Metforvel

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Metforvel: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Metphorvel

ATX code: A10BA02

Active ingredient: metformin (Metformin)

Manufacturer: OOO Velpharm (Russia)

Description and photo update: 2020-18-08

Prices in pharmacies: from 72 rubles.

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Metforvel is an oral hypoglycemic drug from the biguanide group.

Release form and composition

Dosage form - film-coated tablets: biconvex; at a dosage of 500 mg - round, at a dosage of 850 mg - oval; the film membrane and the core in the cross section - from white to almost white [10 pcs. in blisters made of PVC (polyvinyl chloride) film and aluminum lacquered printing foil, in a cardboard box from 1 to 6 cell packs and instructions for the use of Metforvel; 10, 20, 30, 40, 50, 60 pcs. in polypropylene cans with a stretch lid made of high pressure polyethylene or polyethylene cans with a stretch lid made of low pressure polyethylene, or with a screw cap made of low pressure polyethylene, in a carton box 1 can and instructions for use of the preparation].

Composition for one tablet:

active substance: metformin hydrochloride - 500 or 850 mg;
auxiliary ingredients: pregelatinized corn starch, sodium starch glycolate (sodium carboxymethyl starch, primogel), povidone K30 (kollidon, plasdon K29 / 32), sodium stearyl fumarate, macrogol 6000 (polyethylene oxide 6000, polyethylene glycol 6000), talc;
film casing: Opadray 03F180011 white (titanium dioxide, hypromellose, macrogol).

Pharmacological properties

Pharmacodynamics

As an active substance, Metforvel contains metformin, which reduces hyperglycemia, but does not lead to the development of hypoglycemia. In healthy individuals, it does not stimulate the production of insulin and does not have a hypoglycemic effect, in contrast to PSM (sulfonylurea derivatives). Metformin increases the sensitivity of peripheral receptors to insulin and increases the utilization of glucose in the body; by inhibiting the processes of gluconeogenesis and glycogenolysis, it reduces the production of glucose by the liver, delays its absorption in the intestine.

Glycogen synthesis by metformin is stimulated by influencing glycogen synthase. Metforvel increases the transport capacity of all types of membrane carrier proteins responsible for the transport of glucose across the cell membrane. At the same time, it has a beneficial effect on fat metabolism, reducing the content of total cholesterol (total cholesterol), LDL (low density lipoproteins) and TG (triglycerides).

When taking Metforvel, the patient's weight remains stable or moderately decreases.

Clinical trials have also established the effectiveness of metformin in the prevention of diabetes mellitus in patients with prediabetes and additional risk factors for the development of overt type 2 diabetes mellitus, who have failed to achieve adequate glycemic control through lifestyle changes.

Pharmacokinetics

absorption and distribution: after oral administration, metformin is absorbed from the gastrointestinal tract (gastrointestinal tract) quite completely. Its absolute bioavailability is fixed at 50-60%. The maximum concentration (C _max) of the substance in the blood plasma is approximately 2 μg / ml (15 μmol) and is reached after 2.5 hours. Simultaneous intake of Metforvel with food delays and reduces its absorption. The degree of binding of metformin to blood plasma proteins is insignificant, therefore, it is distributed quickly in tissues and organs;
metabolism and excretion: the substance is metabolized to a very weak extent, after which it is excreted by the kidneys. In healthy subjects, the clearance of metformin reaches ~ 400 ml / min, which is four times higher than that of creatinine, and indicates active tubular secretion. T _1/2 (half-life) is ~ 6.5 hours. In patients with renal insufficiency, it may increase, increasing the likelihood of metformin cumulation.

Indications for use

Metforvel is used for the treatment of type 2 diabetes mellitus, mainly in obese patients, in case of ineffectiveness of diet therapy and physical activity:

adult patients: as a monotherapy drug, or in combination with insulin or other hypoglycemic drugs for oral administration;
children over 10 years old: as a monotherapy drug or in combination with insulin.

Metforvel is also prescribed for the prevention of non-insulin-dependent diabetes mellitus in patients with prediabetes, aggravated by additional circumstances that increase the risk of developing type 2 diabetes mellitus, who have not been able to achieve adequate glycemic control by lifestyle changes.

Contraindications

Absolute:

renal failure [CC (creatinine clearance) index below 45 ml / min];
urgent conditions that increase the risk of developing impaired renal function: dehydration due to diarrhea or vomiting, severe infectious diseases, shock, etc.;
liver failure;
diabetic ketoacidosis, diabetic precoma / coma;
clinically pronounced diseases in the acute or chronic stage leading to the development of histotoxic hypoxia (including respiratory failure, acute heart failure, chronic heart failure with unstable hemodynamic parameters, acute myocardial infarction);
extensive surgical interventions and injuries in which insulin therapy is necessary;
acute alcohol intoxication, chronic alcoholism;
period of pregnancy;
children under 10 years of age;
lactic acidosis (including history);
application less than 48 hours before and after radioisotope or X-ray studies with the introduction of a radio-opaque substance containing iodine;
adherence to a low-calorie diet (with a daily intake of less than 1000 kcal);
hypersensitivity to metformin and / or to any auxiliary component in the Metforvel tablets.

The drug should be taken with caution: children aged 10-12; elderly patients over 60 years of age performing heavy physical work (due to the increased risk of lactic acidosis); patients with renal insufficiency (CC = 45-59 ml / min); breastfeeding women.

Metforvel, instructions for use: method and dosage

Metforvel film-coated tablets are intended for oral administration. They should be taken daily, without interruption. Discontinuation of therapy must be reported to the attending physician.

Recommended doses of metformin for adult patients receiving Metforvel as a monotherapy drug or as part of a combination treatment with other hypoglycemic agents for oral administration, in type 2 diabetes mellitus:

standard starting dose: 500 or 850 mg, 2 or 3 times a day, after meals or with meals. Once every 10-15 days, based on the data on the concentration of glucose in the blood plasma, the dose is adjusted, bringing it to the maintenance dose. Due to the slow increase in the dose, the frequency of side effects from the gastrointestinal tract is reduced;
maintenance dose: from 1500 to 2000 mg per day; to reduce adverse reactions from the gastrointestinal tract, it should be divided into 2-3 doses;
maximum allowable dose: 3000 mg per day, divided into 3 doses.

When planning to switch to Metforvel from another oral hypoglycemic agent, you must stop taking the latter and start taking metformin from the standard starting dose indicated above.

Metformin can be used in combination with insulin to achieve better blood sugar control in patients with type 2 diabetes. Metforvel is received in a standard initial dose of 500 or 850 mg, 2 or 3 times a day, and the dose of insulin is determined by gradual selection based on the blood glucose level.

Recommended doses of metformin for children 10 years of age and older receiving Metforvel as a monotherapy drug or as part of a combination treatment with insulin for type 2 diabetes mellitus:

standard starting dose: 500 or 850 mg once a day, after meals or during meals. Once every 10-15 days, based on the data on the concentration of glucose in the blood plasma, the dose is adjusted;
maximum allowable dose: 2000 mg per day, divided into 2 or 3 doses.

Monotherapy with type 2 diabetes mellitus with metformin: the standard therapeutic dose ranges from 1000 to 1700 mg per day, divided into 2 doses; take tablets after meals or during meals. In this case, you should regularly monitor the blood sugar level in order to assess the need for further treatment with Metforvel.

Metformin can be used for moderate renal failure (CC from 45 to 59 ml / min) in the absence of conditions that increase the risk of developing lactic acidosis, in the following doses:

standard initial: 500 or 850 mg once a day;
maximum allowable: 1000 mg per day, divided into 2 doses. Renal function should be closely monitored every 3–6 months.

If CC is less than 45 ml / min, Metforvel should be stopped immediately.

In elderly patients, a decrease in renal function is possible, therefore, for them, the selection of a therapeutic dose of Metforvel is carried out with regular monitoring of renal function (the content of creatinine in the blood serum is determined at least 2-4 times a year).

Side effects

The frequency of side effects is assessed on the following scale: very often (≥ 10%); often (≥ 1%, but <10%); infrequently (≥ 0.1%, but <1%); rarely (≥ 0.01%, but <0.1%); extremely rare (<0.01%), with an uncertain frequency (based on the data obtained, it is impossible to estimate the frequency of development).

System and organ disorders observed when taking Metforvel:

metabolism and nutrition: extremely rarely - lactic acidosis; due to prolonged use of metformin, a decrease in the absorption of vitamin B ₁₂ may develop (when diagnosing megaloblastic anemia, it is necessary to take into account the likelihood of such an etiology);
nervous system: often - dysgeusia (taste disturbance);
Gastrointestinal tract: very often - abdominal pain, nausea / vomiting, diarrhea, lack of appetite (mainly appear at the beginning of treatment and disappear spontaneously in most cases). To reduce the risk of this symptomatology, it is recommended to divide the daily dose of metformin into 2 or 3 doses and take the tablets with or after meals. In addition, a slow increase in dose may improve gastrointestinal tolerance;
skin and subcutaneous fat: extremely rare - skin reactions (itching, rash, erythema);
hepatobiliary system: extremely rarely - changes in hepatic function indicators, hepatitis. These undesirable reactions completely disappear after discontinuation of metformin.

According to published data and the results of post-marketing observations, as well as the results of controlled clinical trials conducted in a limited population of children and adolescents aged 10 to 16 years, it was found that the side effects of Metforvel in children are similar in nature and severity to those in adult patients.

Overdose

The use of metformin at a dose of 85,000 mg (which is 42.5 times higher than the maximum permissible daily dose) did not cause hypoglycemia, however, the development of lactic acidosis was observed, the symptoms of which are abdominal pain, severe weakness, myalgia, increased sleepiness, respiratory disorders … Patients with severe lactic acidosis were diagnosed with arterial hypotension and resistant bradyarrhythmia.

If signs of lactic acidosis appear, Metforvel should be stopped immediately. The patient is subject to urgent hospitalization, after determining the concentration of lactate, the diagnosis is verified. Hemodialysis is the most effective way to remove lactate and metformin from the body. If necessary, symptomatic therapy is recommended.

special instructions

With the accumulation of metformin, it is possible to develop a rare, but serious complication - lactic acidosis, in the absence of urgent therapy, which is often fatal. Basically, taking metformin caused this disease in patients with diabetes mellitus with severe renal failure. In addition, there are associated risk factors such as prolonged fasting, ketosis, uncompensated diabetes mellitus, liver failure, alcoholism and any other condition accompanied by severe hypoxia. Close control of all of the above factors can reduce the incidence of lactic acidosis. In addition, it is necessary to take into account the high likelihood of lactate accumulation in the event of the appearance of such non-specific signs as muscle cramps accompanied by abdominal pain,dyspeptic disorders and severe asthenia. Lactic acidosis is characterized by acidotic dyspnea, abdominal pain, and hypothermia followed by coma. Diagnostic laboratory parameters characteristic of the state: blood pH ˂ 7.25; blood lactate level> 5 mmol / l; increased anion gap and ratio of lactate to pyruvate. At the slightest suspicion of metabolic acidosis, the drug should be discontinued and immediately seek medical attention from a doctor. At the slightest suspicion of metabolic acidosis, the drug should be discontinued and immediately seek medical attention from a doctor. At the slightest suspicion of metabolic acidosis, the drug should be discontinued and immediately seek medical attention from a doctor.

In the case of planning a surgical intervention, Metforvel is discontinued 48 hours before the operation and treatment is continued no earlier than 48 hours after its completion, provided that after examination of the renal function, it is recognized as normal.

Metformin is excreted from the body by renal elimination, therefore, before the start of the course and further, it is important to regularly determine the CC value: for patients with normal renal function (CC ≥ 60 ml / min) - at least 1 time per year; elderly patients, as well as patients with CC at the lower limit of the norm (CC ≥ 45 ml / min) - at least 2-4 times a year. With CC 45 ml / min, Metforvel is contraindicated. With extreme caution, metformin should be taken simultaneously with antihypertensive drugs, diuretics or non-steroidal anti-inflammatory drugs, as well as in case of possible renal dysfunction in elderly patients.

Patients with heart failure are at increased risk of developing oxygen deprivation and renal failure. In chronic heart failure, regular monitoring of heart and kidney function is recommended while taking metformin. Metforvel is contraindicated in patients with heart failure with unstable hemodynamic parameters.

Other precautions for metformin therapy:

It is important for patients to maintain a consistent diet of carbohydrates throughout the day. Overweight patients should continue to follow a low-calorie diet, but not less than 1000 kcal per day.
You should promptly inform your endocrinologist about any therapy and any transmitted infections.
In order to control diabetes mellitus, standard laboratory tests are performed regularly.
Monotherapy with metformin does not cause the development of hypoglycemia *, however, when it is taken in combination with insulin or other hypoglycemic agents (for example, PSM, repaglinide, etc.), care must be taken.

* Symptoms of hypoglycemia: dizziness, headache, weakness, hyperhidrosis, heart palpitations, deterioration of visual perception, impaired concentration.

Metforvel is taken for the prevention of non-insulin dependent diabetes in prediabetes and additional risk factors for the development of overt type 2 diabetes mellitus, such as:

age ˂ 60 years;
BMI (body mass index) ≥ 35 kg / m ²;
history of gestational diabetes mellitus;
family history of diabetes mellitus in 1st degree relatives;
increased triglyceride levels;
reduced concentration of HDL cholesterol;
arterial hypertension.

Influence on the ability to drive vehicles and complex mechanisms

With metformin monotherapy, the development of hypoglycemia is extremely unlikely, therefore, such a scheme for taking Metforvel does not affect the psychophysical abilities of a person. Nevertheless, in the case of using metformin in combination with other hypoglycemic agents (PSM, repaglinide, insulin, etc.), the risk of hypoglycemia increases significantly. Since its symptoms (such as headache, dizziness, weakness, blurred vision, disorientation, etc.) can affect the reaction rate and ability to concentrate, caution should be exercised if it is necessary to drive vehicles and complex mechanisms during this period.

Application during pregnancy and lactation

It is contraindicated to use Metforvel for the treatment of pregnant and breastfeeding women.

In the case of the appearance of decompensated diabetes mellitus during gestation, the risk of developing congenital malformations in the fetus and the level of perinatal mortality increase. The limited amount of evidence indicates that the risk of developing birth defects in a child does not increase when pregnant women take metformin.

During the planning period of pregnancy, as well as during conception against the background of treatment with metformin for prediabetes and type 2 diabetes mellitus, Metforvel should be taken immediately. Patients with type 2 diabetes mellitus are prescribed insulin therapy. To reduce the risk of developing fetal malformations, blood sugar should be maintained at a level closest to normal.

During lactation, Metformin passes into breast milk. In breastfed infants, no side effects were observed with the mother taking metformin. But due to the limited amount of data, women are not recommended to use Metforvel during this period. The decision to stop breastfeeding is made based on a comparison of the benefits of breast milk for the infant and the potential risk of side effects.

Pediatric use

In pediatric practice, the use of Metforvel is contraindicated for the treatment of children under 10 years of age.

In children and adolescents, it is required to confirm the presence of type 2 diabetes before starting metformin.

As a result of clinical studies that lasted 12 months, it was found that there is no effect of metformin on the growth of the child and its development in puberty. But the insufficient amount of long-term observation data suggests careful monitoring of the condition of children and adolescents with the further use of Metforvel, especially during puberty. The most careful monitoring should be provided to children aged 10 to 12 years.

With impaired renal function

It is contraindicated to prescribe Metforvel to patients with renal failure with CC ˂ 45 ml / min, as well as in acute conditions occurring with a risk of impaired renal function, such as dehydration due to diarrhea or vomiting, severe infections, shock.

With caution, Metforvel tablets are prescribed to patients with renal failure with CC = 45-59 ml / min.

For violations of liver function

The appointment of Metforvel is contraindicated in patients with hepatic insufficiency.

Use in the elderly

Elderly patients over 60 years of age, especially those receiving heavy physical activity, should take Metforvel with caution due to the increased likelihood of developing lactic acidosis.

Given the likelihood of age-related decline in renal function, the dose of metformin for elderly patients is selected subject to regular monitoring of indicators of the urinary system: determination of CC in blood serum from 2 to 4 times a year and more often.

Drug interactions

It is contraindicated to use metformin in combination with iodine-containing X-ray contrast agents, since in case of functional renal failure, diagnostic studies using iodine-containing X-ray contrast agents in patients with diabetes can cause lactic acidosis. Reception of Metforvel, depending on renal function, must be canceled 48 hours before the start or at the time of the X-ray examination and not resumed earlier than 48 hours after its completion, provided that the renal function was recognized as normal during the examination.

It is not recommended to use alcoholic beverages or alcohol-containing drugs during Metforvel therapy. In the case of acute alcohol intoxication, the risk of lactic acidosis increases, especially in malnourished patients on a low-calorie diet, and in liver failure.

Drugs, the combined use of which with metformin requires caution:

Danazol: It is not recommended to take it simultaneously with metformin to avoid hyperglycemic effect. If necessary, joint use after the completion of the Danazol course, the dose of Metforvel is adjusted under the control of blood sugar;
chlorpromazine: taking high doses, up to 100 mg per day, increases blood glucose, stopping the release of insulin; during therapy with antipsychotics and after its completion, the dose of Metforvel is adjusted under the control of blood sugar;
glucocorticoids for systemic and local use: reduce glucose tolerance, increase its concentration in the blood, sometimes cause ketosis; if necessary, joint use and after the completion of the use of glucocorticosteroids, the dose of metformin is adjusted under the control of blood sugar;
diuretics: loop diuretics, due to possible impairment of renal function when used simultaneously with metformin, can contribute to the development of lactic acidosis; in this combination, Metforvel is prescribed only to patients with CC more than 60 ml / min; in addition, more frequent monitoring of blood sugar levels may be needed, especially at the beginning of joint therapy; the dose of metformin, if necessary, is adjusted during treatment and after its completion;
β ₂ -adrenomimetics (parenteral): increase blood sugar due to stimulation of β ₂ -adrenergic receptors, which requires control of blood glucose levels; insulin is recommended to regulate carbohydrate metabolism; more frequent monitoring of blood sugar levels may be required, especially at the beginning of joint therapy; the dose of metformin, if necessary, is adjusted during treatment and after its completion;
antihypertensive drugs [except ACE (angiotensin-converting enzyme) inhibitors]: can lower blood sugar; if necessary, adjust the dose of metformin;
PSM, insulin, acarbose, salicylates: when used together with Metforvel, hypoglycemia may develop;
nifedipine: enhances absorption and increases C _{max of} metformin;
cationic drugs (amiloride, vancomycin, digoxin, morphine, quinidine, quinine, procainamide, ranitidine, trimethoprim, triamterene): since their secretion occurs in the renal tubules, these drugs are competitors of metformin for the general transport systems of tubular secretion and can increase its C _max;
glucagon, nicotinic acid, isoniazid, oral contraceptives, sympathomimetics, slow calcium channel blockers, levothyroxine sodium, phenytoin, phenothiazides, estrogens: may reduce the hypoglycemic activity of Metforvel;
cimetidine: reduces the rate of excretion of metformin, which contributes to the development of lactic acidosis;
propranolol and ibuprofen: no changes in pharmacokinetic parameters were observed in healthy volunteers when used simultaneously with metformin;
indirect anticoagulants: metformin can inhibit their effect;
substrates of transporter proteins of organic cations 1 (OCT1) and 2 (OCT2): since metformin itself is a substrate of organic cations OCT1 and OCT2, when used together with OCT1 inhibitors (verapamil), the hypoglycemic effect of metformin decreases; with inducers OCT1 (rifampicin) - the absorption of metformin in the gastrointestinal tract increases and its hypoglycemic effect is potentiated; with OCT2 inhibitors (cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole) - it is possible to reduce the elimination of metformin by the kidneys and increase its content in blood plasma; with inhibitors OCT1 and OCT2 (crizotinib, olaparib) - the hypoglycemic effect of metformin may be weakened.

Analogs

Analogues of Metforvel are Bagomet, Glyformin, Glyformin Prolong, Glucophage Long, Glucophage, Diasfor, Diaformin OD, Merifatin MV, Merifatin, Metadien, Metfogamma 850, Metfogamma 1000, Metformin Long, Metformin, NovoFormin, Rinmetforin, Rinmetforin, Rinmetforin Long, Formin Pliva et al.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Metforvel

There are few reviews of Metforvel, taken according to indications for the treatment and prevention of type 2 diabetes. Patients recommend its use and call the drug effective and affordable.

The effects of metformin are often discussed on blogs and weight loss websites. The drug is interested in people who want to lose weight quickly, for a long time, without making any special efforts, exclusively on pills. Endocrinologists warn against this approach to losing excess weight, because the action of metformin is not aimed at directly fighting excess pounds. This can only be helped by the formation of healthy eating habits and rational eating behavior.

Price for Metforvel in pharmacies

Approximate price for Metforvel, film-coated tablets:

dosage 500 mg: pack of 30 - 70–78 rubles, packing of 60 pcs. - 147-162 rubles;
dosage 850 mg: pack of 30 - 107 rubles; packing 60 pcs. - 112–201 rubles.

Metforvel: prices in online pharmacies

Drug name

Price

Pharmacy

Metforvel tablets p.p. 500mg 30 pcs.

RUB 72

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Metforvel tablets p.p. 850 mg 30 Pcs.

107 RUB

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Metforvel tab. p.p. 500 mg 60 pcs.

143 r

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Metforvel tab. p.p. 850 mg 60 pcs.

198 RUB

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!