Metformin-Astrapharm

Release Forms:

The composition 1 tablets:

  • active substance: metformin;
  • 1 tablet contains metformin hydrochloride 500 mg or 850 mg or 1000 mg;
  • excipients: povidone, magnesium stearate; coverage: hypromellose 2910, 5cPz; PEG 6000; titanium dioxide.

Dosage form. Film-coated tablets.

Basic physical and chemical properties:

  • tablets of 500 mg: round tablets with a biconvex surface, film-coated white;
  • tablets of 850 mg: oval-shaped tablets with a biconvex surface, film-coated white;
  • 1000 mg tablets: oval-shaped tablets with a biconvex surface, film-coated white, with a line on one side.
10 tablets in a blister, 3 or 6 or 9 blisters in a cardboard box.

10 tablets in a blister, 3 or 6 or 9 blisters in a cardboard box.

Indications for use.

Hypoglycemic agents, with the exception of insulins. Biguanides.

Diabetes mellitus type 2, with the ineffectiveness of diet therapy and exercise regimen, especially in overweight patients:

  • as monotherapy and combination therapy in conjunction with other oral hypoglycemic agents, or in conjunction with insulin for the treatment of adults.
  • as monotherapy or combination therapy with insulin for the treatment of children over 10 years of age.

To reduce complications of diabetes in adults with type 2 diabetes mellitus and overweight, as a first-line drug after ineffective diet therapy.

Contraindications.

  • Hypersensitivity to metformin or any other component of the drug;
  • diabetic ketoacidosis, diabetic precoma;
  • moderate renal failure (stage IIIb) and severe or impaired renal function (creatinine clearance (CC) <45 ml / min, or glomerular filtration rate (GFR) <45 ml / min / 1.73 m2);
  • acute conditions occurring with the risk of developing renal dysfunction, such as: dehydration, severe infectious diseases, shock;
  • diseases that can lead to the development of tissue hypoxia (especially acute diseases or exacerbation of a chronic disease):
  • decompensated heart failure, respiratory failure, recent myocardial infarction, shock;
  • liver failure, acute alcohol poisoning, alcoholism.

Method of administration and dosage.

Adults.
Monotherapy or combination therapy in conjunction with other oral hypoglycemic agents.
The usual starting dose is 500 mg or 850 mg 2-3 times a day during or after meals.
After 10-15 days, the dose must be adjusted according to the results of the blood glucose measurements.
Slowly increasing the dose helps to reduce side effects from the digestive tract.
When treating with high doses (2000-3000 mg per day), it is possible to replace every 2 tablets of the drug, 500 mg per 1 tablet of the drug 1000 mg.
The maximum recommended dose is 3000 mg per day, divided into 3 doses.
If you switch from another antidiabetic drug, you must stop taking this drug and prescribe metformin as described above.
Combination therapy with insulin.
Metformin and insulin can be used in combination therapy to achieve better blood glucose control. The usual starting dose is 500 mg or 850 mg of metformin hydrochloride 2-3 times a day, while the dose of insulin should be adjusted according to the blood glucose results.

Children.
Monotherapy or combination therapy with insulin.
Metformin-Astrafarm is used in children over 10 years of age. The usual starting dose is 500 mg or 850 mg of metformin once a day during or after meals. After 10-15 days, the dose must be adjusted according to the results of the blood glucose measurements.
Slowly increasing the dose helps to reduce side effects from the digestive tract.
The maximum recommended dose is 2000 mg per day for 2-3 doses.
In elderly patients, a decrease in renal function is possible, therefore, the dose of metformin should be selected on the basis of an assessment of renal function, which should be carried out regularly.
Patients with renal impairment.
Metformin can be used in patients with moderate renal failure, stage IIIa (CC 45-59 ml/min or GFR 45-59 ml/min / 1.73 m2), only in the absence of other factors increasing the risk of lactic acidosis with subsequent dose adjustment. The initial dose is 500 mg or 850 mg of metformin hydrochloride 1 time per day. The maximum dose is 1000 mg per day and should be divided into 2 doses. Renal function should be closely monitored (every 3-6 months).
If creatinine clearance or GFR decreases to <45 ml/min or 45 ml/min /1.73 m2, respectively, metformin should be discontinued immediately.

Children.
Metformin-Astrafarm is used in children over 10 years of age.