Metformin tablets 500mg №30

Metformin tablets 500mg №30

Product Code: 6029
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Composition

active substance: metformin;

1 tablet contains Metformin hydrochloride 500 mg or 850 mg, or 1000 mg

Excipients: povidone, magnesium stearate coating: hypromellose 2910, 5spz; PEG 6000;

titanium dioxide.

The

Dosage form

film-coated Tablets.

basic physico-chemical properties:

tablets of 500 mg round-shaped tablets with biconvex surface, coated with a white film shell

pills for 850 mg tablet oval shape with a concave surface, film-coated white color

tablets 1000 mg tablets of oval shape with concave surface, film-coated white color, with a notch on one side.

The

drug description

Hypoglycemic agents, except insulin. Biguanides. Code ATH A10V A02.

The

Pharmacological properties

Pharmacological.

Metformin - biguanide with antihyperglycemic effect. Reduces the level of glucose in plasma blood on an empty stomach or after a meal. It does not stimulate insulin secretion and does not cause hypoglycemic effect mediated by this mechanism.

Metformin acts in three ways:

The
  • leads to a decrease in glucose production in the liver by inhibiting gluconeogenesis and glycogenolysis;
  • improves insulin sensitivity in muscles, resulting in improved peripheral glucose capture and utilization
  • delays the absorption of glucose in the intestine.

Metformin stimulates intracellular glycogen synthesis by acting on glycogen. Increases the transport capacity of all known types of glucose membrane carriers (GLUT).

Regardless of the effect on blood glucose levels, Metformin has a positive effect on lipid metabolism. Metformin reduces total cholesterol, low-density lipoprotein and triglycerides.

In the course of research in the application of Metformin, body weight of patients remained stable or moderately decreased.

The Pharmacokinetics.

Suction

. After taking Metformin time to achieve maximum concentration is about 2.5 hours. Bioavailability of Metformin in the form of tablets of 500 mg or 800 mg is about 50-60% in healthy volunteers. After ingestion fraction nevsosavsheysya and excreted with feces is 20-30%.

after oral administration, Metformin absorption is saturated and incomplete.

pharmacokinetics of Metformin absorption is Assumed to be non-linear. When used in the recommended doses of Metformin and dosing stable concentration in plasma is reached within 24-48 hours and is less than 1 µg/ml. In studies, the maximum level of Metformin in blood plasma did not exceed 5 mcg/ml even when using maximum doses.

while eating, Metformin absorption decreases and slows down slightly.

after oral dose 850 mg there was a decrease in the maximum concentration in blood plasma by 40%, a decrease in the area under the curve "concentration-time" - by 25% and an increase of 35 minutes to reach the maximum concentration in blood plasma. The clinical significance of these changes is unknown.

Distribution. Binding to plasma proteins is insignificant. Metformin penetrates the red blood cells. The maximum concentration in the blood is lower than the maximum concentration in the blood plasma, and is achieved after about the same time. Red blood cells most likely represent a secondary compartment of distribution. The average volume of distribution ranges from 63-276 liters.

Metabolism. Metformin is excreted unchanged in the urine. Metabolites in humans have not been found.

The Output. The renal clearance of Metformin is>400 ml/min This indicates the excretion of Metformin by glomerular filtration and tubular secretion. After receiving, the half-life is about 6.5 hours. Renal clearance decreases in proportion to creatinine clearance and therefore the half-life period increases, which leads to an increase in the level of Metformin in blood plasma.

Reading

Diabetes mellitus type 2, with poor diet and regime of physical activity, especially in patients with excessive body weight

The
  • 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 the treatment of children aged 10 years.

to reduce complications of diabetes in adult patients with type 2 diabetes and overweight, as a first-line drug with ineffective diet therapy.

Contra

The
  • hypersensitivity to Metformin or to any other component of the drug;
  • diabetic ketoacidosis, diabetic coma;
  • moderate renal failure (stage II) and severe renal impairment (creatinine clearance (CC)
  • The
  • acute conditions occurring with risk of impaired renal function such as: dehydration, severe infection, shock
  • The
  • of the disease, which can lead to the development of tissue hypoxia (especially of acute illness or exacerbation of chronic disease) decompensated heart failure, respiratory failure, recent myocardial infarction, shock
  • The
  • liver failure, acute alcohol poisoning, alcoholism.
The

Interaction with other medicinal products and other forms of interaction

Combinations are not recommended.

Alcohol . Acute alcohol intoxication is associated with an increased risk of lactic acidosis, especially in cases of starvation or low-calorie diet, as well as liver failure. When treatment with Metformin should avoid drinking alcohol and medicines containing alcohol.

Iodinated x-ray contrast agents. Intravenous use of iodine-containing x-ray contrast agents can lead to renal failure and, as a consequence, the cumulation of Metformin and increase the risk of lactic acidosis.

patients with GFR>60 ml/min/1.73 m 2 should discontinue use of Metformin before or during the study and should not resume earlier than 48 hours after the study and only after re-evaluation of renal function and confirmation of the absence of further deterioration of the kidney.

patients with moderate renal insufficiency (GFR 45-60 ml/min/1.73 m 2 ) should discontinue the use of Metformin 48 hours before the introduction of iodine-containing x-ray contrast agents and not resume earlier than 48 hours after the study, only after re-evaluation of renal function and confirmation of the absence of further deterioration of the kidney.

the Combination should be used with caution.

Medicines, providing gipoglikemisirutee action (corticosteroids systemic and local action, sympathomimetics) . It is necessary to monitor blood glucose levels more often, especially at the beginning of treatment. During and after the termination of such joint therapy, it is necessary to adjust the dose of Metformin-Astrafarm.

Diuretics, especially loop diuretics, can increase the risk of lactic acidosis due to a possible decrease in kidney function.

application Features

lactic acidosis is very rare but serious metabolic complication (high mortality in the absence of urgent treatment) that may occur as a result of accumulation of Metformin hydrochloride. Reported cases of lactic acidosis in patients with diabetes mellitus, with renal insufficiency or sudden worsening of renal function. Caution should be exercised in cases where kidney function may be impaired, such as dehydration (severe diarrhea or vomiting), or at the beginning of treatment with antihypertensive drugs, diuretics and at the beginning of therapy with NSAIDs (NSAIDs). In case of these exacerbations, it is necessary to temporarily stop the use of Metformin.

other risk factors should be considered in order to avoid the development of lactic acidosis: poorly controlled diabetes mellitus, ketosis, prolonged starvation, excessive alcohol consumption, liver failure or any condition associated with hypoxia (decompensated heart failure, acute myocardial infarction).

lactic Acidosis can occur in the form of muscle cramps, digestive disorders, abdominal pain and severe asthenia. Patients should immediately inform the doctor about the occurrence of such reactions, especially if earlier patients well tolerated the use of Metformin. In such cases, it is necessary to temporarily discontinue the use of Metformin until clarification situations. Metformin therapy should be resumed after evaluating the benefit/risk ratio in each case and evaluating kidney function.

Diagnostics . Lactic acidosis is characterized by shortness of breath, abdominal pain and hypothermia, further development of coma. Diagnostic performance of laboratory reduction of blood pH, increasing the concentration of serum lactate above 5 mmol/l increase in anion gap and the ratio lactate/pyruvate. In case of lactic acidosis, the patient should be hospitalized immediately. The doctor should warn patients about the risk of the development and symptoms of lactic acidosis.

Renal failure . Since Metformin is excreted by the kidneys, before and regularly during treatment with Metformin it is necessary to check creatinine clearance (can be estimated by blood plasma creatinine level using The cocroft-golt formula) or GFR:

The
  • patients with normal renal function-at least 1 time per year;
  • patients with creatinine clearance at the lower limit of normal and elderly patients - at least 2-4 times a year.

in the case where KK

Reduced renal function in elderly patients occurs frequently and is asymptomatic. Caution should be exercised in cases where renal function may be impaired, for example, in the case of dehydration or at the beginning of treatment with antihypertensive agents, diuretics and at the beginning of therapy with NSAIDs. In such cases, it is also recommended to monitor kidney function before starting treatment with Metformin.

Cardiac function . Patients with heart failure have a higher risk of hypoxia and renal failure. Patients with stable chronic heart failure, Metformin can be used in regular monitoring of cardiac and renal function. Metformin is contraindicated in patients with acute and unstable heart failure.

Iodine-containing radiographic contrast agents . Intravenous x-ray contrast media for radiological studies can lead to renal failure, and as a result, lead to accumulation of Metformin and increases the risk of lactic acidosis. Patients with GFR 60 ml/min/1.73 m 2 should discontinue use of Metformin before or during the study and should not resume earlier than 48 hours after the study and only after re-evaluation of renal function and confirmation of the absence of further deterioration of the kidney.

patients with moderate renal insufficiency (GFR 45-60 ml/min/1.73 m 2 ) should discontinue the use of Metformin 48 hours before the introduction of iodine-containing x-ray contrast agents and not resume earlier than 48 hours after the study and only after re-evaluation of renal function and confirmation of the absence of further deterioration of the kidney.

Surgical intervention . It is necessary to stop the use of Metformin 48 hours before the planned surgery, which is carried out under General, spinal or peridural anesthesia and not to resume earlier than 48 hours after surgery or restoration of oral nutrition and only if the restoration of normal kidney function.

Children . Before treatment with Metformin, a diagnosis of type 2 diabetes mellitus should be confirmed. According to the results of studies no effect of Metformin on growth and puberty in children was revealed. However, there is no data on the effect of Metformin growth and puberty with prolonged use of Metformin, so it is recommended to carefully monitor these parameters in children who are treated with Metformin, especially during puberty.

Children aged 10 to 12 years. According to the results of studies, the effectiveness and safety of Metformin in children aged 10 to 12 years did not differ from that in the case of older children. The drug should be administered with caution to children aged 10 to 12 years.

other precautions . Patients need to follow a diet, even intake of carbohydrates during the day. Overweight patients should continue to follow a low-calorie diet. It is necessary to regularly monitor the carbohydrate metabolism of patients.

Monotherapy with Metformin does not cause hypoglycaemia, but caution should be exercised with concomitant use of Metformin with insulin or other oral hypoglycemic agents (e.g. sulfonylureas or meglitinides).

use during pregnancy or lactation.

Pregnancy.

Uncontrolled diabetes during pregnancy (gestational or permanent) increases the risk of congenital abnormalities and perinatal mortality. Available limited data on the use of Metformin in pregnant women do not indicate an increased risk of congenital abnormalities. Preclinical studies have not demonstrated adverse effects on pregnancy, development of the embryo or fetus, childbirth and postnatal development. In the case of pregnancy planning, as well as in the case of pregnancy, Metformin is recommended for the treatment of diabetes, and insulin to maintain blood glucose levels as close to normal as possible to reduce the risk of fetal malformations.

breast-Feeding.

Metformin is excreted in breast milk, but no side effects have been observed in infants/infants who were breastfed. However, since there is insufficient data on the safety of the drug, breastfeeding is not recommended during the therapy with Metformin. The decision on the termination of breastfeeding must take into account the benefit of breast-feeding and potential risk of side effects for the baby.

Fertility .

Metformin had no effect on fertility in animals when used in doses of 600 mg/kg of body weight per day, which is almost 3 times higher than the maximum recommended daily dose for humans based on surface area of the body.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms. 

monotherapy with Metformin does not affect the rate of reaction when driving vehicles or other mechanisms, because the drug does not cause hypoglycemia. However, be careful when using Metformin in combination with other hypoglycemic agents (sulfonylurea derivatives, insulin or meglitinides) due to the risk of hypoglycemia.

Method of application and doses

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.

in 10 to 15 days the dose should be adjusted according to the results of measurements of glucose level in the blood serum.

slowly increasing the dose helps reduce side-effects from the digestive tract.

in the treatment of high doses (2000-3000 mg per day) may be replaced every 2 tablets of the drug at 500 mg per 1 tablet of the drug at 1000 mg.

the Maximum recommended dose of 3000 mg/day in 3 divided doses.

in case of transition from other antidiabetic agent it is necessary to stop receiving this agent and to appoint Metformin as it is specified above.

Combination therapy in combination with insulin .

Metformin and insulin can be used as combination therapy to achieve better control of blood glucose levels. Usually, the initial dose is 500 mg or 850 mg of Metformin hydrochloride 2-3 times a day, while the insulin dose should be selected in accordance with the results of measuring blood glucose levels.

Children .

Monotherapy or combination therapy with insulin.

Metformin Is a Mineral prescribed for children aged 10 years. Typically, the initial dose is 500 mg or 850 mg of Metformin once a day during or after meals. In 10 to 15 days the dose should be adjusted according to the results of measurements of glucose level in the blood serum.

slowly increasing the dose helps reduce side-effects from the digestive tract.

the Maximum recommended dose is 2000 mg per day in 2-3 reception.

elderly patients may have decreased renal function, so the dose of Metformin should be selected based on the evaluation of kidney function, which should be carried out regularly.

patients with renal insufficiency.

Metformin may be used in patients with moderate renal insufficiency, stage Sha (UK 45-59 ml/min or GFR 45-59 ml/min/1.73 m 2 ), 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 once a day. The maximum dose is 1000 mg per day and should be divided into 2 doses. It is necessary to carefully monitor renal function (every 3-6 months).

if CC or GFR is reduced to

Children.

Metformin Is a Mineral prescribed for children aged 10 years.

Overdose

when using the drug at a dose of 85 g of hypoglycemia was not observed. However, in this case observed the development of lactic acidosis. A significant overdose of Metformin or concomitant risks may cause lactic acidosis. Lactic acidosis is an urgent condition that requires treatment in hospital. The most effective measure for removal from the body lactate and Metformin is hemodialysis.

Side effects

Frequent adverse reactions at the beginning of treatment are nausea, vomiting, diarrhea, abdominal pain, lack of appetite. These symptoms in most cases pass on their own. To prevent these side effects it is recommended that a slow increase in dosage and use the daily dose into 2-3 doses.

From the metabolic: lactic acidosis. With prolonged use of the drug may decrease the absorption of vitamin b 12, which is accompanied by a decrease in its level in serum. It is recommended to consider such a possible cause of hypovitaminosis in 12 , if the patient has megaloblastic anemia.

From the nervous system: impairment of taste.

from the digestive tract: nausea, vomiting, diarrhea, abdominal pain, lack of appetite. Most often, these side effects occur at the beginning of treatment and in most cases spontaneously disappear. To prevent the occurrence of side effects from the gastrointestinal tract, a slow increase in dosage and a daily dose of the drug in 2-3 doses during or after meals are recommended.

From the digestive system: abnormal liver function tests or hepatitis, to completely disappear after discontinuation of Metformin.

skin: skin reactions including erythema, itching, urticaria.

The

shelf Life

tablets, coated Tablets 500 mg, 850 mg 5 years.

Tablets, film-coated 1000 mg - 3 years.

storage Conditions

Store in its original packaging at a temperature not exceeding 25 ° C.

keep out of reach of children.

The

Packaging

tablets of 500 mg of 10 tablets in a blister film of polyvinyl chloride and aluminum foil printed lacquered; 3 or 6 blisters in a cardboard box.

tablets of 850 mg and 1000 mg of 7 tablets in a blister film of polyvinyl chloride and aluminum foil printed lacquered; 4 or 8 blisters in a cardboard box.

The

Category vacation

According to the recipe.

The

Manufacturer

LLC "Astrafarm".

location of the manufacturer and address of the place of business

08132, Ukraine, Kiev region, Kievo-Svyatoshinskiy R-n., Vyshneve, Kyivska street, 6.

TABLETS METFORMIN 500 MG

Metformin tablets 500 mg №30 – antidiabetic drug intended for the treatment of patients with diabetes mellitus type II and I. In the preparation composition contains hydrochloride Metformin. The substance has a positive effect on inhibition of gluconeogenesis in the body without producing hypoglycemic effect.

Pharmacological action

as a result of taking the medicine:

    The
  • Decrease the oxidation of fats.
  • The
  • Reduced the concentration of ATP inside cells.
  • The
  • Decreases in serum baseline level of glucose.
  • The
  • Increases the insulin sensitivity of the peripheral receptors.

Metformin suppresses appetite and contributes to diabetes and obesity to reduce body mass, causing an increase in the level of lipoproteins by 30%. 

Dosage and method of application

Pills are consumed after a meal, swallow the capsule whole. The recommended starting dosage for adults and adolescents from 12 years – up to 1000 mg per day (2 tablets). After two weeks of taking the medication the doctor needs to adjust the rule and, if necessary, increase dose to 3,000 mg. Children under 10 years it is recommended to use 1 tablet a day for 30 days. The course of therapy depends on the level of glucose in the patient's blood and can be increased to 2 months.

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