Metforminum

Metforminum – peroral hypoglycemic means.

Form of release and structure

Dosage form – the tablets covered with a kishechnorastvorimy cover: a round biconvex form, white color (on 10 pieces in the blister, in a cardboard pack 3 blisters).

Active ingredient of Metforminum – Metforminum a hydrochloride, in 1 tablet – 0,5 g.

Auxiliary components: starch corn, K90 povidone, magnesium stearate, кросповидон, talc.

Structure of a cover: a macrogoal 6000, methylmethacrylate and methacrylic acid copolymer (eudragit L 100-55), talc, titanium dioxide.

Indications to use

• Diabetes mellitus 2 types without tendency to ketoacidosis (especially at patients with obesity) at inefficiency of therapy by means of a diet;
• Combination therapy of a diabetes mellitus 2 types with insulin, especially at patients with secondary resistance to insulin against the background of heavy degree of obesity.

Contraindications

• Diabetic ketoacidosis, diabetic prekoma or coma;
• Respiratory or heart failure, acute myocardial infarction and other diseases in an acute or chronic form, capable to cause development of a fabric hypoxia;
• Renal failure;
• The acute forms of pathologies proceeding with risk of development of functional disorder of kidneys: dehydration (against the background of vomiting, diarrhea), fever, severe forms of infectious diseases, a condition of a hypoxia (renal infections, shock, bronchopulmonary diseases, sepsis);
• Abnormal liver function;
• Extensive surgeries and severe injuries;
• Lactic acidosis (including the anamnesis);
• Observance of a hypocaloric diet (consumption in days is less than 1000 calories);
• Alcoholism, period of an acute alcoholic poisoning;
• Inclusion in the period in two days prior to and within two days after carrying out X-ray or radio isotope inspections using contrast iodinated agent;
• Period of pregnancy and breastfeeding;
• Individual intolerance of components of drug.

Because of the increased risk of development of lactic acidosis Metforminum is not recommended to patients to appoint more senior than 60 years when performing of hard physical activity by them.

Route of administration and dosage

Pill is taken inside, swallowing entirely and washing down with enough water, in time or right after food.

The doctor appoints a drug dose on the basis of clinical indications taking into account the individual level of concentration of glucose in blood.

The recommended daily dosing:

• Initial dose: 0,5-1 g (1-2 tablets) within 10-15 days, then, depending on the level of content of glucose in blood, perhaps gradual increase in a dose;
• Maintenance dose: 1,5-2 g (3-4 tablets);
• Maximum dose: no more than 3 g (6 tablets).

To lower by-effects from digestive tract it is recommended to divide a daily dose into 2-3 receptions.

Patients of advanced age should appoint no more than 1 g (2 tablets) a day.

At heavy metabolic disturbances the dose of Metforminum needs to be lowered not to allow development of lactoacidosis.

Side effects

• Alimentary system: metal smack in a mouth, nausea, lack of appetite, vomiting, diarrhea, abdominal pains, a meteorism (the listed symptoms arise at the beginning of use more often and have passing character);
• Endocrine system: hypoglycemia;
• Bodies of a hemopoiesis: in some cases – megaloblastny anemia;
• Metabolism: in rare instances – lactoacidosis; against the background of prolonged use – a hypovitaminosis _{of B12} (malabsorption);
• Allergic reactions: skin rash.

Special instructions

For decrease in undesirable effects from the alimentary system simultaneous use of spasmolysants, antacids or derivatives of atropine is recommended.

In case of development of lactoacidosis immediate drug withdrawal is required.

Treatment should be accompanied with regular control of function of kidneys, especially at patients of advanced age. At least once in half a year and at development of a mialgiya it is necessary to determine the level of maintenance of a lactate in a blood plasma, creatinine in blood serum. At creatinine level women is higher than 110 have some, and men have 135 µmol/l – Metforminum should not be accepted.

Perhaps simultaneous use of drug with sulphonylurea derivatives. This combination demands careful control of level of content of glucose in blood.

Administration of drug should be stopped in 2 days prior to and to resume in 2 days after carrying out X-ray contrast (an intravenous angiography, urography) researches.

In case of development of a bronchopulmonary infection, infectious pathologies of urinogenital system the patient needs to see the attending physician urgently.

During administration of drug alcohol intake and etanolsoderzhashchy medicines is contraindicated.

At monotherapy Metforminum does not exert impact on ability of the patient to control of vehicles and mechanisms.

At a drug combination with insulin, sulphonylurea derivatives, other hypoglycemic means it is necessary to refrain from potentially dangerous types of activity demanding the high speed of psychomotor reactions and concentration of attention.

Medicinal interaction

At simultaneous use of Metforminum:

• Chlorpromazinum – in a daily dose of 0,1 g reduces insulin release, raises a glycemia;
• Acarbose, sulphonylurea derivatives, insulin, non-steroidal anti-inflammatory drugs, monoamine oxidase inhibitors, inhibitors of an angiotensin-converting enzyme, Oxytetracyclinum, Clofibratum derivatives, beta adrenoblockers, cyclophosphamide – can strengthen hypoglycemic effect of drug;
• Neuroleptics – during the period and after treatment demand dose adjustment of Metforminum taking into account glycemia level;
• Cimetidinum – increases risk of development of lactoacidosis as slows down Metforminum removal processes;
• Niacin derivatives, glucocorticosteroids, Epinephrinum, glucagon, sympathomimetics, hormones of a thyroid gland, derivatives of a fenotiazin, loopback and thiazide diuretics, oral contraceptives – promote Metforminum decrease of the activity;
• Anticoagulants (coumarin derivatives) – reduce the clinical action.

At a combination with Metforminum даназол increases the glycemic action therefore this combination should be avoided; in case of need a concomitant use it is recommended to adjust Metforminum dose taking into account glycemia level.

In the period of an acute drunkenness the probability of emergence of lactoacidosis, especially against the background of observance of a low-calorie diet and starvation, or at patients with a liver failure increases.

Terms and storage conditions

To store in the protected from light, dry place at a temperature of 15-25 °C. To protect from children.

Period of validity – 3 years.