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1 tablet includes 2,5 mg of Glibenclamidum and 400 mg of Metforminum of a hydrochloride – active ingredients.
- 57,5 mg – corn starch;
- 65,0 mg – microcrystallic cellulose;
- 20,0 mg – silicon dioxide colloid;
- 17,5 mg – glycerin (glitserol);
- 40,0 mg – gelatin;
- 7,5 mg – magnesium stearate;
- 15,0 mg – talc.
- 0,5 mg – diethyl phthalate;
- 2,0 mg – atsetilftaliltsellyuloza;
- 2,5 mg – talc.
Glibomet's drug is issued in the form of tablets in a cover, on 40; 60 or 100 pieces in one packaging.
Pharmacodynamics and pharmacokinetics
Glibomet is combined peroral (for internal reception) the hypoglycemic drug derivative of a bituanid and sulfonilmochevina of the II generation which shows extra pancreatic and pancreatic action.
Derivative sulfonilmochevina of the II generation – Glibenclamidum possesses the stimulating impact on insulin secretion, by means of lowering by glucose of the irritating threshold of beta cells of a pancreas.
Glibenclamidum strengthens a susceptibility to insulin and durability of its bonds with target cells, increases insulin release, increases its impact on glucose absorption process by a liver and muscles, in fatty tissue constrains a lipolysis. Effect of drug is shown in the second stage of production of insulin.
Derivative guanyl guanidine – Metforminum shows a promoting effect in relation to peripheral sensitivity of fabrics to effects of insulin (strengthens receptor communication of insulin and increases its effects at the post-receptor level).
In intestines reduces glucose absorption, the gluconeogenesis oppresses and favorably influences lipid metabolism, promotes lowering of excess weight at patients with a diabetes mellitus. Possesses fibrinolitic efficiency due to oppression of inhibitor of the activator of fabric plasminogen.
Hypoglycemic action of Glibomet develops in 2 hours and is observed for 12 hours.
The synergistic combination of two active ingredients of drug – a promoting effect derivative sulfonilmochevina on production of own insulin (pancreatic action) and immediate effect of guanyl guanidine on fatty and muscular fabrics (extra pancreatic action — substantial increase of digestion of glucose) and liver tissue (reduction of a gluconeogenesis), allows at a certain proportion of doses to reduce the maintenance of each element.
This circumstance helps to avoid excess activation of beta cells in a pancreas, and thus to reduce risk of disturbances of its functionality, and also to increase safety of use of hypoglycemic means and to reduce the frequency of possible side effects.
Absorption of Glibenclamidum in a gastrointestinal tract happens quickly and at rather high level (84%). The maximum concentration is observed in 1-2 hours. Communication with plasma proteins at the level of 97%. It is almost completely metabolized (to inactive metabolites) in a liver. It is removed with bile and urine in a proportion of 50/50%, with an elimination half-life from 5 to 10 hours.
Absorption in Metforminum gastrointestinal tract also rather full. Drug almost does not contact plasma proteins and quickly spreads in fabric. In an organism it is not metabolized. About 7 hours are removed mostly by kidneys and in a small amount intestines, with an elimination half-life.
Indications to use
Glibomet's drug is shown for therapy of a diabetes mellitus 2 types, in case of inefficiency of a dietotherapy and the previous treatment by guanyl guanidines and derivatives of a sulfonilmochevina, and also other hypoglycemic peroral medicines.
- hypersensitivity to Glibenclamidum (including to sulfonilmochevina derivatives), to Metforminum or other ingredients of drug;
- gestational diabetes;
- diabetes mellitus of 1 type;
- lactoacidosis (including in the anamnesis);
- prekoma, ketoacidosis, coma (diabetic);
- states which are characterized by disturbance of assimilation of food and forming of a hypoglycemia;
- acute states with risk of renal failures: heavy infections, dehydration, shock, administration of contrast iodinated agents (intravascular);
- disturbance of hepatic function;
- pathologies of kidneys (at creatinine for men it is more than 135 mmol/l also for women more than 110 mmol/l);
- the states connected with a hypoxia (respiratory or heart failure, shock, the previous myocardial infarction, serious painful conditions of respiratory tracts);
- gangrene, infectious diseases, extensive surgical interventions, acute big blood loss, injuries, extensive burns and other states which need an insulin therapy;
- span of 48 hours before an operative measure, or carrying out radiological or radio isotope testing with administration of contrast iodinated agent;
- dystrophic changes (lipodystrophy, miotonichesky dystrophy);
- maintenance of a hypocaloric diet (to 1000 kcal a day);
- acute intoxication alcohol, alcoholism;
- insufficiency of a glyukozo-6-phosphodehydrogenase;
- age till 18 years;
- pregnancy and chest feeding.
Do not recommend to accept Glibomet to patients is more senior than 60 years which are engaged in a hard physical activity because of the increased risk of developing of lactoacidosis.
- heavy exercise stresses (risk of developing of lactoacidosis);
- pathologies of a thyroid gland;
- feverish syndrome;
- hypofunction of bark of adrenal glands and/or front share of a hypophysis.
System of digestion:
- disorders of appetite;
- morbidity in a stomach;
- threw smack in an oral cavity;
- activation of enzymes of a liver.
System of a hemopoiesis:
- hemolitic anemia;
- megaloblastny anemia;
At detection of displays of lactoacidosis (the general weakness, abdominal pains, vomiting, muscular spasms) it is necessary to stop immediately reception of tablets of Glibomet and to see a doctor.
- disulfiramopodobny reaction, is shown at alcohol intake and characterized by reddening of upper part of a trunk and face skin, a headache, a heart consciousness, nausea and vomiting, increase of the ABP.
Glibomet's tablets, application instruction
The application instruction of Glibomet recommends to take a drug pill orally (inside), it is desirable during food.
The dosage and duration of therapy are selected by the attending physician, proceeding from a condition of carbohydrate metabolism of the patient and content in glucose blood.
As a rule, the initial daily dose equals to 1-3 tablets, with the subsequent gradual adjustment for the purpose of selection of a nayeffektivneyshy dosage which will provide steady normalization of content of glucose in blood.
The most admissible daily dosage — 6 tablets.
At overdose noted development of a hypoglycemia (Glibenclamidum) and a laktatsidoz (Metforminum).
At a hypoglycemia observed: feeling of hunger, weakness, the increased perspiration, neurologic frustration (temporality), heartbeat, paresthesia in an oral cavity, pallor of integuments, a tremor, headaches, feeling of concern, pathological drowsiness, sensation of fear, frustration of a dream, a lack of coordination. When progressing this state noted loss of self-checking and consciousness.
In case of a hypoglycemia of an easy current recommend the sugar reception, drinks or food containing a large amount of carbohydrates (honey, jam, sweet tea). If the hypoglycemia is followed by a loss of consciousness, in/in enter 40% solution of a dextrose (glucose) of 40-80 ml then appoint infusional introduction of 5-10% of solution of a dextrose. In the subsequent perhaps additional introduction of 1 mg of a glucagon.
If the patient remains in an unconsciousness the above described procedures are repeated. Absence of effect in this case, gives a reason for carrying out an intensive care.
At a laktatsidoza noted: the expressed weakness, respiratory disturbances, muscle pains, drowsiness, nausea, abdominal pains, vomiting, reflex bradyarrhythmia, diarrhea, lowering of the ABP, a hypothermia, confusion and a loss of consciousness.
In case of suspicion on laktatsidoz it is necessary to cancel immediately drug, to hospitalize the patient and to carry out procedure of a hemodialysis.
Hypoglycemic effects of Glibomet amplify at the combined use with coumarin derivatives (Syncumarum, Warfarin), beta adrenoblockers, salicylates, Oxytetracyclinum, Cimetidinum, Allopyrinolum, streptocides, MAO inhibitors, Probenetsid, Phenylbutazone and its derivatives, chloramphenicol, Sulfonamide, cyclophosphamide, Pergeksilin, Miconazolum (peroral), Feniramidol, Sulfinpyrazonum and ethanol.
Against Glibomet's reception strengthening of effects of anticoagulants is possible.
Parallel reception of Cimetidinum can increase risk of emergence of a laktatsidoz.
Beta adrenoblockers can mask manifestations of a hypoglycemia (an exception the increased perspiration makes).
Use of X-ray contrast iodinated means (for introduction intravascularly) can lead to disturbance of renal function and cumulation of Metforminum (risk of emergence of a laktatsidoz).
Terms of sale
Glibomet is released on presentation of the recipe of the doctor.
Storage temperature – to 30 °C.
Period of validity
During therapy patients are obliged to follow strictly all recommendations of the doctor, concerning a dosage and a method of use of drug, the mode of exercise stresses, observance of a diet and independent control over glucose level in blood.
Laktatsidoz – dangerous, but fortunately rare morbid condition which is shown by cumulation of lactic acid in blood, because of accumulation of Metforminum. Observed cases of emergence of a laktatsidoz at the patients accepting Metforminum were most often noted at patients with a diabetes mellitus with the parallel expressed renal and heart failure.
For the purpose of prevention of a possible laktatsidoz it is necessary to designate all concurrent factors of risk, such as: a ketosis, dekompensirovanny diabetes, long starvation, a liver failure, aggravation by alcoholic beverages and any state leading to a hypoxia.
When passing therapy by Glibomet it is necessary to control constantly amount of creatinine in serum, not less than 1 time in 12 months at normal function of kidneys and not less than 2-4 times in 12 months at advanced age and at amount of creatinine close to VGN.
It is necessary to observe extra care in cases of emergence of risk of a renal failure (NPVS initiation of treatment, anti-hypertensive drugs, diuretics).
Therapy by Glibomet needs to be interrupted in 48 hours prior to radiological testing with in/in administration of contrast iodinated agents (in this span it is necessary to accept other hypoglycemic drugs).
Resuming of treatment is possible after transition of the patient to peroral food or in 48 hours after carrying out operation, on condition of normal functioning of kidneys.
It is necessary to show care when driving transport or performing exact and dangerous work.
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