Active substanceMetformin hydrochlorideMetformin hydrochloride
Similar drugsTo uncover
Dosage form: & nbspfilm-coated tablets
Composition:

1 tablet, film-coated, contains:

active substance: metformin hydrochloride 1000 mg;

Excipients: hypromellose (15000 CPS) 35.2 mg, povidone (K-25) 53.0 mg, magnesium stearate 5.8 mg; composition of the film membrane: hypromellose (5 CPS) 11.5 mg, macrogol 6000 2.3 mg, titanium dioxide 9.2 mg.

Description:Oblong white tablets coated with a film sheath, with a risk, on a broken white color, practically odorless.
Pharmacotherapeutic group:Hypoglycemic agent for oral administration of the biguanide group
ATX: & nbsp

A.10.B.A   Biguanides

A.10.B.A.02   Metformin

Pharmacodynamics:

In patients with diabetes mellitus metformin reduces the concentration of glucose in the blood by suppressing 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. 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. Stimulates intracellular glycogenesis, activating glycogen synthase.

Pharmacokinetics:After oral administration metformin is absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is 50-60%. The maximum concentration in the blood plasma is achieved after 2 hours after ingestion. Virtually does not bind to plasma proteins. It accumulates in the salivary glands, muscles, liver and kidneys. Penetrates into red blood cells. It is excreted unchanged by the kidneys. The half-life is 6.5 hours. If the renal function is impaired, cumulation of the drug 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 failure or impaired renal function (creatinine clearance less than 60 ml / min);

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

- Dehydration (with diarrhea, vomiting), severe infectious 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 surgery and trauma, when insulin therapy is indicated (see section "Special instructions");

- liver failure, a violation of liver function;

- chronic alcoholism, acute alcohol poisoning;

- lactic acidosis (including in the anamnesis);

- Pregnancy;

- use less than 48 hours before and within 48 hours after radioisotope or X-ray studies with the introduction of an iodine-containing contrast medium (see section "Interaction with other drugs");

- compliance with the hypocaloric diet (less than 1000 kcal / day);

- Children under 18 years.

Carefully:People over 60 years of age who perform heavy physical work (increased risk of lactic acidosis).
Pregnancy and lactation:The drug is contraindicated for use in pregnancy. When planning or in the event of pregnancy, Metformamma® 1000 should be discontinued and pneuliotherapy prescribed.The patient should be warned about the need to inform the doctor if a pregnancy occurs. Mother and child should be monitored. A limited amount of data on the use of metformin in pregnant women does not indicate an increased risk of congenital malformations in children. Metformin penetrates into breast milk. Side effects in newborns with breastfeeding against metformin were not observed. However, due to the limited amount of data, the use of the drug during breastfeeding is not recommended. The decision to stop breastfeeding should be taken in consideration of the benefits of breastfeeding and the potential risk of side effects in the child.
Dosing and Administration:

The dose of Metofamma® 1000 is determined individually, taking into account the concentration of glucose in the blood. The initial dose is usually 500-1000 mg (1/2 - 1 tablet) per day, it is possible to further gradually increase the dose, depending on the effect of therapy.

The maintenance daily dose of the drug is 1-2 g (1-2 tablets) per day.The maximum daily dose - 3 g (3 tablets), the appointment of higher doses does not contribute to an increase in the effect of the treatment.

In elderly patients, the daily dose should not exceed 1000 mg / day. Metformamma® 1000 tablets should be taken with food, with a small amount of liquid (a glass of water). The course of treatment with the drug is long.

Due to the increased risk of lactic acidosis, the dose of the drug should be reduced in case of severe metabolic disorders.

Side effects:

From the digestive system: nausea, vomiting, abdominal pain, diarrhea, lack of appetite, "metallic" taste in the mouth. In these cases, it is usually not necessary to stop treatment, and the symptoms go away without changing the dose of the drug. The frequency and severity of side effects may decrease with a gradual increase in the dose of metformin,

Impaired liver function or hepatitis disappear after discontinuation of the drug.

Allergic reactions: skin rash, itching.

From the side of metabolism: lactoacidosis (requires discontinuation of treatment), with prolonged treatment - hypovitaminosis B12 (impaired absorption).

On the part of the hematopoiesis system: megaloblastic anemia.

When combined with Metfogamma 1000 with sulfonylureas, hypoglycemia may develop.

Overdose:When overdosing Methofogma® 1000, lactoacidosis can develop with a fatal outcome. The cause of the development of lactic acidosis may also be cumulation of the drug due to impaired renal function. 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. In case of signs of lactic acidosis, treatment with Methofamma® 1000 should be stopped immediately, the patient should be hospitalized immediately and, after determining the concentration of lactate, confirm the diagnosis. The most effective measure for excretion from the body of lactate and metformin is hemodialysis. Conduct also symptomatic treatment.
Interaction:

Unrecommended combinations

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, correction of metformin dose under the control of glycemia 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 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. At simultaneous application with neuroleptics and after the termination, their reception the correction of a dose of metformin under the control of a glycemia is required.

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

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

Radiological study 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 radiologic examination using iodine-containing radiopaque agents.

The use of beta2-adrenomimetics reduces the hypoglycemic effect of metformin due to stimulation of beta2-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.

Loop diuretics and non-steroidal 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 treatment with Metfogamma® 1000, the concentration of glucose in the blood should be monitored on an empty stomach and after meals.

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

Lactoacidosis is characterized by severe weakness, acidotic dyspnea, abdominal pain and hypothermia, followed by the development of coma.

Diagnostic laboratory indicators for lactic acidosis: a decrease in blood pH, an increase in plasma lactate concentration above 5 mmol / l, an increase in the anion interval and an increase in the lactate / pyruvate ratio. If metabolic acidosis is suspected, metformin should be discontinued and the patient should be immediately hospitalized.

Lactic acidosis is a rare but serious metabolic complication that may occur in connection with the cumulation of metformin. The cases of lactic acidosis were noted mainly in patients with diabetes mellitus with severe renal insufficiency.Risk factors are decompensated diabetes mellitus, ketosis, prolonged fasting, excessive alcohol consumption, liver failure and other conditions accompanied by hypoxia. If there is a suspicion of the development of metabolic lactic acidosis metformin must be canceled and the patient should be immediately hospitalized.

Kidney function

Because the metformin it is necessary to determine the creatinine clearance in the blood serum at least 1 time per year in patients with normal renal function and at least 2-4 times a year in patients with reduced creatinine clearance and elderly patients.

Particular caution should be exercised in cases of impaired renal function, for example, during the initial period of concomitant therapy with antihypertensive drugs, diuretics, and NSAIDs.

Carrying out X-ray study (urography, intravenous angiography) with the use of iodine-containing radiocontrast agents can lead to renal failure. Preparation Metfogamma® 1000 should be discontinued 48 hours before the X-ray examination, and resume the drug no earlier than 48 hours after it.

When conducting surgical interventions under general anesthesia, spinal or epidural anesthesia, Metfogamma 1000 should be discontinued 48 hours before surgery. Resume the drug is recommended not earlier than 48 hours after the operation.

When treating Metfogamma® 1000, you should follow a diet with a uniform distribution of carbohydrates throughout the day. Patients with excessive body weight should follow a diet with calorie restriction.

Standard laboratory tests should be routinely performed to monitor diabetes mellitus, especially at the beginning of treatment with Metfogamma® 1000.

Metformin with monotherapy does not cause hypoglycemia, but caution should be exercised when using the drug together with insulin or other hypoglycemic drugs (for example, sulfonylurea derivatives or repaglinide). In this case, a particularly careful control of the concentration of glucose in the blood is necessary.

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 use of the drug Metfogamma 1000 should refrain from drinking alcohol in connection with an increased risk of hypoglycemia and disulfiramoid-like effect. Hypovitaminosis B12 when taking the drug is caused by a violation of absorption and has a reversible character - the content of vitamin B12 is quickly restored when the drug is withdrawn. Reduction of vitamin B12 content should be taken into account in patients with megaloblastic anemia.

Effect on the ability to drive transp. cf. and fur:Preparation Metfogamma 1000 with monotherapy does not cause hypoglycemia, therefore does not affect the ability to drive vehicles and work with mechanisms. When combined metformin with other hypoglycemic agents (insulin, repaglinide and others), it is possible to 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, film-coated 1000 mg.
Packaging:

For 10 or 15 tablets in blisters of PVC film and aluminum foil.

For 3, 12 blisters (when packing 10 tablets in a blister) or 2, 8 blisters (when packing 15 tablets in a blister), together with the instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:LS-002407
Date of registration:07.02.2011
Expiration Date:Unlimited
The owner of the registration certificate:Wörwag Pharma GmbH & Co. KG. KGWörwag Pharma GmbH & Co. KG. KG Germany
Manufacturer: & nbsp
Information update date: & nbsp11.05.2018
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