a diet, taking alcohol, receiving heavy exercise stresses at a hypocaloric diet is the most probable. Care in appointment, careful selection of a dose and implementation of recommendations of the doctor reduce probability of a disease.

Alcohol intake along with Glyukovans is forbidden.

Before purpose of drug and during reception it is regularly necessary to conduct researches on determination of level of concentration of creatinine in blood serum. The analysis should be carried out to patients with normal function of kidneys at least 1 time a year, with functional disturbances of kidneys and the patient of advanced age – 2-4 times a year.

At emergence of infectious diseases of bronchial tubes, easy or urinogenital bodies it is necessary to see a doctor immediately.

Patients have to be careful at control of vehicles and performance of other types of activity which performance demands the increased concentration of attention and high speed of psychomotor reactions.

Medicinal interaction

Administration of drug should be stopped in 2 days prior to and to renew in 2 days after intravenous administration of iodinated contrast means.

Simultaneous use with Miconazolum, in connection with a high probability of development of a hypoglycemia is forbidden, up to coma.

The drug combination to etanolsoderzhashchy medicines and phenylbutazone as they increase hypoglycemic effect of Glyukovans is not recommended.

At simultaneous use with bozentany the risk of a hepatotoxic action increases, effect of glibenclamide decreases.

The high dose of Chlorpromazinum reduces insulin emission, promoting increase in level of a glycemia.

Hypoglycemic effect of drug decreases at a combination with glucocorticosteroids, tetrakozaktidy, diuretics, danazoly and beta2-adrenomimetikam.

At a concomitant use to inhibitors of an angiotensin-converting enzyme (APF), including enalapril and captopril, there is a decrease in content of glucose in blood.

Extra care is demanded by a combination with Metforminum from patients with a functional renal failure as against the background of reception of "loopback" diuretics, the probability of development of a laktatsidoz is high.

The drug combination to sympathomimetics, beta adrenoblockers, Reserpinum, clonidine, guanetidiny hides hypoglycemia symptoms.

Dose adjustment of drug is necessary at reception of a flukonazol, there is a risk of development of a hypoglycemia.

Glibenclamidum reduces antidiuretic effect of desmopressin.

The hypoglycemic effect of drug increases at simultaneous use with monoamine oxidase inhibitors (MAO), streptocides, anticoagulants (coumarin derivatives), ftorkhinolona, chloramphenicol, pentoksifilliny, hypolipidemic means from group of fibrat, Disopyramidum.

Terms and storage conditions

To store at a temperature up to 30 °C. To protect from children.

Period of validity – 3 years.