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


Type 2 diabetes is often treated today with metformin. This is the main indication for this drug. The full composition of the product and detailed information on its indications are indicated in the manufacturer's instructions.

The release form of the drug is oval biconvex tablets in a white or beige shell, which contain the active drug - metformin hydrochloride (500 g, 850, 1000 mg). Their appearance is the presence of marks and embossing of the symbol “f” on different sides. The outline blister packs contain 10, 15, 20 tablets. The medicine is sold in cardboard packs, which contain 3 or 6 contour packs, as well as instructions for using the medicine.

Features of the impact

Metformin is a hypoglycemic agent that belongs to the biguanide group. The active substance of the same name is distinguished by its ability to reduce glucose synthesis. In addition, the drug increases sensitivity to insulin and improves the processing of glucose by cells. When taking metmorphine, it is possible to stabilize the patient’s body weight, and in some cases even reduce it.

After oral administration, the drug is slowly absorbed into the gastrointestinal tract. The maximum amount of active substance in the blood is observed after approximately a couple of hours. In this case, the bioavailability of the drug is 50-60%. If the medicine is taken with fatty foods, the absorption of the active substance slows down.

Indications and contraindications

Metformin, the instructions emphasize this, is prescribed for the treatment of type 2 diabetes mellitus (non-insulin dependent). It is indicated in cases where diet therapy and planned effective exercise have proven ineffective in the fight against obesity. For adults, the drug can be used as monotherapy, as well as in combination with insulin or other drugs with a hypoglycemic effect. For children, a combination is possible only with insulin or as a stand-alone drug.

The main contraindication for taking the drug is hypersensitivity to the active substance and other auxiliary components in the composition. The medicine is not prescribed for people under 10 years of age or during pregnancy, since pathologies in the development of intrauterine pathologies in the unborn child cannot be ruled out. Also prohibited from using the product are various kidney pathologies, as well as diseases that lead to disruption of their functions.

Other contraindications:

  • Liver disorders.
  • Heart and respiratory failure.
  • Myocardial infarction.
  • Postoperative conditions and injuries.
  • Diabetic ketoacidosis.
  • Lactic acidosis.

Treatment with the drug should be avoided in case of chronic alcoholism, as well as in a state of acute alcohol poisoning. This increases the risk of developing lactic acidosis. There are other contraindications that the doctor will definitely take into account when prescribing treatment for type 2 diabetes with metformin.

Prescribe medication to older people with caution. Dangers arise after 60 years for those who work physically hard. The doctor makes an informed decision about taking the drug in the presence of renal failure. When breastfeeding, there is a risk of side effects in the baby, since the active substance passes into the mother's milk. When prescribing the drug, the doctor must take into account the compatibility of metformin with other medications.

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.

Possible adverse reactions

Negative reactions can occur from various systems of the human body. In particular, disruptions in the functioning of the nervous system occur, which are characterized by impaired taste perception. Side effects may include nausea, diarrhea, and vomiting. These occurrences are accompanied by loss of appetite and pain. Sometimes taking the drug is accompanied by itching and rash on the skin. Metabolism develops much less frequently, which provokes the development of lactic acidosis. Irregularities in the liver and problems with the biliary tract were also recorded, but after stopping metformin, such manifestations disappear.

In case of overdose, an increase in blood glucose levels is not observed. But if the maximum daily dose is exceeded, the risks of an increase in lactic acid levels in the blood increase, which leads to the development of lactic acidosis. In this case, the use of the medication is stopped and the patient is hospitalized. Treatment is symptomatic. If necessary, a decision is made about hemodialysis.

Special instructions and precautions

Risk of developing lactic acidosis

Metformin can cause a rare but very serious complication, lactic acidosis, especially if kidney function is impaired. The risk of developing lactic acidosis increases in the case of uncontrolled diabetes, serious infections, prolonged fasting, alcoholism, dehydration (see information below), liver failure and any pathology in which hypoxia occurs (for example, severe heart disease).

If you have any of these conditions, talk to your doctor before using metformin.

Stop taking metformin for a short time if you have a risk of dehydration (more body fluid loss than necessary), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or insufficient fluid intake.

If you have any questions, consult your doctor,

If you develop symptoms of lactic acidosis, stop taking metformin and tell your doctor or go to your nearest hospital immediately, as lactic acidosis can lead to coma.

Symptoms of lactic acidosis:

  • vomit
  • abdominal pain
  • muscle spasms
  • general poor health, accompanied by severe fatigue
  • labored breathing
  • decreased body temperature and heart rate

Lactic acidosis requires emergency medical attention.

If you are having major surgery, you should stop taking metformin for the duration of surgery and for some time afterward.

Your doctor will advise you when to stop and restart treatment.

Metformin as monotherapy does not cause hypoglycemia (lowering blood glucose levels). However, when used simultaneously with other antidiabetic drugs (sulfonylurates, insulin, meglitinides), there is a risk of developing hypoglycemia.

If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, or problems with vision or concentration, you should immediately drink or eat something containing sugar.

Renal function should be closely monitored at least once a year during treatment with metformin, or more often if you are elderly or have worsening kidney function.

Drug interactions

If you need to have intravascular injection of iodinated contrast agents, such as for x-rays, you must stop taking metformin before or during the procedure. Your doctor will tell you when to stop or when to restart taking metformin.

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need to have your blood glucose levels and kidney function assessed more frequently, or your doctor may need to adjust your metformin dose.

It is especially important to note the following medications:

  • medications that increase urine production (diuretics).
  • medications that have analgesic and anti-inflammatory effects (NSAIDs and COX-2 inhibitors such as ibuprofen and celecoxib).
  • certain medications to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
  • beta-2 adrenergic agonists such as salbutamol or terbutaline (drugs used to treat asthma).
  • corticosteroids (used to treat various conditions such as severe skin inflammation or asthma).
  • Medicines that may affect blood levels of metformin, especially if kidney function is impaired (eg, verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
  • other medicines used to treat diabetes mellitus

Metformin and alcohol

Avoid excessive drinking of alcohol while taking metformin as this may cause lactic acidosis (see Warnings and Precautions).

Pregnancy and breastfeeding

During pregnancy, you need insulin to treat diabetes.

Check with your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant before taking this drug as it may change your treatment.

It is not recommended to take metformin while breastfeeding.

Dosage and use of the product

For the treatment of type 2 diabetes mellitus in adults, it is recommended to start taking the drug with a minimum dosage. This is 500 mg 2-3 times a day. Dose adjustments are made 10-15 days after measuring glucose levels. By increasing the dose at a slow pace, it is possible to minimize the risks of disruptions in the gastrointestinal tract. A maintenance dose of metformin is considered to be 2000 mg/day, divided into 2-3 doses. It is possible to increase it to 3000 mg/day.

To improve control of blood glucose levels in patients suffering from type 2 diabetes mellitus, complex therapy with insulin is used. In this case, the initial dose is also 500 mg or 850 mg 2-3 times a day, but the dosage of insulin is selected depending on the concentration of glucose in the blood. During long-term treatment with the drug, it is necessary to perform regular glycemic control. The drug can be taken without interruption every day. If you refuse the drug, you must inform your doctor.

Taking the medication does not affect the ability to drive. This is explained by the fact that hypoglycemia does not occur when treated with it. The shelf life of the drug is 2 years. To do this, you need to choose a dark, dry place that is inaccessible to children.

Metformin

Use during pregnancy and breastfeeding

There have been no adequate and strictly controlled studies of the safety of metformin during pregnancy.
Use during pregnancy is possible in cases of extreme necessity, when the expected benefit of therapy for the mother outweighs the possible risk to the fetus. Metformin penetrates the placental barrier. Metformin is excreted in small quantities into breast milk, and the concentration of metformin in breast milk may be 1/3 of the concentration in maternal plasma. No side effects were observed in breastfeeding newborns while taking metformin. However, due to limited data, use during breastfeeding is not recommended. The decision to stop breastfeeding should be made taking into account the benefits of breastfeeding and the potential risk of side effects in the baby.

Preclinical studies have shown that metformin does not have a teratogenic effect at doses that are 2-3 times higher than therapeutic doses used in humans. Metformin does not have mutagenic potential and does not affect fertility.

Use for liver dysfunction

Contraindicated in cases of severe liver dysfunction.

Use for renal impairment

Contraindicated in cases of severe renal impairment.

special instructions

Use is not recommended for acute infections, exacerbation of chronic infectious and inflammatory diseases, injuries, acute surgical diseases, or danger of dehydration.

Do not use before surgery and within 2 days after surgery.

Metformin should be used with caution in elderly patients and people 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 caused by taking antihypertensive drugs or diuretics, as well as NSAIDs.

If during treatment the patient develops muscle cramps, indigestion (abdominal pain) and severe asthenia, 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.

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