Metformin tablets 1000mg, Teva No. 60

Type 2 diabetes mellitus in adults (especially in obese patients) with ineffective diet and exercise as monotherapy or in combination with other oral hypoglycemic agents or insulin.

Inside, but time or immediately after eating.

Monotherapy and combination therapy with other oral hypoglycemic agents
Initial dose: 500-1000 mg once a 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 in the evening. Perhaps a further gradual increase in the dose, 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. A slow increase in the dose may help to improve the gastrointestinal tolerance of the drug.

Patients taking metformin at doses of 2000-3000 mg / day can be switched to 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 agent 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 insulin dose 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 combined treatment: 2 g / day in 2-3 doses. In elderly patients, the daily dose should not exceed 1000 mg / day.

Film-coated tablets of white or almost white color, oval, with a line on both sides, engraved with '9' to the left of the line and '3' to the right of the line on one side, and '72' to the left of the line and '14' to the right from risks to another.

1 tab.

Active ingredient: 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: white opadry Y-1-7000H (hypromellose (E464) - 20 mg, titanium dioxide (E171) - 10 mg, macrogol 400 - 2 mg).

• Hypersensitivity to metformin or to any excipient of the drug.

• Diabetic ketoacidosis, diabetic precoma, coma.

• Renal failure or impaired renal function (creatinine clearance (CC) less than 60 ml / min).

• Acute conditions occurring with the risk of developing impaired renal function:

  • dehydration (with diarrhea, vomiting), fever, severe infectious diseases,

  • states of hypoxia (shock, sepsis, renal 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 trauma, when insulin therapy is indicated (see section 'Special instructions').

• Liver failure, abnormal liver function.

• Chronic alcoholism, acute alcohol poisoning.

• Lactic acidosis (including history).

• Application for at least 48 hours before and within 48 hours after carrying out radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent (see the section 'Interaction with other medicinal products').

• A period of at least 48 hours before and within 48 hours after surgery under general anesthesia, spinal or epidural anesthesia.

• Compliance with a hypocaloric diet (less than 1000 kcal / day).

• Children under the age of 18.

With caution: in persons over 60 years of age, performing heavy physical work (increased risk of lactic acidosis).

Application during pregnancy and during breastfeeding

The drug is contraindicated for use during pregnancy and during breastfeeding.

When planning or the onset of pregnancy, Metformin-Teva should be canceled and insulin therapy should be prescribed. The patient should be warned about the need to notify the doctor in case of pregnancy. The mother and child should be monitored.

It is not known whether metformin is excreted in breast milk. If necessary, the use of the drug during lactation should stop breastfeeding.

Trade name: Metformin-Teva

INN: metformin

Dosage form:

film-coated tablets

Description
Tablets 500 mg: white or almost white oval film-coated tablets engraved with '93' on one side and '48' on the other.
Tablets 850 mg: White or off-white oval film-coated tablets engraved with '93' on one side and '49' on the other.
Tablets 1000 mg: white or almost white oval film-coated tablets with a scored on both sides, engraved with '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 of the risks to the other.

Pharmacotherapeutic group: hypoglycemic agent for oral administration of the biguanide group.

ATX code: ј10¬ј02.

Pharmacological properties

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 (GIT) 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, 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

Absorption
After taking the drug inside, metformin is completely absorbed from the gastrointestinal tract. The absolute bioavailability is 50-60%. The maximum concentration (Cmax) in plasma is approximately 2 ?g / ml or 15 ?mol / L and is reached after 2.5 hours. After 7 hours, absorption from the gastrointestinal tract ends, and the concentration of metformin in plasma gradually decreases. With the simultaneous intake of food, the absorption of metformin decreases and slows down.

Distribution
Metformin practically does not bind to plasma proteins and is rapidly distributed into body tissues. Penetrates into erythrocytes. It accumulates in the salivary glands, liver and kidneys. The apparent volume of distribution is 63-276 liters.

Metabolism and excretion
Excreted by the kidneys unchanged 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) with ineffective diet and exercise 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 (CC) less than 60 ml / min).

• Acute conditions occurring with the risk of developing impaired renal function:

  • dehydration (with diarrhea, vomiting), fever, severe infectious diseases,

  • states of hypoxia (shock, sepsis, renal 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 trauma, when insulin therapy is indicated (see section 'Special instructions').

• Liver failure, abnormal liver function.

• Chronic alcoholism, acute alcohol poisoning.

• Lactic acidosis (including history).

• Application for at least 48 hours before and within 48 hours after carrying out radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent (see the section 'Interaction with other medicinal products').

• A period of at least 48 hours before and within 48 hours after surgery under general anesthesia, spinal or epidural anesthesia.

• Compliance with a hypocaloric diet (less than 1000 kcal / day).

• Children under the age of 18.

With caution: in persons over 60 years of age, performing heavy physical work (increased risk of lactic acidosis).

Application during pregnancy and during breastfeeding

The drug is contraindicated for use during pregnancy and during breastfeeding.

When planning or the onset of pregnancy, Metformin-Teva should be canceled and insulin therapy should be prescribed. The patient should be warned about the need to notify the doctor in case of pregnancy. The mother and child should be monitored.

It is not known whether metformin is excreted in breast milk. If necessary, the use of the drug during lactation should stop breastfeeding.

Method of administration and dosage
Inside, but time or immediately after eating.

Monotherapy and combination therapy with other oral hypoglycemic agents
Initial dose: 500-1000 mg once a 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 in the evening. Perhaps a further gradual increase in the dose, 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. A slow increase in the dose may help to improve the gastrointestinal tolerance of the drug.

Patients taking metformin at doses of 2000-3000 mg / day can be switched to 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 agent 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 insulin dose 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 combined treatment: 2 g / day in 2-3 doses. In elderly patients, the daily dose should not exceed 1000 mg / day.

Side effects
Side effects are classified according to the following frequency: very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - at least 0.1%, at less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including isolated cases.

From the side of 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, arising in the initial period of treatment and in most cases 'spontaneously passing; isolated cases - impaired liver function indicators or hepatitis, completely disappearing after discontinuation of the drug.

Allergic reactions: very rarely - erythema, pruritus, rash.

From the side of metabolism: very often - lactic acidosis (requires discontinuation of the drug).

Others: very rarely - with prolonged use, hypovitaminosis B12 develops.

Overdose

Symptoms
When using metformin at a dose of 85 g, no hypoglycemia was observed, however, the development of lactic acidosis was noted. Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, a decrease in body temperature, pain and abdominal pain, muscle pain; in the future, there may be increased breathing rate, dizziness, impaired consciousness and the development of coma.

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

Interaction with other medicinal products

Combinations not recommended
With the simultaneous use of metformin with danazol, the development of a hyperglycemic effect is possible. If it is necessary to treat with danazol and after stopping it, a dose adjustment of metformin is required under glycemic control. With the simultaneous use of metformin with alcohol and ethanol-containing drugs, the risk of developing lactic acidosis during acute alcohol intoxication increases, especially when fasting or following a low-calorie diet, as well as with liver failure.

Combinations requiring special care
Chlorpromazine in high doses (100 mg / day) reduces the release of insulin and increases the concentration of glucose in the blood. With simultaneous use with antipsychotics and after the termination of their intake, a dose adjustment of metformin is required under glycemic control. Glucocorticosteroids (GCS) decrease glucose tolerance and increase blood glucose concentration, in some cases causing ketosis. If it is necessary to use such a combination and after cessation of corticosteroids, a dose adjustment of metformin is required under glycemic control.

With the simultaneous use of 'loop' diuretics and metformin, there is a risk of lactic acidosis due to the possible appearance of functional renal failure.

Radiological examination with the use of iodine-containing X-ray contrast 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 should not be resumed earlier than 48 hours after an X-ray examination using radiopaque contrast agents.

Appointment in the form of injections of beta2-adrenergic agonists 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 can lower blood glucose levels. The dose of metformin should be adjusted if necessary.

With the simultaneous use of metformin with sulfonylurea derivatives, insulin, acarbose and salicylates, an increase in the hypoglycemic effect is possible. Loop diuretics and non-steroidal anti-inflammatory drugs (IPAIs) increase the risk of decreased kidney function. In this case, care must be taken when using metformin.

Special instructions
During the period of 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 occurs. These symptoms can be a sign of incipient lactic acidosis. The drug Metformin-Teva should be discontinued 48 hours before and within 48 hours after the X-ray examination (including urography, intravenous angiography) using X-ray contrast agents.

The drug Metformin-Teva should be discontinued 48 hours before and within 48 hours after surgery under general anesthesia, spinal or epidural anesthesia. Since metformin is excreted by the kidneys, CC should be determined before starting treatment and regularly thereafter: in patients with preserved renal function once a year, in patients with low CC and in elderly patients 2-4 times a year.

Particular caution should be exercised in case of impaired renal function, 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 bronchopulmonary infection or an 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 hypoglycemia and disulfiram-like effect. B12 hypovitaminosis when taking Metformin-Teva is caused by impaired absorption of vitamin B12 and is reversible. When the drug Metformin-Teva is discontinued, the signs of B12 hypovitaminosis quickly disappear.

Influence on the ability to drive vehicles and control mechanisms
Monotherapy with Metformin-Teva does not cause hypoglycemia and therefore does not affect the ability to drive and operate mechanisms. When using the drug Metformin-Teva with other hypoglycemic agents (sulfonylurea derivatives, insulin, etc.), hypoglycemic conditions may develop, in which the ability to drive vehicles and engage in other potentially hazardous activities that require increased attention and rapid psychomotor reactions deteriorates.

Release form
Film-coated tablets, 500 mg, 850 mg and 1000 mg. 10 tablets in PVC / PVDC / aluminum foil blisters; 3 or 6 blisters together with instructions for use in a cardboard box.

Storage conditions
At a temperature not exceeding 25 ? —.
Keep out of the reach of children.

Shelf life is
3 years. Do not use after the expiration date.

Terms of dispensing from pharmacies
Prescription.

The owner of the RU: Teva Pharmaceutical Enterprises Ltd., 5 Basel St., PO Box 3190, Petah Tikva 49131, Israel.

Address for receiving claims: 119049, Moscow, st. Shabolovka, 10, building 1.

Manufacturing, packaging and release: Teva Pharmaceutical Enterprises Ltd., 64 HaShikma Str., PO Box 353, Kfar Sava 44102, Israel.

Alternative production site for 1000 mg tablets: Teva Pharmaceutical Enterprises Ltd., 2 HaMarpeh Str., PO Box 1142, Jerusalem 91010, Israel.