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Film-coated tablets White, round, biconvex
500 mg of metformin hydrochloride
Inactive ingredients: hypromellose, povidone, magnesium stearate, macrogol 6000, titanium dioxide (E171).
After oral administration, Cmax plasma levels achieved after approximately 2.5 hours. When the suction decreases food intake and slows down slightly. Cmax of metformin in the plasma at the maximum dosage does not exceed 4 micrograms / ml. The absolute bioavailability in healthy subjects is approximately 50-60%.
Almost does not bind to plasma proteins. Middle Vd is 63-276 liters.
Excreted in the urine in unchanged form. Renal clearance was 400 ml / min. After ingestion T1 / 2 is about 6.5 hours.
Pharmacokinetics in special clinical situations
By reducing the renal clearance is reduced in proportion to creatinine clearance. Thus, T1 / 2 of metformin is prolonged and the concentration in plasma increased
From the digestive system: at the beginning of treatment — nausea, vomiting, «metallic» taste in the mouth, loss of appetite, diarrhea, flatulence, abdominal pain. Reduce the frequency and intensity of these side effects can be a gradual increase in the drug dose and during or after a meal. Discontinuation of treatment is not required, as in most cases the complaints disappear even with an unchanged dose of the drug.
From a metabolism: in a few cases (in case of overdose, the presence of diseases in which the use of the drug is contraindicated in alcoholism) may develop lactic acidosis (requires cessation of treatment). Prolonged treatment may develop hypovitaminosis B12 (malabsorption).
From the hematopoietic system: in some cases — megaloblastic anemia.
From the Endocrine: hypoglycemia (in violation of the dosing regimen).
Allergic reactions: seldom — skin rash.
Before the appointment of the drug, and every 6 months is necessary to monitor liver and kidney function.
It is necessary to control the level of lactate in the blood of at least 2 times a year.
The course of treatment Siofor® Siofor® 500 and 850 should be replaced by other treatment hypoglycemic agents (eg insulin) 2 days prior to X-ray studies on / in the iodine-containing contrast agents, and 2 days before the operation under general anesthesia, and to continue this therapy for a further 2 days after the survey or after surgery.
In combination therapy with sulfonylurea careful monitoring of blood glucose levels.
Effects on ability to drive vehicles and management mechanisms
In applying the drug Siofor® not recommended to engage in activities requiring concentration of attention and fast psychomotor reactions, because of the risk of hypoglycemia.
— Type 2 diabetes mellitus (insulin dependent), especially in combination with obesity with poor diet.
Possible to assign a single agent and in combination with other oral hypoglycemic agents or insulin.
— Type 1 diabetes mellitus;
— A complete cessation of its own secretion of insulin in the body in diabetes mellitus type 2;
— Diabetic ketoacidosis, diabetic precoma, coma;
— Dysfunction of the liver and / or kidney problems;
— Myocardial infarction;
— Heart failure;
— Severe lung disease with respiratory failure;
— Severe infections;
— Surgery, trauma;
— Catabolic state (a state with strengthening the process of decay, such as tumor diseases);
— Hypoxic conditions;
— Chronic alcoholism;
— Lactic acidosis (including history);
— Lactation (breastfeeding);
— Diet with restriction of caloric intake (less than 1000 kcal /);
— Children’s age;
— The application for 48 hours or less before and within 48 hours after the radioisotope or radiological examinations with iodinated contrast agent administration
While the use of sulfonylureas, acarbose, insulin, NSAIDs, inhibitors of MAO, oxytetracycline, ACE inhibitors, clofibrate derivatives, cyclophosphamide, beta-blockers may increase the hypoglycemic effect of the drug Siofor®.
While the use of corticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormones, phenothiazine derivatives, nicotinic acid may reduce the hypoglycemic effect of the drug Siofor®.
Siofor® can weaken the effect of indirect anticoagulants.
While the use of ethanol increases the risk of lactic acidosis.
Furosemide increases Cmax metformin plasma.
Nifedipine increases absorption, Cmax metformin plasma prolongs its excretion.
Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, vancomycin
Dose set individually depending on the level of glucose in the blood. Therapy should be gradually increasing doses ranging from 0.5-1 g (1-2 tablets) of the drug Siofor® 500 or 850 mg (1 tablet) formulation Siofor® 850. Then, depending on the level of glucose in the blood increases with dose intervals of 1 week to an average daily dose of 1.5 g (3 tablets) of the drug Siofor® 500 or 1.7 g (2 tablets) of the drug Siofor® 850. The maximum daily dose Siofor® 500 — 3 g (6 tablets) of the drug Siofor® 850 — 2.55 g (3 tablets). The average daily dose is 2 Siofor® 1000 g (2 tablets). The maximum daily dose Siofor® 1000 — 3 g (3 tablets). The drug should be taken during meals, without chewing, drinking plenty of fluids. If the daily dose is more than 1 tablet, it should be divided into 2-3 doses. Long-term use Siofor® determined by your doctor. Missed the drug should not be compensated for by a single dose, respectively, more pills. Due to the increased risk of lactic acidosis, the dose should be reduced in severe metabolic disorders.