Siofor 850 - Instructions For The Use Of Tablets, Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Siofor 850

Siofor 850: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Siofor 850

ATX code: A10BA02

Active ingredient: Metformin (Metformin)

Producer: Menarini-Von Heyden GmbH (Germany), Dragenopharm Apotheker Puschl (Germany), Berlin-Chemie (Germany)

Description and photo update: 2018-24-10

Prices in pharmacies: from 256 rubles.

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Siofor 850 is an oral hypoglycemic drug from the biguanide group.

Release form and composition

Dosage form Siofor 850 - coated tablets: oblong, white, with a risk on both sides (15 pcs. In blisters, in a cardboard box of 2, 4 or 8 blisters).

Composition of 1 tablet:

• active substance: metformin hydrochloride - 850 mg;
• additional components: hypromellose - 30 mg; magnesium stearate - 5 mg; povidone - 45 mg;
• shell: hypromellose - 10 mg; titanium dioxide (E 171) - 8 mg; macrogol 6000 - 2 mg.

Pharmacological properties

Pharmacodynamics

Siofor 850 has a hypoglycemic effect. Provides a decrease in postprandial and basal plasma glucose concentration in the blood. It does not stimulate insulin secretion, so it does not lead to the development of hypoglycemia.

Metformin belongs to the biguanide group. Its action is based on the following mechanisms:

• an increase in muscle sensitivity to insulin and, as a result, an improvement in the utilization and absorption of glucose in the periphery;
• a decrease in the production of glucose in the liver, which is associated with inhibition of glycogenolysis and gluconeogenesis;
• inhibition of glucose absorption in the intestine.

By acting on glycogen synthase, metformin stimulates intracellular glycogen synthesis. Promotes an increase in the transport capacity of all known membrane transport proteins of glucose.

It has a beneficial effect on lipid metabolism, regardless of its effect on the plasma concentration of glucose in the blood, leads to a decrease in the concentration of triglycerides, low-density lipoprotein cholesterol and total cholesterol.

Body weight in patients with diabetes mellitus decreases moderately or remains stable.

Pharmacokinetics

After oral administration, metformin is almost completely absorbed from the gastrointestinal tract, the time to reach C _max (maximum concentration of the substance) in the blood plasma is 2.5 hours, when the maximum dose is taken, it does not exceed 0.004 mg / ml.

With the simultaneous administration of the drug with food, the degree of absorption decreases: C _max decreases by 40%, AUC (area under the concentration-time curve) - by 25%; there is also a slight slowdown in the absorption of metformin from the gastrointestinal tract (the time to reach C _{max is} reduced by 35 minutes).

Equilibrium concentration in blood plasma when used in recommended doses is achieved within 24–48 hours, it usually does not exceed 0.001 mg / ml. In healthy volunteers, the absolute bioavailability is approximately 50-60%.

Metformin penetrates into erythrocytes, practically does not bind to blood plasma proteins. C _max in the blood below the plasma C _max in the blood and is achieved in about the same period of time. Red blood cells are likely to represent the secondary compartment of distribution. V _d (average volume of distribution) is in the range from 63 to 276 liters.

It is excreted unchanged by the kidneys. In the body, metabolites are not found. Renal clearance -> 400 ml / min. T _1/2 (half-life) is approximately 6.5 hours. With a decrease in renal function, the clearance of metformin decreases in proportion to the clearance of creatinine, respectively, the concentration of the substance in the blood plasma increases and T _{1/2 is} lengthened.

With a single dose of 500 mg of metformin in children, the pharmacokinetic parameters have similar values to those in adults.

Indications for use

Siofor 850 is prescribed for the treatment of type 2 diabetes mellitus in order to control the plasma concentration of glucose in the blood, especially in patients with overweight, in the following cases:

• adults: monotherapy or in combination with insulin / other oral hypoglycemic drugs;
• children from 10 years old: monotherapy or in combination with insulin.

Therapy for type 2 diabetes mellitus should be carried out simultaneously with diet correction and an increase in physical activity (in the absence of contraindications).

Contraindications

Absolute:

• diabetic precoma / ketoacidosis, coma;
• chronic / acute conditions, accompanied by tissue hypoxia (recently suffered myocardial infarction, heart / respiratory failure, shock);
• acute conditions that occur with the risk of impaired renal function: shock, dehydration (in particular, against the background of diarrhea, vomiting), infectious diseases in severe course;
• period of 48 hours before / after surgical interventions;
• a period of 48 hours before / after radioisotope / X-ray studies, in which X-ray contrast media containing iodine are used (including angiography or urography);
• liver dysfunction, liver failure;
• lactic acidosis, including a burdened history;
• impaired renal function (with creatinine clearance <60 ml / min);
• adherence to a low-calorie diet (when taken per day <1000 kcal);
• acute alcohol intoxication, chronic alcoholism;
• pregnancy;
• age up to 10 years;
• individual intolerance to any of the components of the drug.

Relative (Siofor 850 is prescribed under medical supervision):

• age 10-12 years;
• period of breastfeeding;
• age over 60 years old while doing hard physical work.

Instructions for the use of Siofor 850: method and dosage

Siofor 850 is taken orally, during / after meals.

The regimen for taking the drug (dose, duration of the course) is determined individually based on the plasma concentration of glucose in the blood.

Adults

The recommended initial single dose for monotherapy or in combination with other oral hypoglycemic drugs is 850 mg, the frequency of administration is 2-3 times a day.

The maximum daily dose is 3000 mg in 3 divided doses.

After 10-15 days, based on the glucose concentration, the dose can be gradually increased to an average daily dose of 2-3 tablets. With a gradual increase in the dose, the likelihood of disturbances from the gastrointestinal tract decreases.

Transfer to Siofor 850 from therapy with other hypoglycemic drugs is carried out after their cancellation.

When combined with insulin, Siofor 850 is prescribed according to the scheme described above. The dose should be increased with an interval of about 7 days. The insulin dosage regimen is determined based on the values of the plasma concentration of glucose in the blood.

Due to the fact that in elderly patients renal function may be impaired, the dose of Siofor 850 should be selected taking into account the plasma concentration of creatinine in the blood (during the period of use of the drug, a regular assessment of this indicator is required).

Children from 10 to 18 years old

Children 10-18 years old Siofor 850 is prescribed 1 tablet per day. In the future, after 10-15 days after the start of taking the drug, a gradual increase in the dose is possible. The maximum daily dose is 2000 mg in 2-3 doses.

Side effects

Possible adverse reactions in adults and children (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01%, taking into account individual reports - very rare):

• digestive system: very often - vomiting, nausea, abdominal pain, diarrhea, loss of appetite (usually appear at the beginning of use and, as a rule, pass on its own; to reduce the likelihood of these disorders, it is recommended to divide the daily dose into 2-3 doses, take the drug during / after meals, and increase the dose gradually);
• nervous system: often - taste disturbances;
• liver / biliary tract: very rarely - hepatitis, liver dysfunctions of a reversible nature (in the form of increased activity of hepatic transaminases);
• metabolism and nutrition: very rarely - lactic acidosis (requires discontinuation of the drug); with prolonged use - a decrease in the absorption of vitamin B ₁₂ and a decrease in its concentration in the blood plasma (important for patients with megaloblastic anemia);
• skin / subcutaneous tissue: very rarely - skin reactions (in particular, itching, erythema, rash).

Overdose

The appearance of hypoglycemia while taking metformin at a dose of up to 85 g was not observed.

In cases of significant overdose, lactic acidosis may occur. The main symptoms: respiratory disorders, severe weakness, abdominal pain, drowsiness, vomiting, nausea, diarrhea, reflex bradyarrhythmia, hypothermia, lowering blood pressure. Muscle cramps, confusion / loss of consciousness are also possible. If there is a suspicion of lactic acidosis, Siofor 850 should be immediately canceled, and the patient should be urgently hospitalized.

The most effective method for removing metformin and lactate from the body is hemodialysis.

special instructions

Lactic acidosis is a very rare and serious pathological condition. It is associated with the accumulation of lactate in the blood, including due to the accumulation of metformin. In patients with diabetes mellitus with severe renal failure, lactic acidosis developed more frequently.

Preventive measures include identifying all risk factors a patient has, including decompensated diabetes mellitus, liver failure, prolonged fasting, ketosis, alcohol abuse, and any conditions associated with hypoxia. If there is a suspicion of the development of lactic acidosis, the cancellation of therapy and emergency hospitalization of the patient is indicated.

During the period of taking Siofor 850, it is necessary to monitor the concentration of serum creatinine: with normal renal function - at least 1 time per year; in elderly patients, as well as with serum creatinine concentration close to the upper limit of the norm - at least 2-4 times a year.

Patients need special supervision in cases of a risk of impaired renal function, in particular, at the beginning of therapy with drugs with antihypertensive action, nonsteroidal anti-inflammatory drugs or diuretics.

Reception Siofor 850 diet and daily exercise does not replace.

Before the appointment of therapy for children, the diagnosis of type 2 diabetes must be confirmed.

Influence on the ability to drive vehicles and complex mechanisms

When driving vehicles, patients who take Siofor 850 in combination with other hypoglycemic drugs, including insulin, should be careful because of the likelihood of hypoglycemic conditions.

Application during pregnancy and lactation

• pregnancy: therapy is contraindicated; the doctor must be informed about planning / pregnancy; to maintain the concentration of glucose in the blood plasma at the level closest to normal values (in order to reduce the likelihood of fetal malformations), it is recommended to use insulin;
• lactation period: Siofor 850 is prescribed with caution after assessing the benefit / risk ratio.

Pediatric use

• up to 10 years: therapy is contraindicated;
• 10-12 years: Siofor 850 is prescribed with caution.

With impaired renal function

Contraindications to therapy are:

• acute conditions that occur with the risk of impaired renal function;
• impaired renal function (with creatinine clearance <60 ml / min).

For violations of liver function

Liver dysfunction and liver failure are contraindications to taking Siofor 850.

Use in the elderly

According to the instructions, Siofor is prescribed with caution to 850 patients aged 60 and over against the background of heavy physical work, which is associated with an increased risk of lactic acidosis.

Drug interactions

The likelihood of lactic acidosis increases with acute alcohol intoxication or simultaneous use with drugs containing ethanol, especially in case of malnutrition / starvation, as well as in patients with liver failure. Thus, during the period of taking Siofor 850, it is recommended to avoid taking alcohol and ethanol-containing drugs.

With intravascular administration of X-ray contrast agents containing iodine in patients with diabetes mellitus, complications of renal failure may occur, this leads to the accumulation of metformin and an increased risk of lactic acidosis. Reception Siofor 850 in the period 48 hours before / after the study with the use of such drugs is contraindicated.

Careful combinations:

• chlorpromazine (in a daily dose of 100 mg): an increase in the plasma concentration of glucose in the blood, a decrease in the release of insulin; during combined use with antipsychotics / after stopping their use, the doctor can adjust the dose of Siofor 850 (based on the concentration of glucose in the blood plasma);
• danazol: development of a hyperglycemic effect; in cases of combined use, the doctor can adjust the dose of Siofor 850 (based on the concentration of glucose in the blood plasma);
• nifedipine: increased absorption, C _{max of} metformin in blood plasma, lengthening of its excretion;
• glucocorticoids (for systemic / local use), beta ₂ -adrenomimetics (in the form of injection solutions): manifestation of hyperglycemic activity, which requires more careful monitoring of the plasma glucose concentration in the blood, especially at the beginning of treatment; during combined use / after stopping therapy, the doctor may adjust the dose of Siofor 850 (based on the concentration of glucose in the blood plasma);
• anticoagulants of indirect action: weakening of their action;
• sulfonylurea derivatives, insulin, acarbose, salicylates: increased hypoglycemic action;
• angiotensin-converting enzyme inhibitors and other antihypertensive drugs: lowering the concentration of glucose in the blood plasma; the doctor can adjust the dose of Siofor 850;
• oral contraceptives, epinephrine, glucagon, thyroid hormones, phenothiazine derivatives, nicotinic acid: increased plasma glucose concentration;
• furosemide: a decrease in its C _max and T _1/2;
• triamterene, amiloride, procainamide, morphine, quinidine, ranitidine, quinine, vancomycin and other cationic drugs secreted in the tubules (with long-term treatment): an increase in C _{max of} metformin in blood plasma;
• diuretics, especially loop diuretics: increased likelihood of lactic acidosis, which is associated with the potential ability of diuretics to reduce renal function.

Analogs

The analogues of Siofor 850 are: Formin Pliva, Metfogamma, Diasfor, Metadien, Glucophage, Baghomet, Glyformin, Metformin, Sopamet, Formetin and others.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Siofor 850

According to reviews, Siofor 850 is an effective drug used to control the plasma glucose concentration in the blood in type 2 diabetes. A convenient dosing regimen is noted, as well as the fact that as a result of its use, a disturbed metabolism is restored, weight is reduced (as a result of a decrease in appetite). Of the shortcomings, they usually indicate the high cost and the development of pronounced adverse reactions.

Price for Siofor 850 in pharmacies

The approximate price for Siofor 850 (60 tablets per pack) is 282–354 rubles.

Siofor 850: prices in online pharmacies

Drug name Price Pharmacy

Siofor 850 850 mg film-coated tablets 60 pcs. 256 RUB Buy

Siofor 850 tab. p / o film. 850mg No. 60 283 r 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!