Metformin Canon

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, any condition associated with severe hypoxia, severe infectious disease and concomitant use with certain medications (see section "Interaction with other drugs"). medicines"). 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 disorders, abdominal pain and severe asthenia, and dehydration (chronic or severe diarrhea, repeated bouts of vomiting).

Lactic acidosis is characterized by severe malaise with general weakness, acidotic shortness of breath, abdominal pain and hypothermia followed by coma.

Diagnostic laboratory parameters are a decrease in blood pH (less than 7.35), lactate content in the blood plasma over 5 mmol/l, an increased anion gap and the lactate/pyruvate ratio. If metabolic acidosis is suspected, stop taking the drug and consult a doctor immediately.

Surgical operations

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

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;
in patients with CC 45-59 ml/min, CC determination should be carried out every 3-6 months
in patients with CC 30-44 ml/min, CC determination should be carried out every 3 months.

In the case of CC less than 30 ml/min, the use of metformin is contraindicated.

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.

Heart failure

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 exercise regularly; Inform your doctor if you are undergoing any treatment or any infectious diseases, such as respiratory viral infections, respiratory or urinary tract infections.

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

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, etc.).

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

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 mellitus in first-degree relatives;
increased concentration of triglycerides;
reduced concentration of HDL cholesterol;
arterial hypertension.

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

Metformin-Canon, 1000 mg, film-coated tablets, 60 pcs.

Lactic acidosis

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

Kidney function

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

- at least once a year in patients with normal renal function;

- at least 2-4 times a year in elderly patients, as well as in patients with creatinine clearance (CC) at the lower limit of normal.

In case of creatinine clearance (CC) less than 45 ml/min, the use of the drug is contraindicated.

Heart failure

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 Canon. 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

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

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, etc.).

The use of Metformin Canon 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) ≥ 35 kg/m2;

- history of gestational diabetes mellitus;

- family history of diabetes mellitus in first-degree relatives;

- increased concentration of triglycerides;

- reduced concentration of HDL cholesterol;

- arterial hypertension.

Impact on the ability to drive vehicles and machinery

Metformin monotherapy does not cause hypoglycemia and therefore does not affect the ability to drive vehicles and machines.

However, patients should be warned about the risk of hypoglycemia when using metformin in combination with other hypoglycemic drugs (sulfonylureas, insulin, repaglinide, etc.).

Metformin-Canon (tab.pl/vol.500mg No. 60)

A country

Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Metformin

Compound

1 tablet contains: metformin hydrochloride 500 mg. Excipients: hypromellose 2208 (hydroxypropyl methylcellulose 2208) - 155 mg, hypromellose (hydroxypropyl methylcellulose) 2910 - 4.3 mg, colloidal silicon dioxide - 7.6 mg, magnesium stearate - 7 mg, microcrystalline cellulose - 26 .1 mg. Extended-release tablets are white or off-white, round, biconvex.

pharmachologic effect

An oral hypoglycemic agent from the biguanide group (dimethylbiguanide). The mechanism of action of metformin is associated with its ability to suppress gluconeogenesis, as well as the formation of free fatty acids and fat oxidation. Increases the sensitivity of peripheral receptors to insulin and the utilization of glucose by cells. Metformin does not affect the amount of insulin in the blood, but changes its pharmacodynamics by reducing the ratio of bound to free insulin and increasing the ratio of insulin to proinsulin. Metformin stimulates glycogen synthesis by acting on glycogen synthetase. Increases the transport capacity of all types of membrane glucose transporters. Delays the absorption of glucose in the intestine. Reduces the level of triglycerides, LDL, VLDL. Metformin improves the fibrinolytic properties of the blood by suppressing tissue-type plasminogen activator inhibitor. While taking metformin, the patient's body weight either remains stable or moderately decreases.

Mode of application

Taken orally, during or after a meal. The dose and frequency of administration depend on the dosage form used. For monotherapy, the initial single dose for adults is 500 mg, depending on the dosage form used, the frequency of administration is 1-3 times a day. It is possible to use 850 mg 1-2 times a day. If necessary, the dose is gradually increased at intervals of 1 week. up to 2-3 g/day. For monotherapy for children aged 10 years and older, the initial dose is 500 mg or 850 1 time/day or 500 mg 2 times/day. If necessary, at intervals of at least 1 week, the dose can be increased to a maximum of 2 g / day in 2-3 divided doses. After 10-15 days, the dose must be adjusted based on the results of blood glucose determination. For combination therapy with insulin, the initial dose Metformin is 500-850 mg 2-3 times/day. The dose of insulin is selected based on the results of determining blood glucose.

Interaction

When used simultaneously with sulfonylurea derivatives, acarbose, insulin, salicylates, MAO inhibitors, oxytetracycline, ACE inhibitors, with clofibrate, cyclophosphamide, the hypoglycemic effect of metformin may be enhanced. When used simultaneously with GCS, hormonal contraceptives for oral administration, danazol, epinephrine, glucagon, hormones thyroid gland, phenothiazine derivatives, thiazide diuretics, nicotinic acid derivatives, the hypoglycemic effect of metformin may be reduced. In patients receiving metformin, the use of iodine-containing contrast agents for the purpose of diagnostic studies (including IV urography, IV cholangiography, angiography , CT) increases the risk of developing acute renal dysfunction and lactic acidosis. These combinations are contraindicated. Injectable beta2-adrenergic agonists increase the concentration of glucose in the blood due to stimulation of β2-adrenergic receptors. In this case, monitoring of blood glucose concentration is necessary. If necessary, it is recommended to prescribe insulin. Simultaneous use of cimetidine may increase the risk of developing lactic acidosis. Simultaneous use of loop diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Concomitant use with ethanol increases the risk of developing lactic acidosis. Nifedipine increases the absorption and Cmax of metformin. Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) secreted in the renal tubules compete with metformin for tubular transport systems and can lead to an increase in its Cmax.

Side effect

From the digestive system: - possible (usually at the beginning of treatment) nausea, vomiting, diarrhea, flatulence, feeling of discomfort in the abdomen; - in isolated cases - impaired liver function indicators, hepatitis (disappear after cessation of treatment). From the metabolic side: very rarely - lactic acidosis (cessation of treatment is required). From the hematopoietic system: very rarely - impaired absorption of vitamin B12. The profile of adverse reactions in children aged 10 years and older is the same as in adults.

Contraindications

- acute or chronic metabolic acidosis, diabetic ketoacidosis, diabetic precoma and coma; - renal failure, impaired renal function (Overdose). Overdose may cause some side effects, which is why it is recommended to take tablets only at the indicated dose. When taking metformin at a dosage of 85 g, a case was recorded overdose, as a result of which lactic acidosis developed, in which vomiting, nausea, muscle pain, diarrhea, abdominal pain were noted. If help is not provided in a timely manner, dizziness, impaired consciousness and coma may develop. The most effective method of removing metformin from the body is hemodialysis. Next, symptomatic therapy is prescribed.

special instructions

Use is not recommended for acute infections, exacerbation of chronic infectious and inflammatory diseases, injuries, acute surgical diseases, danger of dehydration. Do not use before surgical operations and within 2 days after them. Metformin should be used with caution in elderly patients and persons performing heavy physical work, which is associated with an increased risk of developing lactic acidosis. Elderly patients often experience asymptomatic renal dysfunction. Particular caution is required if renal dysfunction is provoked by taking antihypertensive drugs or diuretics, as well as NSAIDs. If during treatment the patient experiences muscle cramps, indigestion (abdominal pain) and severe asthenia, then it should be borne in mind that these symptoms may indicate the onset of lactic acidosis. During treatment, it is necessary to monitor renal function; determination of lactate content in plasma should be carried out at least 2 times a year, as well as when myalgia appears. When metformin is used as monotherapy in accordance with the dosage regimen, hypoglycemia, as a rule, does not occur. However, when combined with insulin or sulfonylurea derivatives, there is a risk of developing hypoglycemia. In such cases, particularly careful monitoring of blood glucose concentrations is necessary. During treatment, patients should avoid drinking alcohol due to the risk of developing lactic acidosis. Preclinical studies have shown that metformin does not have carcinogenic potential.

Dispensing conditions in pharmacies

On prescription

Metformin Long Canon (500, 750, 1000 mg)

Lactic acidosis

Lactic acidosis is a rare but serious complication (high mortality if not treated promptly) 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.

The risk of developing lactic acidosis should be taken into account when nonspecific signs appear, such as muscle cramps accompanied by dyspeptic disorders, abdominal pain, and severe asthenia.

Lactic acidosis is characterized by severe malaise with general weakness, acidotic shortness of breath, vomiting, abdominal pain, muscle cramps and hypothermia followed by coma. Diagnostic laboratory parameters are a decrease in blood pH (less than 7.25), plasma lactate concentration 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 has been found to be normal during the examination.

Kidney function

Since metformin is excreted by the kidneys, before starting treatment and regularly thereafter, it is necessary to determine creatinine clearance: 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 creatinine clearance at lower limit of normal.

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 for acute failure and chronic heart failure with unstable hemodynamic parameters is contraindicated.

Other Precautions

Patients should inform their physician about any treatment they are undergoing and any infectious diseases such as colds, respiratory tract infections, or urinary tract infections.

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

Metformin does not cause hypoglycemia when used alone, but caution is recommended when used in combination with insulin or other oral hypoglycemic agents (for example, sulfonylureas or repaglinide, etc.). Symptoms of hypoglycemia include weakness, headache, dizziness, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating.

It is necessary to warn the patient that the inactive components of the drug Metformin Long Canon can be excreted unchanged through the intestines, which does not affect the therapeutic activity of the drug.

Impact on the ability to drive vehicles and machinery

Monotherapy with Metformin Long Canon, extended-release tablets, does not cause hypoglycemia and therefore does not affect the ability to drive vehicles and machines.

However, it is possible to develop hypoglycemia when using metformin in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin, repaglinide, etc.). If symptoms of hypoglycemia appear, you should not drive vehicles or machinery.