Metformin-Teva, pills 1000mg 60pcs

Composition

Active ingredient:

metformin hydrochloride 1000 mg;

Auxiliary substances:

povidone K 30;

povidone K 90;

colloidal silicon dioxide;

magnesium stearate;

Opadray white shell Y-1-7000H (hypromellose (E 464); titanium dioxide (E 171); macrogol 400

Pharmacological action

Metformin has a hypoglycemic effect.

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). It does not stimulate insulin secretion and does not cause hypoglycemic reactions. It has an effect on lipid metabolism-reduces the concentration of triglycerides, cholesterol and low-density lipoproteins in the blood serum. It stimulates intracellular glycogenesis by activating glycogen synthase.

Pharmacokinetics

Suction After oral use, metformin is sufficiently fully 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 reached in 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, metformin absorption decreases and slows down.

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

Metabolism and elimination 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 cases

In patients with renal insufficiency, the renal clearance of metformin decreases in proportion to the decrease in creatinine clearance, T 1/2 increases, which leads to an increase in the concentration of metformin in the blood. Cumulation is possible.

Indications

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 insufficiency or impaired renal function (creatinine clearance (CC) less than 60 ml / min).
• Acute conditions with a risk of developing impaired renal function: dehydration (with diarrhea, vomiting), fever, severe infectious diseases, hypoxia (shock, sepsis, kidney infections, bronchopulmonary diseases).
• Clinically expressed manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including heart OR respiratory failure, acute myocardial infarction).
• Extensive surgical operations and injuries, when insulin therapy is indicated (see the section “Special instructions”).
• Hepatic insufficiency, impaired liver function.
• Chronic alcoholism, acute alcohol poisoning.
• Lactic acidosis (including in the anamnesis).
• 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 (see the section “Interaction with other drugs”).
• A period of at least 48 hours before and within 48 hours after surgery under general anesthesia, spinal or peridural anesthesia.
• Compliance with a hypocaloric diet (less than 1000 kcal / day).
• Children under 18 years of age.

With caution:  in people over 60 years of age who perform heavy physical work (increased risk of lactic acidosis).

Side effects

From the central nervous system:  often-a violation of taste (metallic taste in the mouth).

From the digestive system:  very often – nausea, vomiting, abdominal pain, lack of appetite that occur during the initial period of treatment and in most cases “spontaneously pass”; isolated cases – violation of 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).

Other services:  very rarely – with prolonged use, hypovitaminosis develops in 12.

Interaction

Not recommended combinations With the simultaneous use of metformin with danazol, a hyperglycemic effect may develop. If treatment with danazol is necessary and after discontinuation of its use, it is necessary to adjust the dose of metformin under the control of glycemia. Concomitant use of metformin with alcohol and ethanol-containing drugs increases the risk of lactic acidosis during acute alcohol intoxication, especially when fasting or following a low-calorie diet, as well as with liver failure.

Combinations requiring extreme caution Chlorpromazine in high doses (100 mg/day) reduces the release of insulin and increases the concentration of glucose in the blood. When used concomitantly with antipsychotics and after discontinuation of their use, a dose adjustment of metformin is required under the control of glycemia. Glucocorticosteroids (corticosteroids) reduce glucose tolerance and increase blood glucose concentrations, in some cases causing ketosis. If it is necessary to use this combination and after discontinuation of corticosteroids, it is necessary to adjust the dose of metformin under the control of glycemia.

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 radiopaque 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 earlier than 48 hours after X-ray examination with the use of radiopaque agents.

use of beta-2-adrenomimetics by injection reduces the hypoglycemic effect of metformin due to stimulation of beta-2-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 medications may reduce blood glucose concentrations. If necessary, the metformin dose should be adjusted.

Concomitant use of metformin with sulfonylurea derivatives, insulin, acarbose and salicylates may increase the hypoglycemic effect. Loop diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of decreased kidney function. In this case, caution should be exercised when using metformin.

How to take, course of use and dosage

Inside, during or immediately after a meal.

Monotherapy and combination therapy with other oral hypoglycemic agents

The initial dose is 500-1000 mg once a day in the evening. After 7-15 days, if there are no 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.

The maintenance dose is 1500-2000 mg / day. To reduce side effects from the gastrointestinal tract, the dose should be divided into 2-3 doses. The maximum daily dose is 3000 mg / day in 3 divided doses.

A slow increase in the dose may improve the gastrointestinal tolerance of the drug.

Patients taking metformin at doses of 2000-3000 mg / day can be transferred to a dose of 1000 mg. The maximum recommended dose is 3000 mg / day in 3 divided doses.

When switching to therapy from another hypoglycemic agent, you should stop taking another drug and start taking Metformin-Teva at the dose indicated above.

Combinations with insulin

Metformin-Teva and insulin can be used as a combination therapy to achieve better glycemic control.

The drug is prescribed in the usual initial dose of 500 or 850 mg 2-3 times a day. The dose of insulin is selected based on the results of blood glucose measurement. 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 is 2 g / day in 2-3 divided doses.

In elderly patients, the daily dose should not exceed 1000 mg / day.

Overdose

Symptoms:  When using metformin at a dose of 85 g, hypoglycemia was not observed, but lactic acidosis was observed. Early symptoms of lactic acidosis include nausea, vomiting, diarrhea, a decrease in body temperature, abdominal pain, muscle pain, and later rapid breathing, dizziness, impaired consciousness, and coma may occur.

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

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 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. The drug Metformin-Teva should be discontinued 48 hours before and within 48 hours after X-ray examination (including urography, intravenous angiography) with the use of radiopaque agents.

Metformin-Teva should be discontinued 48 hours before and 48 hours after surgery under general anesthesia, spinal or peridural anesthesia. Since metformin is excreted by the kidneys, creatinine clearance should be determined before starting treatment and regularly thereafter: in patients with preserved renal function 1 time a year, in patients with reduced creatinine clearance and in elderly patients 2-4 times a year.

Special care should be taken when renal function is impaired, for example, during the initial period of therapy with antihypertensive agents, diuretics, NSAIDs.

The patient should be informed about the need to consult a doctor if symptoms of a bronchopulmonary infection or an infectious disease of the genitourinary organs appear. While using the drug Metformin-Teva, you should refrain from taking alcohol, due to the increased risk of hypoglycemia and disulfiram-like effect. B12 hypovitaminosis when taking Metformin-Teva is caused by a violation of the absorption of vitamin B12 and is reversible. When the drug Metformin-Teva is discontinued, the signs of hypovitaminosis in 12 quickly disappear.

Composition

Tablet Form of production

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Metformin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets