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Glibenclamidum таб. 0,005 No. 30

Препарат Глибенкламид таб. 0,005 № 30. ЗАО "Лекхим-Харьков" Украина


Producer: CJSC Lekhim-Kharkiv Ukraine

Code of automatic telephone exchange: A10B B01

Release form: Firm dosage forms. Tablets.

Indications to use: Diabetes mellitus of type 2 (non-insulin-dependent).


General characteristics. Structure:

Active ingredient: 1 tablet contains Glibenclamidum 5 mg; excipients: lactoses monohydrate, potato starch or starch corn, sodium of a kroskarmelloz, povidone 25, magnesium stearate, aerosil, indigo carmine.




Pharmacological properties:

Glibenclamidum - the peroral antidiabetic means derivative of sulphonylurea ІІ generations.
Has hypoglycemic effect due to insulin secretion stimulation by the functioning pancreas β-cells, and also due to increase in sensitivity of receptors of peripheral fabrics to insulin. Has hypolipidemic effect, in a certain measure normalizes processes of intravascular microcirculation. Considerably surpasses Tolbutamidum, Chlorproramidum in hypoglycemic activity. Hypoglycemic effect after administration of drug in 2 h, the maximum effect – in 7-8 h, action duration – over 12 h inside occurs.


Indications to use:

Non-insulin-dependent diabetes mellitus.

Drug is used only on doctor's orders! Owing to high antihyperglycemic activity even the small overdose of drug can cause a hypoglycemia. At treatment by Glibenclamidum the risk of development of a hypoglycemia in patients with an abnormal liver function and kidneys considerably increases, at an alcohol abuse, starvation or inadequately reduced consumption of carbohydrates, excessive exercise stresses.
Reception of sympatholytics (blockers of β-adrenoceptors, Reserpinum, a clonidine) can mask hypoglycemia symptoms. Elderly people, patients with atherosclerosis of brain vessels and senile dementia have a risk of development of a hypoglycemia and degree of its weight increase in this connection it is more preferable to appoint Glibenclamidum in respectively reduced doses.
Drug is not recommended to patients with severe forms of a diabetes mellitus, in the presence of ketoacidosis or a diabetic coma in the anamnesis, at a hyperglycemia more than 13,9 mmol/l.


Route of administration and doses:

Glibenclamidum is applied inside, in 1 (till a breakfast) or 2 receptions (in 30 min. prior to food). The drug dose, including initial, is selected individually by the doctor, depending on the nature of course of a diabetes mellitus, efficiency of therapy, existence of associated diseases.
Usually treatment begin with a dose 2,5-5 mg a day, if necessary raise a dose to 10-15 mg a day. The maximum daily dose – 20 mg. At normalization of content of glucose in blood establish a maintenance dose – usually 2,5-5 mg a day.
If the daily dose equal of 15-20 mg, does not result in effect within 4-6 weeks, pass to a combination therapy with guanyl guanidines or with insulin drugs.
At overdose of drug there are hypoglycemia symptoms: hunger, the increased perspiration, tachycardia, a tremor, concern, a headache, a depression, irritability, a sleep disorder, coordination of movements, the speech, sight, decrease in attention, a lump.
At an easy hypoglycemia appoint reception of sugar or the food rich with glucose, at heavy – intravenous administration of strong solutions of glucose. In case of undesirable reactions it is necessary to stop administration of drug and to see immediately a doctor. The doctor will appoint the corresponding treatment.


Features of use:

Surely report to the doctor about your previous reaction to administration of drugs of this group.
Long reception of Glibenclamidum can cause resistance to it which is overcome by a combination therapy with single-step administration of drugs of insulin.


Side effects:

At use of Glibenclamidum there can be a hypoglycemia, nausea, vomiting, diarrhea, a photosensitization; extremely seldom – a passing granulocytopenia, thrombocytopenia and an erythrocytopenia, hemolitic anemia, hypersensitivity reactions in the form of skin rash, a hyperthermia, an arthralgia; cholestatic jaundice, hepatitis, proteinuria.


Interaction with other medicines:

If you accept any other medicines, surely consult with the doctor about a possibility of use of drug!
Strengthening of gipoglikemiziruyushchy effect of drug happens at a concomitant use to streptocides, salicylates, chloramphenicol, fibrata, azapropazony, coumarin derivatives, Miconazolum, tetracyclines, MAO inhibitors, fenfluraminy, pentoksifilliny, APF inhibitors, anabolic steroids, fluoxetine, cyclophosphamide, tritokvaliny, insulin and other antidiabetic means (metformin, acarbose).
The hypoglycemic effect of drug is reduced by barbiturates, Phenytoinum, rifampicin, a glucagon, adrenaline and other sympathomimetic means, hormones of a thyroid gland, bark of adrenal glands, diuretics, niacin in high doses, fenotiazina, diazoxide, drugs of sex hormones (gestagen, estragenes).
Alcohol and antagonists of H2 receptors can both weaken, and to strengthen gipoglikemiziruyushchy effect of Glibenclamide.


Contraindications:

Glibenclamidum is contraindicated at prekomatozny and coma states, ketoacidosis, liver failure, it is lower than 30 ml/min. of renal failure with clearance of creatinine, during pregnancy and feeding by a breast, at children's and youthful age, at changes in peripheral blood (a leukopenia, thrombocytopenia), hypersensitivity to drugs of sulphonylurea and streptocides.


Overdose:

Hypoglycemia symptoms: feeling of hunger, the increased perspiration, tachycardia, a tremor, concern, a headache, a depression, irritability, a sleep disorder, coordination of movements, the speech, sight, decrease in attention, a lump.


Treatment: at an easy hypoglycemia - the reception of sugar or food rich in glucose. At a hypoglycemic coma - enter glucose (40-100 ml of 20% of solution), then infusionally - 5-10% solution of glucose and intramusculary or subcutaneously 1-2 mg of a glucagon. After a heavy hypoglycemia regularly control sugar level in blood within 48 hours. At acute poisoning and long coma carry out a gastric lavage, reception of absorbent carbon, appoint long infusion of 5-10% glucose solution. In 20 min. perhaps repeated administration of solution of glucose.


Storage conditions:

It is not necessary to use drug after the expiry date specified on packaging. To store in the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children!

Period of validity - 3 years.


Issue conditions:

According to the recipe


Packaging:

On 30 tablets in containers polymeric.



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