Metformin-Richter - instructions for use, dose, side effects, contraindications

Composition:1 tablet contains:
active substance - Metformin hydrochloride - 500 mg or 850 mg.
Auxiliary substances (a sufficient amount to produce a tablet weighing 625.0 mg and 1062.5 mg (excluding shell)): copovidone, polyvidone (povidone), salted [98% microcrystalline cellulose and 2% silicon dioxide colloid], magnesium stearate.
Auxiliary substances (a sufficient amount to obtain a tablet with a coating weight of 0.650 g and 1.105 g): Opadrai II 33G28523 white (titanium dioxide 25%, triacetin 6.0%, macrogol 4000 8.0%, hypromellose 40.0%, lactose monohydrate 21.0%).

Description:Tablets 500 mg: tablets, covered with a film coating of white color, round, biconvex, on a transverse section of white color.
Tablets 850 mg: tablets covered with a film shell of white color, oblong, biconvex, on a cross-section of white color.

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

ATX: & nbsp

A.10.B.A.02 Metformin

Pharmacodynamics:Metformin inhibits gluconeogenesis in the liver, reduces the absorption of glucose from the intestine, enhances peripheral utilization of glucose, and also increases the sensitivity of tissues to insulin. In this case, it has no effect on the secretion of insulin by beta cells of the pancreas, does not cause hypoglycemic reactions. Reduces the content of total cholesterol, triglycerides and low density lipoproteins in the blood.

Pharmacokinetics:After oral administration metformin is absorbed from the gastrointestinal tract. Bioavailability is 50-60%. The maximum concentration in the blood plasma (Cmax) is reached 2.5 hours after ingestion. The intake of food reduces Cmax by 40% and slows its achievement by 35 minutes. The volume of distribution for the dose (850 mg) is 296 - 1012 liters. Metformin quickly distributed in tissues, practically does not bind to plasma proteins.Exposed to a very weak degree of metabolism and excreted by the kidneys. The clearance of metformin in healthy subjects is 400 ml / min (4 times greater than the creatinine clearance), which indicates the presence of active tubular secretion. The half-life is 6.5 hours.
If the kidneys are damaged, cumulation of the drug is possible.

Indications:Diabetes mellitus type 2 (especially in patients with obesity) without a tendency to ketoacidosis with ineffectiveness of diet therapy.

Contraindications:- hypersensitivity to the drug;
- diabetic ketoacidosis, diabetic precoma, coma;
- impaired renal function (creatinine clearance less than 60 ml / min);
- acute diseases that occur with a risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), fever, severe infectious diseases, hypoxia conditions (shock, sepsis, kidney infections, bronchopulmonary diseases);
- clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (cardiac or respiratory failure, acute myocardial infarction, etc.);
- Serious surgical operations and traumas (against which background insulin therapy is shown);
- impaired liver function;
- chronic alcoholism, acute alcohol poisoning;
- pregnancy, the period of breastfeeding;
- lactic acidosis (including in the anamnesis);
- use for at least 2 days before and within 2 days after carrying out radioisotope or X-ray studies with the introduction of iodine-containing contrast agent;
- compliance with the hypocaloric diet (less than 1000 kcal / day);
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption; It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Pregnancy and lactation:When planning pregnancy, as well as in case of pregnancy on the background of taking metformin, it should be canceled and insulin therapy prescribed. Since there is no data on the penetration into human milk, this medication is contraindicated in breastfeeding. If metformin is needed during breastfeeding, breast-feeding should be discontinued.

Dosing and Administration:The dose of the drug is determined by the doctor individually depending on the concentration of glucose in the blood.
Tablets, film-coated 500 mg. The initial dose is 500-1000 mg / day. After 10-15 days, a further gradual increase in the dose, depending on the concentration of glucose in the blood, is possible. The maintenance dose of the drug is usually 1000-2000 mg / day. The maximum dose is 3000 mg / day.
Film-coated tablets 850 mg: The initial dose is 850 mg / day. After 10-15 days, a further gradual increase in the dose, depending on the concentration of glucose in the blood, is possible. The maintenance dose of the drug is usually 1700 mg / day. The maximum dose is 2550 mg / day.
In elderly patients, the recommended daily dose should not exceed 1 g. Tablets should be taken whole during or immediately after meals, with a small amount of liquid. To reduce side effects from 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 occur especially often at the beginning of treatment and, as a rule, pass by themselves. These symptoms can be reduced by the appointment of antacids, m-holinoblokatorov or antispasmodics. In rare cases - increased activity of "hepatic" transaminases or hepatitis, disappearing after drug withdrawal.
From the side of metabolism: in rare cases - lactic acidosis (requires discontinuation of treatment); with prolonged treatment - hypovitaminosis B12 (a violation of its absorption).
From the hematopoiesis: in some cases - megaloblastic anemia.
From the endocrine system: hypoglycemia.
Allergic reactions: skin rash, itching.

Overdose:With an overdose of Metformin-Richter, 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.
Treatment: in the case of the appearance of signs of lactic acidosis, treatment with Metformin-Richter should be stopped immediately, the patient immediately hospitalized 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:Not recommended combinations: simultaneous danazol is not recommended to avoid hyperglycemia. If it is necessary to treat danazol and after stopping the intake of the latter, correction of the dose of metformin under the control of the level of glycemia is required.
Combinations that require special care: chlorpromazine - when taken in high doses (100 mg per day) increases the concentration of glucose in the blood, reducing the release of insulin. When treating with antipsychotics and after stopping the intake of the latter, correction of the dose of metformin is required under the control of blood glucose concentration.
When used simultaneously with derivatives of sulfonylurea, salicylates,
acarbose, insulin, non-steroidal anti-inflammatory drugs, monoamine oxidase inhibitors, oxytetracycline,inhibitors of angiotensin-converting enzyme, derivatives of fibroic acid, cyclophosphamide, P-adrenergic blockers may increase the hypoglycemic effect of metformin. When used simultaneously with glucocorticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, preparations of iodine-containing thyroid hormones, thiazide and loop diuretics, phenothiazine derivatives, nicotinic acid derivatives, a decrease in the hypoglycemic effect of metformin is possible.
Nifedipine increases absorption, Cmax, slows the excretion of metformin.
Cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis.
Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene and vancomycin), secreted by the renal tubules, compete for tubular transport systems and with prolonged therapy can increase Metformin Cmax by 60%.
Metformin can weaken the effect of indirect anticoagulants (coumarin derivatives).
The risk of developing lactic acidosis increases with acute alcohol intoxication, especially in case of fasting, compliance with a low-calorie diet or liver failure.
During treatment should refrain from taking alcohol and medications containing ethanol.
Possible cumulation of metformin and the development of lactic acidosis with intravascular injection of iodine-containing contrast agents.

Special instructions:During the treatment period, it is necessary at least 2 times a year, as well as with the appearance of myalgia, to determine the lactate content in the plasma.
In addition, once in 6 months, monitoring of creatinine in the blood serum (especially in elderly patients) is necessary.
It is possible to use metformin in combination with sulfonylurea derivatives.
In this case, a particularly careful control of the concentration of glucose in the blood is necessary. 48 hours before and within 48 hours after the radiocontrast study (urography, intravenous angiography) should stop taking metformin.
When a broncho-pulmonary infection or an infectious disease of the genito-urinary organs occurs, the patient should immediately inform the attending physician.

Effect on the ability to drive transp. cf. and fur:The use of the drug in monotherapy does not affect the ability to drive vehicles and other mechanisms.
When metformin is combined with other hypoglycemic agents (derivatives of sulfonylureas, insulin, etc.) hypoglycemic conditions may develop, 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:Film coated tablets, 500 mg or 850 mg.

Packaging:For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. By 1,2, 3,4 or 6 contour squares with the instruction for use are put in a cardboard pack.

Storage conditions:List B.
At a temperature of no higher than 25 ° C.
Keep out of the reach of children!

Shelf life:3 years.
Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001149

Date of registration:21.06.2010

Expiration Date:Unlimited

The owner of the registration certificate:GEDEON RICHTER-RUS, CJSC GEDEON RICHTER-RUS, CJSC Russia

Manufacturer: & nbsp

GEDEON RICHTER-RUS, CJSC Russia

Information update date: & nbsp2016-09-26

Illustrated instructions

Instructions

Metformin-Richter (Metformin-Richter)