Diaformin AUDE

General characteristics. Structure:

Active ingredient: 500 mg of Metforminum of a hydrochloride.

Excipients: cellulose microcrystallic, a karmelloza of sodium, the water purified *, a gipromelloza, magnesium stearate. (* - evaporates in the course of production). 

Drug for treatment of a diabetes mellitus of the 2nd type.

Pharmacological properties:

Peroral hypoglycemic means from group of guanyl guanidines (dimethylguanyl guanidine). The mechanism of effect of metformin is connected with its ability to suppress a gluconeogenesis, and also formation of free fatty acids and oxidation of fats. Metforminum does not influence amount of insulin in blood, but changes its pharmacodynamics due to decrease in a ratio of the connected insulin to free and increases in a ratio of insulin to pro-insulin. An important link in the mechanism of effect of metformin is stimulation of digestion of glucose muscle cells.

Metforminum strengthens blood circulation in a liver and accelerates process of transformation of glucose into a glycogen. Reduces the level of triglycerides, LPNP, LPONP. Metforminum improves fibrinolitic properties of blood due to suppression of inhibitor of a plasminogen activator of fabric type.

Pharmacokinetics. Metforminum is absorbed from a GIT. Cmax in plasma is reached approximately in 2 h after intake. In 6 h absorption from a GIT comes to an end and concentration of Metforminum in plasma gradually decreases.

Practically does not contact proteins of plasma. Collects in sialadens, a liver and kidneys.

T1/2 is 1.5-4.5 h. It is removed by kidneys.

At renal failures Metforminum cumulation is possible.

Indications to use:

Treatment of a diabetes mellitus 2 types at adults (especially at patients with obesity), at inefficiency of a dietotherapy and exercise stresses as monotherapy or in combination with other peroral hypoglycemic means or with insulin.

Route of administration and doses:

To the patients who are not receiving insulin in the first 3 days - on 500 mg 3 or on 1 g 2 in time or after food. From the 4th day to the 14th day - on 1 g 3 After the 15th day the dose is regulated taking into account glucose level in blood and in urine. The maintenance dose makes 100-200 mg / At simultaneous use of insulin in a dose less than 40 PIECES / Metforminum dosing mode the same, at the same time the dose of insulin can be lowered gradually (by 4-8 PIECES / every other day). If the patient receives more than 40 PIECES/, then use of Metforminum and a dose decline of insulin demands big care and is carried out in a hospital.

Features of use:

Use at acute infections, an exacerbation of chronic infectious and inflammatory diseases, injuries, acute surgical diseases is not recommended, to danger of dehydration.

Do not apply before surgeries and within 2 days after their carrying out.

It is not recommended to apply Metforminum at patients 60 years and the persons performing hard physical activity that is connected with the increased risk of development of lactic acidosis are more senior.

During treatment it is necessary to control function of kidneys; determination of content of a lactate in plasma it is necessary to carry out at least 2 times a year, and also at emergence of a mialgiya.

Use of Metforminum in a combination with sulphonylurea derivatives is possible. In this case especially careful control of level of glucose in blood is necessary.

It is recommended to apply Metforminum as a part of a combination therapy with insulin in the conditions of a hospital.

Side effects:

From the alimentary system: nausea, vomiting, diarrhea are possible (usually in an initiation of treatment).

From endocrine system: a hypoglycemia (it is preferential at use in inadequate doses).

From a metabolism: in some cases - lactic acidosis (demands the treatment termination).

From system of a hemopoiesis: in some cases - megaloblastny anemia.

Interaction with other medicines:

At simultaneous use with sulphonylurea derivatives, acarbose, insulin, salicylates, MAO inhibitors, Oxytetracyclinum, APF inhibitors, with Clofibratum, cyclophosphamide strengthening of hypoglycemic effect of metformin is possible.

At simultaneous use with GKS, hormonal contraceptives for intake, the adrenaline, a glucagon, hormones of a thyroid gland, derivatives of a fenotiazin, thiazide diuretics derivative of niacin reduction of hypoglycemic effect of metformin is possible.

The concomitant use of Cimetidinum can strengthen risk of development of lactoacidosis

Contraindications:

The expressed abnormal liver functions and kidneys, heart and respiratory failure, an acute phase of a myocardial infarction, an alcoholism, a diabetic coma, ketoacidosis, lactoacidosis (including in the anamnesis), a syndrome of diabetic foot, pregnancy, a lactation, hypersensitivity to Metforminum.

Use at pregnancy and feeding by a breast

It is contraindicated at pregnancy and in the period of a lactation.

Use at abnormal liver functions

It is contraindicated at the expressed abnormal liver functions.

Use at renal failures

It is contraindicated at the expressed renal failures.

Use for elderly patients

It is not recommended to apply Metforminum at patients 60 years are more senior that is connected with the increased risk of development of lactic acidosis.

Overdose:

At use of Metforminum in a dose of 85 g (by 42,5 times exceeding the maximum daily dose) development of a hypoglycemia was not observed. However in this case development of lactoacidosis was observed. Early symptoms of lactoacidosis are nausea, vomiting, diarrhea, decrease in body temperature, an abdominal pain, muscle pain, hurried breathing, dizziness, disturbance of consciousness and development of a coma can be noted further.

Treatment: in case of symptoms of lactoacidosis treatment by drug needs to be stopped immediately, urgently to hospitalize the patient and, having defined concentration of a lactate, to specify the diagnosis. The most effective action for removal from an organism of a lactate and Metforminum is the hemodialysis. Carry out also symptomatic treatment.

Storage conditions:

To store in the dry place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years. Not to use on expiry date, uukazanny on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets of the prolonged action on 500 mg. 10 tablets in a blister strip packaging (blister) from PVH/PVDH/Al; on 3, 6 or 9 blisters in a cardboard pack together with the application instruction.