Release form, composition and packing Bagomet
Tablets, coated white, round, biconvex, with two cross-positioned risks on one side and a logo - on the other, on a break - the rough surface of white. 1 tab. metformin hydrochloride 500 mg.
Inactive ingredients: croscarmellose sodium, povidone, stearic acid, corn starch, lactose monohydrate, purified water. The composition of the shell: Opadry White YS-30-18056 (ready mix for the shell, consisting of lactose, hypromellose, titanium dioxide and triacetin in a ratio of 40:40:10:10), Opadry clear YS 1-7006 (ready mix for the shell, consisting of hypromellose and polyethylene glycol in a ratio of 90:10), purified water, sodium saccharin.
Extended release tablets, coated in blue, Valium, with Valium on one side and a logo - on the other, on a break - the rough surface of white. 1 tab. metformin hydrochloride 850 mg. Inactive ingredients: hypromellose, povidone, magnesium stearate, alcohol, lactose monohydrate, methylene chloride. The composition of the shell: Opadry White YS-30-18056 (ready mix for the shell, consisting of lactose, hypromellose, titanium dioxide and triacetin in a ratio of 40:40:10:10), Opadry clear YS 1-7006 (ready mix for the shell, consisting of hypromellose and polyethylene glycol in a ratio of 90:10), purified water, sodium saccharin, vanilla, food coloring Brilliant Blue.
Clinico-pharmacological group: oral hypoglycemic agents.
Pharmacological action
Hypoglycemic drug from biguanide group. Inhibits hepatic gluconeogenesis, decreases absorption of glucose from the intestine, enhances peripheral glucose utilization and increases tissue insulin sensitivity. In this case, has no effect on the secretion of insulin Ī²-cells in the pancreas. Bagomet lowers triglyceride and LDL cholesterol in the blood.
Mildly anorectics effect that helps patients to diet, stabilize or reduce body weight. Improves fibrinolytic properties of blood due to suppression of plasminogen activator inhibitor type of tissue.
Pharmacokinetics
Absorption and distribution
After oral administration, metformin is absorbed from the gastrointestinal tract. Bioavailability after administration of standard dose is 50-60%. Cmax in plasma achieved 2 h after ingestion. Practically does not bind to plasma proteins. Accumulates in the salivary glands, liver and kidneys.
Breeding
Stands unchanged by the kidneys. T1 / 2 is approximately 6.5 hours
Pharmacokinetics in special clinical situations
If the kidney function is possible cumulative effect of the drug.
Statement
Type 2 diabetes patients without the propensity to ketoacidosis with the ineffectiveness of diet (especially in obese).
Dosing regimen
Set individually depending on the level of glucose in the blood. The initial dose is 0.5-1 g / day. 10-15 days may further gradual increase in the dose depending on the level of glucose in the blood. Maintenance dose is usually 1.5-2 g / day. The maximum dose - 3 g / day. To reduce the side effects on the digestive system of the daily dose should be divided into 2-3 doses.
Elderly patients recommended daily dose should not exceed 1 g.
In severe metabolic disturbances dose
Bagometa be reduced (due to an increased risk of lactic acidosis). The tablets should be taken entirely Bagometa during or immediately after the meal with a small amount of liquid (water glass).
Side effect
From the digestive system: nausea, vomiting, metallic taste, anorexia, diarrhea, flatulence, abdominal pain.
From the hemopoietic system: in some cases - megaloblastic anemia.
From the Endocrine: hypoglycemia (when used in inadequate doses) and in rare cases, lactic acidosis (requires treatment).
Allergic reactions: skin rash.
Other: long-term use - Hypovitaminosis B12 (due to malabsorption).
Contraindications
diabetic ketoacidosis;
diabetic precoma;
coma;
marked impairment of renal function;
liver function;
cardiac and respiratory failure;
acute phase of myocardial infarction;
acute cerebrovascular accident;
dehydration;
lactic acidosis (including history);
chronic alcoholism, and other conditions that might promote lactic acidosis;
major surgery and trauma (when shown an insulin);
acute alcohol poisoning;
application for at least 2 days before and within 2 days after the application of radioisotope iodine-containing drugs or X-ray;
adherence to a strict diet (less than 1000 kcal / day).
pregnancy;
Lactation (breastfeeding);
hypersensitivity to the drug.
Not recommended to prescribe the drug to people over 60 years of performing heavy physical load (due to an increased risk of lactic acidosis).
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breastfeeding).
Use in hepatic dysfunction
Contraindicated in marked hepatic dysfunction.
Use in renal impairment
Contraindicated in marked renal impairment.
Cautions
During the period of treatment needed to control renal function. Need to monitor lactate levels were at least 2 times a year, as well as the appearance of myalgia.
Bagometa possible to use in combination with sulfonylureas. In this case, requires particularly careful monitoring of blood glucose.
At the use of ethanol during treatment
Bagometa may develop lactic acidosis.
Overdose
Symptoms: may develop lactic acidosis with fatal consequences (for reasons of development may also include the cumulation of the drug due to renal dysfunction). The early symptoms include nausea, vomiting, diarrhea, drop in body temperature, abdominal pain in muscles and in the future possibly shortness of breath, dizziness, impaired consciousness and the development of coma.
Treatment: medication to terminate immediately, the patient should be hospitalized immediately and determine the concentration of lactate. The most effective hemodialysis. If necessary, symptomatic treatment.
Combination therapy with sulfonylureas Bagometa possible hypoglycemia.
Drug Interactions
In an application with sulfonylureas, acarbose, insulin, NSAIDs, MAO inhibitors, oxytetracycline, ACE inhibitors, derivatives of clofibrate, cyclophosphamide, beta-blockers may increase hypoglycemic action of metformin.
In an application with corticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormone drugs, thiazide and loop "diuretics, phenothiazine derivatives, derivatives of nicotinic acid may decrease hypoglycemic effect of metformin.
With the simultaneous application of cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis. With the simultaneous application of metformin may reduce the action of anticoagulants (coumarin derivatives).
Conditions and terms of
List B. The drug should be stored in a dry place, protected from light and away from children, at up to 25 ° C. Shelf life - 2 years.
Tablets, coated white, round, biconvex, with two cross-positioned risks on one side and a logo - on the other, on a break - the rough surface of white. 1 tab. metformin hydrochloride 500 mg.
Inactive ingredients: croscarmellose sodium, povidone, stearic acid, corn starch, lactose monohydrate, purified water. The composition of the shell: Opadry White YS-30-18056 (ready mix for the shell, consisting of lactose, hypromellose, titanium dioxide and triacetin in a ratio of 40:40:10:10), Opadry clear YS 1-7006 (ready mix for the shell, consisting of hypromellose and polyethylene glycol in a ratio of 90:10), purified water, sodium saccharin.
Extended release tablets, coated in blue, Valium, with Valium on one side and a logo - on the other, on a break - the rough surface of white. 1 tab. metformin hydrochloride 850 mg. Inactive ingredients: hypromellose, povidone, magnesium stearate, alcohol, lactose monohydrate, methylene chloride. The composition of the shell: Opadry White YS-30-18056 (ready mix for the shell, consisting of lactose, hypromellose, titanium dioxide and triacetin in a ratio of 40:40:10:10), Opadry clear YS 1-7006 (ready mix for the shell, consisting of hypromellose and polyethylene glycol in a ratio of 90:10), purified water, sodium saccharin, vanilla, food coloring Brilliant Blue.
Clinico-pharmacological group: oral hypoglycemic agents.
Pharmacological action
Hypoglycemic drug from biguanide group. Inhibits hepatic gluconeogenesis, decreases absorption of glucose from the intestine, enhances peripheral glucose utilization and increases tissue insulin sensitivity. In this case, has no effect on the secretion of insulin Ī²-cells in the pancreas. Bagomet lowers triglyceride and LDL cholesterol in the blood.
Mildly anorectics effect that helps patients to diet, stabilize or reduce body weight. Improves fibrinolytic properties of blood due to suppression of plasminogen activator inhibitor type of tissue.
Pharmacokinetics
Absorption and distribution
After oral administration, metformin is absorbed from the gastrointestinal tract. Bioavailability after administration of standard dose is 50-60%. Cmax in plasma achieved 2 h after ingestion. Practically does not bind to plasma proteins. Accumulates in the salivary glands, liver and kidneys.
Breeding
Stands unchanged by the kidneys. T1 / 2 is approximately 6.5 hours
Pharmacokinetics in special clinical situations
If the kidney function is possible cumulative effect of the drug.
Statement
Type 2 diabetes patients without the propensity to ketoacidosis with the ineffectiveness of diet (especially in obese).
Dosing regimen
Set individually depending on the level of glucose in the blood. The initial dose is 0.5-1 g / day. 10-15 days may further gradual increase in the dose depending on the level of glucose in the blood. Maintenance dose is usually 1.5-2 g / day. The maximum dose - 3 g / day. To reduce the side effects on the digestive system of the daily dose should be divided into 2-3 doses.
Elderly patients recommended daily dose should not exceed 1 g.
In severe metabolic disturbances dose
Bagometa be reduced (due to an increased risk of lactic acidosis). The tablets should be taken entirely Bagometa during or immediately after the meal with a small amount of liquid (water glass).
Side effect
From the digestive system: nausea, vomiting, metallic taste, anorexia, diarrhea, flatulence, abdominal pain.
From the hemopoietic system: in some cases - megaloblastic anemia.
From the Endocrine: hypoglycemia (when used in inadequate doses) and in rare cases, lactic acidosis (requires treatment).
Allergic reactions: skin rash.
Other: long-term use - Hypovitaminosis B12 (due to malabsorption).
Contraindications
diabetic ketoacidosis;
diabetic precoma;
coma;
marked impairment of renal function;
liver function;
cardiac and respiratory failure;
acute phase of myocardial infarction;
acute cerebrovascular accident;
dehydration;
lactic acidosis (including history);
chronic alcoholism, and other conditions that might promote lactic acidosis;
major surgery and trauma (when shown an insulin);
acute alcohol poisoning;
application for at least 2 days before and within 2 days after the application of radioisotope iodine-containing drugs or X-ray;
adherence to a strict diet (less than 1000 kcal / day).
pregnancy;
Lactation (breastfeeding);
hypersensitivity to the drug.
Not recommended to prescribe the drug to people over 60 years of performing heavy physical load (due to an increased risk of lactic acidosis).
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breastfeeding).
Use in hepatic dysfunction
Contraindicated in marked hepatic dysfunction.
Use in renal impairment
Contraindicated in marked renal impairment.
Cautions
During the period of treatment needed to control renal function. Need to monitor lactate levels were at least 2 times a year, as well as the appearance of myalgia.
Bagometa possible to use in combination with sulfonylureas. In this case, requires particularly careful monitoring of blood glucose.
At the use of ethanol during treatment
Bagometa may develop lactic acidosis.
Overdose
Symptoms: may develop lactic acidosis with fatal consequences (for reasons of development may also include the cumulation of the drug due to renal dysfunction). The early symptoms include nausea, vomiting, diarrhea, drop in body temperature, abdominal pain in muscles and in the future possibly shortness of breath, dizziness, impaired consciousness and the development of coma.
Treatment: medication to terminate immediately, the patient should be hospitalized immediately and determine the concentration of lactate. The most effective hemodialysis. If necessary, symptomatic treatment.
Combination therapy with sulfonylureas Bagometa possible hypoglycemia.
Drug Interactions
In an application with sulfonylureas, acarbose, insulin, NSAIDs, MAO inhibitors, oxytetracycline, ACE inhibitors, derivatives of clofibrate, cyclophosphamide, beta-blockers may increase hypoglycemic action of metformin.
In an application with corticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormone drugs, thiazide and loop "diuretics, phenothiazine derivatives, derivatives of nicotinic acid may decrease hypoglycemic effect of metformin.
With the simultaneous application of cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis. With the simultaneous application of metformin may reduce the action of anticoagulants (coumarin derivatives).
Conditions and terms of
List B. The drug should be stored in a dry place, protected from light and away from children, at up to 25 ° C. Shelf life - 2 years.
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