Metformin-Richter pills 500mg N60
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Active ingredients
Metformin
Release form
Pills
Composition
1 tablet contains: Metformin hydrochloride 500 mg Auxiliary substances: copovidone, polyvidone (povidone), prosolv (microcrystalline cellulose - 98%, colloidal silicon dioxide - 2%), magnesium stearate. Composition of the shell: opadry II 33G28523 white (titanium dioxide - 25% , triacetin - 6%, macrogol 4000 - 8%, hypromellose - 40%, lactose monohydrate - 21%).
Pharmacological effect
Hypoglycemic drug. It inhibits gluconeogenesis in the liver, reduces the absorption of glucose from the intestine, increases peripheral glucose utilization, and also increases the sensitivity of tissues to insulin. It has no effect on insulin secretion by pancreatic β-cells, does not cause hypoglycemic reactions. It reduces the content of total cholesterol, triglycerides and LDL in the blood.
Pharmacokinetics
AbsorptionAfter oral administration, metformin is absorbed from the gastrointestinal tract. Bioavailability is 50-60%. Cmax in plasma is achieved 2.5 hours after ingestion. Eating reduces Cmax by 40% and slows it to reach 35 minutes. The distribution of Vd when taking the drug in a dose of 850 mg is 296-1012 l. Metformin is rapidly distributed in tissues, practically does not bind to plasma proteins. Metabolism and excretion Subject to metabolism in a very low degree. Excreted by the kidneys. The clearance of metformin in healthy individuals is 400 ml / min (4 times more than QC), which indicates the presence of active tubular secretion. T1 / 2 composes 6.5 hours. Pharmacokinetics in special clinical situations. In case of impaired renal function, the drug may accumulate.
Indications
- diabetes mellitus type 2 without a tendency to ketoacidosis (especially in patients with obesity) with the ineffectiveness of diet therapy.
Contraindications
- diabetic ketoacidosis; - diabetic precoma, coma; - impaired liver function; - impaired renal function (CC less than 60 ml / min); - acute diseases occurring with the risk of developing impaired renal function (dehydration / diarrhea, vomiting), fever, severe infectious diseases, hypoxia / shock, sepsis, kidney infections, broncho-pulmonary diseases /); - clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (moderate or respiratory failure, acute myocardial iocarda, etc.); - serious surgical interventions and injuries when insulin therapy is indicated; - chronic alcoholism, acute alcohol poisoning; - lactic acidosis (includingin history); - use of the drug for at least 2 days before and within 2 days after radioisotope and X-ray studies with the introduction of iodine-containing contrast agent; - adherence to a low-calorie diet (less than 1000 kcal / day); - pregnancy; - breastfeeding period - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome; - Hypersensitivity to the drug components. It is not recommended to use the drug for people over 60 years old who perform hard physical work, which is connected with an increased risk of lactic acidosis.
Precautionary measures
In elderly patients, the recommended daily dose should not exceed 1 g. Due to the increased risk of lactic acidosis, the dose of the drug should be reduced in case of severe metabolic disorders.
Use during pregnancy and lactation
When planning a pregnancy, as well as in the event of pregnancy with the use of metformin, the drug should be canceled and insulin therapy should be prescribed. data on the allocation of metformin in breast milk is not, the drug is contraindicated during breastfeeding. If necessary, the use of the drug during lactation breastfeeding should be discontinued.
Dosage and administration
The drug is taken orally, during or immediately after a meal. Tablets should be swallowed whole with a small amount of liquid (glass of water). To reduce side effects from the gastrointestinal tract, the daily dose should be divided into 2-3 doses. The dose of the drug is set by the doctor individually, depending on the concentration of glucose in the blood. Tablets 0.5 g: the initial dose is 0.5-1 g / day. After 10-15 days, a further gradual increase in dose is possible depending on the concentration of glucose in the blood. Maintenance dose of the drug is usually 1.5-2 g / day. The maximum dose is 3 g / day. Tablets 0.85 g: the initial dose is 0.85 g / day. After 10-15 days, a further gradual increase in dose is possible depending on the concentration of glucose in the blood. Maintenance dose of the drug is usually 1.7 g / day. The maximum dose - 2.55 g / day.
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 taking antacids, m-anticholinergics or antispasmodics.Rarely - increased activity of liver aminotransferases or hepatitis, disappearing after discontinuation of the drug. Metabolism: rarely - lactacidosis (requires discontinuation of treatment); with long-term treatment - hypovitaminosis B12 (impaired absorption). From the hematopoietic system: in some cases - megaloblastic anemia. From the endocrine system: hypoglycemia. Allergic reactions: skin rash, pruritus.
Overdose
Symptoms: in case of an overdose of the drug Metformin-Richter, lactic acidosis may develop with a fatal outcome. The cause of the development of lactic acidosis may also be the cumulation of the drug due to impaired renal function. The early symptoms of lactic acidosis are nausea, vomiting, diarrhea, lowering of body temperature, abdominal pain, muscle pain, and further, there may be increased respiration, dizziness, impaired consciousness and coma. Treatment: if signs of lactic acidosis appear, treatment with Metformin-Richter is necessary discontinue immediately, hospitalize the patient immediately and, after determining the concentration of lactate in the blood, confirm the diagnosis. The most effective measure for the elimination of lactate and metformin from the body is hemodialysis. Symptomatic treatment is also performed.
Interaction with other drugs
It is not recommended to take danazol at the same time 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 requiring special care Chlorpromazine when taken in large doses (100 mg / day) increases the concentration of glucose in the blood, reducing the release of insulin. In the treatment of neuroleptic and after discontinuation of the last dose correction needed metformin under the control of glucose concentration krovi.Pri simultaneous use of sulfonylurea derivatives, salicylates, acarbose, insulin, NSAIDs, MAO inhibitors, oxytetracycline, ACE inhibitors, fibric acid derivatives, cyclophosphamide, beta blockers perhaps increased hypoglycemic effect of metformin. When used simultaneously with the corticosteroids, oral contraceptives, epinephrine, sympathomimetics, glitch Gon, thyroid hormones,thiazide and loop diuretics, phenothiazine derivatives, nicotinic acid derivatives may decrease the hypoglycemic effect of metformin. Nyphedipine increases absorption and Cmax, slows down the excretion of metformin. , quinidine, quinine, ranitidine, triamterene and vancomycin), secreted by the renal tubules, compete for canalicular transport systems and long-term therapy can increase Cmax of metformin by 60%. Metformin can weaken the effect of indirect anticoagulants (coumarin derivatives). The risk of lactic acidosis increases with acute alcohol intoxication, especially in the case of fasting, low-calorie diet or liver failure. You should refrain from treatment during treatment alcohol and drugs containing ethanol. Metformin may be cumulated and lactic acidosis may develop when intravascular iodine-containing contrast preparations are administered. at.
special instructions
During the period of treatment, it is necessary at least 2 times a year (as well as the appearance of myalgia) to determine the content of lactate in the blood plasma. It is necessary to monitor the content of creatinine in serum 1 time in 6 months (especially in elderly patients). Perhaps the use of the drug Metformin-Richter in combination with sulfonylurea derivatives. In this case, especially careful monitoring of the glucose concentration in the blood is necessary. For 48 hours before and within 48 hours after the radiopaque study (urography, IV angiography), metformin should be stopped. When a broncho-pulmonary infection or infection of the urinary organs develops, the patient you should immediately notify your doctor. Influence on the ability to drive vehicles and control mechanisms. In monotherapy, Metformin-Richter does not affect the ability to drive m. 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.