TEVA #For_diabetics #Sugar_level_regulation #HEALTH_CARE
Product description
Tablets "Metformin-Teva" are used for the following indications:
- type 2 diabetes mellitus with ineffective diet and exercise regimen, especially in overweight patients (as monotherapy or 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 treatment children over the age of 10 and adolescents);
- reduction of diabetes complications in adult patients with type 2 diabetes mellitus and overweight who used metformin as a first-line drug with ineffective dietary therapy.
Structure
The active ingredient is metformin hydrochloride (one tablet contains 1000 mg of metformin hydrochloride).
Excipients: povidone K-30, anhydrous colloidal silicon dioxide, magnesium stearate, white opadry Y-1-7000 (hypromellose, titanium dioxide (E 171), macrogol).
Contraindications
- hypersensitivity to metformin or to any other component of the drug;
- any type of acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis);
- diabetic precoma;
- severe renal impairment (GFR <30 ml / minute);
- acute conditions occurring with the risk of developing impaired renal function: dehydration, severe infectious diseases, shock;
- diseases that can lead to the development of tissue hypoxia (especially acute diseases or exacerbations of a chronic disease): decompensated heart failure, respiratory failure, recent myocardial infarction, shock;
- liver failure;
- acute alcohol intoxication, alcoholism.
Mode of application
Adults
Monotherapy or combination therapy in conjunction with other oral hypoglycemic agents. Usually, the initial dose is 500 mg or 850 mg (use in the appropriate dosage) of metformin hydrochloride 2-3 times a day during or after meals. After 10-15 days, the dose must be adjusted according to the results of measurements of the glucose level in the blood serum. Slowly increasing the dose helps to reduce side effects from the digestive tract. The maximum recommended dose is 3000 mg / 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 in combination 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 (to be used at the appropriate dosage) of metformin hydrochloride 2-3 times a day, while the dose of insulin should be adjusted according to the results of blood glucose measurements.
Children
Monotherapy or combination therapy with insulin. Metformin hydrochloride should be used in children over 10 years of age and adolescents. Usually, the initial dose is 500 mg or 850 mg (use in the appropriate dosage) of metformin hydrochloride 1 time per day during or after meals. After 10-15 days, the dose must be adjusted according to the results of measurements of the glucose level in the blood serum. Slowly increasing the dose helps to reduce side effects from the digestive tract. The maximum recommended dose is 2000 mg / day, divided into 2-3 doses.
Application features
Pregnant
Uncontrolled diabetes during pregnancy (gestational or permanent) increases the risk of congenital anomalies and perinatal mortality. There are limited data on the use of metformin in pregnant women, which does not indicate an increased risk of congenital anomalies. Animal studies have shown no adverse effects on pregnancy, embryo or fetal development, childbirth and postpartum development. In the case of planning pregnancy, as well as in case of pregnancy, it is recommended to use metformin for the treatment of diabetes, and insulin to maintain blood glucose levels as close to normal as possible to reduce the risk of developing fetal malformations.
Metformin passes into breast milk, but no side effects have been observed in breastfed neonates / infants. However, since there is insufficient data on the safety of using metformin during breastfeeding, its use is not recommended during this period. The decision to stop breastfeeding should be made with the benefits of breastfeeding and the potential risk of side effects to the baby in mind.
Metformin did not affect the fertility of animals when used in doses of 600 mg / kg / day, which is almost 3 times higher than the maximum recommended daily dose for humans based on body surface area.
Drivers
Monotherapy with metformin does not affect the reaction rate when driving or operating other mechanisms, since the drug does not cause hypoglycemia.
However, care should be taken when using metformin in combination with other hypoglycemic agents (sulfonylurea derivatives, insulin or meglitinides) because of the risk of hypoglycemia.
Overdose
When using the drug at 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 excess of the dose of metformin or associated risk factors can lead to the occurrence of lactic acidosis. Lactic acidosis is a medical emergency and should be treated in a hospital. The most effective measure for removing lactate and metformin from the body is hemodialysis.
Side effects
Frequent adverse reactions, especially at the beginning of treatment, are nausea, vomiting, diarrhea, abdominal pain, and lack of appetite.
Storage conditions
Special storage conditions are not provided. Keep out of the reach of children.
Shelf life is 3 years.
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