Metformin (Siofor) 850 mg – [60 tablets]

Metformin belongs to the group of biguanides. It has hypoglycemic action. It provides reduction of both basal and postprandial blood plasma glucose concentrations. It does not stimulate insulin secretion and therefore does not lead to hypoglycemia.

The action of metformin is based on the following mechanisms:

– reduction of glucose production in the liver due to inhibition of gluconeogenesis and glycogenolysis;

– increased muscle sensitivity to insulin and, consequently, improved glucose absorption and utilization in the periphery;

– Inhibition of glucose absorption in the intestine.

Metformin through its action on glycogen synthase stimulates intracellular glycogen synthesis. Increases the transport capacity of all hitherto known membrane glucose transport proteins.

Has, regardless of its effect on plasma glucose concentration, a favorable effect on lipid metabolism, leads to lower concentrations of total cholesterol, low-density lipoprotein cholesterol and triglycerides.

Against the background of metformin administration in patients with diabetes, body weight either remains stable or decreases moderately.

Diabetes mellitus type 2, especially in overweight patients, for adequate control of plasma glucose concentration, when diet therapy and physical activity are ineffective:

– In adults as monotherapy or as part of combined therapy with other oral hypoglycemic agents and insulin;

– In children over 10 years as monotherapy or in combination with insulin. Prophylaxis of diabetes mellitus type 2 in patients with prediabetes mellitus type 2 with additional risk factors of development of diabetes mellitus type 2, in whom changes in lifestyle did not allow to achieve adequate glycemic control.

– Hypersensitivity to metformin or excipients of the drug;

– diabetic ketoacidosis, diabetic precoma, coma;

– renal impairment (creatinine clearance < 60 ml/min);

– acute conditions with risk of renal dysfunction: dehydration (e.g., diarrhea, vomiting), severe infectious diseases, shock;

– acute or chronic conditions accompanied by tissue hypoxia (cardiac or respiratory failure, recent myocardial infarction, shock);

– the period within 48 h before and 48 h after radioisotopic or radiological examinations with iodine-containing radiopaque agents (including angiography or urography) (intravenous administration of iodine-containing radiopaque agents can lead to renal dysfunction);

– the period within 48 h before and 48 h after surgical interventions;

– hepatic insufficiency, impaired liver function;

– lactoacidosis (including anamnesis);

– acute alcohol intoxication, chronic alcoholism;

– observance of a low-caloric diet (less than 1000 kcal per day);

– children under 10 years of age;

– pregnancy.

• By mouth.
• The drug Siofor 850 should be taken daily, without interruption. In case of discontinuation of therapy, the patient should inform the physician.
• Adults with normal reflux function (CK> 90 ml/min)
• Monotherapy or in combination therapy in combination with other oral hypoglycemic agents in type 2 diabetes mellitus
• The recommended starting dose is 850 mg (1 tablet of Siofork 850) 2 to 3 times daily during or after main meals.
• In 10-15 days after starting to take the drug, it is possible to increase gradually the dose depending on plasma glucose concentration up to an average daily dose of 2-3 tablets of Sioforc 850. Gradual increase in dose improves tolerability of the drug from the gastrointestinal tract.
• Maximum daily dose of metformin is 3000 mg divided into 3 doses.
• If a metformin dose of 3000 mg is necessary, patients may be switched to metformin in a dose of 1000 mg.
• If a patient is transferred to treatment with Siofor 850 from therapy with other hypoglycemic drugs, the other drug should be discontinued and Siofor 850 should be started at the dose indicated above.
• Combination with insulin
• Siofor 850 and insulin may be combined to improve glycemic control. The standard starting dose is 850 mg (1 tablet of Siofor 850) 2 to 3 times daily, with a gradual increase in doses at approximately 1-week intervals to an average daily dose of 2-3 tablets; the insulin dose is determined on the basis of plasma glucose concentration.
• The maximum daily dose of metformin is 3000 mg divided into 3 doses.
• If a 3000 mg dose of metformin is necessary, patients may be switched to a 1000 mg dose of metformin.
• Children 10 to 18 years of age.
• Monotherapy and combination with insulin
• Standard initial dose is 850 mg (1 tablet of Siofor 850) once daily during or after main meals.
• In 10-15 days after the start of the drug, a further gradual increase in the dose is possible, depending on the plasma glucose concentration. Gradual increase in dose improves drug tolerability in the gastrointestinal tract.
• The maximum daily dose of metformin for children is 2000 mg divided into 2-3 doses.
• If it is necessary to take metformin in a dose of 2000 mg, patients may be transferred to a metformin preparation in a dose of 1000 mg.
• When combined with insulin, the dose of insulin is determined on the basis of plasma glucose concentration.
• Monotherapy for prediabetes.
• The usual dose is 1000-1700 mg per day after or during meals, divided into 2 doses. Regular glycemic control is recommended to assess the need for further use of the drug.
• If a 1000 mg dose of metformin is required, patients may be switched to a 1000 mg dose of metformin.
• Patients with renal impairment.
• Metformin may be used in patients with renal impairment with a CKR of 30-59 mL/min only if there are no conditions/risk factors that may increase the risk of lactoacidosis.
• Renal function (CK) should be assessed before starting therapy with metformin and then at least once a year. Renal function should be monitored more frequently (every 3-6 months) in patients at increased risk of progression of renal failure and in the elderly.
• If CK is below 30 ml/min, the drug should be stopped immediately.
• Creatinine clearance (mL/min) Maximum daily dose (divided into 2-3 doses per day) Additional information
• 60-89 3000 mg Due to decreased renal function, a reduction in metformin dose should be considered.
• 45-59 2000 mg Before starting therapy with metformin, factors that increase the risk of lactoacidosis should be investigated (see section “Cautions”).  The starting dose is half of the maximum daily dose.
• 30-44 1000 mg
• <30 – Metformin administration is contraindicated.
• Elderly patients.
• Due to possible impairment of renal function in elderly patients, the dose of Sioform 1000 is adjusted with regard to plasma creatinine concentration. Regular assessment of renal function is necessary.