Глюкофаж

Глюкофаж – drug with hypoglycemic action.

Form of release and structure

Глюкофаж release in the form of tablets:

• 500 or 850 mg: film coated, white, biconvex, round, on cross section – homogeneous white mass (500 mg: on 10 pieces in blisters, on 3 or 5 blisters in a cardboard pack; on 15 pieces in blisters, on 2 or 4 blisters in a cardboard pack; on 20 pieces in blisters, on 3 or 5 blisters in a cardboard pack; 850 mg: on 15 pieces in blisters, on 2 or 4 blisters in a cardboard pack; on 20 pieces in blisters, on 3 or 5 blisters in a cardboard pack);
• 1000 mg: film coated, white, biconvex, oval, with risky on both sides and a text "1000" on one of the parties; on cross section – homogeneous white mass (on 10 pieces in blisters, on 3, 5, 6 or 12 blisters in a cardboard pack; on 15 pieces in blisters, on 2, 3 or 4 blisters in a cardboard pack).

Is a part of 1 tablet:

• Active agent: Metforminum hydrochloride – 500, 850 or 1000 mg;
• Auxiliary components (respectively): povidone – 20/34/40 mg; magnesium stearate – 5/8,5/10 mg.

Structure of a film cover:

• Tablets on 500 and 850 mg (respectively): a gipromelloza – 4/6,8 mg;
• Tablets on 1000 mg: опадрай pure (macrogoal of 400 - 4,55%; a gipromelloza – 90,9%; a macrogoal of 8000 - 4,55%) – 21 mg.

Indications to use

Глюкофаж appoint for treatment of a diabetes mellitus of the 2nd type, especially at patients with obesity, at inefficiency of exercise stresses and a dietotherapy:

• Adults: as monotherapy or along with other peroral hypoglycemic medicines or with insulin;
• Children of 10 years: as monotherapy or along with insulin.

Contraindications

• Renal failure or renal failure (the clearance of creatinine (CC) is less than 60 ml in a minute);
• Diabetic: ketoacidosis, prekom, coma;
• The clinical expressed displays of chronic or acute diseases which can lead to developing of a fabric hypoxia, including heart failure, respiratory insufficiency, an acute myocardial infarction;
• Acute states at which there is a risk of development of a renal failure: serious infectious diseases, dehydration (at vomiting, diarrhea), shock;
• Abnormal liver functions, liver failure;
• Injuries and extensive surgeries (in cases when performing insulin therapy is shown);
• Laktatsidoz (including in the anamnesis);
• Acute poisoning with ethanol, alcoholism;
• Observance of a hypocaloric diet (it is less than 1000 kcal in day);
• The period is not less than 48 hours to and 48 hours after carrying out X-ray or radio isotope inspections with intravenous administration of iodinated contrast means;
• Pregnancy;
• Hypersensitivity to drug components.

Глюкофаж patients should take with caution 60 years, to the feeding women, and also patients performing hard physical activity are more senior (because of high risk of development of a laktatsidoz).

Route of administration and dosage

Глюкофаж it is necessary to accept inside.

Adults can use drug in the form of monotherapy or along with other peroral hypoglycemic drugs.

The initial single dose usually makes 500 or 850 mg. Drug is accepted by 2-3 times a day during food or right after meal. Depending on concentration of glucose in blood perhaps further gradual increase in a dose.

The supporting daily dose of Glyukofazha usually makes 1500-2000 mg (as much as possible – 3000 mg). Administration of drug 2-3 times a day allows to reduce expressiveness of side effects from digestive tract. Also improvement of gastrointestinal portability of drug can be promoted by gradual increase in a dose.

The patients receiving Metforminum in doses of 2000-3000 mg a day can be transferred to reception of Glyukofazha in a dose of 1000 mg (as much as possible – 3000 mg a day divided into 3 receptions). When planning transition from reception of other hypoglycemic medicine it is necessary to stop its reception and to begin use of Glyukofazha in the dose stated above.

In blood it is possible to apply to achievement of the best control of glucose at the same time metformin and insulin. The initial single dose of Glyukofazha usually makes 500 or 850 mg, frequency rate of reception – 2-3 times a day. The dose of insulin should be selected on the basis of concentration of glucose in blood.

Children of 10 years of Glyukofazh can accept in the form of monotherapy or along with insulin. The initial single dose usually makes 500 or 850 mg, frequency rate of reception – once a day. On the basis of concentration of glucose of blood in 10-15 days the dose can be corrected. The maximum daily dose – 2000 mg, divided into 2-3 receptions.

Patients of advanced age need to select a dose of Metforminum under regular control of indicators of function of kidneys (content of creatinine in blood serum should be determined not less than 2-4 times a year).

Глюкофаж accept daily, without interruption. At the termination of therapy of the patient has to report about it to the doctor.

Side effects

• Alimentary system: very often – vomiting, nausea, diarrhea, lack of appetite, an abdominal pain. Most often such symptoms develop in an initial stage of therapy and, as a rule, pass spontaneously. For improvement of gastrointestinal portability it is recommended to accept drug in time or after meal 2-3 times a day. It is necessary to increase a dose gradually;
• Nervous system: often – taste disturbance;
• Metabolism: very seldom – лактацидоз; at long therapy absorption of B12 vitamin can decrease that needs especially to be considered at patients with megaloblastny anemia;
• Liver and biliary tract: very seldom – hepatitis, disturbance of indicators of function of a liver. As a rule, side reactions after Metforminum cancellation completely disappear;
• Skin and hypodermic fabrics: very seldom – an itch, an erythema, rash.

Side effects at children in weight and character are similar to those at adult patients.

Special instructions

Because of cumulation of Metforminum development of a rare, but serious complication – a laktatsidoz is possible (there is a high probability of mortality in the absence of urgent treatment). In most cases the disease develops at patients with a diabetes mellitus with the expressed renal failure. It is also necessary to consider also other interfaced risk factors: the ketosis, a dekompensirovanny diabetes mellitus, alcoholism, a liver failure, long starvation and any states connected with the expressed hypoxia.

Such nonspecific signs as the muscular spasms which are followed by dispepsichesky symptoms, an abdominal pain and the expressed adynamy can demonstrate development of a laktatsidoz. The disease is characterized by an atsidotichesky asthma and a hypothermia with the subsequent coma.

Use of Glyukofazha needs to be interrupted in 48 hours prior to carrying out planned surgeries. It is possible to resume therapy not earlier, than in 48 hours after operation provided that at inspection renal function was recognized as normal.

Before reception of Glyukofazha, and also regularly further it is necessary to define clearance of creatinine: at patients with normal function of kidneys – at least once a year; at patients of advanced age, and also at clearance of creatinine on the lower bound of norm – 2-4 times a year.

Extra care is required at a possible renal failure from patients of advanced age, and also at simultaneous use of Glyukofazha with anti-hypertensive medicines, diuretics or non-steroidal anti-inflammatory drugs.

At use of drug in pediatrics, prior to treatment the diagnosis of a diabetes mellitus of the 2nd type has to be confirmed. Metforminum does not influence puberty and growth. However due to the lack of long-term data it is recommended to control carefully the subsequent influence of Glyukofazha on these parameters at children, especially during puberty. Children of 10-12 years need the most careful control.

Patients are recommended to continue to keep to a diet with uniform consumption of carbohydrates during the day. At excess body weight it is necessary to continue to adhere to a hypocaloric diet (but not less than 1000 kcal a day).

For control of a diabetes mellitus it is recommended to carry out standard laboratory analyses regularly.

At monotherapy Metforminum does not cause a hypoglycemia, however at its use along with insulin or other hypoglycemic means (including with sulphonylurea derivatives, repaglinidy) it is necessary to show care at control of motor transport and difficult mechanisms.

Medicinal interaction

Глюкофаж it is impossible to apply along with iodinated X-ray contrast means.

Drug is not recommended to be accepted together with ethanol (the risk of development of a laktatsidoz at an acute drunkenness increases in case of a liver failure, observance of a low-calorie diet and a hyponutrient).

With caution it is necessary to take Glyukofazh with danazoly, Chlorpromazinum, glucocorticosteroids for topical and system administration, "loopback" diuretics, beta2-adrenomimetika in the form of injections. At simultaneous use with above-mentioned medicines, especially in an initiation of treatment, more frequent control of content of glucose in blood can be required. If it is necessary, Metforminum dose in the course of treatment should be corrected.

Inhibitors of an angiotensin-converting enzyme and other anti-hypertensive drugs can lower concentration of glucose in blood. If necessary Metforminum dose adjustment is necessary.

At simultaneous use of Glyukofazha with acarbose, sulphonylurea derivatives, salicylates and insulin development of a hypoglycemia is possible.

Cationic medicines (digoxin, amiloride, procaineamide, morphine, quinidine, Triamterenum, quinine, ranitidine, Vancomycinum and Trimethoprimum) compete with Metforminum for canalicular transport systems that can lead to increase in its average maximum concentration (Cmax).

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity:

• Tablets on 500 and 850 mg – 5 years;
• Tablets on 1000 mg – 3 years.