Metformin, tablets 850 mg 60 pcs

Metformin inhibits gluconeogenesis in liver, decreases glucose absorption from intestine, increases peripheral glucose utilization, and increases tissue sensitivity to insulin. At the same time it has no effect on insulin secretion by the beta cells of the pancreas and does not cause hypoglycemic reactions.

Limits triglycerides and low-density linoproteins in the blood. Stabilizes or reduces body weight. Has a fibrinolytic effect by inhibiting tissue-type plasminogen activator inhibitor.

After oral administration metformin is absorbed from the gastrointestinal tract. Bioavailability after a standard dose is 50-60%. Cmax in plasma is reached 2.5 hours after oral administration. Practically does not bind with plasma proteins. It accumulates in salivary glands, muscles, liver and kidneys.

Indications

Type 2 diabetes mellitus in adults (especially in obese patients) with ineffective diet therapy and exercise, as monotherapy or in combination with other oral hypoglycemic agents or insulin.

Type 2 diabetes mellitus in children from 10 years of age – both as monotherapy and in combination with insulin.

Pharmacological effect

Metformin inhibits gluconeogenesis in the liver, reduces the absorption of glucose from the intestine, enhances peripheral glucose utilization, and also increases tissue sensitivity to insulin. At the same time, it does not affect the secretion of insulin by beta cells of the pancreas and does not cause hypoglycemic reactions.

Reduces the level of triglycerides and low-density linoproteins in the blood. Stabilizes or reduces body weight. It has a fibrinolytic effect due to the suppression of tissue-type plasminogen activator inhibitor.

After oral administration, metformin is absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is 50-60%. Cmax in blood plasma is achieved 2.5 hours after oral administration. Practically does not bind to plasma proteins. Accumulates in the salivary glands, muscles, liver and kidneys.

It is excreted unchanged by the kidneys. T1/2 is 9-12 hours. In case of impaired renal function, cumulation of the drug is possible.

Special instructions

During treatment, it is necessary to monitor kidney function. At least 2 times a year, and also when myalgia appears, the lactate content in plasma should be determined. In addition, once every 6 months it is necessary to monitor the level of creatinine in the blood serum (especially in elderly patients). Metformin should not be prescribed if the blood creatinine level is above 135 µmol/L in men and 110 µmol/L in women.

It is possible to use the drug Metformin in combination with sulfonylurea derivatives. In this case, particularly careful monitoring of blood glucose levels is necessary.

Metformin should be stopped 48 hours before and 48 hours after X-ray contrast (urography, intravenous angiography).

If a patient develops a bronchopulmonary infection or an infectious disease of the genitourinary organs, you should immediately inform your doctor.

During treatment, you should refrain from drinking alcohol and medications containing ethanol. .

Impact on the ability to drive vehicles and operate machinery

The use of the drug in monotherapy does not affect the ability to drive vehicles or operate machinery.

When Metformin is combined with other hypoglycemic agents (sulfonylurea derivatives, insulin), hypoglycemic conditions may develop, which impair the ability to drive vehicles and engage in other potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Active ingredient

Metformin

Composition

1 tablet contains:

Active substances:

metformin 850 mg

Excipients:

Povidone K-30 59.5 mg;

Magnesium stearate 8.5 mg.

Composition of the film shell (dry mixture of the film shell “Vivacoat PC-1P-058” from white to almost white) 27.2 including: hypromellose 16.32 mg; talc 5.44 mg; titanium dioxide 2.992 mg; macrogol 4000 (polyethylene glycol 4000) 2.448 mg.

Contraindications

diabetic ketoacidosis, diabetic precoma, coma;

renal dysfunction;

acute diseases that occur with the risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), fever, severe infectious diseases, hypoxia conditions (shock, sepsis, kidney infections, bronchopulmonary diseases);

clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (heart or respiratory failure, acute myocardial infarction);

serious surgical operations and injuries (when insulin therapy is indicated);

liver dysfunction;

chronic alcoholism, acute alcohol poisoning;

use for at least 2 days before and for 2 days after radioisotope or x-ray studies with the introduction of an iodine-containing contrast agent;

lactic acidosis (including history);

following a hypocaloric diet (less than 1000 cal/day);

pregnancy;

lactation period;

hypersensitivity to the drug.

It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Side Effects

From the digestive system: nausea, vomiting, metallic taste in the mouth, lack of appetite, diarrhea, flatulence, abdominal pain. These symptoms occur especially often at the beginning of treatment and, as a rule, go away on their own. These symptoms can be reduced by the use of anthocides, atropine derivatives or antispasmodics.

Metabolic disorders: in rare cases – lactic acidosis (requires cessation of treatment); with long-term treatment – hypovitaminosis B12 (malabsorption).

From the hematopoietic organs: in some cases – megaloblastic anemia.

From the endocrine system: hypoglycemia.

Allergic reactions: skin rash.

Interaction

Contraindicated combinations

Radiological studies using iodine-containing radiopaque agents can cause the development of lactic acidosis in patients with diabetes mellitus against the background of functional renal failure. The use of metformin should be discontinued 48 hours before and not resumed until 48 hours after an X-ray examination using radiocontrast agents.

Combinations not recommended

With the simultaneous use of metformin with alcohol and ethanol-containing drugs, during acute alcohol intoxication, during fasting or following a low-calorie diet, as well as in liver failure, the risk of developing lactic acidosis increases.

Combinations requiring special caution

When metformin is used simultaneously with danazol, a hyperglycemic effect may develop. If treatment with danazol is necessary and after stopping its use, a dose adjustment of metformin is required under the control of blood glucose concentrations.

Chlorpromazine in high doses (100 mg/day) reduces insulin release and increases blood glucose concentrations. When used simultaneously with antipsychotics and after stopping their use, a dose adjustment of metformin is required under the control of blood glucose concentrations.

Glucocorticosteroids (GCS), when administered parenterally and locally, reduce glucose tolerance and increase blood glucose concentrations, in some cases causing ketosis.

If it is necessary to use such a combination and after stopping the use of corticosteroids, a dose adjustment of metformin is required under the control of blood glucose concentrations.
With the simultaneous use of loop diuretics and metformin, there is a risk of developing lactic acidosis due to the possible occurrence of functional renal failure.

The use of beta2-adrenergic agonists by injection reduces the hypoglycemic effect of metformin due to stimulation of beta2-adrenergic receptors. In this case, you should monitor the concentration of glucose in the blood and, if necessary, use insulin.

Angiotensin-converting enzyme inhibitors and other antihypertensive drugs may decrease blood glucose concentrations. If necessary, the dose of metformin should be adjusted.

With simultaneous use of metformin with sulfonylurea derivatives, insulin, acarbose and salicylates, the hypoglycemic effect may be enhanced.

Nifedipine increases the absorption and Cmax of metformin, which must be taken into account when using them simultaneously.

Loop diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of decreased kidney function. In this case, caution must be exercised when using metformin.

Overdose

Symptoms: when using metformin at a dose of 85 g, no hypoglycemia was observed, but the development of lactic acidosis was noted. Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, decreased body temperature, abdominal pain, muscle pain, and later rapid breathing, dizziness, impaired consciousness and the development of coma may occur.

Treatment: If signs of lactic acidosis appear, treatment with the drug must be stopped immediately, the patient must be urgently hospitalized and, having determined the lactate concentration, the diagnosis must be clarified. The most effective measure for removing lactate and metformin from the body is hemodialysis. Symptomatic treatment is also carried out.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life

2 years.

Manufacturer

Ozon, Russia