METFORMIN

Metformin - official * instructions for use

* registered by the Ministry of Health of the Russian Federation

Registration number:

LSR-007322 / 08-120908

Trade name: Metformin

International non-proprietary name:

Metformin

Dosage Form:

enteric-coated tablets

Composition

1 tablet contains:

active ingredient: metformin hydrochloride 500.00mg;

excipients: povidone K 90, corn starch, crospovidone, magnesium stearate, talc;

shell composition: metacrylic acid and methyl methacrylate copolymer (Eudragit L 100-55), macrogol 6000, titanium dioxide, talc.

Description:

Round biconvex tablets, enteric-coated, white.

Pharmacotherapeutic group:

Hypoglycemic agent for oral administration of the biguanide group.

ATX Code: [А10ВА02]

Pharmacological properties

Pharmacodynamics.

Metetformin inhibits gluconeogenesis in the liver, reduces the absorption of glucose from the intestine, enhances peripheral glucose utilization, and also increases the insulin sensitivity of tissues. It does not affect insulin secretion by pancreatic beta cells, does not cause hypoglycemic reactions. It lowers triglycerides and low density lipoproteins in the blood. Stabilizes or reduces body weight. It has a fibrinolytic effect due to the suppression of a tissue-type plasminogen activator inhibitor.

Pharmacokinetics.

After oral administration, mittformin is absorbed from the gastrointestinal tract. Bioavailability after taking the standard dose is 50-60%. The maximum plasma concentration is reached 2.5 hours after ingestion. Practically not bound to plasma proteins. It accumulates in the salivary glands, muscles, liver and kidneys. Excreted unchanged by the kidneys. The half-life is 9-12 hours. In case of impaired renal function, the drug may accumulate.

Indications for use

Type 2 diabetes without a tendency to ketoacidosis (especially in patients with obesity) with the ineffectiveness of diet therapy.

  • in combination with insulin, in case of diabetes mellitus type 2, especially with a pronounced degree of obesity, accompanied by secondary insulin resistance.

Contraindications

  • diabetic ketoacidosis, diabetic precoma, coma;
  • impaired renal function;
  • acute diseases that are at risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), fever, serious infectious diseases, hypoxia (shock, sepsis, renal infections, bronchopulmonary diseases);
  • clinically significant manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (cardiac or respiratory failure, acute myocardial infarction, etc.);
  • serious surgery and trauma (when insulin therapy is indicated);
  • liver dysfunction:
  • chronic alcoholism, acute alcohol poisoning;
  • pregnancy, breastfeeding period;
  • hypersensitivity to the drug;
  • lactic acidosis (including history);
  • use for at least 2 days before and within 2 days after radioisotope or x-ray examinations with the introduction of iodine-containing contrast agent;
  • adherence to a low-calorie diet (less than 1000 calories / day);

It is not recommended to use the drug in persons older than 60 years who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis in them.

Use during pregnancy and during breastfeeding

When planning a pregnancy, as well as in the case of the occurrence of pregnancy while taking Metformin, it should be canceled and insulin therapy prescribed. Since there is no data on the penetration into breast milk, this drug is contraindicated during breastfeeding. If necessary, the use of Metformin during breastfeeding, breast-feeding should be discontinued.

Dosage and administration

The dose of the drug is set by the doctor individually, depending on the level of glucose in the blood.

The initial dose is 500-1000 mg / day. (1-2 tablets). After 10-15 days, a further gradual increase in dose is possible depending on the level of blood glucose.

Maintenance dose of the drug is usually 1500-2000 mg / day. (3-4 tablets) The maximum dose is 3000 mg / day. (6 tablets).

In elderly patients, the recommended daily dose should not exceed 1 g. (2 tablets)

Metformin tablets should be taken whole during or immediately after a meal, washed down with a small amount of liquid (a glass of water). To reduce the side effects of the gastrointestinal tract, the daily dose should be divided into 2-3 doses.

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

Side effects

On the part of the digestive system: nausea, vomiting, "metallic" taste in the mouth, lack of appetite, diarrhea, flatulence, abdominal pain.

These symptoms are particularly common at the beginning of treatment and, as a rule, go away on their own. These symptoms can be reduced by administering anthocides, atropine derivatives, or antispasmodics.

On the part of metabolism: in rare cases - lactic acidosis (requires discontinuation of treatment); with long-term treatment - hypovitaminosis B12 (absorption disorder).

On the part of blood-forming organs: in some cases - megaloblastic anemia.

On the part of the endocrine system: hypoglycemia.

Allergic reactions: skin rash.

Overdose

With an overdose of the drug Metformin may develop lactic acidosis with a fatal outcome. The cause of lactic acidosis may also be the cumulation of the drug due to impaired renal function. Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, decrease in body temperature, abdominal pain, muscle pain, and there may be an increase in breathing, dizziness, impaired consciousness and the development of coma.

Treatment: In case. appearance of signs of lactic acidosis, treatment with Metformin should be immediately stopped, the patient should be urgently hospitalized and, after determining the concentration of lactate, confirm the diagnosis. The most effective measure for the elimination of lactate and metformin from the body is hemodialysis. Symptomatic treatment is also performed.

In combination therapy with metformin sulfonylurea drugs, hypoglycemia may develop.

Interaction with other drugs

Not recommended combinations: simultaneous administration of danazol is not recommended in order to avoid hyperglycemic action of the latter. If necessary, treatment with danazol and after discontinuation of the latter requires a dose adjustment of metformin under the control of glycemia.

Combinations that require special caution: Chlorpromazine - when taken in high doses (100 mg per day) increases glycemia, reducing the release of insulin. When treating neuroleptics and after discontinuation of the latter, a dose adjustment of metformin is required under the control of the glycemia level.

With simultaneous use with sulfonylurea derivatives, acarbose, insulin, nonsteroidal anti-inflammatory drugs, monoamine oxidase inhibitors, oxytetracycline, angiotensin converting enzyme inhibitors, clofibrate derivatives, cyclophosphamide inhibitors, clofibrate, cyclophosphamide, adrenergic blockers, clofibrate, cyclophosphamide, adrenergic blockers, clofibrate, cyclophosphamide, adrenergic blockers, clofibrate derivatives, cyclophosphamide, β-adrenergic blockers, inhibitors of clofibrate, cyclophosphamide, β-adrenergic blockers, inhibitors, clofibrate, cyclophosphamide, and adrenaline inhibitors; With simultaneous use with glucocorticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormones, thiazide and "loop" diuretics, phenothiazine derivatives, nicotinic acid derivatives, the hypoglycemic action of metformin may decrease. Cimetidine slows down the elimination of metformin, resulting in an increased risk of lactic acidosis.

Methotformin can weaken the effect of anticoagulants (coumarin derivatives). Alcohol intake increases the risk of lactic acidosis during acute alcohol intoxication, especially in cases of starvation or low-calorie diets, as well as liver failure.

Special instructions

During the period of treatment, it is necessary to monitor renal function. At least 2 times a year, as well as the appearance of myalgia should determine the content of lactate in the plasma.

In addition, 1 time in 6 months control of serum creatinine level is necessary (especially in patients of old age). It is not necessary to prescribe Methformin if the level of creatinine in the blood is higher than 135 µmol / l in men and 110 µmol / l in women.

Perhaps the use of the drug Methformin in combination with sulfonylurea derivatives. In this case, extremely careful control of the glucose level in the blood is necessary.

48 hours before and within 48 hours after a radiopaque (urography, intravenous angiography), stop taking Metformin.

When a patient has a bronchopulmonary infection or an infection of the urinary organs, you should immediately inform your doctor.

During treatment, you should refrain from taking alcohol and drugs containing ethanol.

Influence on ability to drive motor transport and work with mechanisms

The use of the drug in monotherapy does not affect the ability to drive and work with mechanisms.

When Metformin is combined with other hypoglycemic agents (sulfonylurea derivatives, insulin, etc.), hypoglycemic states can develop, which impair the ability to drive vehicles and engage in other potentially dangerous activities that require increased attention and quick psychomotor reactions.

Release form

Enteric-coated tablets 500 mg. On 10 tablets in the blister from AL / PVC. On 3 blisters together with the application instruction in a pack cardboard.

Shelf life

2 years.

Do not use after expiration date.

Storage conditions

Store in a dry, dark place at a temperature of from 15 to 25 ° C. Keep out of the reach of children!

Pharmacy sales terms:

On prescription.


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