Metformin MB-Teva - instructions for use, dose, side effects, contraindications

Composition:1 tablet contains active substance metformin hydrochloride 500.0 mg; Excipients: hypromellose 320.0 mg, ethylcellulose 7 cps 25.0 mg, microcrystalline cellulose 170.0 mg, magnesium stearate 5.0 mg.

Description:White or almost white oval tablets engraved with "93" on one side and "7267" on the other.

Pharmacotherapeutic group:Hypoglycemic agent for oral administration of the biguanide group

ATX: & nbsp

A.10.B.A.02 Metformin

Pharmacodynamics:Metformin - oral hypoglycemic agent from the biguanide group. In patients with diabetes mellitus, the concentration of glucose in the blood is reduced by suppressing gluconeogenesis in the liver,decrease the absorption of glucose from the gastrointestinal tract (GIT) and increase its utilization in tissues by increasing their sensitivity to insulin (predominantly striated muscle, and to a lesser extent - adipose tissue). Stimulates intracellular glycogenesis, activating glycogen synthase. Does not stimulate the secretion of insulin, hypoglycemic reactions do not cause. Has an effect on lipid metabolism - reduces the concentration in the blood serum of triglycerides, cholesterol and low density lipoproteins. Stabilizes or reduces body weight. Has a fibrinolytic effect due to inhibition of the inhibitor of tissue-type plasminogen activator.

Pharmacokinetics:

Suction. The time to reach the maximum concentration (Cmax after oral administration is 7 hours. When taken on an empty stomach, the area under the pharmacological curve (AUC) is reduced by 30%, C max and the time of its achievement does not change.

The absorption of metformin in sustained-release tablets does not depend on the composition of the food. When taking metformin prolonged action in a dose up to 2000 mg does not occur its accumulation.

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

Metabolism and excretion. It is 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 (11/2) is approximately 6.5 hours.

Pharmacokinetics in special clinical cases.

In patients with renal failure, renal clearance of metformin decreases in proportion to a decrease in creatinine clearance, T1 / 2 increases, which leads to an increase in the concentration of metformin in the blood. Cumulation is possible.

Indications:Diabetes mellitus type 2 in adults (especially in obese patients) with ineffectiveness of diet and exercise, as a monotherapy or in combination with other oral hypoglycemic agents or insulin.

Contraindications:

- Hypersensitivity to metformin or to any auxiliary substance.

- Diabetic ketoacidosis, diabetic precoma, coma.

- Renal insufficiency or renal dysfunction (creatinine clearance (CC) less than 45 ml / min).

- Acute conditions that occur with a risk of developing renal dysfunction:

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

- the state of hypoxia (shock, sepsis, kidney infections, bronchopulmonary diseases).

- Clinically expressed manifestations of acute and chronic diseases, which can lead to the development of tissue hypoxia (including cardiac or respiratory failure, acute myocardial infarction).

- Extensive surgery and trauma, when insulin therapy is indicated (see section "Special instructions").

- Hepatic failure, a violation of the liver.

- Chronic alcoholism, acute alcohol poisoning.

- Lactic acidosis (including in the anamnesis).

- Use for at least 48 hours before and within 48 hours after carrying out radioisotope or X-ray studies with the introduction of iodine-containing contrast medium (see section "Interaction with other drugs").

- Period not less than 48 hours before and within 48 hours after surgical interventions under general anesthesia, spinal or epidural anesthesia.

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

- Children under 18 years.

Carefully:In persons over the age of 60, performing heavy physical work (increased risk of lactic acidosis).

Pregnancy and lactation:

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

When planning or developing a pregnancy, the drug Metformin MV-Teva should be discontinued and insulin therapy should be prescribed. The patient should be warned about the need to inform the doctor if a pregnancy occurs. Mother and child should be monitored.

It is not known whether metformin with breast milk. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Inside, during or immediately after a meal.

Monotherapy and combination therapy with other oral hypoglycemic agents. The initial dose of 1 tablet (500 mg) 1 time a day in the evening. After 10-15 days, in the absence of adverse effects on the part of the gastrointestinal tract, 2 tablets (1000 mg) are prescribed once a day in the evening.A further gradual increase in the dose is possible depending on the concentration of glucose in the blood. The maximum daily dose is 4 tablets (2000 mg) 1 time / day in the evening. To reduce side effects from the gastrointestinal tract, the dose can be divided into 2 tablets (1000 mg) 2 times a day in the morning and in the evening.

If this regimen is ineffective, patients should be given metformin tablets with normal release at a maximum dose of 3000 mg / day. Patients receiving metformin with normal release, the initial dose of metformin prolonged action should be equivalent to a daily dose of metformin with normal release.

For patients receiving metformin in a dose exceeding 2000 mg per day, metformin therapy with prolonged action is not recommended.

When switching from another oral hypoglycemic agent to metformin should stop taking the previous drug and appoint metformin prolonged action according to the above scheme.

Combination with insulin. A drug Metformin MB-Teva and insulin can be used as a combination therapy to achieve better glycemic control.A drug Metformin MB-Teva is prescribed in the usual initial dose - 1 tablet (500 mg) once a day in the evening. The dose of insulin is selected based on the results of measuring the blood glucose concentration. After 10-15 days, the dose is adjusted depending on the blood glucose values. The maximum daily dose of metformin in combined treatment is 2000 mg / day, divided into 2 doses.

Patients with renal insufficiency

Metformin can be used in patients with moderate renal insufficiency of moderate severity (CK 45-59 ml / min) only in the absence of conditions that may increase the risk of developing lactic acidosis.

The initial dose is 500 mg once a day. The maximum dose is 1000 mg per day. Kidney function should be carefully monitored every 3-6 months. If the SC is below 45 ml / min, the drug should be discontinued immediately.

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

Dose skip

In case of missed intake of the next dose, the patient should take the next dose at the usual time. Do not take a double dose of the drug Metformin MB-Teva.

Side effects:

Frequency of development of side effectsclassified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; sometimes - not less than 0.1%, but 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 central nervous system: often - a taste disorder (metallic taste in the mouth).

From the digestive system: very often - nausea, vomiting, abdominal pain, lack of appetite, diarrhea, flatulence that occur during the initial period of treatment and in most cases spontaneously passing; single cases - a violation of liver function indicators or hepatitis, completely disappearing after drug withdrawal. Allergic reactions: very rarely - erythema, itchy skin. rash, hives.

From the side of metabolism: very rarely - lactic acidosis (requires withdrawal of the drug).

Other: very rarely - with prolonged use develops hypovitaminosis B12 (including megaloblastic anemia) and folic acid (impaired absorption).

Overdose:

Symptoms. With the use of metformin in a dose of 85 g there was no hypoglycemia, but there was a development of lactic acidosis.The early symptoms of lactic acidosis are nausea, vomiting, diarrhea, lower body temperature, abdominal pain, muscle pain, there may be more rapid breathing, dizziness, impaired consciousness and coma development.

Treatment. In case of signs of lactic acidosis, the drug should be discontinued immediately, the patient must be hospitalized and, having determined the concentration of lactate, clarify the diagnosis. The most effective measure for excretion from the body of lactate and metformin is hemodialysis. Conduct also symptomatic treatment.

Interaction:

Contraindicated combinations. Radiological studies using iodine-containing radiocontrast agents can cause the development of lactic acidosis in diabetic patients on the background of functional renal failure. The use of metformin should be discontinued 48 hours before and not resumed earlier 48 hours after radiographic examination using radiopaque means. Uncommon combinations. With simultaneous use of metformin with alcohol and ethanol-containing drugs, the risk of developing lactic acidosis during acute alcoholicintoxication, especially when fasting or observing a low-calorie diet, as well as with liver failure.

Combinations that require special care. With the simultaneous use of metformin with danazol may develop a hyperglycemic effect. If it is necessary to treat danazol and after stopping its intake, a dose adjustment of metformin is required under the control of the glucose concentration in the blood.

Chlorpromazine in high doses (100 mg / day) reduces the release of insulin and increases the concentration of glucose in the blood. When used simultaneously with neuroleptics and after stopping their intake, a dose adjustment of metformin is required under the control of the glucose concentration in the blood.

Glucocorticosteroids (GCS) for parenteral and topical application reduce glucose tolerance and increase the concentration of glucose in the blood, in some cases, causing ketosis. If it is necessary to use this combination, and after stopping the GCS, correction of the dose of metformin is required under the control of the glucose concentration in the blood.

With the simultaneous use of "loop" diuretics and metformin, there is a risk of lactic acidosis because of the possible emergence of functional renal failure.

The administration of beta2-adrenomimegics in the form of injections reduces the hypoglycemic effect of metformin due to stimulation of 2-adrenoreceptors. In this case, you should monitor the blood glucose and, if necessary, prescribe insulin.

Angiotensin converting enzyme inhibitors and other antihypertensive drugs can reduce the concentration of glucose in the blood. If necessary, the dose of metformin should be adjusted.

With the simultaneous use of metformin with derivatives of sulfonylurea, insulin, acarbose and salicylates, an increase in hypoglycemic effect is possible. Nifediin increases the absorption and C max of metformin. which must be taken into account when appointing at the same time.

"Loopback" diuretics and non-staging anti-inflammatory drugs (NSAIDs) increase the risk of decreased kidney function. In this case, care must be taken when applying metformin.

Special instructions:

During the period of drug treatment Metformin MB-Teva should regularly monitor the concentration of glucose in the blood on an empty stomach and after eating.

The patient should be warned about the need to stop taking the drug and see a doctor if there is vomiting, abdominal pain, muscle pain,general weakness and severe malaise. These symptoms can be a sign of beginning lactic acidosis.

A drug Metformin MB-Teva should be discontinued 48 hours before and during the 48-hour period after the X-ray examination (including urography, intravenous angiography) using radiopaque means.

A drug Metformin MB-Teva should be discontinued 48 hours before and during the 48-hour period after surgery under general anesthesia, spinal or epidural anesthesia.

Because the metformin is excreted by the kidneys, before the start of treatment and regularly in the subsequent should be determined QA: in patients with preserved kidney function 1 time per year; in patients with reduced QC and in elderly patients - 2-4 times a year.

Particular caution should be exercised in cases of impaired renal function, for example, during the initial period of therapy with antihypertensive agents, diuretics, NSAIDs. It is necessary to inform the patient about the need to consult a doctor if symptoms of bronchopulmonary infection or infectious disease of the genito-urinary organs appear.

Against the background of the drug Metformin MB-Teva should refrain from taking alcohol because of the increased risk of hypoglycemia and disulfiram-like effect.

Hypovitaminosis B12 when taking the drug Metformin MB-Teva is caused by a violation of absorption and has a reversible character. With cancellation of the drug Metformin MV-Teva signs of hypovitaminosis B12 rapidly disappear.

Effect on the ability to drive transp. cf. and fur:Monotherapy with the drug Metformin MB-Teva does not cause hypoglycemia and therefore does not affect the ability to drive and work with machinery. When using the drug Metformin MV-Teva with other hypoglycemic agents (derivatives of sulfonylureas, insulin, etc.) may develop hypoglycemic conditions, in which the ability to drive vehicles and engage in other potentially dangerous activities that require increased attention and rapid psychomotor reactions deteriorates.

Form release / dosage:Tablets prolonged action of 500 mg.

Packaging:

For 10 tablets in a blister of PVC / PA / aluminum foil.

By 3, 6 or 12 blisters together with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature of ns above 25 ° C.

Keep out of the reach of children.

Shelf life:

2.5 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001968

Date of registration:14.01.2013 / 22.06.2017

Expiration Date:14.01.2018

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Pharmaceutical Industries, Ltd. Israel

Representation: & nbspTeva Teva Israel

Information update date: & nbsp12.05.2018

Illustrated instructions

Instructions

Metformin MB-Teva (Metformin-MV-Teva)