Metformin-Astrapharm tablets are indicated for use in: type 2 diabetes mellitus when diet therapy and exercise regimen are ineffective, especially in patients with excess body weight (as monotherapy or combination therapy together with other oral hypoglycemic agents or together with insulin for the treatment of adults; as monotherapy or combination therapy with insulin for the treatment of children aged 10 years and older); to reduce complications of diabetes in adult patients with type 2 diabetes mellitus and excess body weight, as a first-line drug when diet therapy is ineffective.
Composition
One tablet contains metformin hydrochloride 1000 mg.
Excipients: povidone, magnesium stearate; coating: hydroxypropylmethylcellulose 2910, 5sPz; PEG 6000, titanium dioxide.
Contraindication
Hypersensitivity to metformin or any component of the drug; diabetic ketoacidosis, diabetic precoma; moderate (stage IIIb) and severe renal failure or impaired renal function (creatinine clearance (CC) <45 ml / minute, or glomerular filtration rate (GFR) <45 ml / minute / 1.73 m 2); acute conditions with a 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 application
Adults
Monotherapy or combination therapy 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 should be adjusted according to the results of serum glucose measurements; 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 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 metformin hydrochloride 2-3 times a day, while the insulin dose should be adjusted according to the results of blood glucose measurements.
Children
Monotherapy or combination therapy with insulin: the drug is prescribed to children aged 10 years and older, usually the initial dose is 500 mg or 850 mg of metformin once a day during or after meals; after 10-15 days, the dose should be adjusted according to the results of serum glucose measurements; a slow increase in the dose helps reduce side effects from the digestive tract; the maximum recommended dose is 2000 mg per day in 2-3 doses.
Application features
Pregnant women
Uncontrolled diabetes during pregnancy (gestational or permanent) increases the risk of congenital anomalies and perinatal mortality. Limited data on the use of metformin in pregnant women do not indicate an increased risk of congenital anomalies. Preclinical studies have not revealed any adverse effects on pregnancy, embryonal or foetal development, labour and postnatal development. When planning pregnancy and during pregnancy, it is recommended that insulin, rather than metformin, be used to treat diabetes to maintain blood glucose levels as close to normal as possible to reduce the risk of foetal malformations.
Metformin is excreted in breast milk, but no adverse effects have been observed in breastfed newborns/infants. However, due to insufficient data on the safety of the drug, breastfeeding is not recommended during metformin therapy. A decision to discontinue breastfeeding should be made taking into account the benefits of breastfeeding and the potential risk of adverse effects to the child.
Drivers
Metformin monotherapy does not affect the reaction speed when driving or using other mechanisms, since the drug does not cause hypoglycemia. However, caution should be exercised when using metformin in combination with other hypoglycemic agents (sulfonylurea derivatives, insulin or meglitinide) due to the risk of hypoglycemia.
Overdose
When using the drug in a dose of 85 g, hypoglycemia was not observed. However, in this case, the development of lactic acidosis was observed. A significant excess of the metformin dose or concomitant risk factors can cause lactic acidosis. Lactic acidosis is an emergency condition that requires treatment in a hospital. The most effective measure for removing lactate and metformin from the body is hemodialysis.
Side effects
Common adverse reactions at the beginning of treatment are nausea, vomiting, diarrhea, abdominal pain, lack of appetite. These symptoms in most cases resolve 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
Shelf life - 3 years.
