Glucophage instructions for use contraindications. Glucophage. Contraindications to the use of the drug. Combination with drugs

To date, endocrinologists have a rich selection of sugar-lowering agents that have an exhaustive evidence base for their safety and effectiveness. It is already known that in the first year of using pharmacotherapy in the treatment of diabetes mellitus, the effectiveness of using various groups hypoglycemic agents (biguanides, sulfonamides), if it differs, then it is insignificant. In this regard, when prescribing a drug, one should be guided by a host of other properties of prescribed drugs, such as: the effect on the heart and blood vessels associated with their use, potential macrovascular complications, the risk of occurrence and growth of atherogenic pathologies. After all, it is this pathogenetic “tail” that is decisive in the fatal question “is there life after diabetes mellitus”. Long-term monitoring of blood glucose levels is largely complicated by the progressive deterioration of β-cell function. For this reason, the importance of drugs that protect these cells, their properties and functions is increasing. Among the heap clinical protocols and standards for the treatment of diabetes mellitus adopted in different countries, the red line is the same name: glucophage (INN - metformin). This hypoglycemic drug is used in the fight against diabetes 2 types for over four decades. Glucophage is, in fact, the only antidiabetic drug with a proven effect on reducing the incidence of diabetic complications. This was clearly demonstrated in a large study conducted in Canada, during which patients taking glucophage had an overall 40% lower overall and cardiovascular mortality rates than those taking sulfonylurea drugs.

Unlike the same glibenclamide, glucophage does not stimulate the production of insulin and does not potentiate hypoglycemic reactions. The main mechanism of its action is aimed primarily at increasing the sensitivity of peripheral tissue receptors (mainly muscle and liver) to insulin. Against the background of insulin loading, glucophage also increases glucose utilization. muscle tissue and intestines. The drug improves the degree of oxidation of glucose in the absence of oxygen and activates the production of glycogen in the muscles. Prolonged use of glucophage has a positive effect on fat metabolism, leading to a decrease in the concentration of total “bad” cholesterol (LDL) in the blood.

Glucophage is available in tablets. In most cases, the reception is started with a dose of 500 or 850 mg 2-3 times a day during or after meals. At the same time, careful monitoring of the level of glucose in the blood is carried out, according to the results of which a gradual increase in the dose to a maximum of 3000 mg per day is possible. When taking glucophage, patients in their gastronomic "schedule" should evenly divide all carbohydrates taken per day. At overweight body shows a hypocaloric diet. Glucophage monotherapy, as a rule, is not associated with hypoglycemia, however, when taking the drug with other antihyperglycemic agents or insulin, one must be on the alert and constantly monitor one's biochemical parameters.

Pharmacology

Oral hypoglycemic drug from the group of biguanides.

Glucophage ® reduces hyperglycemia without leading to the development of hypoglycemia. Unlike sulfonylurea derivatives, it does not stimulate insulin secretion and does not have a hypoglycemic effect in healthy individuals.

Increases the sensitivity of peripheral receptors to insulin and the utilization of glucose by cells. Reduces the production of glucose by the liver by inhibiting gluconeogenesis and glycogenolysis. Delays the absorption of glucose in the intestine.

Metformin stimulates glycogen synthesis by acting on glycogen synthetase. Increases the transport capacity of all types of membrane glucose carriers.

In addition, it has a beneficial effect on lipid metabolism: it reduces the content total cholesterol, LDL and TG.

While taking metformin, the patient's body weight either remains stable or moderately decreases.

Pharmacokinetics

Suction

After taking the drug inside, metformin is quite completely absorbed from the gastrointestinal tract. At simultaneous reception food absorption of metformin is reduced and delayed. Absolute bioavailability is 50-60%. C max in plasma is approximately 2 μg / ml or 15 μmol and is reached after 2.5 hours.

Distribution

Metformin is rapidly distributed into body tissues. Practically does not bind to plasma proteins.

Metabolism

It is metabolized to a very small extent and excreted by the kidneys.

breeding

Metformin clearance in healthy individuals is 400 ml / min (4 times more than CC), which indicates active tubular secretion.

T 1/2 is approximately 6.5 hours.

Pharmacokinetics in special clinical situations

In patients with renal insufficiency T 1/2 increases, there is a risk of accumulation of metformin in the body.

Release form

Film-coated tablets white color, round, biconvex; on the transverse section - a homogeneous white mass.

Excipients: povidone - 20 mg, magnesium stearate - 5.0 mg.

Compound film shell: hypromellose - 4.0 mg.

10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
15 pcs. - blisters (2) - packs of cardboard.
15 pcs. - blisters (4) - packs of cardboard.
20 pcs. - blisters (3) - packs of cardboard.
20 pcs. - blisters (5) - packs of cardboard.

Dosage

The drug is taken orally.

adults

Monotherapy and combination therapy with other oral hypoglycemic agents

The usual initial dose is 500 mg or 850 mg 2-3 times / day after or during meals. Possible further gradual increase doses depending on the concentration of glucose in the blood.

The maintenance dose of the drug is usually 1500-2000 mg / day. For decreasing side effects from the gastrointestinal tract daily dose should be divided into 2-3 doses. Maximum dose is 3000 mg / day, divided into 3 doses.

Slow dose escalation may improve gastrointestinal tolerance.

Patients receiving metformin at doses of 2000-3000 mg/day can be switched to taking Glucophage ® 1000 mg. The maximum recommended dose is 3000 mg/day divided into 3 divided doses.

If you plan to switch from taking another hypoglycemic drug, you must stop taking the other drug and start taking Glucophage ® at the dose indicated above.

Combination with insulin

To achieve better blood glucose control, metformin and insulin can be used as combination therapy. The usual initial dose of Glucophage ® is 500 mg or 850 mg 2-3 times / day, while the dose of insulin is selected based on the concentration of glucose in the blood.

Children and teenagers

Elderly patients

because of possible reduction renal function, the dose of metformin should be selected under regular monitoring of kidney function indicators (to determine the content of creatinine in the blood serum at least 2-4 times a year).

Glucophage ® should be taken daily, without interruption. In the event of discontinuation of treatment, the patient must inform the doctor.

Overdose

Symptoms: when using metformin at a dose of 85 g (42.5 times the maximum daily dose), hypoglycemia was not observed, but the development of lactic acidosis was noted.

Significant overdose or associated risk factors may lead to the development of lactic acidosis.

Treatment: immediate withdrawal of the drug Glucophage ® , urgent hospitalization, determination of the concentration of lactate in the blood; carry out if necessary symptomatic therapy. To remove lactate and metformin from the body, hemodialysis is most effective.

Interaction

Contraindicated combinations

Iodine-containing radiopaque agents: against the background of functional kidney failure in patients with diabetes mellitus, radiological examination using iodine-containing radiopaque agents can cause the development of lactic acidosis. Treatment with Glucophage ® must be discontinued, depending on kidney function, 48 hours before or at the time of x-ray examination with the use of iodine-containing radiopaque agents and not resume earlier than 48 hours after, provided that during the examination renal function was considered normal.

Ethanol - for acute alcohol intoxication the risk of developing lactic acidosis increases, especially in the case of:

Malnutrition, low-calorie diet;

liver failure.

During the use of the drug, alcohol and medicines containing ethanol should be avoided.

Combinations requiring caution

The simultaneous use of danazol is not recommended in order to avoid the hyperglycemic effect of the latter. If treatment with danazol is necessary and after discontinuation of the latter, a dose adjustment of the drug Glucophage ® is required under the control of blood glucose concentration.

Chlorpromazine, when used in high doses (100 mg / day), increases the concentration of glucose in the blood, reducing the release of insulin. In the treatment of neuroleptics and after discontinuation of the latter, a dose adjustment of the drug is required under the control of the concentration of glucose in the blood.

GCS for systemic and local application reduce glucose tolerance, increase the concentration of glucose in the blood, sometimes causing ketosis. In the treatment of corticosteroids and after discontinuation of the latter, a dose adjustment of the drug Glucophage ® is required under the control of the concentration of glucose in the blood.

Simultaneous use of "loop" diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Do not prescribe Glucophage ® if the CC is less than 60 ml / min.

Beta 2 -agonists in the form of injections increase the concentration of glucose in the blood due to stimulation of β 2 -adrenergic receptors. In this case, it is necessary to control the concentration of glucose in the blood. If necessary, it is recommended to prescribe insulin.

With the simultaneous use of the above drugs, more frequent monitoring of blood glucose levels may be required, especially at the beginning of treatment. If necessary, the dose of metformin can be adjusted during treatment and after its termination.

ACE inhibitors and other antihypertensives medicines may lower blood glucose levels. If necessary, the dose of metformin should be adjusted.

With the simultaneous use of the drug Glucophage ® with sulfonylurea derivatives, insulin, acarbose, salicylates, hypoglycemia may develop.

Nifedipine increases the absorption and Cmax of metformin.

Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) secreted into renal tubules, compete with metformin for tubular transport systems and can lead to an increase in its C max .

Side effects

Frequency detection side effects: very often (≥1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<1/10 000). Побочное действие представлено в порядке снижения значимости.

From the side of metabolism: very rarely - lactic acidosis; with prolonged use, a decrease in the absorption of vitamin B 12 is possible. Decreased vitamin B12 levels should be considered in patients with megaloblastic anemia.

From the nervous system: often - a violation of taste.

From the digestive system: very often - nausea, vomiting, diarrhea, abdominal pain, lack of appetite. Most often, these symptoms occur during the initial period of treatment and in most cases resolve spontaneously. To prevent symptoms, it is recommended to take metformin 2 or 3 times / day during or after meals. Slow dose escalation may improve gastrointestinal tolerance.

From the skin and subcutaneous tissues: very rarely - erythema, itching, rash.

From the side of the liver and biliary tract: very rarely - a violation of liver function, hepatitis. After the abolition of metformin, adverse reactions completely disappear.

Published data, post-marketing data, and data from controlled clinical trials in a limited pediatric population in the age group of 10 to 16 years show that side effects in children are similar in nature and severity to those in adult patients.

Indications

Type 2 diabetes mellitus, especially in obese patients, with the ineffectiveness of diet therapy and physical activity:

  • in adults as monotherapy or in combination with other oral hypoglycemic drugs, or with insulin;
  • in children aged 10 years and older as monotherapy or in combination with insulin.

Contraindications

  • hypersensitivity to the components of the drug;
  • diabetic ketoacidosis, diabetic precoma, diabetic coma;
  • renal insufficiency or impaired renal function (CK<60 мл/мин);
  • acute conditions in which there is a risk of developing impaired renal function: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;
  • clinically pronounced manifestations of acute or chronic diseases that can lead to the development of tissue hypoxia (including respiratory failure, heart failure, acute myocardial infarction);
  • major surgery and trauma (when insulin therapy is indicated);
  • liver failure, liver dysfunction;
  • chronic alcoholism, acute ethanol poisoning;
  • pregnancy;
  • lactic acidosis (including history);
  • a period of at least 48 hours before and within 48 hours after radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent;
  • adherence to a hypocaloric diet<1000 ккал/сут).

With caution, the drug should be used in patients over the age of 60 who perform heavy physical work (which is associated with an increased risk of developing lactic acidosis in them); during the period of breastfeeding.

Application features

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy.

Decompensated diabetes during pregnancy is associated with an increased risk of congenital malformations and perinatal mortality. Limited data suggest that the use of metformin in pregnant women does not increase the risk of birth defects in children.

When planning pregnancy, as well as in the event of pregnancy while taking metformin, the drug should be canceled and insulin therapy prescribed. Plasma glucose levels should be maintained as close to normal as possible to reduce the risk of fetal malformations.

Metformin is excreted in breast milk. Side effects in newborns during breastfeeding while taking metformin were not observed. However, due to the limited amount of data, the use of the drug 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.

Application for violations of liver function

Contraindicated in violations of liver function, renal failure.

Application for violations of kidney function

Contraindicated in patients with impaired renal function or renal insufficiency (CK<60 мл/мин).

Use in children

In children aged 10 years and older, Glucophage ® can be used both as monotherapy and in combination with insulin. The usual initial dose is 500 mg or 850 mg 1 time / day after or during a meal. After 10-15 days, the dose must be adjusted based on the concentration of blood glucose. The maximum daily dose is 2000 mg divided into 2-3 doses.

special instructions

lactic acidosis

Lactic acidosis is a rare but serious (high mortality in the absence of emergency treatment) complication that can occur due to the accumulation of metformin. Cases of lactic acidosis while taking metformin occurred mainly in patients with diabetes mellitus with severe renal insufficiency.

Other associated risk factors should also be considered, 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 non-specific signs appear, such as muscle cramps, accompanied by dyspeptic symptoms, abdominal pain and severe asthenia. Lactic acidosis is characterized by acidotic dyspnea, abdominal pain, and hypothermia followed by coma.

Diagnostic laboratory indicators are a decrease in blood pH (<7.25), содержание лактата в плазме крови свыше 5 ммоль/л, повышенные анионный промежуток и отношение лактат/пируват. При подозрении на метаболический ацидоз необходимо прекратить прием препарата и немедленно обратиться к врачу.

Surgical operations

Metformin should be discontinued 48 hours before elective surgery and may be continued no earlier than 48 hours after, provided that renal function was 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 the 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 CK on the lower border of the norm.

Particular caution should be exercised with possible impaired renal function in elderly patients, while the use of antihypertensive drugs, diuretics or NSAIDs.

Pediatric use

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

In clinical studies lasting 1 year, it was shown that metformin does not affect growth and puberty. However, in view of the lack of long-term data, careful monitoring of the subsequent effect of metformin on these parameters in children is recommended, especially during puberty. The most careful monitoring is necessary for children aged 10-12 years.

Other Precautions

Patients are advised to continue to follow a diet with an even intake of carbohydrates throughout the day. Patients with overweight are advised to continue to follow a low-calorie diet (but not less than 1000 kcal / day).

Metformin in monotherapy does not cause hypoglycemia, however, caution is recommended when it is used in combination with insulin or other hypoglycemic agents (including sulfonylurea derivatives, repaglinide).

Influence on the ability to drive vehicles and control mechanisms

Monotherapy with Glucophage ® does not cause hypoglycemia, therefore it does not affect the ability to drive vehicles and mechanisms. However, patients should be warned about the risk of hypoglycemia when using metformin in combination with other hypoglycemic drugs (including sulfonylurea derivatives, insulin, repaglinide).

With hyperglycemia, endocrinologists prescribe Glucophage 500 - instructions for using the drug include information about taking it simultaneously with food in order to normalize blood sugar levels. The properties of the drug to break down fats led to the fact that the medicine was used for weight loss. Check out the information on whether it is possible to lose weight with these pills, as well as how to normalize the concentration of glucose in type 2 diabetes.

Glucophage tablets

According to the pharmacological classification, Glucophage belongs to the group of oral hypoglycemic agents that lower blood sugar levels in patients with diabetes mellitus. This medicine has good gastrointestinal tolerance, the active substance of the composition has metformin hydrochloride, which is part of the biguanide group (their derivatives).

Compound

Glucophage Long 500 or simply Glucophage 500 - these are the main forms of release of the drug. The first is characterized by a prolonged action. There are other tablets with different concentrations of metformin hydrochloride. Their detailed composition:

Glucophage

Glucophage Long

The concentration of the active substance, mg per 1 pc.

500, 850 or 1000

Description

White, round (oval for 1000, engraved)

White capsular

Povidone, Hypromellose, Magnesium Stearate, Pure Opadry (Hypromellose, Macrogol)

sodium carmellose, magnesium stearate, hypromellose

Package

10, 15 or 20 pieces in a blister

30 or 60 pcs. in a pack

Pharmacodynamics and pharmacokinetics

A drug with a hypoglycemic effect from the biguanide group reduces the development of hyperglycemia, preventing hypoglycemia. Compared to sulfonylurea derivatives used in the treatment of diabetes mellitus, the agent does not stimulate insulin secretion. The drug increases the sensitivity of receptors, accelerates the excretion of glucose by cells, reduces the synthesis of sugar by the liver by suppressing gluconeogenesis and glycogenolysis. The tool can delay the absorption of glucose in the intestine.

The active substance metformin hydrochloride activates the production of glycogen, acts on the enzyme that breaks it down, increases the transport capacity and volume of all membrane sugar carriers. In addition, the component accelerates lipid metabolism, reduces total cholesterol, which leads to stabilization or a moderate decrease in the patient's body weight.

After taking the drug is absorbed in the stomach and intestines, its absorption is affected by food intake in the direction of slowing down. The bioavailability of metformin hydrochloride is 55%, reaching a maximum in plasma after 2.5 hours (for Glucophage Long, this time is 5 hours). The active substance enters all tissues, minimally binds to plasma proteins, is slightly metabolized and excreted by the kidneys.

Indications for the use of Glucophage

Doctors prescribe Glucophage 500 - the instructions for use of the drug say about its indications for use:

  • type 2 diabetes mellitus, including patients requiring treatment for obesity, with the ineffectiveness of diet and exercise therapy;
  • monotherapy for diabetes or in combination with other oral hypoglycemic drugs or with the appointment of insulin;
  • complex therapy with insulin or the use of solo for the treatment of diabetes in children older than 10 years.

Glucophage for diabetes

The drug increases the sensitivity of insulin receptors and accelerates the processing of sugar in the muscles, which leads to a decrease in blood glucose levels. This helps prevent hyperglycemia, which can accompany type 2 diabetes. A single (for Glucophage Long) or double dose of the drug helps to stabilize the condition of a patient with diabetes mellitus.

Glucophage 500 for weight loss

In addition to normalizing blood sugar levels, Glucophage is used for weight loss. According to doctors, it is undesirable to take pills to healthy people, because manifestations of negative reactions are not uncommon. The drug reduces the level bad cholesterol and normalizes the metabolism of fats only in diabetics. Some do not pay attention to the statements of doctors and drink diet pills. In this case, consultation and compliance with the instructions is required:

  • drink at a dosage of 500 mg before meals three times a day, the maximum daily dose of metformin is 3000 mg;
  • if the dose is high (dizziness and nausea are observed), reduce it by half;
  • the course lasts 18-22 days, you can repeat the reception in a few months.

How to take Glucophage

According to the instructions for use, the drug Glucophage is taken orally. For adults, the initial dose for monotherapy is 500 mg or 850 mg 2-3 times a day after meals or simultaneously with it. The maintenance dose is 1500-2000 mg per day, divided into 3 doses, and the maximum daily dose is 3000 mg. When combined with insulin, the initial dose is 500-850 mg 2-3 times a day.

For children over 10 years of age, the initial dosage is 500-850 mg once a day after or during meals. After 10-15 days, the dose is adjusted, the maximum daily dose is 2000 mg in two divided doses. In the elderly, due to a decrease in kidney function, the dose is determined based on the content of creatinine in the blood serum. Adults over 18 years of age take Glucophage Long once a day during dinner, the initial dose is 1 tablet, after 10-15 days it is adjusted to 1.5 g (2 tablets) once a day. If this is not enough, the maximum vine will be 2.25 g (3 tablets) once a day.

special instructions

There is a point of special instructions in the instructions for use, which must be studied especially carefully:

  • due to the accumulation of metformin, a rare but serious disease lactic acidosis with high mortality (causes may be renal failure, ketosis, starvation, low carbohydrate diet, alcoholism);
  • medication should be stopped 2 days before elective surgery and continued 2 days after surgery;
  • in monotherapy, the drug is not able to cause hypoglycemia;
  • the agent does not affect the concentration of attention and the speed of psychomotor reactions, therefore it can be taken when controlling mechanisms.

Glucophage during pregnancy

The use of the drug is contraindicated during pregnancy, but, according to the few reviews of pregnant women who are still forced to take it, no development of organ defects in newborns was observed. When planning pregnancy or when it occurs, drug therapy should be discontinued, insulin should be prescribed. Metformin is excreted in breast milk; breastfeeding during drug therapy is not recommended.

drug interaction

The instructions for the use of Glucophage indicate its drug interaction with other medicines:

  • it is forbidden to combine the drug with iodine-containing radiopaque substances, so as not to cause lactic acidosis and complications of diabetes;
  • the combination with Danazol is used with caution to avoid hyperglycemic action;
  • Chlorpromazine increases the concentration of glucose in the blood, reducing the release of insulin;
  • treatment with neuroleptics requires dose adjustment of Glucophage;
  • glucocorticosteroids reduce glucose tolerance, increase its level in the blood, and can cause ketosis;
  • during therapy with diuretics, the development of lactic acidosis is possible;
  • injections of beta-agonists increase the concentration of sugar, ACE inhibitors and antihypertensive therapy reduce this indicator;
  • when combined with sulfonylurea derivatives, Acarbose, salicylates, hypoglycemia may occur;
  • Amilord, Morphine, Quinidine, Ranitidine lead to an increase in the concentration of the active substance.

Interaction with alcohol

An unrecommended combination is the combination of Glucophage with alcohol intake. Ethanol in acute alcohol poisoning increases the risk of developing lactic acidosis, which increases against the background of a low-calorie diet, a low-calorie diet, and liver failure. During the entire course of drug treatment, alcohol-containing drinks and drugs, alcohol consumption should be avoided.

Side effects

The instructions for use of Glucofage 500 indicate the possible manifestation of the following side effects:

  • lactic acidosis, decreased absorption of vitamin B12;
  • taste disturbance, nausea, vomiting, the remedy may reduce appetite;
  • pain in the abdomen, head;
  • erythema, itching, skin rash, hepatitis, impaired liver function;
  • in children, side effects are similar in nature and severity to those in adults.

Overdose

Symptoms of an overdose of the drug are signs of lactic acidosis. These include drowsiness, weakness, heaviness in the limbs, nausea. Pathology develops in a few hours, diarrhea, vomiting, confusion begin abruptly. Treatment includes urgent hospitalization, hemodialysis to remove lactate and metformin from the body, symptomatic therapy.

Contraindications

The instructions for use indicate the presence of the following contraindications, in which the drug is prohibited:

  • hypersensitivity to components;
  • diabetic coma, ketoacidosis, precoma;
  • renal failure, impaired renal function;
  • dehydration, infectious diseases of the kidneys, shock;
  • respiratory and heart failure, acute myocardial infarction;
  • chronic alcoholism;
  • pregnancy;
  • lactic acidosis, compliance with hypocaloric work.

Terms of sale and storage

You can buy Glucophage only with a prescription. The drug is stored away from children in a dark place at temperatures up to 25 degrees, the shelf life is 3-5 years, depending on the concentration of metformin hydrochloride in tablets.

Analogues

There are several direct and indirect analogues of Glucophage. The former are similar to the drug in terms of the active composition and active ingredients, the latter in terms of the effect shown. On the shelves of pharmacies, you can find the following substitutes for the drug, produced in factories in Russia and abroad:

  • Metformin;
  • Siofor;
  • Bahomet;
  • Glycomet;
  • Dianormet;
  • Diaformin;
  • Insufor;
  • Langerin.

Price Glucophage 500

You can buy the drug through the Internet or pharmacy departments at a cost, the level of which is affected by the trade margin, the concentration of the active substance in the tablets, their number in the package. Approximate prices for tablets will be:

Metformin hydrochloride concentration, mg

Number of tablets in a package, pcs.

Internet price, in rubles

Pharmacy price in rubles

Video

Today, when most people, both at home and at work, adhere to a sedentary lifestyle, the problem of obesity in the country has become quite acute. Having neither the strength nor the opportunity to regularly visit the gym and eat right, they rely on various nutritional supplements and medicines that supposedly help in normalizing weight.

And Glucophage is one of those drugs. But is it as effective as marketers present it? And will it lead to serious health problems in the future? Let's try to figure it out.

Forms of release and analogues

In 2017, Glucophage is sold on the drug market in the form of biconvex round white tablets with a dosage of the active substance (metformin hydrochloride): 500, 850 and 1000 mg. They are packed in 10 pieces in blisters, of which there can be 10, 15 or 20 in one carton pack. The shelf life of the drug is 3 years, the permissible storage temperature range is 15 ° -25 ° C.

In pharmacies, you can find Glucophage Long - a type of drug that has a prolonged (prolonged) effect. The dosage of metformin in it is 500 mg, and the excipients are sodium carmellose, magnesium stearate, hypromellose 2208 and 2910, and microcrystalline cellulose. Such a composition contributes to the fact that the digestive organs take much more time to absorb the active substance, which means that it will be enough and less likely to take it.

Among other analogues of Glucophage, the most famous are:

  • Metformin;
  • Metformin-Teva;

Which drug to choose in the end? If we consider these drugs as hypoglycemic drugs, then the final decision here is up to the attending physician. If the result of losing weight is at the forefront, then it is better to make a choice based on the minimum number of side effects of the drug and their severity.

Although the composition of analogue drugs is almost identical (metformin is responsible for weight loss in all of them), various sugar shells, dyes and other auxiliary elements (which do not play an important role as supplements) may have different degrees of purification, and hence some other side effects.

Operating principle

Glucophage refers to hypoglycemic drugs. Due to its constituent metformin, the drug reduces the manifestation of hyperglycemia in the body, while not contributing to the development of hypoglycemia.

In addition, he:

  • stabilizes lipid metabolism by reducing the level of triglycerides, total cholesterol and LDL (low density lipoprotein);
  • increases the sensitivity of peripheral receptors to a number of therapeutic drugs (for example, to insulin);
  • stimulates muscle cells for better absorption of glucose;
  • significantly slows down the absorption of carbohydrates by the intestines and gluconeogenesis occurring in the liver.

Dosage

This is a powerful drug. Therefore, the attending physician should determine the dosage and course that is optimal for your body. Independence in this matter is fraught with extremely serious consequences (even death).

The generalized instructions for use in diabetes are as follows:

  1. The drug is allowed to be taken, both in combination with other drugs, and independently of them.
  2. It is best to drink Glucophage during a meal, drinking plenty of non-carbonated boiled water at room temperature.
  3. To reduce the risk of side effects and accelerate the process of addiction of the digestive tract to the drug, increasing the dose should be done systematically. At the beginning of the course in an adult, the dosage (at one time) should not exceed 500 mg.
  4. Every day the patient should take an average of 1500 to 2 thousand mg of the drug. The maximum allowable daily dose is 3 thousand mg.
  5. To achieve the optimal concentration of glucose in the blood, it is worth combining Glucophage with insulin.
  6. Patients who are in old age or have not yet reached the age of majority are not recommended to drink the drug. However, if such a need arose, it is worth taking under strict control the performance of the kidneys and the concentration of creatinine in the blood serum.

We remind you that Glucophage is a potent drug, and therefore a preliminary consultation with a doctor is required!

Indications for use

As we already know, initially, Glucophage is not a diet pill at all, but an oral hypoglycemic drug. Assign it, as a rule, to those who need to lower their blood glucose levels:

  • patients with type 1 and type 2 diabetes;
  • people with severe obesity who are not helped by either physical activity or diet therapy;
  • those who take insulin or various oral hypoglycemic drugs, but do not get enough benefit from them.

In other cases, metformin-containing drugs are trying to replace them with analogues that have a milder effect, as well as various dietary supplements and herbal preparations. The positive effect of their use is about the same, but the harm to health is significantly less.

Contraindications

Like any other drug, the drug in question not only heals, but also cripples. That's only if for a healthy person its impact, say, on the kidneys, will be insignificant, then in the case of those who suffer from acute renal failure, an attempt to lose extra pounds can turn out to be tragic. Therefore, the drug today in pharmacies is dispensed exclusively by prescription.

Just take a look at what an extensive list of contraindications to the use of Glucophage can be distinguished:

  • insufficient (up to 10 years, and for Glucophage XR - up to 18 years) or excessive (over 60 years) age of losing weight;
  • interruptions in the work of the kidneys, liver, adrenal glands;
  • hypoxia and respiratory failure;
  • infectious, broncho-pulmonary and other serious diseases that can adversely affect the condition of the liver and kidneys;
  • diabetic ketoacidosis and heart failure;
  • poisoning of the body (regardless of etiology);
  • pregnancy and breastfeeding period;
  • lactic acidosis, even if it is currently in history;
  • consumption of losing weight less than 1 thousand kcal per day (for example, as part of a hypocaloric diet);
  • chronic alcoholism, drug addiction (including cured);
  • indications for insulin therapy (for example, in the presence of certain injuries or in the postoperative period);
  • participation of a losing weight in x-ray or radioisotope studies.

Even if all of the above is not about you, do not forget that no one has canceled individual intolerance to the drug. Therefore, before you start taking Glucophage, consult your doctor. Otherwise, you are drawing to face an overdose and all the ensuing consequences.

Overdose: how to recognize and what to do?

Although the drug is released strictly by prescription, some people (thanks to unscrupulous pharmacists) manage to buy it without any prescriptions. In such cases, the regimen is drawn up by the patient himself and, as a rule, does not correspond to either the needs or the capabilities of the body. The result of such amateur performance is often an overdose, which is accompanied by the following symptoms:

  • dehydration (dehydration);
  • nausea, vomiting and diarrhea;
  • shortness of breath, fever, impaired consciousness;
  • the appearance of pain in the abdomen and muscles.

If you do not take the necessary measures promptly, your weight loss risks ending with lactic acidosis, hyperlactacidemic coma, hypoglycemia (extremely rare), and even death. It will only help in this case:

  • complete rejection of Glucophage when the first characteristic signs of deterioration in well-being appear;
  • immediate hospitalization and testing of blood lactate levels;
  • hemodialysis and symptomatic therapy.

You do not need to rely on the instructions for use when compiling the course. Still, it is designed for people who are struggling with the disease, and not with extra pounds and centimeters.

Side effects

Even if you drink Glucophage correctly, it will not protect you from side effects. And they, it should be noted, the drug is quite serious. So, after a couple of - three days after the start of the reception, you can find problems in the work:

  1. Digestive system. A sharp metallic taste will appear in the mouth, flatulence (excessive gas formation) will begin, there are pulling pains in the abdomen. Appetite may partially or completely disappear, and taste sensations may change.
  2. immune system. The absorption of vitamin B12 worsens and, as a result, hypovitaminosis develops, an allergic rash may appear on the skin. Cases of metabolic disorders and the appearance of lactic acidosis are not uncommon.
  3. Of cardio-vascular system. Cases of blood damage and megaloblastic anemia have been recorded.
  4. Other internal organs. Often there is liver damage, complete disappearance of the patient's appetite, the occurrence of drug-induced hepatitis.

Most of these manifestations are temporary and disappear in the first week after the start of treatment. However, since there is no specific antidote for the harmful effects of this drug, it is worth monitoring your health with increased attention. And if after 7 days the symptoms only worsen, or other side effects not mentioned above occur, you should immediately consult a doctor.

Is there a result?

The main thing that worries every patient is, of course, the final result. To evaluate the effectiveness of a drug, you can refer to medical forums and sites where people who have already taken it actively share their experiences. Reading them, it becomes clear that the drug will be useful for diabetics and people whose degree of obesity exceeds the initial one, and BMI crept up to 30 kg / m² or exceeded it.

Those who plan to use these “miracle pills” for express weight loss (for example, to tidy up before the upcoming corporate party) should abandon their idea, because along with weight they can lose a significant part of their health.

Is it possible to give Glucophage to children?

While user reviews are often embellished and biased, medical statistics based solely on the results of various experiences and tests provide clear information on the issue. So, in particular, scientists at the University of Oregon conducted clinical studies in 2014, in which they assessed the expediency of using Glucophage and a number of other metformin-containing drugs in the treatment of obesity in children and adolescents.

The tests were carried out for six months. About a thousand young patients aged 10 to 16 years old with a body mass index ranging from 26 to 41 kg / m², who do not suffer from diabetes, took part in them. At the same time, in all subjects, glucose tolerance was within the normal range.

The results of studies have shown that the drug is not particularly effective for children. Its use in combination with exercise and diet therapy proved to be hardly more effective than using these methods alone. The best result was a decrease in BMI by 1.38 units, which in percentage terms is no more than 5%.

For a remedy with such an extensive list of side effects, this figure is more than disappointing. And this, in turn, means that it is better not to use it for weight loss of underage patients who are obese, but do not have diabetes.

Interaction with drugs

The correct dosage is far from the only indicator that affects the effectiveness of Glucophage. If you combine it with another drug, the result can often be unpredictable.

Prohibited combinations:

  1. Parallel use with alcohol and alcohol-containing drugs in the vast majority of cases ends in failure. The patient first earns himself hypoglycemia, then falls into a hypoglycemic coma and (in the absence of emergency assistance) dies.
  2. If you do not limit yourself to the consumption of foods with a high glucose content (for example, white sugar or sweets) while taking the drug, then your attempts to lose weight will be like fighting windmills.
  3. Iodine-containing radiocontrast agents with Glucophage are also absolutely incompatible. Therefore, if you do not want to earn lactic acidosis, you should stop taking the drug 2 days before radiological and x-ray studies. The course should also be resumed no earlier than 48 hours later (provided that during the examination no abnormalities in the work of the internal organs were detected).
  4. Nutrition in combination with the use of this remedy threatens to turn into serious disruptions in the work of internal organs. During the course of treatment (weight loss) - the body must receive all the necessary minerals and vitamins.

Combinations requiring extra caution:

  1. If you plan to take this drug with diuretics and indirect hyperglycemic drugs, be prepared to check your blood glucose more carefully and more often.
  2. The combination "Glucophage + loop diuretics" against the background of renal or functional liver failure threatens to turn into lactic acidosis.
  3. When trying to combine with insulin, salicylates and sulfonylurea derivatives, the patient's disease with hypoglycemia has already been detected more than once.
  4. Cationic and antihypertensive drugs can contribute to a significant adjustment in the dose of the drug and the course of its use.
  5. Nifedipine, chlorpromazine and a number of beta 2-agonists increase the concentration of glucose in the blood, and therefore, at a high dosage, they can neutralize the effect of the drug, aimed at reducing it, and provoke the appointment of insulin.
  6. Do not take Glucophage together without first consulting with your doctor. Although these drugs have a similar principle of action, the result of their combination can be a double blow to the internal systems of the body.

The drug market is developing more and more dynamically every year. Therefore, if you did not find other medications you take in these lists, this does not mean at all that their use in conjunction with Glucophage will not have negative consequences. To protect your body from unnecessary risks, everything is also possible only by contacting a doctor. So you won’t confuse the dosage, and you will learn about the nuances of the complex reception, known only to an experienced specialist.

Necessary dietary changes

Diet when taking Glucophage is required. Moreover, you will have to adhere to it even after the completion of the treatment course. The only consolation for those who love to eat heartily is that conditions are milder than fasting or express diets.

You can choose between balanced and unbalanced menus. In the first case, the body will consistently receive all the necessary nutrients from food, while the number of calories consumed will be reduced. The second option focuses on foods high in carbohydrates, but completely excludes lipids from the diet.

Also, in both cases, your menu should include foods high in plant fibers (beans, grains, peas). But about sugar and sugar-containing products will have to be completely forgotten.

Glucophage is one of the most potent drugs and has a fairly long list of contraindications and side effects. Therefore, healthy people (who have no other indications other than being overweight) should not drink it as a means for losing weight. The result achieved will be short-lived, but the consequences for health are severe.

If you still want to lose weight on pills, consult your doctor and ask them to prescribe analogues or advise you on effective dietary supplements. And leave this drug to those who really need it.

To your attention, other drugs that contribute to weight loss:

An original metformin drug that meets all the principles of evidence-based medicine



Glucophage 500/850/1000 mg - official instructions for use

This version of the instructions for medical use is valid from July 6, 2016

Registration number:

P N014600/01

Tradename:

INN:

Metformin

Dosage form

Film-coated tablets

Compound

One tablet contains:
Nucleus:
Active ingredient: metformin hydrochloride - 500/850/1000 mg;
Auxiliary ingredients: povidone 20/34/40 mg, magnesium stearate 5.0/8.5/10.0 mg.
Film sheath:
Dosage 500 mg and 850 mg: hypromellose 4.0/6.8 mg.
Dosage 1000 mg: Opadry pure 21 mg (hypromellose 90.90%, macrogol 400 4.550%, macrogol 8000 4.550%).

Description

Dosage 500 mg, 850 mg:
White, round, biconvex film-coated tablets.

Dosage 1000 mg:
White, oval, biconvex film-coated tablets, scored on both sides and engraved "1000" on one side.
On the transverse section - a homogeneous white mass.

Pharmacotherapeutic group

Hypoglycemic agent of the biguanide group for oral administration.

ATX code: A10BA02

Pharmacotherapeutic properties

Pharmacodynamics

Metformin reduces hyperglycemia without causing hypoglycemia. Unlike sulfonylurea derivatives, it does not stimulate insulin secretion and does not have a hypoglycemic effect in healthy individuals. Increases the sensitivity of peripheral receptors to insulin and the utilization of glucose by cells. Reduces the production of glucose by the liver by inhibiting gluconeogenesis and glycogenolysis.
Delays the absorption of glucose in the intestine.

Metformin stimulates glycogen synthesis by acting on glycogen synthase. Increases the transport capacity of all types of membrane glucose carriers.

In addition, it has a beneficial effect on lipid metabolism: it reduces the content of total cholesterol, low-density lipoprotein and triglycerides.

While taking metformin, the patient's body weight either remains stable or moderately decreases.

Clinical studies have also shown the efficacy of Glucophage ® in the prevention of diabetes mellitus in prediabetic patients with additional risk factors for overt type 2 diabetes mellitus, in whom lifestyle changes have not allowed adequate glycemic control to be achieved.

Pharmacokinetics

Absorption and distribution
After oral administration, metformin is absorbed from the gastrointestinal tract quite completely. Absolute bioavailability is 50-60%. The maximum concentration (Cmax) (approximately 2 μg / ml or 15 μmol) in plasma is reached after 2.5 hours. With simultaneous ingestion of food, the absorption of metformin decreases and lingers. Metformin is rapidly distributed in tissues, practically does not bind to plasma proteins.

Metabolism and excretion
It is metabolized to a very low degree and excreted by the kidneys. Metformin clearance in healthy subjects is 400 ml/min (4 times greater than creatinine clearance), indicating the presence of active tubular secretion. The half-life is approximately 6.5 hours. With renal failure, it increases, there is a risk of cumulation of the drug.

Indications for use

Type 2 diabetes mellitus, especially in obese patients, with the ineffectiveness of diet therapy and physical activity:
  • in adults as monotherapy or in combination with other oral hypoglycemic agents, or with insulin;
  • in children from 10 years of age as monotherapy or in combination with insulin.
Prevention of type 2 diabetes mellitus in prediabetic patients with additional risk factors for type 2 diabetes mellitus in whom lifestyle changes have not achieved adequate glycemic control.

Contraindications

  • Hypersensitivity to metformin or to any excipient;
  • diabetic ketoacidosis, diabetic precoma, coma;
  • renal failure or impaired renal function (creatinine clearance less than 45 ml / min);
  • acute conditions occurring with a risk of developing impaired renal function: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;
  • clinically pronounced manifestations of acute or chronic diseases that can lead to the development of tissue hypoxia (including acute heart failure, chronic heart failure with unstable hemodynamic parameters, respiratory failure, acute myocardial infarction);
  • extensive surgical operations and injuries when insulin therapy is indicated (see section "Special Instructions");
  • liver failure, impaired liver function;
  • chronic alcoholism, acute alcohol poisoning;
  • pregnancy;
  • lactic acidosis (including history);
  • use within less than 48 hours before and within 48 hours after radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent (see section "Interaction with other drugs");
  • adherence to a hypocaloric diet (less than 1000 kcal / day).

With caution

Apply the drug

  • in persons over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis in them;
  • in patients with renal insufficiency (creatine clearance 45-59 ml / min);
  • during the period of breastfeeding.

Use during pregnancy and during breastfeeding

Decompensated diabetes mellitus during pregnancy is associated with an increased risk of congenital malformations and perinatal mortality. Limited data suggest that taking metformin in pregnant women does not increase the risk of birth defects in children.

When planning pregnancy, as well as in the event of pregnancy while taking metformin in prediabetes and type 2 diabetes, the drug should be discontinued, and in the case of type 2 diabetes, insulin therapy is prescribed. Plasma glucose levels should be maintained as close to normal as possible to reduce the risk of fetal malformations.

Metformin passes into breast milk. Side effects in newborns during breastfeeding while taking metformin were not observed. However, due to the limited amount of data, the use of the drug 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.

Dosage and administration

Apply inside.

Adults:
Monotherapy and combination therapy in combination with other oral hypoglycemic agents in type 2 diabetes mellitus:

  • The usual starting dose is 500 mg or 850 mg 2-3 times a day after or during meals.
  • Every 10-15 days, it is recommended to adjust the dose based on the results of measuring the concentration of glucose in the blood plasma. Slowly increasing the dose helps to reduce side effects from the gastrointestinal tract.
  • The maintenance dose of the drug is usually 1500-2000 mg / day. To reduce side effects from the gastrointestinal tract, the daily dose should be divided into 2-3 doses. The maximum dose is 3000 mg / day, divided into three doses.
  • Patients taking metformin at doses of 2000-3000 mg/day can be switched to taking Glucophage ® 1000 mg. The maximum recommended dose is 3000 mg/day divided into 3 divided doses.
If you plan to switch from taking another hypoglycemic drug: you must stop taking the other drug and start taking Glucophage ® at the dose indicated above.

Combination with insulin:
To achieve better control of blood glucose, metformin and insulin in patients with type 2 diabetes can be used as a combination therapy. The usual initial dose of Glucophage ® is 500 mg or 850 mg 2-3 times a day, while the dose of insulin is selected based on the concentration of glucose in the blood.

Children and teenagers:
in children over 10 years of age, Glucophage ® can be used both as monotherapy and in combination with insulin. The usual starting dose is 500 mg or 850 mg once a day after or during a meal. After 10-15 days, the dose must be adjusted based on the concentration of blood glucose.
The maximum daily dose is 2000 mg divided into 2-3 doses.

Monotherapy for prediabetes:
The usual dose is 1000-1700 mg per day after or during a meal, divided into 2 doses.
It is recommended to regularly conduct glycemic control to assess the need for further use of the drug.

Patients with renal insufficiency:
Metformin can be used in patients with moderate renal insufficiency (creatine clearance 45-59 ml / min) only in the absence of conditions that may increase the risk of developing lactic acidosis.

  • Patients with a creatine clearance of 45-59 ml/min: The initial dose is 500 mg or 850 mg once daily. The maximum dose is 1000 mg per day, divided into 2 doses.
Kidney function should be carefully monitored (every 3-6 months).
If creatine clearance is below 45 ml/min, the drug should be discontinued immediately.

Elderly patients:
due to a possible decrease in kidney function, the dose of metformin must be selected under regular monitoring of indicators of kidney function (to determine the concentration of creatinine in the blood serum at least 2-4 times a year).

Duration of treatment

Glucophage ® should be taken daily, without interruption. In the event of discontinuation of treatment, the patient must inform the doctor.

Side effect

The frequency of side effects of the drug is regarded as follows:
Very common: ≥ 1/10
Common: ≥ 1/100, Uncommon: ≥ 1/1000, Rare: ≥ 1/10,000, Very rare: Side effects are listed in decreasing order of importance.

Metabolic and nutritional disorders:
Very rare: lactic acidosis (see "Special Instructions"). With long-term use of metformin, there may be a decrease in the absorption of vitamin B12. When megaloblastic anemia is detected, the possibility of such an etiology must be considered.

Nervous system disorders:
Often: taste disturbance.

Gastrointestinal disorders:
Very common: nausea, vomiting, diarrhoea, abdominal pain and lack of appetite.
Most often they occur in the initial period of treatment and in most cases resolve spontaneously. To prevent symptoms, it is recommended to take metformin 2 or 3 times a day during or after meals. Slow dose escalation may improve gastrointestinal tolerance.

Skin and subcutaneous tissue disorders:
Very rare: skin reactions such as erythema, pruritus, rash.

Liver and biliary tract disorders:
Very rare: abnormal liver function tests and hepatitis; after the abolition of metformin, these adverse events completely disappear.

Published data, post-marketing data, and controlled clinical studies in a limited pediatric population in the 10-16 year age group show that side effects in children are similar in nature and severity to those in adult patients.

Overdose

When using metformin at a dose of 85 g (42.5 times the maximum daily dose), no hypoglycemia was observed. However, in this case, the development of lactic acidosis was observed. A significant overdose or associated risk factors can lead to the development of lactic acidosis (see "Special Instructions").

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

Interaction with other drugs

Contraindicated combinations

Iodine-containing radiopaque agents: against the background of functional renal failure in patients with diabetes mellitus, a radiological examination using iodine-containing radiopaque agents can cause the development of lactic acidosis. Treatment with Glucophage ® should be discontinued, depending on kidney function, 48 hours before or at the time of an x-ray examination using iodine-containing radiopaque agents and not resumed earlier than 48 hours after, provided that during the examination, renal function was found to be normal.

Alcohol: with acute alcohol intoxication, the risk of developing lactic acidosis increases, especially in the case of:

  • malnutrition, low-calorie diet;
  • liver failure.
While taking the drug, alcohol and medicines containing ethanol should be avoided.

Combinations requiring caution

Danazol: concomitant use of danazol is not recommended in order to avoid the hyperglycemic effect of the latter. If treatment with danazol is necessary and after discontinuation of the latter, a dose adjustment of the drug Glucophage ® is required under the control of blood glucose concentration.

Chlorpromazine: when taken in high doses (100 mg per day), it increases the concentration of glucose in the blood, reducing the release of insulin. In the treatment of neuroleptics and after discontinuation of the latter, a dose adjustment of the drug is required under the control of the concentration of glucose in the blood.

Glucocorticosteroids (GCS) systemic and local action reduce glucose tolerance, increase the concentration of glucose in the blood, sometimes causing ketosis. In the treatment of corticosteroids and after discontinuation of the latter, a dose adjustment of the drug Glucophage ® is required under the control of the concentration of glucose in the blood.

Diuretics: simultaneous reception of "loop" diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Do not prescribe Glucophage ® if creatinine clearance is below 60 ml/min.

Assigned in the form of injections of beta 2-adrenergic agonists: increase the concentration of glucose in the blood due to stimulation of beta 2-adrenergic receptors. In this case, it is necessary to control the concentration of glucose in the blood. If necessary, the appointment of insulin is recommended.
With the simultaneous use of the above drugs, more frequent monitoring of blood glucose levels may be required, especially at the beginning of treatment. If necessary, the dose of metformin can be adjusted during treatment and after its termination.

Antihypertensive drugs, with the exception of angiotensin-converting enzyme inhibitors, may lower blood glucose levels. If necessary, the dose of metformin should be adjusted.

With the simultaneous use of the drug Glucophage ® with sulfonylurea derivatives, insulin, acarbose, salicylates possible development of hypoglycemia.

Nifedipine increases 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 C max.

special instructions

lactic acidosis
Lactic acidosis is a rare but serious (high mortality in the absence of emergency treatment) complication that can occur due to the accumulation of metformin. Cases of lactic acidosis while taking metformin occurred mainly in patients with diabetes mellitus with severe renal insufficiency.

Other associated risk factors should also be considered, 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 non-specific signs appear, such as muscle cramps, accompanied by dyspeptic disorders, abdominal pain and severe asthenia. Lactic acidosis is characterized by acidotic dyspnea, abdominal pain, and hypothermia followed by coma. Diagnostic laboratory indicators are a decrease in blood pH (less than 7.25), a lactate content in blood plasma over 5 mmol / l, an increased anion gap and a lactate / pyruvate ratio. If you suspect metabolic acidosis, you should stop taking the drug and consult a doctor immediately.

Surgical operations
Metformin should be discontinued 48 hours before elective surgery and may be continued no earlier than 48 hours after, provided that renal function was 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 the creatinine clearance:

  • 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 at the lower limit of normal.
In the case of creatine clearance less than 45 ml / min, the use of the drug is contraindicated.
Particular caution should be exercised with possible impaired renal function in elderly patients, while the 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 regularly monitor cardiac and renal function while taking metformin. Reception of 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, it was shown that metformin does not affect growth and puberty. However, in view of the lack of long-term data, careful monitoring of the subsequent effect of metformin on these parameters in children is recommended, especially during puberty. The most careful monitoring is necessary for children aged 10-12 years.

Other Precautions:

  • Patients are advised to continue to follow a diet with an even intake of carbohydrates throughout the day. Patients with overweight are advised to continue to follow a low-calorie diet (but not less than 1000 kcal / day).
  • It is recommended that standard laboratory tests be performed regularly to control diabetes mellitus.
  • Metformin does not cause hypoglycemia when used alone, but caution is advised when it is used in combination with insulin or other hypoglycemic agents (eg, sulfonylurea derivatives, repaglinide, etc.).
The use of Glucophage ® is recommended for the prevention of type 2 diabetes mellitus in people with prediabetes and additional risk factors for the development of overt type 2 diabetes, such as:
- age less than 60 years;
- body mass index (BMI) ≥35 kg/m2;
- a history of gestational diabetes mellitus;
- family history of diabetes mellitus in first-degree relatives;
- increased concentration of triglycerides;
- reduced concentration of HDL cholesterol;

Influence on the ability to drive vehicles and mechanisms

Monotherapy with Glucophage ® does not cause hypoglycemia, therefore it does not affect the ability to drive vehicles and mechanisms.
However, patients should be warned about the risk of hypoglycemia when using metformin in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin, repaglinide, etc.).

Release form


10 tablets in a PVC / aluminum foil blister, 3 or 5 blisters, together with instructions for use, are placed in a cardboard box;

Film-coated tablets 850 mg:
15 tablets in a PVC / aluminum foil blister, 2 or 4 blisters, together with instructions for use, are placed in a cardboard box;
20 tablets in a PVC / aluminum foil blister, 3 or 5 blisters, together with instructions for use, are placed in a cardboard box.


10 tablets in a PVC / aluminum foil blister, 3, 5, 6 or 12 blisters, together with instructions for use, are placed in a cardboard box;
15 tablets in a PVC / aluminum foil blister, 2, 3 or 4 blisters, together with instructions for use, are placed in a cardboard box.

Film-coated tablets 500 mg:
15 tablets in a PVC / aluminum foil blister, 2 or 4 blisters, together with instructions for use, are placed in a cardboard box;
20 tablets in a PVC / aluminum foil blister, 3 blisters, together with instructions for use, are placed in a cardboard box.

Film-coated tablets 1000 mg
15 tablets in a PVC / aluminum foil blister, 2 or 4 blisters, together with instructions for use, are placed in a cardboard box.
The blister and carton box are marked with the “M” symbol to protect against falsification.

Storage conditions

Store at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Best before date

Dosages 500 mg and 850 mg: 5 years.
Dosage 1000 mg: 3 years.
Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription.

Manufacturer


Merck Sante s.a.s., France

Or in the case of the packaging of the drug LLC "Nanolek":

Manufacturer
Production of the finished dosage form and packaging (primary packaging)
Merck Sante s.a.s., France
Center de production Semois, 2 rue du Pressoire Ver - 45400 Semois, France

Secondary (consumer packaging) and releasing quality control:
Nanolek LLC, Russia
612079, Kirov region, Orichevsky district, village Levintsy, Biomedical complex "NANOLEK"

Manufacturer
All stages of production, including releasing quality control:
Merck S.L., Spain
Poligono Merck, 08100 Mollet del Valles, Barcelona, ​​Spain.

Consumer claims should be sent to:
Merck LLC

115054 Moscow, st. Gross, d.35.

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