Siofor - Instructions For Use, Reviews, Tablets 500 Mg, 850 Mg, 1000 Mg

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

Siofor

Siofor: 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

ATX code: A10BA02

Active ingredient: metformin (metformin)

Producer: Berlin-Chemie AG / Menarini Group (Germany)

Description and photo update: 2019-16-08

Prices in pharmacies: from 204 rubles.

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Siofor is a hypoglycemic drug from the biguanide group.

Release form and composition

Siofor is available in the form of white film-coated tablets:

• Siofor 500: biconvex, round (10 pieces in blisters, in a cardboard box 3, 6 or 12 blisters);
• Siofor 850: oblong, scored on both sides (15 pieces in blisters, in a cardboard box of 2, 4 or 8 blisters);
• Siofor 1000: oblong, with a notch on one side and a wedge-shaped snap-tab on the other (15 pieces in blisters, in a cardboard box of 2, 4 or 8 blisters).

Composition of 1 tablet:

• active substance: metformin hydrochloride - 500 mg, 850 mg or 1000 mg;
• auxiliary components: povidone, hypromellose, magnesium stearate;
• film shell: macrogol 6000, hypromellose, titanium dioxide.

Pharmacological properties

Pharmacodynamics

Metformin belongs to the biguanide group. Has a hypoglycemic effect, lowers the basal and postprandial glucose concentration in blood plasma. This substance does not stimulate the secretion of insulin, therefore, its intake does not lead to hypoglycemia.

Metformin works by the following mechanisms:

• inhibition of gluconeogenesis and glycogenolysis (the production of glucose in the liver decreases);
• an increase in muscle sensitivity to the influence of insulin (absorption and utilization of glucose in the periphery are stimulated);
• decreased absorption of glucose in the intestine.

Due to its effect on glycogen synthase, metformin stimulates the process of intracellular glycogen synthesis. This substance increases the transport capacity of known membrane proteins that provide glucose transport across the cell membrane.

Regardless of the effect on plasma glucose, metformin has a beneficial effect on lipid metabolism, reduces the concentration of total cholesterol, triglyceride cholesterol and low density lipoproteins.

With diabetes mellitus, while taking metformin, the body weight of patients is moderately reduced or remains stable.

Pharmacokinetics

After oral administration of Siofor, metformin is almost completely absorbed in the gastrointestinal tract. The time to reach the maximum plasma concentration (C _max) is about 2.5 hours. When taking the maximum dose, the C _max value does not exceed 4 μg / ml. When using the recommended doses of the drug, the equilibrium concentration of metformin in plasma is reached within 24–48 hours and is most often less than 1 μg / ml. In healthy volunteers, the absolute bioavailability is approximately 50-60%.

Food intake reduces the degree of absorption of metformin [C _max decreases by 40%, AUC (area under the concentration-time pharmacokinetic curve)] and slightly slows down its absorption from the gastrointestinal tract (the time to reach C _max is reduced by 35 minutes).

Metformin practically does not bind to plasma proteins, penetrates into erythrocytes. The average volume of distribution is 63 to 276 liters. The maximum concentration in blood is lower than in plasma, and is reached within approximately the same time. Red blood cells are likely to represent the secondary compartment of distribution.

Metformin is excreted unchanged by the kidneys. No metabolites were found in the human body. Renal clearance is over 400 ml / min, elimination half-life is about 6.5 hours. The clearance of metformin with reduced renal function decreases in proportion to the clearance of creatinine, the half-life is lengthened, and the concentration of metformin in the blood plasma increases.

In the case of a single dose of 500 mg of metformin, the pharmacokinetic parameters in children were similar to those in adults.

Indications for use

According to the instructions, Siofor is prescribed for type 2 diabetes mellitus, especially for overweight patients in case of ineffectiveness of physical activity and diet therapy.

The drug can be used both as a sole agent and as part of a combination therapy with insulin and other hypoglycemic drugs for oral administration.

Contraindications

Absolute:

• impaired renal function or renal failure (creatinine clearance less than 60 ml / min);
• liver failure;
• chronic or acute diseases that can cause tissue hypoxia (recent myocardial infarction, respiratory or heart failure, shock);
• diabetic precoma, diabetic ketoacidosis;
• lactic acidosis (including a history);
• acute conditions in which kidney function may deteriorate (severe infectious disease, dehydration, etc.);
• adherence to a low-calorie diet (calorie content of the daily diet is less than 1000 kcal);
• intravascular administration of a contrast agent containing iodine;
• chronic alcoholism, acute alcohol intoxication;
• children under 10 years old;
• During pregnancy and breastfeeding;
• hypersensitivity to the ingredients of the drug.

Relative (Siofor is used with caution):

• children's age from 10 to 12 years;
• elderly age over 60 years (when performing hard physical work, which is due to an increased risk of lactic acidosis).

Siofor instructions for use: method and dosage

Siofor is intended for oral administration. The tablets are taken with or after meals.

The dosage regimen and the duration of the course depend on the level of glucose in the blood and are set individually by the attending physician.

Adult patients

When monotherapy with Siofor, the initial dose is 500 mg 1-2 times a day or 850 mg once a day.

After 10-15 days of treatment, the dose can be gradually increased to the average daily dose (3-4 tablets Siofora 500, 2-3 tablets Siofora 850 or 2 tablets Siofor 1000). With a gradual increase in the dose, the number of side effects from the digestive system is less than with a sharp increase in the dose of the drug.

The maximum daily dose is 3000 mg in three divided doses (3 Siofor 1000 tablets or 6 Siofor 500 tablets).

When prescribing the drug in high doses (2000-3000 mg per day), 2 tablets of Siofor 500 can be replaced by 1 tablet of Siofor 1000.

If the patient is transferred from treatment with another antidiabetic drug to Siofor, the first drug should be completely canceled and treatment with Siofor should be started in the above doses.

Metformin can be used concomitantly with insulin to improve glycemic control. In this case, Siofor is prescribed in the same doses as in monotherapy, and the dose of insulin is set depending on the concentration of glucose in the blood.

For elderly patients, the dose of the drug is adjusted taking into account the concentration of creatinine. The functional state of the kidneys should be assessed regularly.

Children and adolescents from 10 to 18 years old

For monotherapy and combined treatment with insulin, the standard starting dose is 500 mg or 850 mg once a day. After 10-15 days, a gradual increase in the dose is possible, taking into account the level of glucose in the blood.

The maximum daily dose for children is 2000 mg in 2-3 doses.

The insulin dose depends on the blood glucose level.

Side effects

• digestive system: lack of appetite, abdominal pain, "metallic" taste in the mouth, vomiting, nausea, diarrhea (the listed side effects occur at the beginning of treatment and most often go away on their own);
• liver and biliary tract: isolated cases - hepatitis or increased activity of liver enzymes, which disappear after drug withdrawal;
• nervous system: often - a violation of taste;
• metabolism: very rarely - lactic acidosis (discontinuation of therapy is required); with long-term treatment - a decrease in the absorption of vitamin B ₁₂ and a decrease in its concentration in plasma;
• allergic reactions: very rarely - itching, hyperemia, urticaria.

Overdose

When using metformin at a dose of up to 85 g, hypoglycemia was not recorded.

In cases of significant overdose, the development of lactic acidosis is possible, in which the following symptoms appear: severe weakness, drowsiness, respiratory disorders, nausea, vomiting, abdominal pain, diarrhea, lowering blood pressure, hypothermia, reflex bradyarrhythmia. Muscle cramps, confusion, or loss of consciousness may occur. If you suspect the development of lactic acidosis, you must immediately stop taking the drug and provide emergency hospitalization.

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

special instructions

If you suspect lactic acidosis, Siofor should be immediately canceled, and the patient should be urgently hospitalized.

Before prescribing the drug, and then regularly during treatment, it is necessary to determine the concentration of creatinine. At risk of impaired renal function, for example, at the beginning of treatment with diuretics, antihypertensive drugs or nonsteroidal anti-inflammatory drugs, special care is required.

48 hours before the planned X-ray examination with intravenous administration of contrast iodine-containing substances, as well as 48 hours after the procedure, Siofor should be temporarily replaced with another hypoglycemic agent, for example, insulin.

The drug should be discontinued 48 hours before the planned surgery with epidural or spinal anesthesia or surgery under general anesthesia. Treatment should be continued after restoration of oral nutrition, or no earlier than 48 hours after surgery, provided that normal renal function is confirmed.

Medication is not a substitute for daily exercise and diet. They must be combined with each other in accordance with the recommendations of the attending physician. During therapy, patients should adhere to a dietary diet, carbohydrate intake should be distributed evenly throughout the day. Overweight patients are advised to follow a low calorie diet.

Laboratory tests are routinely required, which are standard for patients with diabetes.

Before prescribing the drug, children and adolescents 10-18 years old should confirm the diagnosis of type 2 diabetes mellitus. In children aged 10–12 years, during treatment with Siofor, it is recommended to carefully monitor the growth and development parameters.

In monotherapy, the drug does not affect the ability of patients to drive vehicles or operate potentially dangerous machinery. When combined with other hypoglycemic agents (insulin, sulfonylurea derivatives, repaglinide), hypoglycemic conditions may occur, therefore, caution is required when performing work associated with increased concentration.

Application during pregnancy and lactation

Siofor is contraindicated for treatment during pregnancy.

When breastfeeding, the drug should be used with caution.

With uncontrolled diabetes mellitus during pregnancy, the risk of birth defects and perinatal mortality increases. Based on the limited amount of data, it has been shown that the use of metformin in pregnant women does not increase the likelihood of developing congenital anomalies in children.

In the course of animal studies, no negative effects on the course of pregnancy, childbirth, embryonic or postnatal development were found.

In cases of planning or the onset of pregnancy with diabetes mellitus, in order to reduce the likelihood of developing abnormalities in the fetus, it is recommended to prescribe insulin to maintain the plasma glucose concentration at a level close to the normal value.

A patient with diabetes mellitus should be informed about the need to notify the doctor in case of pregnancy.

Metformin is excreted in breast milk. During breastfeeding, no adverse effects have been observed in neonates / infants when taking metformin by the mother, however, due to limited data, the use of metformin during breastfeeding is not recommended. The decision to take the drug during this period should be made based on an assessment of the likelihood of adverse reactions and the potential benefits of breastfeeding for the child.

Pediatric use

Siofor is contraindicated for the treatment of patients under the age of 10 years.

When treating patients aged 10-12 years, the drug should be used with caution.

With impaired renal function

Siofor is contraindicated in case of impaired renal function.

For violations of liver function

Siofor is contraindicated for use in case of impaired liver function and liver failure.

Use in the elderly

When treating elderly patients (over 60 years old) who perform heavy physical work, the drug should be used with caution because of the increased risk of lactic acidosis.

Drug interactions

Siofor is not recommended to be used simultaneously with alcohol and ethanol-containing drugs, as the risk of lactic acidosis increases.

When taken together with danazol, the development of a hyperglycemic effect is possible (correction of the Siofor dose is required); with thyroid hormones, oral contraceptives, glucagon, epinephrine, nicotinic acid, phenothiazine derivatives - the concentration of glucose in the blood may increase; with nifedipine - the absorption of metformin increases, its plasma concentration increases and excretion is prolonged; with cationic drugs (morphine, quinidine, triamterene, amiloride, ranitidine, vancomycin, procainamide) with prolonged use - an increase in the concentration of metformin in blood plasma is possible; with cimetidine - the excretion of the drug slows down and the risk of lactic acidosis increases; with furosemide - the concentration and half-life of furosemide decreases; with indirect anticoagulants - their effect may be weakened.

Beta-adrenomimetics, diuretics and glucocorticoids have a hyperglycemic effect, therefore, a dose adjustment of metformin may be required.

Angiotensin-converting enzyme inhibitors and other medicines to lower blood pressure can lower blood glucose levels. With simultaneous use with these drugs, the dose of Siofor, if necessary, can be adjusted.

When administered together with insulin, salicylates, sulfonylurea derivatives and acarbose, the hypoglycemic effect of the drug can be enhanced.

Analogs

Siofor's analogs are: Glyformin, Glyformin Prolong, Bagomet, Glucophage, Glucophage Long, Diasfor, Metadien, Diaformin OD, Merifatin, Metformin, Metfogamma, Sopamet, Formetin, Formetin Long, Formin Pliva.

Terms and conditions of storage

Store at a temperature not exceeding 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

Reviews of Siofor from doctors indicate that the drug allows patients with diabetes mellitus to restore normal blood sugar levels. In addition, such patients may experience weight loss, but experts warn that healthy people cannot take this drug for weight loss.

At the same time, there are numerous reports of users on the Internet who took Siofor for weight loss. According to them, when using the drug, appetite really decreases, but after the completion of the course of treatment, the weight is quickly restored. There are also numerous reports of side effects (problems in the stomach, pancreas, liver, intestines).

Price for Siofor in pharmacies

The approximate price for Siofor is: 60 tablets of 500 mg - 260 rubles, 60 tablets of 850 mg - 320 rubles, 60 tablets of 1000 mg - 415 rubles.

Siofor: prices in online pharmacies

Drug name Price Pharmacy

Siofor 500 500 mg film-coated tablets 60 pcs. 204 RUB Buy

Reviews Siofor 500 204 RUB Buy

Siofor 500 tablets p.o. 500mg 60 pcs. 255 RUB Buy

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

Reviews Siofor 850 256 RUB Buy

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

Siofor 1000 1000 mg film-coated tablets 60 pcs. 349 r Buy

Siofor tablets p.o. 1000mg 60 pcs. 364 RUB Buy

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!