Merifatin
Merifatin: 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
Latin name: Merifatin
ATX code: A10BA02
Active ingredient: metformin (Metformin)
Manufacturer: LLC Pharmasintez-Tyumen (Russia); Pharmasintez JSC (Russia)
Description and photo update: 2019-08-10
Prices in pharmacies: from 74 rubles.
Buy
Merifatin is an oral hypoglycemic drug of the biguanide class for the treatment and prevention of type 2 diabetes mellitus. Especially recommended for overweight and obese persons.
Release form and composition
The drug is produced in the form of film-coated tablets: biconvex, oblong (500 and 1000 mg) or oval (850 mg), on one side with a risk (1000 mg), with a white film shell; core in cross section - white or almost white (10 pcs. in a blister strip made of aluminum foil and polyvinyl chloride film; 15, 30, 60, 100 or 120 pcs. in a polymer can; in a cardboard box 1-6, 8, 9, 10 packs, or 1 can and instructions for the use of Merifatin).
1 tablet contains:
- active substance: metformin hydrochloride - 500, 850 or 1000 mg;
- additional components: sodium stearyl fumarate, povidone K90 (Kollidone 90F), hypromellose 2208;
- water-soluble film shell: polyethylene glycol 6000 (macrogol 6000), hypromellose 2910, titanium dioxide, polysorbate 80 (tween 80).
Pharmacological properties
Pharmacodynamics
Merifatin is an antidiabetic drug. The active ingredient is metformin hydrochloride, which is included in the biguanide group, and leads to a decrease in hyperglycemia without causing hypoglycemia. In contrast to sulfonylurea derivatives, metformin hydrochloride does not activate insulin production and does not exhibit a hypoglycemic effect in healthy individuals. Strengthens the sensitivity of peripheral receptors to insulin and increases the utilization of glucose by cells. Merifatin, as a result of suppressing gluconeogenesis and glycogenolysis, reduces the production of glucose by the liver, inhibits the absorption of glucose in the intestine, affecting the enzyme glycogen synthase, and enhances glycogen synthesis.
Metformin increases the transport capacity of all groups of membrane proteins that transport glucose. In addition, it was found that the drug has a positive effect on lipid metabolism - it reduces the concentration of total cholesterol, triglycerides (TG) and low density lipoproteins (LDL). During the period of therapy with Merifatin, body weight either remains stable or moderately decreases. According to data from clinical trials, metformin also demonstrated a positive effect in the prevention of diabetes mellitus in patients with prediabetes, aggravated by additional risk factors that predispose to the development of type 2 diabetes mellitus (non-insulin dependent diabetes), and who failed to achieve optimal glycemic control with image modification life.
Pharmacokinetics
After oral administration, metformin is completely absorbed from the gastrointestinal tract (GIT), the absolute bioavailability averages 50-60%. In blood plasma, the maximum concentration (C max) of the active substance is noted 2.5 hours after administration and is approximately equal to 2 μg / ml or 15 μmol. The absorption of the drug when it is taken with food is reduced and delayed.
Metformin is intensively distributed in tissues; it binds extremely weakly to plasma proteins. Metabolic transformation is insignificantly exposed and excreted by the kidneys, the half-life (T 1/2) is approximately 6.5 hours. In healthy subjects, the clearance of the substance is 400 ml / min, which is 4 times higher than the creatinine clearance (CC), this fact confirms the presence of active tubular secretion.
Indications for use
- treatment of type 2 diabetes mellitus in case of ineffectiveness of the combination of diet therapy and physical activity, mainly in obese individuals: in monotherapy mode or in combination with other oral hypoglycemic agents or with insulin in adults; in monotherapy mode or in combination with insulin in adolescents and children over 10 years of age;
- prevention of type 2 diabetes mellitus in persons with prediabetes, aggravated by additional risk factors for the development of type 2 diabetes mellitus, in whom it was not possible to achieve adequate glycemic control through lifestyle changes.
Contraindications
Absolute:
- diabetic ketoacidosis, diabetic precoma, coma;
- acute conditions, accompanied by the threat of renal dysfunction: dehydration (against the background of diarrhea / vomiting), severe forms of infectious lesions, shock;
- liver failure, functional liver disorders;
- renal failure or impaired renal activity, with CC below 45 ml / min;
- clinically pronounced manifestations of acute or chronic pathologies that can cause tissue hypoxia, such as chronic heart failure (CHF) against a background of unstable hemodynamic parameters, acute myocardial infarction, acute heart failure, respiratory failure;
- extensive surgical interventions and injuries, against which insulin therapy is required;
- chronic alcoholism, acute alcohol intoxication;
- lactic acidosis (including history data);
- period of pregnancy;
- use for at least 2 days before and 2 days after the implementation of X-ray or radioisotope studies with the introduction of an iodine-containing contrast agent (against the background of renal dysfunction in patients with diabetes mellitus, the risk of lactic acidosis increases);
- adherence to a hypocaloric diet (daily intake of less than 1000 kcal);
- hypersensitivity to any component of the product.
Relative (it is necessary to take Merifatin with extreme caution): performing heavy physical work by patients over 60 years of age (due to the increased risk of lactic acidosis), renal failure with a CC of 45-59 ml / min, lactation period.
Merifatin, instructions for use: method and dosage
Merifatin tablets are taken orally, simultaneously with food or after meals.
Monotherapy and combined use with other oral hypoglycemic agents in adults with type 2 diabetes mellitus:
- initial dose: as a rule, Merifatin 500 or 850 mg is prescribed, taken 2-3 times a day. During treatment with an interval of 10-15 days (to prevent / reduce the development of gastrointestinal disorders), it is recommended to adjust the dose, taking into account the results of measuring blood glucose;
- maintenance daily dose: on average, it can be 1500-2000 mg, divided into 2-3 doses;
- maximum daily dose: 3000 mg - Merifatin 1000 mg 3 times a day.
Patients receiving metformin in daily doses of 2000–3000 mg can be switched to a 1000 mg dose of Merifatin. If you plan to switch to the use of Merifatin from another hypoglycemic agent, you should stop taking the latter and start therapy with metformin at the doses indicated above.
Combination therapy with insulin in adults can be used to achieve the most effective glycemic control. In the presence of type 2 diabetes mellitus, metformin and insulin can be used as a combination treatment. Usually the initial dose of Merifatin is 850 or 500 mg, taken 2-3 times a day, and the dose of insulin should be selected based on the results of measuring the concentration of glucose in the blood.
For the treatment of type 2 diabetes mellitus in adolescents and children over the age of 10 years, metformin can be prescribed both as monotherapy and in combination with insulin. As a rule, treatment begins with a daily dose of 850 or 500 mg Merifatin, taken 1 time after or during meals. After 10-15 days from the beginning of the course, the dose is adjusted based on the blood glucose levels. The maximum daily dose of metformin for pediatric patients over 10 years of age is 2000 mg, divided into 2–3 doses.
Monotherapy for prophylaxis against the background of a pre-diabetic state: it is recommended to take a standard daily dose of 1000-1700 mg, divided into 2 doses. During treatment, regular glycemic control should be carried out in order to assess the need for further use of the drug.
Merifatin is required to be taken daily, in continuous mode. If the patient stops treatment with the drug, he must inform the doctor about it.
Side effects
- nervous system: often - taste disturbance;
- Gastrointestinal tract: very often - lack of appetite, diarrhea, vomiting, nausea, abdominal pain (most often, these disorders appear during the initial period of therapy, and usually go away on their own); to prevent these symptoms, Merifatin should be taken 2 or 3 times a day during or after meals, a gradual increase in the dose may also help to reduce the development of these side reactions;
- liver and biliary tract: very rarely - abnormal liver function indicators or hepatitis; after the end of taking metformin, these effects completely disappear;
- skin and subcutaneous tissue: extremely rarely - skin reactions in the form of itching, rash, erythema;
- metabolism and nutrition: extremely rare - lactic acidosis; against the background of long-term use of Merifatin, a decrease in the absorption of vitamin B 12 may be recorded; in the case of detection of megaloblastic anemia, it is necessary to take into account the likelihood that it may be caused by a deficiency of vitamin B 12.
According to the available published data and the results of clinical studies, in patients 10-16 years old, the adverse events observed with the use of Merifatin are similar in nature and severity to those in adult patients.
Overdose
When using Merifatin at a dose below 85 g, which corresponds to an excess of the maximum daily dose by 42.5 times, the occurrence of hypoglycemia was not observed, but at the same time the development of lactic acidosis was recorded. Concomitant risk factors or significant overdose may cause lactic acidosis.
In case of signs of this complication, the course of therapy with Merifatin should be interrupted immediately, and the patient should be urgently hospitalized to establish the level of lactate content and clarify the diagnosis. When removing metformin and lactate from the body, hemodialysis is the most effective. Symptomatic treatment is also prescribed.
special instructions
Lactic acidosis is a rare but dangerous metabolic complication (high mortality is recorded in the absence of urgent treatment), which can develop as a result of the accumulation of metformin. Cases of this disease while taking Merifatin were observed mainly in people with diabetes mellitus and severe renal impairment. To reduce the incidence of lactic acidosis, other risk factors must also be considered, which include prolonged fasting, ketosis, alcoholism, liver failure, decompensated diabetes mellitus, and any condition associated with significant hypoxia.
If nonspecific symptoms such as muscle cramps with dyspeptic disorders, severe asthenia and abdominal pain occur, it is also necessary to take into account the threat of lactic acidosis. This complication is characterized by the appearance of acidotic dyspnea, abdominal pain and hypothermia, followed by coma. Laboratory markers of lactic acidosis include a decrease in blood pH (below 7.25), a plasma lactate content of more than 5 mmol / L, an increased anion gap, and a lactate / pyruvate ratio. In case of suspicion of metabolic acidosis, it is necessary to urgently interrupt therapy with Merifatin and immediately consult a doctor.
Since patients with CHF increase the risk of hypoxia and renal failure, during the period of treatment in patients of this group, it is required to regularly monitor cardiac function and renal activity.
Due to the fact that metformin is excreted by the kidneys, before starting treatment and regularly during its course, it is recommended to assess CC: in patients with normal renal function - at least once a year, in the elderly, as well as in patients with CC, whose indicators are at the lower limit of the norm - at least 2–4 times a year.
With extreme caution, Merifatin should be used in case of possible impaired renal function in elderly patients, in combination therapy with antihypertensive drugs, diuretics or non-steroidal anti-inflammatory drugs (NSAIDs).
In the case of a planned surgical operation, the administration of Merifatin should be discontinued 48 hours before the start of the operation and resumed no earlier than 48 hours after its completion, subject to an assessment of renal activity that confirms its stability.
In the course of treatment, you should adhere to a diet with an even intake of carbohydrates throughout the day. Overweight people need to follow a hypocaloric diet (but not less than 1000 kcal / day).
The use of Merifatin is indicated for the prevention of type 2 diabetes mellitus in persons with prediabetes who have the following additional risk factors for the development of overt type 2 diabetes mellitus:
- a history of gestational diabetes mellitus;
- body mass index (BMI) over 35 kg / m²;
- age up to 60 years;
- arterial hypertension;
- diabetes mellitus in first-degree relatives;
- reduced HDL cholesterol;
- increased content of TG.
Influence on the ability to drive vehicles and complex mechanisms
Taking the drug in monotherapy does not lead to the development of hypoglycemia, as a result of which it does not affect the psychomotor functions of the body. However, patients need to be aware of the risk of hypoglycemia while using Merifatin in combination with other antidiabetic agents (including insulin, repaglinide, sulfonylurea derivatives), which may affect the ability to drive vehicles and control complex mechanisms.
Application during pregnancy and lactation
During pregnancy, decompensated diabetes mellitus is associated with an increased risk of congenital anomalies and perinatal mortality. The limited data available suggests that the use of metformin by pregnant women does not increase the risk of developing birth defects in children.
In the case of planning pregnancy, as well as when it occurs during drug treatment against the background of prediabetes and type 2 diabetes mellitus, the use of Merifatin should be canceled, replacing it with insulin therapy. In order to reduce the risk of developing congenital defects in the fetus, it is recommended to maintain the level of plasma glucose concentration in the blood as close to normal as possible.
Metformin is excreted in breast milk. In newborns who were breastfed, no adverse effects were recorded during treatment with metformin. However, due to the limited amount of data, taking Merifatin during lactation is not recommended. The decision to switch to artificial feeding should be made after a careful assessment of the benefits of breastfeeding and the potential threat of side effects in the baby.
Pediatric use
Merifatin is prescribed as monotherapy or in combination with insulin for adolescents and children over the age of 10 years according to the dosage regimen.
Before starting treatment with the drug, the diagnosis of type 2 diabetes mellitus must be confirmed. According to the results of clinical studies conducted within 1 year, metformin did not affect the growth and puberty of children. However, since long-term data are lacking, it is recommended to carefully monitor the subsequent possible effect of Merifatin on these parameters, especially during puberty. During therapy, children aged 10–12 years need the most careful supervision.
With impaired renal function
In patients with impaired renal function, T 1/2 of Merifatin increases and the risk of metformin cumulation is aggravated.
In severe renal failure or impaired renal function (CC below 45 ml / min), drug therapy is contraindicated.
With moderate severity of renal failure (CC 45-59 ml / min), the use of Merifatin is allowed only in the absence of conditions that can aggravate the threat of lactic acidosis.
Patients with CC 45-59 ml / min are recommended to take an initial dose of Merifatin 500 or 850 mg 1 time per day. The maximum dose in patients of this group should not exceed 1000 mg, divided into 2 doses per day. Renal function should be assessed every 3–6 months during therapy.
For violations of liver function
In the presence of liver failure or functional disorders of the liver, treatment with Merifatin is contraindicated.
Use in the elderly
In elderly patients, due to the risk of decreased renal function, the dose of Merifatin must be selected with regular monitoring of renal activity indicators, in particular, the serum creatinine content should be determined at least 2-4 times a year.
Drug interactions
Possible interactions with the combination therapy of metformin with the following drugs:
- glucocorticosteroids (GCS) of local and systemic action: glucose tolerance decreases, the content of glucose in the blood increases, in some cases causing ketosis; with GCS therapy and after its completion, it is required to adjust the dose of metformin under the control of blood glucose levels;
- chlorpromazine (in daily doses of more than 100 mg): blood glucose increases, insulin release decreases; when combined with antipsychotics and after the end of their intake, it is necessary to change the dose of metformin, taking into account the glucose concentration;
- danazol: the hyperglycemic effect of this substance is recorded, and therefore the combined use is not recommended; if it is necessary to carry out combination therapy, blood glucose should be monitored and the dose of Merifatin should be adjusted;
- diuretics (loop): the risk of developing lactic acidosis is aggravated due to possible failure of renal function; if CC is below 60 ml / min, Merifatin should not be prescribed;
- antihypertensive drugs (except for angiotensin-converting enzyme inhibitors): a decrease in blood glucose concentration is possible, requiring a change in the dose of Merifatin;
- ethanol-containing drugs and drinks: against the background of acute alcohol intoxication, there is an increase in the risk of lactic acidosis, especially in the presence of hepatic dysfunction, in the case of a low-calorie diet or insufficient nutrition; the combination is not recommended - during the treatment period, the consumption of ethanol-containing drinks should be avoided;
- nifedipine: there is an increase in absorption and an increase in C max of the hypoglycemic agent;
- insulin, sulfonylurea derivatives, acarbose, salicylates: the risk of hypoglycemia increases;
- digoxin, amiloride, procainamide, ranitidine, quinine, morphine, quinidine, trimethoprim triamterene, vancomycin (cationic drugs secreted in the renal tubules): these drugs compete with metformin for tubular transport systems, which can provoke an increase in its C max;
- β 2 -adrenomimetics (with injection): there is an increase in blood glucose as a result of stimulation of β 2 -adrenergic receptors, it is required to control the concentration of glucose in the blood (especially often at the beginning of combination treatment), if necessary, it is possible to prescribe insulin and adjust the dose of metformin in during therapy and after its completion.
Analogs
Merifatin's analogs are Glucophage, Metfogamma, Metformin-Teva, Metadien, Glyformin, Formetin, Rinformin Long, Metformin Sanofi, Formetin Long, Siofor.
Terms and conditions of storage
Store in a place protected from light, out of reach of children, at a temperature not exceeding 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Merifatin
According to reviews, Merifatin is an affordable hypoglycemic drug that allows you to achieve effective glycemic control in non-insulin dependent diabetes (type 2 diabetes mellitus). Patients note that with the course of taking Merifatin, it helps to clinically significantly lower blood glucose levels, reduce total cholesterol, TG and LDL cholesterol, and moderately reduce body weight while following an appropriate diet.
To the disadvantages of the drug, patients consider a very large, in their opinion, tablet size, especially at a dosage of 1000 mg. There are no complaints about adverse reactions, the cost is assessed as affordable.
Merifatin price
The price of Merifatin, film-coated tablets, depending on the dosage, can be per package containing 60 pieces: 1000 mg - 160 rubles, 850 mg - 130 rubles, 500 mg - 110 rubles.
Merifatin: prices in online pharmacies
Drug name Price Pharmacy |
Merifatin 500 mg film-coated tablets 60 pcs. 74 RUB Buy |
Merifatin tablets p.p. 500mg 30 pcs. RUB 80 Buy |
Merifatin 850 mg film-coated tablets 60 pcs. RUB 96 Buy |
Merifatin tablets p.p. 850mg 60 pcs. 141 r Buy |
Merifatin 1000 mg film-coated tablets 60 pcs. RUB 150 Buy |
Merifatin tablets p.p. 1000mg 60 pcs. 248 r Buy |
Merifatin tablets p.p. 1000mg jar 60 pcs. 268 r Buy |
Merifatin mv prolonged tablets. release 750 mg 60 pcs. 458 r Buy |
See all offers from pharmacies |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, 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!