Metformin-teva 500 mg 60 pcs. film-coated tablets
pharmachologic effect
Metformin inhibits gluconeogenesis in the liver, reduces the absorption of glucose from the intestine, enhances peripheral glucose utilization, and also increases tissue sensitivity to insulin.
At the same time, it does not affect the secretion of insulin by beta cells of the pancreas and does not cause hypoglycemic reactions. Reduces the level of triglycerides and low-density linoproteins in the blood. Stabilizes or reduces body weight. It has a fibrinolytic effect due to the suppression of tissue-type plasminogen activator inhibitor.
After oral administration, metformin is absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is 50-60%. Cmax in blood plasma is achieved 2.5 hours after oral administration. Practically does not bind to plasma proteins. Accumulates in the salivary glands, muscles, liver and kidneys. It is excreted unchanged by the kidneys. T1/2 is 9-12 hours. In case of impaired renal function, cumulation of the drug is possible.
Composition and release form Metformin-teva 500 mg 60 pcs. film-coated tablets
1 tablet contains:
- Active ingredients: metformin 500 mg.
Tablets, 60 pcs.
Description of the dosage form
The tablets are round, biconvex, film-coated, white or almost white. On a cross section it is white or almost white in color.
Directions for use and doses
Adults.
Monotherapy and combination therapy with other oral hypoglycemic agents.
The recommended starting dose is 1000-1500 mg/day. To reduce side effects from the gastrointestinal tract, the dose should be divided into 2-3 doses. After 10-15 days, in the absence of adverse effects from the gastrointestinal tract, a further gradual increase in the dose is possible depending on the concentration of glucose in the blood. Slowly increasing the dose may improve gastrointestinal tolerability of the drug.
The maintenance daily dose is 1500-2000 mg. The maximum daily dose is 3000 mg, divided into 3 doses.
When planning a transition from taking another oral hypoglycemic agent to Metformin, you must stop taking the other hypoglycemic agent and start taking Metformin Canon in the above doses.
Combination therapy with insulin.
The recommended initial dose of Metformin 500 mg and 850 mg is 1 tablet 2-3 times a day, Metformin 1000 mg is 1 tablet 1 time a day, the insulin dose is selected based on blood glucose concentrations.
Children over 10 years old.
Metformin Canon is used in monotherapy and in combination therapy with insulin.
The recommended starting dose of Metformin is 500 mg 1 time per day in the evening with meals. After 10-15 days, the dose of the drug must be adjusted based on the concentration of glucose in the blood. The maintenance dose is 1000-1500 mg/day in 2-3 doses. The maximum daily dose is 2000 mg in 3 divided doses.
Elderly patients.
Due to a possible decrease in renal function, the dose of Metformin should be adjusted under regular monitoring of renal function indicators (monitoring serum creatinine concentrations at least 2-4 times a year).
The duration of treatment is determined by the doctor. It is not recommended to interrupt the drug intake without the instructions of the attending physician.
Pharmacokinetics
Suction
After taking the drug orally, metformin is quite completely absorbed from the gastrointestinal tract. Absolute bioavailability is 50-60%. The maximum concentration (Cmax) in plasma is approximately 2 µg/ml or 15 µmol/l and is achieved after 2.5 hours. After 7 hours, absorption from the gastrointestinal tract ends and the concentration of metformin in plasma gradually decreases. With simultaneous food intake, the absorption of metformin is reduced and slowed down.
Distribution
Metformin practically does not bind to plasma proteins and is quickly distributed into body tissues. Penetrates into red blood cells. Accumulates in the salivary glands, liver and kidneys. The apparent volume of distribution is 63-276 l.
Metabolism and excretion
It is excreted unchanged by the kidneys. The clearance of metformin in healthy individuals is 400 ml/min, which indicates active glomerular filtration and tubular secretion. The half-life (T1/2) is approximately 6.5 hours.
Pharmacokinetics in special clinical situations
In patients with renal failure, the renal clearance of metformin decreases in proportion to the decrease in creatinine clearance, T1/2 increases, which leads to an increase in the concentration of metformin in the blood. Cumulation is possible.
Indications for use Metformin-teva 500 mg 60 pcs. film-coated tablets
Type 2 diabetes mellitus in adults (especially in obese patients) with ineffective diet therapy and exercise, as monotherapy or in combination with other oral hypoglycemic agents or insulin.
Type 2 diabetes mellitus in children from 10 years of age - both as monotherapy and in combination with insulin.
Contraindications
- Diabetic ketoacidosis, diabetic precoma, coma;
- renal dysfunction;
- acute diseases that occur with the risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), fever, severe infectious diseases, hypoxia conditions (shock, sepsis, kidney infections, bronchopulmonary diseases);
- clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (heart or respiratory failure, acute myocardial infarction);
- serious surgical operations and injuries (when insulin therapy is indicated);
- liver dysfunction;
- chronic alcoholism, acute alcohol poisoning;
- use for at least 2 days before and for 2 days after radioisotope or x-ray studies with the introduction of an iodine-containing contrast agent;
- lactic acidosis (including history);
- following a hypocaloric diet (less than 1000 cal/day);
- pregnancy;
- lactation period;
- hypersensitivity to the drug.
It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.
Application of Metformin-teva 500 mg 60 pcs. film-coated tablets during pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and breastfeeding.
If pregnancy is planned or occurs, Metformin Canon should be discontinued and insulin therapy should be used. The patient should be warned about the need to notify the doctor if pregnancy occurs. Mother and child should be monitored.
Do not use in children under 10 years of age.
special instructions
During treatment, it is necessary to monitor kidney function. At least 2 times a year, and also when myalgia appears, the lactate content in plasma should be determined. In addition, once every 6 months it is necessary to monitor the level of creatinine in the blood serum (especially in elderly patients). Metformin should not be prescribed if the blood creatinine level is above 135 µmol/L in men and 110 µmol/L in women.
It is possible to use the drug Metformin in combination with sulfonylurea derivatives. In this case, particularly careful monitoring of blood glucose levels is necessary.
Metformin should be stopped 48 hours before and 48 hours after X-ray contrast (urography, intravenous angiography).
If a patient develops a bronchopulmonary infection or an infectious disease of the genitourinary organs, you should immediately inform your doctor.
During treatment, you should refrain from drinking alcohol and medications containing ethanol. .
Overdose
Symptoms: when using metformin at a dose of 85 g, no hypoglycemia was observed, but the development of lactic acidosis was noted. Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, decreased body temperature, abdominal pain, muscle pain, and later rapid breathing, dizziness, impaired consciousness and the development of coma may occur.
Treatment: If signs of lactic acidosis appear, treatment with the drug must be stopped immediately, the patient must be urgently hospitalized and, having determined the lactate concentration, the diagnosis must be clarified. The most effective measure for removing lactate and metformin from the body is hemodialysis. Symptomatic treatment is also carried out.
Side effects Metformin-teva 500 mg 60 pcs. film-coated tablets
From the digestive system: possible (usually at the beginning of treatment) nausea, vomiting, diarrhea.
From the endocrine system: hypoglycemia (mainly when used in inadequate doses).
Metabolism: in some cases - lactic acidosis (requires cessation of treatment).
From the hematopoietic system: in some cases - megaloblastic anemia.
Drug interactions
When used simultaneously with sulfonylurea derivatives, acarbose, insulin, salicylates, MAO inhibitors, oxytetracycline, ACE inhibitors, clofibrate, cyclophosphamide, the hypoglycemic effect of metformin may be enhanced.
When used simultaneously with GCS, hormonal contraceptives for oral administration, danazol, epinephrine, glucagon, thyroid hormones, phenothiazine derivatives, thiazide diuretics, nicotinic acid derivatives, the hypoglycemic effect of metformin may be reduced.
In patients receiving metformin, the use of iodine-containing contrast agents for the purpose of diagnostic studies (including IV urography, IV cholangiography, angiography, CT) increases the risk of developing acute renal dysfunction and lactic acidosis. These combinations are contraindicated.
Injectable beta2-agonists increase blood glucose concentrations due to stimulation of beta2-adrenergic receptors. In this case, monitoring of blood glucose concentration is necessary. If necessary, it is recommended to prescribe insulin.
Concomitant use of cimetidine may increase the risk of developing lactic acidosis.
Concomitant use of loop diuretics may lead to the development of lactic acidosis due to possible functional renal failure.
When taken simultaneously with ethanol, the risk of developing lactic acidosis increases.
Nifedipine increases the 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 may lead to an increase in its Cmax.
Metformin - Teva TB p/o 1000 mg N 60
Release form, packaging and composition of the drug Metformin-Teva
Film-coated tablets, white or almost white, oval, with a score on both sides, engraved “9” to the left of the score and “3” to the right of the score on one side, and “72” to the left of the score and “14” to the right from risks to another.
1 tab.
metformin hydrochloride 1000 mg
Excipients: povidone K30 - 31.6 mg, povidone K90 - 22.6 mg, colloidal silicon dioxide - 2.4 mg, magnesium stearate - 5.4 mg.
Shell composition: opadry white Y-1-7000H (hypromellose (E464) - 20 mg, titanium dioxide (E171) - 10 mg, macrogol 400 - 2 mg).
10 pieces. - blisters (3) - cardboard packs.
10 pieces. - blisters (6) - cardboard packs.
White or almost white, oval, film-coated tablets, engraved “93” on one side and “48” on the other.
1 tab.
metformin hydrochloride 500 mg
Excipients: povidone K30 - 13.8 mg, povidone K90 - 13.3 mg, colloidal silicon dioxide - 1.2 mg, magnesium stearate - 2.7 mg.
Shell composition: opadry white Y-1-7000H (hypromellose (E464) - 10 mg, titanium dioxide (E171) - 5 mg, macrogol 400 - 1 mg).
10 pieces. - blisters (3) - cardboard packs.
10 pieces. - blisters (6) - cardboard packs.
The film-coated tablets are white or almost white, oval, engraved “93” on one side and “49” on the other.
1 tab.
metformin hydrochloride 850 mg
Excipients: povidone K30 - 23.5 mg, povidone K90 - 22.6 mg, colloidal silicon dioxide - 2 mg, magnesium stearate - 4.6 mg.
Shell composition: opadry white Y-1-7000H (hypromellose (E464) - 16.9 mg, titanium dioxide (E171) - 8.4 mg, macrogol 400 - 1.7 mg).
10 pieces. - blisters (3) - cardboard packs.
10 pieces. - blisters (6) - cardboard packs.
Clinical and pharmacological group: Oral hypoglycemic drug
Pharmacotherapeutic group: Hypoglycemic agent of the biguanide group for oral use
pharmachologic effect
Metformin is an oral hypoglycemic agent from the biguanide group. In patients with diabetes mellitus, it reduces the concentration of glucose in the blood by inhibiting gluconeogenesis in the liver, reducing the absorption of glucose from the gastrointestinal tract and increasing its utilization in tissues by increasing their sensitivity to insulin (mainly striated muscles, to a lesser extent adipose tissue). Does not stimulate insulin secretion and does not cause hypoglycemic reactions. It has an effect on lipid metabolism - it reduces the concentration of triglycerides, cholesterol and low-density lipoproteins in the blood serum. Stimulates intracellular glycogenesis by activating glycogen synthase.
Pharmacokinetics
Suction
After taking the drug orally, metformin is quite completely absorbed from the gastrointestinal tract. Absolute bioavailability is 50-60%. The maximum concentration (Cmax) in plasma is approximately 2 µg/ml or 15 µmol/l and is achieved after 2.5 hours. After 7 hours, absorption from the gastrointestinal tract ends and the concentration of metformin in plasma gradually decreases. With simultaneous food intake, the absorption of metformin is reduced and slowed down.
Distribution
Metformin practically does not bind to plasma proteins and is quickly distributed into body tissues. Penetrates into red blood cells. Accumulates in the salivary glands, liver and kidneys. The apparent volume of distribution is 63-276 l.
Metabolism and excretion
It is excreted unchanged by the kidneys. The clearance of metformin in healthy individuals is 400 ml/min, which indicates active glomerular filtration and tubular secretion. The half-life (T1/2) is approximately 6.5 hours.
Pharmacokinetics in special clinical situations
In patients with renal failure, the renal clearance of metformin decreases in proportion to the decrease in creatinine clearance, T1/2 increases, which leads to an increase in the concentration of metformin in the blood. Cumulation is possible.
Indications for the drug Metformin-Teva
type 2 diabetes mellitus in adults (especially in obese patients) when diet and exercise are ineffective as monotherapy or in combination with other oral hypoglycemic agents or insulin.
Dosage regimen
Inside, during or immediately after meals.
Monotherapy and combination therapy with other oral hypoglycemic agents
Initial dose: 500-1000 mg 1 time per day in the evening. After 7-15 days, in the absence of adverse effects from the gastrointestinal tract, 500-1000 mg is prescribed 2 times a day in the morning and evening. A further gradual increase in the dose is possible depending on the concentration of glucose in the blood.
Maintenance dose: 1500-2000 mg/day. To reduce side effects from the gastrointestinal tract, the dose should be divided into 2-3 doses. Maximum dose: 3000 mg/day in 3 divided doses. Slowly increasing the dose may improve gastrointestinal tolerability of the drug.
Patients taking metformin in doses of 2000-3000 mg/day can be switched to taking a dose of 1000 mg. Maximum recommended dose: 3000 mg/day in 3 divided doses. When switching to therapy from another hypoglycemic agent, you should stop taking the other drug and start taking Metformin-Teva at the dose indicated above.
Combinations with insulin
Metformin-Teva and insulin can be used in combination therapy to achieve better glycemic control.
The drug Metformin-Teva is prescribed in the usual initial dose of 500 mg or 850 mg 2-3 times a day. The dose of insulin is selected based on the results of blood glucose measurements. After 10-15 days, the dose is adjusted depending on the concentration of glucose in the blood. The maximum dose of metformin in combination treatment: 2 g/day in 2-3 doses.
In elderly patients, the daily dose should not exceed 1000 mg/day.
Side effect
Side effects are classified according to the following frequency: very often - at least 10%; often - at least 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rare - less than 0.01%, including isolated cases.
From the central nervous system: often - taste disturbance (metallic taste in the mouth).
From the digestive system: very often - nausea, vomiting, abdominal pain, lack of appetite, which occur during the initial period of treatment and in most cases resolve spontaneously; isolated cases - impaired liver function tests or hepatitis, which completely disappear after discontinuation of the drug.
Allergic reactions: very rarely - erythema, itching, rash.
On the metabolic side: very often - lactic acidosis (requires discontinuation of the drug).
Other: very rarely - with prolonged use, hypovitaminosis B12 develops.
Contraindications for use
hypersensitivity to metformin or to any excipient of the drug;
diabetic ketoacidosis, diabetic precoma, coma;
renal failure or impaired renal function (creatinine clearance less than 60 ml/min);
acute conditions with a risk of developing renal dysfunction;
dehydration (with diarrhea, vomiting), fever, severe infectious diseases;
hypoxia conditions (shock, sepsis, kidney infections, bronchopulmonary diseases);
clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including cardiac or respiratory failure, acute myocardial infarction);
extensive surgical operations and injuries when insulin therapy is indicated;
liver failure, liver dysfunction;
chronic alcoholism, acute alcohol poisoning;
lactic acidosis (including history);
use for at least 48 hours before and 48 hours after radioisotope or x-ray studies with the introduction of an iodine-containing contrast agent;
a period of at least 48 hours before and within 48 hours after surgical interventions under general anesthesia, spinal or epidural anesthesia;
following a hypocaloric diet (less than 1000 kcal/day);
children under 18 years of age.
With caution: in persons over 60 years of age who perform heavy physical work (increased risk of developing lactic acidosis).
Use during pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and breastfeeding.
If pregnancy is planned or occurs, Metformin-Teva should be discontinued and insulin therapy prescribed. The patient should be warned about the need to notify the doctor if pregnancy occurs. Mother and child should be monitored.
It is not known whether metformin is excreted in breast milk. If it is necessary to use the drug during lactation, breastfeeding should be stopped.
Use for liver dysfunction
Contraindicated in case of liver failure or impaired liver function.
Use for renal impairment
Contraindicated in renal failure or impaired renal function (creatinine clearance less than 60 ml/min).
Use in children
Contraindicated for children under 18 years of age.
Use in elderly patients
Use the drug with caution in persons over 60 years of age who perform heavy physical work (increased risk of developing lactic acidosis). In elderly patients, the daily dose should not exceed 1000 mg/day.
special instructions
During treatment with Metformin-Teva, it is necessary to regularly monitor the concentration of glucose in the blood on an empty stomach and after meals.
The patient should be warned about the need to stop taking the drug and consult a doctor if vomiting, abdominal pain, muscle pain, general weakness and severe malaise occur. These symptoms may be a sign of incipient lactic acidosis. Metformin-Teva should be discontinued 48 hours before and 48 hours after an X-ray examination (including urography, intravenous angiography) using radiocontrast agents.
Metformin-Teva should be discontinued 48 hours before and 48 hours after surgery under general anesthesia, spinal or epidural anesthesia. Since metformin is excreted by the kidneys, CK should be determined before starting treatment and regularly thereafter: in patients with preserved renal function once a year, in patients with reduced CK and in elderly patients 2-4 times a year.
Particular caution should be exercised if renal function is impaired, for example, during the initial period of therapy with antihypertensive drugs, diuretics, NSAIDs.
The patient should be informed about the need to consult a doctor if symptoms of a bronchopulmonary infection or infectious disease of the genitourinary organs appear. While using the drug Metformin-Teva, you should refrain from drinking alcohol, due to the increased risk of developing hypoglycemia and a disulfiram-like effect. Hypovitaminosis B12 when taking the drug Metformin-Teva is caused by impaired absorption of vitamin B12 and is reversible. When Metformin-Teva is discontinued, signs of hypovitaminosis B12 quickly disappear.
Impact on the ability to drive vehicles and machinery
Monotherapy with Metformin-Teva does not cause hypoglycemia and therefore does not affect the ability to drive a car or operate machinery. When using the drug Metformin-Teva with other hypoglycemic agents (sulfonylurea derivatives, insulin, etc.), the development of hypoglycemic conditions is possible, in which the ability to drive vehicles and engage in other potentially hazardous activities that require increased attention and rapid psychomotor reactions is impaired.
Overdose
Symptoms
When using metformin at a dose of 85 g, no hypoglycemia was observed, but the development of lactic acidosis was noted. Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, decreased body temperature, abdominal pain, muscle pain, and later rapid breathing, dizziness, impaired consciousness and the development of coma may occur.
Treatment
If signs of lactic acidosis appear, treatment with the drug must be stopped immediately, the patient must be urgently hospitalized and, having determined the lactate concentration, the diagnosis must be clarified. The most effective measure for removing lactate and metformin from the body is hemodialysis. Symptomatic treatment is also carried out.
Drug interactions
Combinations not recommended
With simultaneous use of metformin with danazol, a hyperglycemic effect may develop. If treatment with danazol is necessary and after stopping its use, dose adjustment of metformin under glycemic control is required
With the simultaneous use of metformin with alcohol and ethanol-containing drugs, the risk of developing lactic acidosis during acute alcohol intoxication increases, especially during fasting or following a low-calorie diet, as well as in liver failure.
Combinations requiring special caution
Chlorpromazine in high doses (100 mg/day) reduces insulin release and increases blood glucose concentrations. When used simultaneously with antipsychotics and after stopping their use, dose adjustment of metformin under glycemic control is required. Glucocorticosteroids (GCS) reduce glucose tolerance and increase blood glucose concentrations, in some cases causing ketosis. If it is necessary to use such a combination and after discontinuation of GCS, a dose adjustment of metformin under glycemic control is required.
With the simultaneous use of loop diuretics and metformin, there is a risk of developing lactic acidosis due to the possible occurrence of functional renal failure.
Radiological examination with the use of iodine-containing radiocontrast agents can cause the development of lactic acidosis in patients with diabetes mellitus against the background of functional renal failure. The use of metformin should be discontinued 48 hours before and not resumed until 48 hours after an X-ray examination using radiocontrast agents.
The administration of beta2-adrenergic agonists by injection reduces the hypoglycemic effect of metformin due to stimulation of beta2-adrenergic receptors. In this case, you should monitor the concentration of glucose in the blood and, if necessary, prescribe insulin. Angiotensin-converting enzyme inhibitors and other antihypertensive drugs may decrease blood glucose concentrations. If necessary, the dose of metformin should be adjusted.
With simultaneous use of metformin with sulfonylurea derivatives, insulin, acarbose and sapicylates, the hypoglycemic effect may be enhanced. Loop diuretics and NSAIDs increase the risk of decreased renal function. In this case, caution must be exercised when using metformin.
Storage conditions for the drug Metformin-Teva
At a temperature not higher than 25°C. Keep out of the reach of children.
Shelf life of the drug Metformin-Teva
Shelf life: 3 years.
Terms of sale
On prescription.
Metformin-Teva tab ppo 850mg No. 60
Compound
Active substance: metformin hydrochloride 850 mg.
Excipients: povidone K30 - 23.5 mg, povidone K90 - 22.6 mg, colloidal silicon dioxide - 2 mg, magnesium stearate - 4.6 mg.
Shell composition: opadry white Y-1-7000H (hypromellose (E464) - 16.9 mg, titanium dioxide (E171) - 8.4 mg, macrogol 400 - 1.7 mg).
Pharmacokinetics
Absorption
After taking the drug orally, metformin is quite completely absorbed from the gastrointestinal tract. Absolute bioavailability is 50-60%. The maximum concentration (Cmax) in plasma is approximately 2 µg/ml or 15 µmol/l and is achieved after 2.5 hours. After 7 hours, absorption from the gastrointestinal tract ends and the concentration of metformin in plasma gradually decreases. With simultaneous food intake, the absorption of metformin is reduced and slowed down.
Distribution
Metformin practically does not bind to plasma proteins and is quickly distributed into body tissues. Penetrates into red blood cells. Accumulates in the salivary glands, liver and kidneys. The apparent volume of distribution is 63-276 l.
Metabolism and excretion
It is excreted unchanged by the kidneys. The clearance of metformin in healthy individuals is 400 ml/min, which indicates active glomerular filtration and tubular secretion. The half-life (T1/2) is approximately 6.5 hours.
Pharmacokinetics in special clinical situations
In patients with renal failure, the renal clearance of metformin decreases in proportion to the decrease in creatinine clearance, T1/2 increases, which leads to an increase in the concentration of metformin in the blood. Cumulation is possible.
Indications for use
Type 2 diabetes mellitus in adults (especially in obese patients) when diet and exercise are ineffective as monotherapy or in combination with other oral hypoglycemic agents or insulin.
Contraindications
- Hypersensitivity to metformin or to any excipient of the drug;
- diabetic ketoacidosis, diabetic precoma, coma;
- renal failure or impaired renal function (creatinine clearance less than 60 ml/min);
- acute conditions with a risk of developing renal dysfunction;
- dehydration (with diarrhea, vomiting), fever, severe infectious diseases;
- hypoxia conditions (shock, sepsis, kidney infections, bronchopulmonary diseases);
- clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including cardiac or respiratory failure, acute myocardial infarction);
- extensive surgical operations and injuries when insulin therapy is indicated;
- liver failure, liver dysfunction;
- chronic alcoholism, acute alcohol poisoning;
- lactic acidosis (including history);
- use for at least 48 hours before and 48 hours after radioisotope or x-ray studies with the introduction of an iodine-containing contrast agent;
- a period of at least 48 hours before and within 48 hours after surgical interventions under general anesthesia, spinal or epidural anesthesia;
- following a hypocaloric diet (less than 1000 kcal/day);
- children under 18 years of age.
With caution: in persons over 60 years of age who perform heavy physical work (increased risk of developing lactic acidosis).
Directions for use and doses
Inside, during or immediately after meals.
Monotherapy and combination therapy with other oral hypoglycemic agents
Initial dose: 500-1000 mg 1 time per day in the evening. After 7-15 days, in the absence of adverse effects from the gastrointestinal tract, 500-1000 mg is prescribed 2 times a day in the morning and evening. A further gradual increase in the dose is possible depending on the concentration of glucose in the blood.
Maintenance dose: 1500-2000 mg/day. To reduce side effects from the gastrointestinal tract, the dose should be divided into 2-3 doses. Maximum dose: 3000 mg/day in 3 divided doses. Slowly increasing the dose may improve gastrointestinal tolerability of the drug.
Patients taking metformin in doses of 2000-3000 mg/day can be switched to taking a dose of 1000 mg. Maximum recommended dose: 3000 mg/day in 3 divided doses. When switching to therapy from another hypoglycemic agent, you should stop taking the other drug and start taking Metformin-Teva at the dose indicated above.
Combinations with insulin
Metformin-Teva and insulin can be used in combination therapy to achieve better glycemic control.
The drug Metformin-Teva is prescribed in the usual initial dose of 500 mg or 850 mg 2-3 times a day. The dose of insulin is selected based on the results of blood glucose measurements. After 10-15 days, the dose is adjusted depending on the concentration of glucose in the blood. The maximum dose of metformin in combination treatment: 2 g/day in 2-3 doses.
In elderly patients, the daily dose should not exceed 1000 mg/day.
Storage conditions
At a temperature not higher than 25°C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiration date.
special instructions
During treatment with Metformin-Teva, it is necessary to regularly monitor the concentration of glucose in the blood on an empty stomach and after meals.
The patient should be warned about the need to stop taking the drug and consult a doctor if vomiting, abdominal pain, muscle pain, general weakness and severe malaise occur. These symptoms may be a sign of incipient lactic acidosis. Metformin-Teva should be discontinued 48 hours before and 48 hours after an X-ray examination (including urography, intravenous angiography) using radiocontrast agents.
Metformin-Teva should be discontinued 48 hours before and 48 hours after surgery under general anesthesia, spinal or epidural anesthesia. Since metformin is excreted by the kidneys, CK should be determined before starting treatment and regularly thereafter: in patients with preserved renal function once a year, in patients with reduced CK and in elderly patients 2-4 times a year.
Particular caution should be exercised if renal function is impaired, for example, during the initial period of therapy with antihypertensive drugs, diuretics, NSAIDs.
The patient should be informed about the need to consult a doctor if symptoms of a bronchopulmonary infection or infectious disease of the genitourinary organs appear. While using the drug Metformin-Teva, you should refrain from drinking alcohol, due to the increased risk of developing hypoglycemia and a disulfiram-like effect. Hypovitaminosis B12 when taking the drug Metformin-Teva is caused by impaired absorption of vitamin B12 and is reversible. When Metformin-Teva is discontinued, signs of hypovitaminosis B12 quickly disappear.
Description
Hypoglycemic agent for oral administration of the biguanide group.
Use in children
Contraindicated for children under 18 years of age.
Pharmacodynamics
Metformin is an oral hypoglycemic agent from the biguanide group. In patients with diabetes mellitus, it reduces the concentration of glucose in the blood by inhibiting gluconeogenesis in the liver, reducing the absorption of glucose from the gastrointestinal tract and increasing its utilization in tissues by increasing their sensitivity to insulin (mainly striated muscles, to a lesser extent adipose tissue). Does not stimulate insulin secretion and does not cause hypoglycemic reactions. It has an effect on lipid metabolism - it reduces the concentration of triglycerides, cholesterol and low-density lipoproteins in the blood serum. Stimulates intracellular glycogenesis by activating glycogen synthase.
Side effects
Side effects are classified according to the following frequency: very often - at least 10%; often - at least 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rare - less than 0.01%, including isolated cases.
From the central nervous system: often - taste disturbance (metallic taste in the mouth).
From the digestive system: very often - nausea, vomiting, abdominal pain, lack of appetite, which occur during the initial period of treatment and in most cases resolve spontaneously; isolated cases - impaired liver function tests or hepatitis, which completely disappear after discontinuation of the drug.
Allergic reactions: very rarely - erythema, itching, rash.
On the metabolic side: very often - lactic acidosis (requires discontinuation of the drug).
Other: very rarely - with prolonged use, hypovitaminosis B12 develops.
Use during pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and breastfeeding.
If pregnancy is planned or occurs, Metformin-Teva should be discontinued and insulin therapy prescribed. The patient should be warned about the need to notify the doctor if pregnancy occurs. Mother and child should be monitored.
It is not known whether metformin is excreted in breast milk. If it is necessary to use the drug during lactation, breastfeeding should be stopped.
Interaction
Not recommended combinations
When metformin is used simultaneously with danazol, a hyperglycemic effect may develop. If treatment with danazol is necessary and after stopping its use, a dose adjustment of metformin under glycemic control is required.
With the simultaneous use of metformin with alcohol and ethanol-containing drugs, the risk of developing lactic acidosis during acute alcohol intoxication increases, especially during fasting or following a low-calorie diet, as well as in liver failure.
Combinations requiring special caution
Chlorpromazine in high doses (100 mg/day) reduces insulin release and increases blood glucose concentrations. When used simultaneously with antipsychotics and after stopping their use, dose adjustment of metformin under glycemic control is required. Glucocorticosteroids (GCS) reduce glucose tolerance and increase blood glucose concentrations, in some cases causing ketosis. If it is necessary to use such a combination and after discontinuation of GCS, a dose adjustment of metformin under glycemic control is required.
With the simultaneous use of loop diuretics and metformin, there is a risk of developing lactic acidosis due to the possible occurrence of functional renal failure.
Radiological examination with the use of iodine-containing radiocontrast agents can cause the development of lactic acidosis in patients with diabetes mellitus against the background of functional renal failure. The use of metformin should be discontinued 48 hours before and not resumed until 48 hours after an X-ray examination using radiocontrast agents.
The administration of beta2-adrenergic agonists by injection reduces the hypoglycemic effect of metformin due to stimulation of beta2-adrenergic receptors. In this case, you should monitor the concentration of glucose in the blood and, if necessary, prescribe insulin. Angiotensin-converting enzyme inhibitors and other antihypertensive drugs may decrease blood glucose concentrations. If necessary, the dose of metformin should be adjusted.
With simultaneous use of metformin with sulfonylurea derivatives, insulin, acarbose and sapicylates, the hypoglycemic effect may be enhanced. Loop diuretics and NSAIDs increase the risk of decreased renal function. In this case, caution must be exercised when using metformin.
Overdose
Symptoms
When using metformin at a dose of 85 g, no hypoglycemia was observed, but the development of lactic acidosis was noted. Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, decreased body temperature, abdominal pain, muscle pain, and later rapid breathing, dizziness, impaired consciousness and the development of coma may occur.
Treatment
If signs of lactic acidosis appear, treatment with the drug must be stopped immediately, the patient must be urgently hospitalized and, having determined the lactate concentration, the diagnosis must be clarified. The most effective measure for removing lactate and metformin from the body is hemodialysis. Symptomatic treatment is also carried out.
Impact on the ability to drive vehicles and operate machinery
Monotherapy with Metformin-Teva does not cause hypoglycemia and therefore does not affect the ability to drive a car or operate machinery. When using the drug Metformin-Teva with other hypoglycemic agents (sulfonylurea derivatives, insulin, etc.), the development of hypoglycemic conditions is possible, in which the ability to drive vehicles and engage in other potentially hazardous activities that require increased attention and rapid psychomotor reactions is impaired.