Formetin tablets 500mg, No. 60

Diabetes mellitus type 2 with ineffective diet therapy (especially in obese patients).

Set individually, taking into account the blood glucose level.

The initial dose is 500 mg 1-2 times / day or 850 mg 1 time / day. In the future, gradually (once a week), the dose is increased to 2-3 g / day. The maximum daily dose is 3 g. In elderly patients, the daily dose should not exceed 1 g.

Due to the increased risk of lactic acidosis, when prescribing metformin to patients with severe metabolic disorders, the dose of the drug should be reduced. The tablets should be taken with or after meals without chewing and drinking plenty of fluids.

White tablets

1 tab.

metformin hydrochloride

Excipients: povidone (medium molecular weight polyvinylpyrollidone, povidone K-30), croscarmellose sodium (primellose), magnesium stearate.

• Diabetic ketoacidosis, diabetic precoma, coma;

• severe renal dysfunction;

• conditions that can contribute to the development of lactic acidosis, incl. heart and respiratory failure, acute phase of myocardial infarction, acute cerebrovascular accident, dehydration, chronic alcoholism;

• liver dysfunction;

• acute alcohol poisoning;

• severe infectious diseases;

• lactic acidosis (including history);

• serious surgery and trauma (in these cases, insulin therapy is indicated);

• application within 2 days before and 2 days after carrying out radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent; adherence to a hypocaloric diet (less than 1000 calories / day);

• pregnancy;

• lactation period (breastfeeding);

• hypersensitivity to the components of the drug.

• It is not recommended to use the drug in patients over 60 years of age who perform heavy physical work, due to the increased risk of lactic acidosis.

pharmachologic effect

Oral hypoglycemic drug from the biguanide group. It inhibits gluconeogenesis in the liver, reduces the absorption of glucose from the intestine, enhances peripheral glucose utilization, and also increases tissue sensitivity to insulin. Does not affect the secretion of insulin by the? -Cells of the pancreas, does not cause hypoglycemic reactions. Reduces triglyceride and LDL levels. Stabilizes or reduces body weight. It has a fibrinolytic effect by suppressing tissue-type plasminogen activator inhibitor.

Pharmacokinetics

Suction

After oral administration, metformin is absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is 50-60%. Cmax after oral administration is reached after 2.5 hours.

Distribution

Practically does not bind to plasma proteins. It accumulates in the salivary glands, muscles, liver, kidneys.

Withdrawal

Excreted unchanged in the urine. T1 / 2 is 1.5-4.5 hours.

Pharmacokinetics in special clinical situations

In case of impaired renal function, accumulation of the drug is possible.

Side effect

From the digestive system: nausea, vomiting, 'metallic' taste in the mouth, lack of appetite, diarrhea, flatulence, abdominal pain. From the side of metabolism: rarely - lactic acidosis (requires discontinuation of treatment), with prolonged use - hypovitaminosis B12 (malabsorption). From the hematopoietic system: in some cases - megaloblastic anemia. From the endocrine system: hypoglycemia (when used in inadequate doses). Allergic reactions: skin rash.

Application during pregnancy and lactation

FormetinЃ is contraindicated for use during pregnancy and lactation (breastfeeding).

Application for violations of liver function

The drug is contraindicated in liver dysfunction.

Application for impaired renal function

The drug is contraindicated in severe renal impairment. During the period of use of the drug, the indicators of renal function should be monitored. At least 2 times a year, as well as when myalgia appears, the lactate content in plasma should be determined.

Use in elderly patients

It is not recommended to use the drug in patients over 60 years of age who perform heavy physical work, due to the increased risk of lactic acidosis. In elderly patients, the daily dose should not exceed 1 g.

special instructions

During the period of use of the drug, the indicators of renal function should be monitored. At least 2 times a year, as well as when myalgia appears, the lactate content in plasma should be determined. It is possible to use Formetin in combination with sulfonylurea derivatives, while especially careful monitoring of blood glucose levels is required.

Influence on the ability to drive vehicles and use mechanisms

When used as monotherapy, the drug does not affect the ability to drive vehicles and work with mechanisms. When Formetin is combined with other hypoglycemic drugs (sulfonylurea derivatives, insulin), hypoglycemic conditions may develop, in which the ability to drive vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions deteriorates.

Overdose

Symptoms: the development of lactic acidosis with a fatal outcome is possible. The cause of the development of lactic acidosis may also be the accumulation of the drug due to impaired renal function. Early symptoms of lactic acidosis are general weakness, nausea, vomiting, diarrhea, a decrease in body temperature, abdominal pain, muscle pain, a decrease in blood pressure, reflex bradyarrhythmia, in the future, increased breathing rate, dizziness, impaired consciousness and the development of coma are possible. Treatment: if signs of lactic acidosis appear, treatment with metformin should be stopped immediately, the patient should be urgently hospitalized and, having determined the concentration of lactate, the diagnosis should be confirmed. Hemodialysis is most effective for removing lactate and metformin from the body. If necessary, symptomatic therapy is performed.

Drug interactions

With simultaneous use with sulfonylurea derivatives, acarbose, insulin, NSAIDs, MAO inhibitors, oxytetracycline, ACE inhibitors, clofibrate derivatives, cyclophosphamide and beta-blockers, the hypoglycemic effect of metformin may increase. With simultaneous use with corticosteroids, oral contraceptives, epinephrine (adrenaline), sympathomimetics, glucagon, thyroid hormones, thiazide and loop diuretics, phenothiazine and nicotinic acid derivatives, the hypoglycemic effect of metformin may decrease. Cimetidine slows down the excretion of metformin, as a result of which the risk of developing lactic acidosis increases. Metformin can weaken the effect of anticoagulants (coumarin derivatives). When taken simultaneously with ethanol, the development of lactic acidosis is possible.With the simultaneous use of nifedipine increases the absorption of metformin and Cmax, slows down excretion. Cationic drugs (amlodipine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, vancomycin) secreted in the tubules compete for tubular transport systems and, with prolonged therapy, can increase the Cmax of the drug by 60%.