Metformin-Canon, 1000 mg, film-coated tablets, 60 pcs.
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 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.
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
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 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
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.
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 (500, 850, 1000 mg)
Contraindicated combinations Radiological studies using iodine-containing X-ray contrast 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. Not recommended combinations When using metformin simultaneously 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 concomitantly 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.
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
