Glibomet

Glibomet – hypoglycemic drug for oral administration.

Form of release and structure

Dosage form: tablets of a round biconvex form with dividing risky on one of the parties, coated white color, inodorous (on 20 pieces in blisters, in a cardboard pack of 2, 3 or 5 blisters).

The maintenance of the operating components in 1 tablet:

• Glibenclamidum – 2,5 mg;
• Metforminum a hydrochloride – 400 mg.

Excipients: silicon dioxide colloid, cellulose microcrystallic, глицерол, starch corn, magnesium stearate, gelatin, talc.

Structure of a cover: diethyl phthalate, atsetilftaliltsellyuloz, talc.

Indications to use

Use of drug is shown at treatment of a diabetes mellitus of the 2nd type, in case of inefficiency by the guanyl guanidines derivative of the sulphonylurea preceding therapy or other peroral hypoglycemic means and a dietotherapy.

Contraindications

• Laktatsidoz, including in the anamnesis;
• Diabetes mellitus of the 1st type;
• The states which are followed by disturbance of absorption of food and development of a hypoglycemia;
• Diabetic ketoacidosis, diabetic prekoma and coma;
• Gestational diabetes mellitus;
• The states demanding insulin therapy use including gangrene, extensive burns, big surgical interventions, volume acute blood loss, infectious diseases, injuries;
• Functional disturbances of a liver;
• Renal failure or functional disturbances of kidneys;
• The acute states causing changes of function of kidneys – a heavy infection, dehydration, intravascular introduction of iodinated contrast means, shock;
• Hypoxia against the background of morbid conditions – a recent myocardial infarction, heart or respiratory failure, a serious illness of respiratory tracts, shock;
• Leukopenia;
• Dystrophic diseases, including miotonichesky dystrophy, a lipodystrophy;
• Porphyria;
• The period of 48 h to and 48 h after carrying out: surgical intervention under anesthetic with spinal or epidural anesthesia; the radio isotope or X-ray inspections demanding administration of iodinated contrast medium;
• Rigid hypocaloric diet (to 1000 kcal a day);
• Condition of an acute drunkenness, alcoholism;
• Age up to 18 years;
• The age is more senior than 60 years, in case of performance of heavy exercise stresses (the risk of development of a laktatsidoz is increased);
• Deficit glyukozo-6-fosfatdegidrogenazy;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to components of drug and to sulphonylurea derivatives.

With caution it is recommended to take drug at diseases of a thyroid gland, a feverish syndrome, hypofunction of bark of adrenal glands and/or a front share of a hypophysis.

Route of administration and dosage

Pill is taken orally during food.

The doctor appoints dosing and the period of treatment individually on the basis of clinical indications, considering concentration of glucose in blood and a condition of carbohydrate metabolism.

The initial dose usually makes 1-3 tablets a day. During treatment to the patient the dose, effective for achievement of steady normalization of level of glucose in blood is selected.

The maximum daily dose of drug should not exceed 6 tablets.

Side effects

• From system of a hemopoiesis: seldom – thrombocytopenia, a leukopenia, an erythrocytopenia; very seldom – megaloblastny or hemolitic anemia, an agranulocytosis, a pancytopenia;
• From a nervous system: infrequently – a headache;
• From the alimentary system: seldom – appetite loss, nausea, smack of metal in a mouth, an abdominal pain, vomiting, diarrhea; in some cases – increase in activity of hepatic transaminases;
• From a metabolism: seldom – a hypoglycemia; very seldom – лактацидоз;
• From integuments: seldom – a skin itch, a small tortoiseshell, a photosensitization, an erythema;
• Others: against the background of a concomitant use of alcohol – disulfiramopodobny reaction, with characteristic signs in the form of increase in arterial pressure, a headache, a heart consciousness, erubescence of an upper half of a trunk and the person, nausea, vomiting.

Special instructions

It is necessary to stop administration of drug at emergence of symptoms of a laktatsidoz in the form of the general weakness, vomiting, an abdominal pain, muscular spasms and to see urgently a doctor.

Administration of drug is recommended to be accompanied with regular control of level of concentration of creatinine in blood: to patients with normal function of kidneys – at least 1 time a year, to patients with the level of concentration of creatinine in blood close to the upper bound of norm and to people of advanced age – 2-4 times a year.

Glibomet should stop be accepted in 2 days prior to a planned operative measure with use of an anesthesia (spinal or epidural anesthesia). To continue administration of drug it is allowed with resuming of peroral food, but not earlier than in 2 days after operation if normal function of kidneys is confirmed.

During treatment it is recommended to be careful during the performing of potentially dangerous types of activity and control of vehicles as there is a probability of development of a hypoglycemia and, as a result, reduction in the rate of psychomotor reactions and abilities to concentration of attention.

Efficiency of treatment depends on strict observance of appointments of the doctor, his recommendations concerning the mode of exercise stresses and a diet, regular control of level of glucose in blood.

At Glibomet's use it is necessary to abstain from alcohol intake since ethanol can be the cause of development of a hypoglycemia and/or disulfiramopodobny reaction (an abdominal pain, vomiting, nausea, feeling of heat on an upper part of a trunk and face skin, dizziness, a headache, tachycardia).

Medicinal interaction

Glibomet's action increases at a concomitant use of the beta adrenoblockers derivative of coumarin (warfarin, Syncumarum), Allopyrinolum, Cimetidinum, monoamine oxidase inhibitors (MAO), Oxytetracyclinum, streptocides, chloramphenicol, phenylbutazone and its derivatives, salicylates, a probenetsid, cyclophosphamide, a pergeksilin, sulfonamide, a feniramidol, Sulfinpyrazonum, Miconazolum (at oral administration), ethanol.

Hypoglycemic effect of drug lowers a combination to glucocorticosteroids, adrenaline, oral contraceptives, thiazide diuretics and barbiturates, drugs of hormones of a thyroid gland.

Parallel reception of beta adrenoblockers can hide hypoglycemia signs, except the increased perspiration.

At simultaneous use of Glibomet with Cimetidinum the risk of development of a laktatsidoz increases, to anticoagulants – there is strengthening of their action.

The risk of development in the patient of a laktatsidoz increases at X-ray inspections with intravascular use of iodinated contrast agents.

Terms and storage conditions

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

Period of validity – 3 years.