Siofor 500
Siofor 500: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Siofor 500
ATX code: A10BA02
Active ingredient: metformin (metformin)
Producer: Berlin-Chemie AG / Menarini Group (Germany)
Description and photo update: 2018-24-10
Prices in pharmacies: from 204 rubles.
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Siofor 500 is a hypoglycemic drug for oral administration.
Release form and composition
Dosage form Siofor 500 - coated tablets: white, round, biconvex (10 pcs. In a blister, in a cardboard box 12, 6 or 3 blisters).
1 tablet contains:
- active substance: metformin hydrochloride - 0.5 g;
- auxiliary components: povidone, hypromellose, magnesium stearate;
- shell composition: hypromellose, titanium dioxide (E171), macrogol 6000.
Pharmacological properties
Pharmacodynamics
Siofor 500 is an antihyperglycemic drug of the biguanide group. Its active ingredient, metformin, lowers the basal and postprandial plasma glucose concentrations. The drug does not cause the development of hypoglycemia, since it does not potentiate insulin secretion.
The mechanism of action of metformin is based on the inhibition of gluconeogenesis and glycogenolysis, which leads to a decrease in glucose production in the liver, on an increase in muscle sensitivity to insulin, which improves the absorption and utilization of glucose in the periphery, and on the inhibition of glucose absorption in the intestine.
The action of metformin on glycogen synthetase stimulates intracellular glycogen synthesis. There is an increase in the transport capacity of all membrane transport proteins of glucose.
Regardless of the effect of metformin on blood plasma glucose, it has a beneficial effect on lipid metabolism, causes a decrease in triglycerides, total cholesterol, and low density cholesterol.
Pharmacokinetics
Oral absorption of metformin occurs in the gastrointestinal tract. The maximum concentration in blood plasma occurs in 2.5 hours. After taking the maximum dose, it does not exceed 0.004 mg / ml. Taking the drug with food leads to a decrease in absorption and a slight slowdown in it. In healthy patients, the bioavailability of the drug is approximately 50-60%.
The accumulation of the active substance occurs in the salivary glands, liver, kidneys and muscles, and metformin also penetrates into erythrocytes. There is practically no binding to blood plasma proteins. The volume of distribution can be 63-276 liters.
The half-life of the drug is about 6.5 hours. It is excreted unchanged through the kidneys. The renal clearance of metformin is more than 400 ml / min.
With impaired renal function, metformin clearance decreases in proportion to creatinine clearance (CC). This consequently causes a prolongation of the half-life and an increase in the level of metformin in the blood plasma.
Indications for use
According to the instructions, Siofor 500 is indicated for the treatment of type 2 diabetes mellitus with the ineffectiveness of diet therapy and physical activity, especially in overweight patients.
The drug is prescribed as monotherapy or as part of a combination therapy with insulin. In addition, in adults - in combination with other oral hypoglycemic agents.
Contraindications
- diabetic precoma;
- diabetic ketoacidosis;
- acute conditions that can contribute to a negative effect on kidney function, including dehydration, a severe form of infectious disease;
- impaired renal function, renal failure (CC less than 60 ml / min);
- a chronic or acute form of pathologies that can cause the development of tissue hypoxia (including shock, respiratory failure, heart failure, recent myocardial infarction);
- lactic acidosis (including history);
- liver failure;
- period of pregnancy;
- breast-feeding;
- adherence to a low-calorie diet (less than 1000 kcal per day);
- chronic alcoholism, acute alcohol intoxication;
- intravascular administration of an iodine-containing contrast agent;
- age up to 10 years;
- individual intolerance to the components of the drug.
Caution should be exercised when prescribing Siofor to 500 children aged 10–12 years and patients over the age of 60 who perform heavy physical work.
Instructions for the use of Siofor 500: method and dosage
Siofor 500 tablets are taken orally during or after meals.
The regimen, the dose of the drug, the duration of the course of therapy, the doctor prescribes individually, taking into account the level of glucose concentration in the blood plasma.
Recommended dosage for adults:
- monotherapy: initial dose - 1 pc. (0.5 g) 1-2 times a day for 10-15 days. Then, taking into account the level of glucose in the blood plasma, the dose is gradually increased to 3-4 pcs. in a day. A gradual increase in the dose avoids the symptoms of intolerance from the gastrointestinal tract. The maximum daily dose is 6 pcs. (3d), divided into 3 doses;
- combination therapy with insulin: initial dose - 1 pc. 1-2 times a day. The dose should be increased gradually, with an interval of 7 days. The average daily dose after the increase is 3-4 pcs. Insulin dosage is determined based on blood glucose levels. The daily dose of the drug should not exceed 6 pcs., It should be divided into 3 doses.
The transition from the use of another antidiabetic agent is made by canceling the previous and immediate start of taking Siofor 500 in the above doses.
For elderly patients, the dose of the drug should be prescribed with extreme caution, only taking into account the level of creatinine in the blood plasma. Treatment should take place under regular monitoring of the state of renal function.
The recommended dosage of Siofor 500 for children over 10 years old with monotherapy and in combination with insulin: initial dose - 1 pc. (0.5 g) once a day. To achieve the desired therapeutic response after 10-15 days of administration, you can begin to gradually increase the dose, depending on the level of glucose in the blood plasma. The maximum daily dose for children aged 10 to 18 years is 4 pcs. (2 g of metformin) in 2-3 doses. Insulin dose is determined based on plasma glucose levels.
When appointing 4–6 pcs. (2-3 g) per day, you can use tablets of the drug in a dose of 1 g (Siofor 1000).
Side effects
- from the digestive system: very often - loss of appetite, nausea, vomiting, abdominal pain, metal taste in the mouth, diarrhea;
- on the part of the nervous system: often - a violation of taste;
- dermatological reactions: very rarely - itching, urticaria, hyperemia;
- from the hepatobiliary system: possibly - increased activity of liver enzymes, hepatitis;
- from the side of metabolism: very rarely - lactic acidosis; against the background of long-term use - a decrease in the absorption and level of concentration in the blood plasma of vitamin B 12.
Overdose
Cases of hypoglycemia were not observed when taking metformin in doses up to 85 g.
Symptoms: against the background of a significant overdose, the development of lactic acidosis is possible, which is manifested by severe weakness, drowsiness, respiratory disorders, nausea, vomiting, abdominal pain, diarrhea, hypothermia, reflex bradyarrhythmia, lowering blood pressure. In addition, there may be a feeling of pain in the muscles, confusion, loss of consciousness. When the first signs indicating the development of lactic acidosis appear, immediate cancellation of Siofor 500 and emergency hospitalization of the patient is required.
Treatment: hemodialysis, which is the most effective method for removing metformin and lactate from the body.
special instructions
Lactic acidosis is a severe pathology that occurs when lactic acid accumulates in the blood. In rare cases, it is caused by the accumulation of metformin, more often with severe renal failure in patients with diabetes mellitus. Therefore, when prescribing the drug, it is important to determine all the associated risk factors that affect the appearance of lactic acidosis. These include: decompensated diabetes, prolonged starvation of the patient, ketoacidosis, alcohol abuse, conditions associated with hypoxia, liver failure. In case of suspicion of lactic acidosis, the patient should stop taking Siofor 500 and immediately consult a doctor.
The side effects of the digestive system, which often arise at the beginning of therapy, usually go away spontaneously. To improve the tolerability of the drug on the part of the gastrointestinal tract, the dose should be increased gradually and divided into 2-3 doses per day.
With prolonged use of tablets by patients with megaloblastic anemia, one should take into account the possible decrease in their content of vitamin B 12 in blood plasma.
Before starting the use of metformin, the state of renal function and the level of creatinine in the blood plasma should be determined. During the treatment period, it is recommended to regularly monitor these indicators. The simultaneous use of diuretics, antihypertensive drugs, nonsteroidal anti-inflammatory drugs can only be started after consulting a doctor, since they increase the risk of impaired renal function.
Before undergoing elective surgery using general anesthesia, spinal or epidural anesthesia, tablets should be discontinued 48 hours before. It is possible to resume the use of metformin no earlier than 48 hours after the operation, when the patient's condition will allow him to take food by himself and subject to confirmation of normal renal function.
To ensure a stable therapeutic effect of Siofor 500, its use must be combined with strict adherence to dietary nutrition and daily exercise, in accordance with the doctor's prescription. The patient's diet should include an even intake of carbohydrates throughout the day. Overweight patients should eat a low-calorie diet.
It is necessary to regularly undergo laboratory tests provided for patients with diabetes mellitus.
The use of the drug in children should begin only after confirmation of the diagnosis of type 2 diabetes mellitus. According to the results of clinical studies, which were carried out within one year, metformin does not affect the growth, development and puberty of children. Since there is no data on the effect of the drug with its longer use, it is recommended to carefully monitor the corresponding parameters in pediatric patients, especially children 10-12 years old.
Due to the risk of hypoglycemia in combination therapy with sulfonylurea derivatives or insulin, caution is recommended.
Influence on the ability to drive vehicles and complex mechanisms
The use of Siofor 500 as monotherapy does not cause hypoglycemia and does not affect the patient's ability to drive various vehicles or mechanisms.
As part of combination therapy with other hypoglycemic agents, Siofor 500 can cause the development of hypoglycemic conditions, therefore, patients need to be careful with potentially dangerous types of work that require concentration and high speed of psychomotor reactions.
Application during pregnancy and lactation
The use of Siofor 500 is contraindicated during the period of gestation and breastfeeding.
A patient with type 2 diabetes mellitus should be warned that it is necessary to inform the doctor in case of planning or the onset of pregnancy, since during this period the drug should be discontinued and insulin therapy should be used to normalize or as close as possible to the norm of the glucose concentration in the blood plasma of the expectant mother. This will reduce the risk of the pathological effects of hyperglycemia on fetal development.
Taking into account the need to use the drug during lactation, the attending physician must decide either to cancel Siofor 500, or to stop breastfeeding.
There are no data on the penetration of metformin into mother's breast milk.
Pediatric use
You can not appoint Siofor 500 to children under 10 years of age.
It should be used with caution to treat children 10-12 years old.
Children aged 10 to 18 years old are shown the use of Siofor 500 for monotherapy and in combination with insulin. The initial dose is 1 tablet (0.5 g) once a day. After 10-15 days of admission, a gradual increase in the dose is indicated, taking into account the level of glucose in the blood plasma. The maximum daily dose is 4 tablets (2 g of metformin) in 2-3 doses. Insulin dose is determined based on plasma glucose levels.
With impaired renal function
The appointment of the drug is contraindicated in patients with impaired renal function, renal failure (CC less than 60 ml / min).
For violations of liver function
The use of Siofor 500 is contraindicated in liver failure.
Use in the elderly
Elderly patients (over 60 years of age), whose activities are associated with heavy physical exertion, the drug should be prescribed with caution because of the increased risk of lactic acidosis.
The dose of Siofor 500 should be determined on the basis of plasma creatinine levels. Treatment should be accompanied by regular monitoring of the functional state of the kidneys.
Drug interactions
The use of metformin simultaneously with intravascular administration of iodine-containing contrast agents is contraindicated, since this can cause renal failure in the patient and the accumulation of metformin. Therefore, if it is necessary to use iodine-containing contrast agents for X-ray examination in patients with a normal serum creatinine content, Siofor 500 should be discontinued 48 hours before and resumed only 48 hours after the study. During this period, other hypoglycemic agents, such as insulin, should be used.
It is not recommended to combine taking the drug with ethanol-containing agents and drinking alcohol. Acute alcohol intoxication or the simultaneous use of ethanol-containing drugs, especially against the background of liver failure, disturbed diet or fasting, increase the risk of lactic acidosis.
With the simultaneous use of Siofor 500:
- danazol can contribute to the development of a hyperglycemic effect, therefore, a dose adjustment of metformin is required during the period of administration and after discontinuation of danazol, taking into account the level of glucose in the blood plasma;
- sulfonylurea derivatives, insulin, acarbose, salicylates can increase the hypoglycemic effect of the drug;
- oral contraceptives, epinephrine, glucagon, thyroid hormones, phenothiazine and nicotinic acid derivatives can increase the concentration of glucose in the blood plasma;
- nifedipine increases the absorption and the maximum concentration of metformin in the blood plasma, slows down its excretion;
- cimetidine prolongs the elimination of the drug, increasing the risk of lactic acidosis;
- amiloride, morphine, quinidine, procainamide, ranitidine, vancomycin, triamterene (cationic drugs) with prolonged use can cause an increase in the maximum concentration of metformin in the blood plasma;
- indirect anticoagulants can weaken their therapeutic effect;
- furosemide reduces its maximum concentration and half-life;
- beta-adrenomimetics, diuretics, glucocorticoids have hyperglycemic activity;
- antihypertensive drugs, including angiotensin-converting enzyme inhibitors, can lower plasma glucose levels.
Analogs
Analogs of Siofor 500 are: Bagomet, Diaformin, Glyformin, Metformin, Glucophage, Metfogamma, Formetin.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Siofor 500
Reviews about Siofor 500 patients with type 2 diabetes mellitus are positive. The drug lowers blood sugar levels to optimal levels, provides significant assistance in limiting carbohydrate intake, and normalizes appetite. Decreased appetite in obese patients promotes gradual weight loss. Patients taking other hypoglycemic agents report better tolerability of the drug.
There are positive and negative reviews from healthy patients who took an antihyperglycemic drug in order to reduce body weight. When assessing the effectiveness of the drug, they were guided only by the visible result of the indications of the arrow of the scales, without thinking about the effect of metformin on the state of the body, which does not require lowering blood sugar. Therefore, the assessment of this category of patients should not be taken into account.
Price for Siofor 500 in pharmacies
The price of Siofor 500 for a package containing 60 tablets can range from 255 rubles.
Siofor 500: prices in online pharmacies
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Drug name Price Pharmacy |
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Siofor 500 500 mg film-coated tablets 60 pcs. 204 RUB Buy |
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Siofor 500 tablets p.o. 500mg 60 pcs. 255 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
