Product description

Tablets "Metformin-Astrafarm" are indicated for use in: type 2 diabetes when diet therapy and exercise regime are ineffective, especially in patients with excess body weight (as monotherapy or combined therapy together with other oral hypoglycemic agents or together with insulin for treatment of adults; as monotherapy or combined therapy with insulin for the treatment of children aged 10 and over); to reduce complications of diabetes in adult patients with type 2 diabetes and excess body weight, as a first-line preparation in case of ineffective diet therapy.

Storage

One tablet contains metformin hydrochloride 850 mg.

Excipients: povidone, magnesium stearate; coating: hydroxypropylmethylcellulose 2910, 5sPz; PEG 6000, titanium dioxide.

Contraindication

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

Application method

Adults

Monotherapy or combined therapy together with other oral hypoglycemic agents: usually, the initial 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 measuring the level of glucose in the blood serum; a slow increase in the dose helps to reduce side effects from the digestive tract; the maximum recommended dose is 3000 mg per day in 3 doses (in the case of switching from another antidiabetic agent, it is necessary to stop taking this agent and prescribe metformin, as indicated above).

Combination therapy in combination with insulin: to achieve better blood glucose control, metformin and insulin can be used as combination therapy, usually the starting dose is 500 mg or 850 mg of metformin hydrochloride 2-3 times a day, while the insulin dose should be adjusted according to the results of measuring the level of glucose in the blood.

Children

Monotherapy or combined therapy together with insulin: the preparation is prescribed to children aged 10 and over, usually the initial dose is 500 mg or 850 mg of metformin 1 time per day during or after meals; after 10-15 days, the dose must be adjusted according to the results of measuring the level of glucose in the blood serum; a slow increase in the dose helps to reduce side effects from the digestive tract; the maximum recommended dose is 2000 mg per day in 2-3 doses.

Features of application

pregnant

Uncontrolled diabetes during pregnancy (gestational or persistent) increases the risk of congenital anomalies and perinatal mortality. Available limited data on the use of metformin in pregnant women do not indicate an increased risk of congenital anomalies. Preclinical studies have not revealed negative effects on pregnancy, embryo or fetal development, childbirth and postpartum development. In the event of pregnancy planning, as well as in the event of pregnancy, for the treatment of diabetes, it is recommended not to use metformin, but insulin to maintain blood glucose levels as close to normal as possible in order to reduce the risk of developing fetal defects.

Metformin is excreted in breast milk, but in newborns / infants who were breastfed, side effects were not observed. However, since there is insufficient data on the safety of the preparation, breastfeeding is not recommended during metformin therapy. The decision to stop breastfeeding must be made taking into account the benefits of breastfeeding and the potential risk of side effects for the baby.

Drivers

Metformin monotherapy does not affect the speed of reaction when driving a motor vehicle or other mechanisms, since the preparation does not cause hypoglycemia. However, caution should be exercised when using metformin in combination with other hypoglycemic agents (sulfonylureas, insulin, or meglitinide) due to the risk of hypoglycemia.

Overdose

When using the preparation in a dose of 85 g, the development of hypoglycemia was not observed. However, in this case, the development of lactic acidosis was observed. A significant overdose of metformin or associated risk factors can cause lactic acidosis. Lactic acidosis is an emergency condition that requires hospital treatment. Hemodialysis is the most effective way to remove lactate and metformin from the body.

Side effects

Frequent adverse reactions at the beginning of treatment are nausea, vomiting, diarrhea, abdominal pain, lack of appetite. In most cases, these symptoms go away on their own. To prevent the occurrence of these side effects, it is recommended to slowly increase the dosage and use the daily dose in 2-3 doses.

Storage conditions

Store in the original packaging at a temperature not higher than 25 °C, in a place inaccessible to children.

Shelf life - 5 years.