Metformin

Lactic acidosis

Lactic acidosis is a rare but serious (high mortality unless promptly treated) complication, most often occurring in the setting of acute deterioration of renal function, cardiopulmonary disease or sepsis. Accumulation of metformin against the background of acute deterioration of renal function increases the risk of lactic acidosis.

If dehydration occurs (severe diarrhea or vomiting, fever or decreased fluid intake), you should temporarily stop treatment with metformin and consult a doctor.

Treatment of patients taking metformin with drugs that can acutely worsen renal function (such as antihypertensive drugs, diuretics or NSAIDs) should be initiated with caution.

Other associated risk factors for lactic acidosis should be considered, such as decompensated diabetes mellitus, ketosis, prolonged fasting, alcoholism, liver failure and any other condition associated with severe hypoxia, as well as concomitant use with drugs that can lead to lactic acidosis (see. sections “Contraindications” and “Interaction with other drugs”). This may help reduce the incidence of lactic acidosis.

Patients and/or caregivers should be informed of the risk of lactic acidosis.

Lactic acidosis is characterized by acidotic shortness of breath, abdominal pain, muscle cramps, severe asthenia and hypothermia followed by coma. If suspicious symptoms occur, the patient should stop taking metformin and seek immediate medical attention.

Diagnostic laboratory parameters are a decrease in blood pH (less than 7.35), lactate content in the blood plasma over 5 mmol/l, increased anion gap and lactate/pyruvate ratio.

Doctors should warn patients about the risk of developing and symptoms of lactic acidosis.

Administration of iodinated contrast agents

Intravascular administration of iodinated contrast agents can lead to nephropathy and accumulation of metformin, which increases the risk of developing lactic acidosis. The use of metformin should be stopped 48 hours before such a procedure and resumed no earlier than 48 hours after it, provided that the examination did not reveal renal dysfunction (see section “Interaction with other drugs”).

Surgical operations

The use of metformin should be discontinued 48 hours before elective surgery under general, spinal or epidural anesthesia and can be continued no earlier than 48 hours after surgery, provided that the examination did not reveal impaired renal function.

Kidney function

Since metformin is excreted by the kidneys, it is necessary to determine CC before starting treatment and regularly thereafter:

at least once a year in patients with normal renal function;
every 3-6 months in patients with CC 45-59 ml/min and every 3 months with CC 30-44 ml/min.

When CC is less than 30 ml/min, the use of metformin is contraindicated. Treatment with metformin should be suspended in the presence of conditions that may affect renal function.

Particular caution should be exercised in case of possible impairment of renal function in elderly patients (due to the asymptomatic nature), with simultaneous use of antihypertensive drugs, diuretics or NSAIDs.

Heart failure

Patients with heart failure have a higher risk of developing hypoxia and renal failure. Patients with chronic heart failure should have cardiac and renal function monitored regularly while taking metformin.

Taking metformin in heart failure with unstable hemodynamic parameters is contraindicated.

Children and teenagers

The diagnosis of type 2 diabetes mellitus must be confirmed before starting treatment with metformin.

In clinical studies lasting 1 year, metformin was shown to have no effect on growth and puberty. However, due to the lack of long-term data, careful monitoring of the subsequent effects of metformin on these parameters in children, especially during puberty, is recommended. Clinical experience with metformin in children aged 10 to 12 years is limited, so the most careful monitoring is necessary in children in this age group.

Other Precautions

- Patients are advised to continue to follow a diet with even carbohydrate intake throughout the day. Overweight patients are recommended to continue to follow a hypocaloric diet (but not less than 1000 kcal/day).

— Patients should inform the doctor about any treatment being carried out and any infectious diseases.

— It is recommended that routine laboratory tests be performed regularly to monitor diabetes mellitus.

— Metformin in monotherapy does not cause hypoglycemia, however, it is recommended to exercise caution when using it in combination with insulin or other hypoglycemic agents (for example, sulfonylurea derivatives, repaglinide, etc.).

The use of metformin is recommended for the prevention of type 2 diabetes mellitus in persons with prediabetes and additional risk factors for the development of overt type 2 diabetes mellitus, such as:

age less than 60 years;
body mass index (BMI) > 30 kg/m2;
history of gestational diabetes mellitus;
family history of diabetes in first-degree relatives;
increased concentration of triglycerides;
reduced concentration of HDL cholesterol;
arterial hypertension.

Symptoms of hypoglycemia include weakness, headache, dizziness, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating.

Metformin did not affect fertility in male or female rats when administered at doses three times the maximum recommended daily dose for humans.

Metformin, 60 pcs., 500 mg, film-coated tablets

Lactic acidosis

Lactic acidosis is a rare but serious (high mortality unless promptly treated) complication that may occur due to accumulation of metformin. Cases of lactic acidosis when taking metformin occurred mainly in patients with diabetes mellitus with severe renal failure.

Other associated risk factors should be taken into account, such as decompensated diabetes mellitus, ketosis, prolonged fasting, alcoholism, liver failure and any condition associated with severe hypoxia. This may help reduce the incidence of lactic acidosis.

The risk of developing lactic acidosis should be taken into account when nonspecific signs appear, such as muscle cramps accompanied by dyspeptic symptoms, abdominal pain and severe asthenia. Lactic acidosis is characterized by acidotic shortness of breath, abdominal pain and hypothermia followed by coma.

Diagnostic laboratory parameters are a decrease in blood pH (less than 7.25), lactate content in the blood plasma over 5 mmol/l, increased anion gap and lactate/pyruvate ratio.

If metabolic acidosis is suspected, stop taking the drug and consult a doctor immediately.

Surgical operations

The use of metformin should be discontinued 48 hours before elective surgery and can be continued no earlier than 48 hours after, provided that renal function was found to be normal during the examination.

Metformin should be replaced with another hypoglycemic drug (for example, insulin) 48 hours before an x-ray examination with intravenous contrast agents and continued for another 48 hours after this examination.

Kidney function

Since metformin is excreted by the kidneys, before starting treatment and regularly thereafter, it is necessary to determine CC: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients, as well as in patients with CC at the lower limit norms.

Particular caution should be exercised in case of possible impairment of renal function in elderly patients, with simultaneous use of antihypertensive drugs, diuretics or non-steroidal anti-inflammatory drugs.

Use in children and adolescents

The diagnosis of type 2 diabetes mellitus must be confirmed before starting treatment with metformin.

In clinical studies lasting 1 year, metformin was shown to have no effect on growth and puberty. However, due to the lack of long-term data, careful monitoring of the subsequent effects of metformin on these parameters in children, especially during puberty, is recommended. The most careful monitoring is necessary in children aged 10–12 years.

Other Precautions

Patients are advised to continue to follow a diet with even carbohydrate intake throughout the day. Overweight patients are recommended to continue to follow a hypocaloric diet (but not less than 1000 kcal/day).

It is recommended that routine laboratory tests be performed regularly to monitor diabetes mellitus.

It is not recommended to prescribe the drug if there is a risk of dehydration.

Metformin does not cause hypoglycemia when used alone, but caution is recommended when used in combination with insulin or other hypoglycemic agents (for example, sulfonylureas, repaglinide). When combined treatment requires careful monitoring of blood glucose concentrations.

Impact on the ability to drive vehicles and machinery

Monotherapy with the drug does not cause hypoglycemia and therefore does not affect the ability to drive vehicles and machines. Patients should be warned about the risk of developing hypoglycemia when using metformin in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin, repaglinide, etc.), which impair the ability to drive vehicles and engage in other potentially hazardous activities that require increased alertness and quick response. psychomotor reactions.

METFORMIN MV

Directions for use and doses

The drug Metformin MB is taken orally.
The tablets are swallowed whole, without chewing, with a sufficient amount of liquid. 1 time per day during dinner. The dose of Metformin MB is selected by the doctor individually for each patient based on the results of measuring the concentration of glucose in the blood. Monotherapy and combination therapy in combination with other hypoglycemic agents

— For patients who have not taken metformin, the recommended starting dose of Metformin MB is 500 mg, 750 mg or 850 mg once daily with dinner.

- Every 10-15 days it is recommended to adjust the dose based on the results of measuring blood glucose concentrations. Slowly increasing the dose helps reduce gastrointestinal side effects.

- For patients already receiving treatment with metformin, the initial dose of Metformin MB should be equivalent to the daily dose of regular-release tablets.

— Patients taking metformin in the form of regular-release tablets at a dose exceeding 2000 mg are not recommended to switch to Metformin MB.

- If you plan to switch from another hypoglycemic drug, you must stop taking the other drug. Selection of the dose of metformin is carried out, starting with the prescription of the drug Metformin MV 500 mg, 750 mg or 850 mg, with a possible subsequent transition to the drug Metformin MV 1000 mg.

Combination with insulin

To achieve better control of blood glucose concentrations, metformin and insulin can be used in combination therapy. The usual starting dose of Metformin MB is one 500 mg, 750 mg or 850 mg tablet once daily with dinner, while the insulin dose is adjusted based on blood glucose measurements. Next, it is possible to switch to the drug Metformin MB 1000 mg.

Daily dose

The maximum recommended dose of Metformin MB:

1) 4 tablets 500 mg per day (2000 mg);

2) 2 tablets 750 mg per day (1500 mg);

3) 2 tablets 850 mg per day (1700 mg);

4) 2 tablets of 1000 mg per day (2000 mg).

If adequate glycemic control is not achieved, the dose of Metformin MB may be increased to the maximum daily dose.

To reduce side effects from the gastrointestinal tract, the daily dose of the drug can be divided into 2 doses.

If adequate blood glucose control is not achieved when taking the maximum recommended dose once daily with dinner, then the maximum dose may be divided into two doses:

- 2 tablets with breakfast and 2 tablets with dinner for a dosage of 500 mg;

- 1 tablet with breakfast and 1 tablet with dinner for a dosage of 1000 mg. If adequate blood glucose control is not achieved with the maximum recommended dose of metformin extended-release tablets, switching to metformin regular-release tablets with a maximum daily dose of 3000 mg may be considered.

Patients with kidney failure

Metformin can be used in patients with moderate renal failure (creatinine clearance 45-59 ml/min) only in the absence of conditions that may increase the risk of developing lactic acidosis. The initial dose is 500 mg, 750 mg or 850 mg once a day. The maximum dose is 1000 mg per day. Renal function should be carefully monitored every 3-6 months. If creatinine clearance is below 45 ml/min, the drug should be stopped immediately (see section "Contraindications").

Elderly patients

For elderly patients, the dose of metformin is adjusted based on an assessment of renal function, which must be carried out regularly, at least 2 times a year (see section "Special Instructions").

Duration of treatment

Metformin MB should be taken daily, without interruption. If treatment is stopped, the patient must inform the doctor.

Missing a dose

If a dose is missed, the patient should take the next dose at the usual time. You should not take a double dose of Metformin MB.