Metformin-Teva - Instructions For Use, 1000 And 500 Mg, Price, Reviews

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

Metformin-Teva

Metformin-Teva: instructions for use and reviews

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

Latin name: Metformin-Teva

ATX code: A10BA02

Active ingredient: metformin (Metformin)

Manufacturer: Teva Pharmaceutical Enterprises Ltd. (Teva Pharmaceutical Industries, Ltd.) (Israel)

Description and photo update: 09.10.2019

Prices in pharmacies: from 148 rubles.

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Metformin-Teva is a hypoglycemic drug for oral administration.

Release form and composition

The drug is produced in the form of film-coated tablets, oval, almost white or white:

• dosage 500 mg: engraved on one side - "93", on the other - "48";
• dosage 850 mg: engraved on one side - "93", on the other - "49";
• dosage 1000 mg: there are dividing lines on both sides of the tablet; engraving on one side to the left of the risks - "9", to the right of the risks - "3", engraving on the other side to the left of the risks - "72", to the right of the risks - "14".

Packing: 10 tablets in a blister of PVC (polyvinyl chloride) / PVDC (polyvinylidene chloride) film and aluminum foil, in a cardboard box 3 or 6 blisters. Packing in bulk (bulk drugs) in a double plastic bag of 5, 10, 15, 20 or 30 kg tablets, in a cardboard or plastic drum 1 packet and instructions for use of Metformin-Tev.

1 tablet contains:

• active substance: metformin hydrochloride - 500, 850 or 1000 mg;
• additional components: povidone K-90, povidone K-30, magnesium stearate, colloidal silicon dioxide;
• film shell; Opadry white Y-1-7000H (titanium dioxide E171, hypromellose E464, macrogol-400).

Pharmacological properties

Pharmacodynamics

Metformin-Teva is an oral hypoglycemic drug. Metformin is its active component and belongs to the biguanide group. In the presence of diabetes mellitus, it provides a decrease in blood glucose by blocking gluconeogenesis in the liver, weakening the absorption of glucose from the gastrointestinal tract (GIT) and increasing its utilization in tissues as a result of an increase in their sensitivity to insulin (mainly striated muscle tissue, to a lesser extent degree - fatty).

The agent does not stimulate the production of insulin, does not cause hypoglycemic reactions. Affects lipid metabolism by lowering serum triglycerides, low density lipoprotein and cholesterol levels in the blood. The drug stimulates intracellular glycogen production by activating the glycogen synthase enzyme. During the period of metformin therapy, the patient's body weight either remains stable or moderately decreases.

Pharmacokinetics

After oral administration, Metformin is actively absorbed from the gastrointestinal tract (GIT), its absolute bioavailability is 50-60%. In blood plasma, the maximum concentration (C _max) of the active substance is on average 2 μg / ml or 15 μmol / l and is fixed 2.5 hours after administration. After 7 hours, absorption from the gastrointestinal tract is completed and the plasma content of metformin gradually decreases. With the simultaneous administration of the drug with food, its absorption decreases and slows down somewhat.

The agent almost does not bind to plasma proteins and quickly penetrates into the tissues of the body. It is detected in erythrocytes, accumulates in the liver, kidneys and salivary glands, the apparent volume of distribution can vary from 63 to 276 liters.

Metformin is excreted unchanged by the kidneys. In healthy individuals, the renal clearance of metformin is 400 ml / min, which indicates that the substance is excreted by glomerular filtration and tubular secretion. The half-life (T _1/2) is an average of 6.5 hours.

Indications for use

Metformin-Teva is recommended for the treatment of type 2 diabetes mellitus in case of ineffectiveness of the combination of diet therapy and physical activity (especially in overweight patients), as a monotherapy drug or in combination with insulin - for adults, adolescents and children over 10 years old, or in combination with other oral hypoglycemic drugs - for adults.

The drug is also indicated for the prevention of type 2 diabetes mellitus at the stage of prediabetes with additional risk factors for diabetes mellitus, if it is impossible to achieve adequate glycemic control solely by changing the lifestyle.

Contraindications

Absolute:

• acute conditions, against the background of which the threat of renal dysfunction is aggravated: hypoxia (bronchopulmonary lesions, renal infections, shock, sepsis); dehydration (in case of diarrhea, vomiting);
• renal failure or renal dysfunction, with creatinine clearance (CC) below 45 ml / min;
• chronic alcoholism, acute ethanol intoxication;
• functional disorders of the liver, liver failure;
• diabetic ketoacidosis, coma, diabetic precoma;
• clinical manifestations of acute / chronic pathologies that can cause tissue hypoxia, including heart or respiratory failure, acute myocardial infarction;
• trauma and major surgical interventions in which insulin therapy is necessary;
• lactic acidosis (including a history of indications);
• reception for less than 2 days before and 2 days after surgical interventions under general anesthesia, spinal or epidural anesthesia, as well as after the administration of an iodine-containing contrast agent during X-ray or radioisotope studies (drug treatment can be resumed only after examination confirming that the function kidneys are normal);
• period of pregnancy;
• age up to 10 years;
• adherence to a low-calorie diet (less than 1000 kcal / day);
• hypersensitivity to any component of the hypoglycemic agent.

Relative (it is recommended to use Metformin-Teva with extreme caution): renal failure (CC 45-59 ml / min); hard physical work performed by patients after 60 years; breastfeeding period.

Metformin-Teva, instructions for use: method and dosage

Metformin-Teva tablets are taken orally, during or immediately after a meal.

When using the drug in adults with type 2 diabetes mellitus in monotherapy mode or in combination with other oral hypoglycemic agents:

• initial dose: 500–1000 mg taken 1 time per day in the evening. 7-15 days after the start of the course in the absence of side effects from the gastrointestinal tract, the dose is increased to 500-1000 mg 2 times a day in the morning and in the evening. Taking into account the level of glucose in the blood, in the future, a gradual increase in the dose is possible;
• maintenance daily dose: in adults, it may be 1500-2000 mg. To reduce the risk of developing disorders of the digestive system, it is recommended to divide the dose into 2-3 doses;
• the maximum daily dose is 3000 mg, divided into 3 doses. Slow dose escalation may help to improve drug tolerance.

Patients who receive the drug in daily doses of 2000-3000 mg can switch to Metformin-Teva 1000 mg, but not more than 3 tablets per day.

If the patient is transferred to treatment with Metformin-Teva from therapy with another hypoglycemic agent, you should stop using the other agent and start taking the drug at the dose indicated above.

In order to achieve the most adequate glycemic control in adults with type 2 diabetes mellitus, the drug is used in combination with insulin. In the beginning, as a rule, Metformin-Teva 500 or 850 mg taken 2-3 times a day. The insulin dose is adjusted according to the blood glucose measurement. After 10-15 days, the dose is changed depending on the glucose level. In combination therapy, metformin is prescribed in a maximum daily dose of 2000 mg in 2-3 doses.

When prescribing the drug to children over 10 years of age and adolescents, the initial dose of Metformin-Tev, both in monotherapy and in combination with insulin, is usually 500 or 850 mg once a day. After 10-15 days, a dose adjustment for glucose is required. The maximum daily dose should not exceed 2000 mg, divided into 2-3 doses.

When carrying out monotherapy at the stage of prediabetes, use a dose of Metformin-Tev 1000-1700 mg, divided into 2 doses, subject to regular glycemic control in order to assess the need for further treatment.

Side effects

• nervous system: often - metallic taste in the mouth;
• metabolism: extremely rarely - lactic acidosis (drug withdrawal is necessary); in the case of long-term treatment with metformin, a decrease in the absorption of vitamin B ₁₂ and a decrease in its serum level are possible; in the presence of megaloblastic anemia, it is necessary to take into account the likelihood of such a cause of this disease; when drug therapy is canceled, signs of vitamin B ₁₂ hypovitaminosis are quickly removed;
• digestive system: very often - abdominal pain, nausea, lack of appetite, vomiting, developing in the initial period of the course of therapy and mostly passing independently; in isolated cases - violations of liver function indicators or hepatitis, after discontinuation of the drug, they are completely stopped;
• allergic reactions: very rarely - rash, pruritus, erythema.

Overdose

When Metformin-Tev was taken at a dose of 85 g, there was no occurrence of hypoglycemia, but the development of lactic acidosis was recorded. Early symptoms of lactic acidosis include a decrease in body temperature, abdominal pain, diarrhea, nausea, vomiting, and muscle pain. In the future, there may be increased breathing rate, dizziness, impaired consciousness and the development of coma.

If you observe signs of lactic acidosis, you must immediately stop taking the drug. The patient is recommended to urgently hospitalize and clarify the diagnosis by determining the level of lactate. Hemodialysis is the most effective way to eliminate metformin and lactate from the body. Symptomatic treatment is also recommended.

special instructions

Lactic acidosis is a rare and serious metabolic complication (in the absence of urgent therapy, leading to high mortality) and occurs as a result of the accumulation of metformin. Cases of the development of lactic acidosis, according to available reports, were recorded mainly in patients with diabetes mellitus and with significant renal failure. To reduce the risk of developing this complication, it is also necessary to take into account the presence of the following factors: prolonged fasting, poorly controlled diabetes mellitus, ketosis, liver failure, alcoholism and any condition leading to hypoxia.

You should also take into account the risk of lactic acidosis in the development of disorders such as muscle cramps in combination with general weakness, severe malaise, abdominal pain, dyspeptic disorders. Lactic acidosis can lead to acidotic dyspnea, hypothermia, followed by coma. Laboratory indicators against the background of the development of complications demonstrate a decrease in blood pH below 7.25; the plasma level of lactate in the blood is above 5 mmol / l; an increase in the anion gap and the ratio of lactate / pyruvate. If there is a suspicion of lactic acidosis, it is necessary to refuse treatment with Metformin-Teva and urgently consult a doctor.

Before prescribing Metformin-Tev, children should be verified with a diagnosis of type 2 diabetes mellitus. In accordance with the results of clinical studies, which lasted for 1 year, metformin demonstrated the same efficacy and safety of use in children as in adults, and did not affect the growth and puberty of children. However, since long-term data are not available, close monitoring of the subsequent potential effect of the drug on these parameters is required during treatment, especially in children aged 10-12 years.

During the period of therapy, to control diabetes mellitus, it is necessary to regularly carry out standard tests.

All patients with diabetes mellitus, including those with excess body weight, must strictly adhere to the recommendations of the attending physician regarding diet and exercise regimen during treatment.

Influence on the ability to drive vehicles and complex mechanisms

When using Metformin-Teva as a monotherapy drug, it does not cause hypoglycemia and, as a result, does not affect the ability to drive vehicles and other complex mechanisms. However, with the combined use of the drug with other antidiabetic agents (insulin, sulfonylurea derivatives, etc.), it is necessary to remember about the risk of possible hypoglycemic conditions, against which the ability to concentrate worsens and the speed of psychomotor reactions decreases.

Application during pregnancy and lactation

During pregnancy, the use of Metformin-Teva is contraindicated. If pregnancy is planned or during the period of therapy, the drug should be discontinued and insulin therapy should be prescribed. The patient must inform the doctor about pregnancy without fail. In this case, the mother and child need close supervision.

It has been established that metformin is able to be excreted in breast milk. In infants whose mothers took the drug during lactation, no adverse events were noted. However, since there is insufficient data on the safety of the drug, its use is not recommended for nursing women. If it is necessary to treat with metformin during lactation, it is necessary to resolve the issue of transferring the child to artificial feeding.

Pediatric use

Metformin-Teva therapy is contraindicated in children under 10 years of age.

For adolescents and children over 10 years of age, the drug is indicated both as monotherapy and in combination with insulin for the treatment of type 2 diabetes mellitus.

With impaired renal function

In the presence of impaired renal function, the clearance of metformin decreases in proportion to the decrease in CC, and T _1/2 increases, which is associated with an increase in the concentration of the drug in the blood. Cumulation is possible.

Patients with renal insufficiency or impaired renal function, with CC below 45 ml / min, are contraindicated in taking the drug. With CC 45-59 ml / min, the drug should be used with caution and only in the absence of conditions that may increase the likelihood of developing lactic acidosis. Patients with CC 45-59 ml / min are recommended to use an initial dose of Metformin-Teva 500 or 850 mg once a day, but not more than 1000 mg, divided into 2 doses. During therapy, every 3–6 months it is required to assess the activity of the kidneys.

For violations of liver function

In the presence of liver failure, Metformin-Tev is contraindicated.

Use in the elderly

Elderly patients (after 60 years) performing heavy physical work, due to the increased risk of lactic acidosis, drug therapy should be carried out with caution. The drug should be prescribed to the elderly in a daily dose not exceeding 1000 mg. In view of the threat of a decrease in renal function in patients of this age category, the dose of the drug must be selected with systematic monitoring of renal activity, including the determination of serum creatinine at least 2-4 times a year.

Drug interactions

• iodine-containing X-ray contrast agents: the combination is contraindicated, since the risk of lactic acidosis is aggravated in persons with diabetes mellitus and functional renal failure;
• ethanol: acute alcohol intoxication can increase the threat of lactic acidosis, especially against the background of fasting or adherence to a low-calorie diet, as well as in the presence of liver failure; during the period of drug treatment, you should avoid the use of ethanol-containing drinks and drugs that include ethyl alcohol;
• danazol: a hyperglycemic effect may develop, which makes this combination not recommended; if combined treatment is necessary and after the end of the use of danazol, the blood glucose level should be monitored and the dose of Metformin-Tev adjusted;
• glucocorticosteroids (GCS): glucose tolerance decreases and its level in the blood rises, in some cases provoking the onset of ketosis; if necessary, this combination in the process of its implementation and after the completion of the intake of corticosteroids while monitoring the glucose content, the dose of Metformin-Tev must be adjusted
• diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs): against the background of a combination with loop diuretics and NSAIDs, the threat of lactic acidosis increases due to the risk of renal failure; the combination requires special care;
• chlorpromazine (in a daily dose of 100 mg): the release of insulin decreases due to an increase in the level of glucose in the blood, it is required to adjust the dose of the hypoglycemic agent under the control of glycemia during combination therapy and after stopping the intake of antipsychotics;
• nifedipine: absorption and C _{max of} metformin increases;
• antihypertensive drugs, except for angiotensin-converting enzyme (ACE) inhibitors: a decrease in blood glucose is possible;
• salicylates, acarbose, insulin, sulfonylurea derivatives: an increase in hypoglycemic action is possible; treatment must be carried out with caution;
• β ₂ -adrenergic agonists (during injections): the blood glucose level increases due to the stimulation of β ₂ -adrenergic receptors; monitoring of glucose levels is required, if necessary, the appointment of insulin is indicated;
• amiloride, morphine, vancomycin, triamterene, digoxin, quinine, procainamide, ranitidine, quinidine, trimethoprim (cationic drugs excreted by the renal tubules): there is competition between these drugs and metformin for the tubular transport systems, which can cause an increase in its C _max.

Analogs

Analogs of Metformin-Teva are Metformin, Bagomet, Glyformin, Glucophage Long, Metadien, Diasfor, Merifatin, Metfogamma, Sopamet, Siofor, etc.

Terms and conditions of storage

Store out of the 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 Metformin-Teva

Reviews of Metformin-Teva, left by patients on medical sites, are mostly positive. Almost everyone notes that the drug, when taken continuously, gradually lowers blood glucose levels and allows you to achieve effective glycemic control in type 2 diabetes. In addition, the hypoglycemic agent has an effect on lipid metabolism, thereby contributing to a moderate reduction in body weight when dieting and exercising. Many patients consider the drug's low cost to be an advantage.

The disadvantages of Metformin-Tev include the frequent development of adverse events, mainly observed at the beginning of the course from the gastrointestinal tract, such as nausea, a feeling of fullness in the stomach, thirst, diarrhea. Some patients report very large tablets. When a tablet with a dosage of 1000 mg has to be broken into two parts (there is a dividing risk on the tablet), an unpleasant smell of urea is felt. There are complaints about the lack of the drug in pharmacies.

Price for Metformin-Teva in pharmacies

The price of Metformin-Teva, film-coated tablets, can be per package: 60 pcs. dosage of 500 mg - 155 rubles, 30 pcs. dosage 1000 mg - 170 rubles, 60 pcs. dosage 1000 mg - 290 rubles.

Metformin-Teva: prices in online pharmacies

Drug name Price Pharmacy

Metformin-Teva 500 mg film-coated tablets 60 pcs. 148 RUB Buy

Metformin-Teva 1000 mg film-coated tablets 30 pcs. 168 RUB Buy

Metformin-Teva 850 mg film-coated tablets 60 pcs. 189 r Buy

Metformin-Teva 1000 mg film-coated tablets 60 pcs. 243 r Buy

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!