Metformin | Glucophage tablets 850 mg 60 pcs.

Special Price $17.64 Regular Price $25.00
In stock
SKU
BID463148
Release form

Coated tablets.
Release form

Coated tablets.



packaging 60 pcs. each 0.85 g.

Pharmacological action

Oral hypoglycemic preparation from the biguanide group.

Glucophage reduces hyperglycemia without causing hypoglycemia. Unlike sulfonylurea derivatives, it does not stimulate insulin secretion and does not have a hypoglycemic effect in healthy individuals.

Increases peripheral receptor sensitivity to insulin and glucose utilization by cells. Reduces liver glucose production by inhibiting gluconeogenesis and glycogenolysis. Delays intestinal absorption of glucose.

Metformin stimulates glycogen synthesis by acting on glycogen synthetase. Increases transport capacity of all types of membrane glucose transporters.

In addition, it has a beneficial effect on lipid metabolism: it lowers total cholesterol, LDL and TG.

While taking metformin, the patient’s body weight either remains stable or decreases moderately.

Indications

Type 2 diabetes mellitus, especially in obese patients, with ineffective diet therapy and physical activity:

• in adults as monotherapy or in combination with other oral hypoglycemic agents, or with

insulin • in children from 10 years of age monotherapy or in combination with insulin.

Prevention of type 2 diabetes in patients with prediabetes with additional risk factors for type 2 diabetes, in which lifestyle changes did not allow achieving adequate glycemic control.

Contraindications

Diabetic ketoacidosis.

Diabetic precoma.

Diabetic coma.

Impaired renal function (CC <60 ml / min).

Renal failure.

Acute conditions at which there is a risk of impaired renal function: dehydration, (with diarrhea, vomiting), severe infectious diseases, conditions, shock.

Clinical manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including respiratory failure, heart failure, acute myocardial infarction).

Extensive surgery and trauma (when insulin therapy is indicated).

Hepatic failure.

Impaired liver function.

Chronic alcoholism, acute ethanol poisoning.

Lactic acidosis (including history).

A period of at least 48 hours before and within 48 hours after conducting radioisotope or x-ray studies with the introduction of an iodine-containing contrast medium.

Following a low-calorie diet (<1000 kcal / day).

Pregnancy.

Hypersensitivity to the drug.

Caution: the drug should be used in patients over the age of 60 who perform heavy physical work (which is associated with an increased risk of developing lactic acidosis) during breastfeeding.

Use during pregnancy and lactation

The drug is contraindicated in pregnancy.

Uncompensated diabetes mellitus during pregnancy is associated with an increased risk of birth defects and perinatal mortality. A limited amount of data suggests that the use of metformin in pregnant women does not increase the risk of congenital malformations in children.

When planning a pregnancy, as well as in case of pregnancy on the background of taking metformin, the drug should be discontinued, and insulin therapy is prescribed. It is necessary to maintain the glucose content in blood plasma at the level closest to normal to reduce the risk of fetal malformations.

Metformin is excreted in breast milk. Side effects in newborns during breastfeeding while taking metformin were not observed. However, due to the limited amount of data, the use of the drug in breastfeeding is not recommended. The decision to stop breastfeeding should be made taking into account the benefits of breastfeeding and the potential risk of side effects in the baby.

Special instructions

Lactic acidosis

Lactic acidosis is a rare but serious (high mortality rate without urgent treatment) complication that may occur due to cumulation of metformin. Cases of lactic acidosis when taking metformin occurred mainly in patients with diabetes mellitus with severe renal failure.

Other related risk factors, such as decompensated diabetes mellitus, should be considered. ketosis, prolonged fasting, alcoholism, liver failure and any condition associated with severe hypoxia. This can help reduce the incidence of lactic acidosis.

The risk of lactic acidosis should be considered when nonspecific symptoms appear, such as muscle cramps accompanied by dyspeptic symptoms, abdominal pain, and severe asthenia. Lactic acidosis is characterized by acidotic shortness of breath, abdominal pain and hypothermia followed by coma.

Diagnostic laboratory parameters are a decrease in blood pH (less than 7.25), a lactate content in plasma of more than 5 mmol / l, an increased anion gap and a lactate / pyruvate ratio. If metabolic acidosis is suspected, it is necessary to stop taking the drug and consult a doctor immediately.

Surgical operations

Metformin should be discontinued 48 hours before elective surgery and can be continued no earlier than 48 hours after, provided that renal function was found to be normal during the examination.

Renal function

Since metformin is excreted by the kidneys, prior to treatment and regularly thereafter, it is necessary to determine QC: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients, as well as in patients with QC at the lower limit of the norm.

Special care should be taken in case of possible impaired renal function in elderly patients, while the use of antihypertensive drugs, diuretics or NSAIDs.

Pediatric Use

The diagnosis of type 2 diabetes mellitus should be confirmed before starting treatment with metformin.

In clinical trials lasting 1 year, it was shown that metformin does not affect growth and puberty. However, due to the lack of long-term data, careful monitoring of the subsequent effect of metformin on these parameters in children, especially during puberty, is recommended. The most careful monitoring is necessary for children aged 10-12 years.

Other Precautions

Patients are advised to continue on a diet with an even carb intake throughout the day. Overweight patients are advised to continue to follow a low-calorie diet (but not less than 1000 kcal / day).

It is recommended that routine laboratory tests be performed to monitor diabetes.

Metformin does not cause hypoglycemia during monotherapy, but caution is advised when used in combination with insulin or other hypoglycemic agents (including sulfonylureas, repaglinide).

Influence on the ability to drive vehicles and control mechanisms

Monotherapy with glucophage does not cause hypoglycemia, therefore it does not affect the ability to drive vehicles and mechanisms. Nevertheless, patients should be cautioned about the risk of hypoglycemia when using metformin in combination with other hypoglycemic drugs (including sulfonylurea derivatives, insulin, repaglinide).

Composition

1 tablet contains:

Active ingredient: metformin hydrochloride - 850 mg.

Excipients: povidone - 34 mg, magnesium stearate - 8.5 mg.

Composition of the film membrane: hypromellose - 6.8 mg.

Dosage and administration of

The drug is taken orally.

Adults

Monotherapy and combination therapy with other oral hypoglycemic agents

The usual starting dose is 500 mg or 850 mg 2-3 times / day after or during meals. A further gradual increase in dose is possible depending on the concentration of glucose in the blood.

The maintenance dose of the drug is usually 1500-2000 mg / day. To reduce side effects from the gastrointestinal tract, the daily dose should be divided into 2-3 doses. The maximum dose is 3000 g / day, divided into 3 doses.

Slow dose increases may contribute to improved gastrointestinal tolerance.

Patients receiving metformin in doses of 2-3 g / day can be transferred to the drug Glucofage 1000 mg. The maximum recommended dose is 3000 mg / day, divided into 3 doses.

If you plan to switch from taking another hypoglycemic drug: you must stop taking another drug and start taking Glucophage in the dose indicated above.

Monotherapy for prediabetes:

The usual dose is 1000-1700 mg per day after or during meals, divided into 2 doses. It is recommended to regularly conduct glycemic control to assess the need for further use of the drug.

Combination with insulin

To achieve better blood glucose control, metformin and insulin can be used as a combination therapy. The usual initial dose of Glucophage is 500 mg or 850 mg 2-3 times / day, while the dose of insulin is selected based on the concentration of glucose in the blood.

Children and adolescents

In children aged 10 years and older: Glucophage can be used both as monotherapy and in combination with insulin. The usual starting dose is 500 mg or 850 mg 1 time / day after or during meals. After 10-15 days, the dose must be adjusted based on the concentration of blood glucose. The maximum daily dose is 2000 mg, divided into 2-3 doses.

Elderly patients

Due to a possible decrease in renal function, the dose of metformin must be selected under regular monitoring of renal function indicators (to determine the serum creatinine content at least 2-4 times a year). Gyukofazh should be taken daily, without a break. If treatment is discontinued, the patient should inform the doctor.

Side effects

Determination of the frequency of side effects:

Very often (? 1/10).

Often (? 1/100, <1/10).

Infrequently (? 1/1000, <1/100).

Rarely (? 1/10 000, <1/1000).

Very rare (<1/10 000).

Side effects are presented in decreasing order of importance.

Metabolism: very rare - lactic acidosis with prolonged use may reduce the absorption of vitamin B12. Decreased vitamin B12 levels must be considered in patients with megaloblastic anemia.

From the nervous system: often - a violation of taste.

From the digestive system: very often - nausea, vomiting, diarrhea, abdominal pain, lack of appetite. Most often, these symptoms occur during the initial period of treatment and in most cases pass spontaneously. To prevent symptoms, it is recommended that you take metformin 2 or 3 times / day during or after meals. Slow dose increases can improve gastrointestinal tolerance.

From the skin and subcutaneous tissues: very rarely - erythema, itching, rash.

From the liver and biliary tract: very rarely - impaired liver function, hepatitis. After discontinuation of metformin, adverse reactions completely disappear.

Published data, post-marketing data, as well as data from controlled clinical trials in a limited child population in the age group of 10 to 16 years, show that side effects in children are similar in nature and severity to those in adult patients.

Drug interaction

Contraindicated combinations

Iodine-containing radiopaque agents: against the background of functional renal failure in patients with diabetes mellitus, a radiological study using iodine-containing radiopaque agents may cause the development of lactic acidosis. Treatment with Glucophage must be canceled depending on the function of the kidneys 48 hours before or at the time of the X-ray examination using iodine-containing radiopaque agents and not be resumed earlier than 48 hours after, provided that during the examination, renal function was recognized as normal.

Not recommended combinations

Alcohol: in case of acute alcohol intoxication, the risk of lactic acidosis increases, especially in the case of:

Undernutrition, following a low-calorie diet.

Hepatic failure.

Alcohol and medicines containing ethanol should be avoided while taking the drug.

Combinations requiring caution

The simultaneous administration of danazol is not recommended in order to avoid the hyperglycemic effect of the latter. If treatment with danazol is necessary and after stopping the latter, dose adjustment of the drug Glucofage is required under the control of the concentration of glucose in the blood.

Chlorpromazine when taken in high doses (100 mg / day) increases the concentration of glucose in the blood, decreasing insulin release. In the treatment of antipsychotics and after stopping the latter, dose adjustment is required under the control of blood glucose concentration.

corticosteroids for systemic and topical use reduce glucose tolerance, increase the concentration of glucose in the blood, sometimes causing ketosis. In the treatment of corticosteroids and after stopping the intake of the latter, dose adjustment of the drug Glucofage is required under the control of the concentration of glucose in the blood.

The simultaneous use of loop diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Glucophage should not be prescribed if the CC is less than 60 ml / min.

Injection beta2-adrenergic agonists increase the concentration of glucose in the blood due to the stimulation of 2 -adrenoreceptors. In this case, it is necessary to control the concentration of glucose in the blood. If necessary, insulin is recommended.

With the simultaneous use of the above medicines, more frequent monitoring of blood glucose may be required, especially at the beginning of treatment. If necessary, the dose of metformin can be adjusted during treatment and after its termination.

ACE inhibitors and other antihypertensive drugs can lower blood glucose. If necessary, the dose of metformin should be adjusted.

With the simultaneous use of the drug Glucofage with sulfonylurea derivatives, insulin, acarbose, salicylates, hypoglycemia may develop.

Nifedipine enhances absorption and Cmax of metformin.

Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamteren, trimethoprim and vancomycin), secreted in the renal tubules, compete with metformin for tubular transport systems and can lead to an increase in its Cmax.

overdose

Symptoms: with metformin at a dose of 85 (at 42, 5 times the maximum daily dose) no hypoglycemia was observed, however, the development of lactic acidosis was noted. Significant overdose or associated risk factors can lead to the development of lactic acidosis.

Treatment: immediate withdrawal of the drug Glucophage, urgent hospitalization, determination of the concentration of lactate in the blood, if necessary, conduct symptomatic therapy. To remove lactate and metformin from the body, hemodialysis is most effective.

Storage conditions

Keep out of the reach and sight of children at temperatures not exceeding 25 РC.

Shelf life

5 years.

Deystvuyushtee substance

Metformin

Dosage form

tablets

Possible product names

Glucofage 0.85 N60 TABLE P / O

Glucofage 0.85 N60 TABLE P / FILM / SHELL

g Glu. p / pl / rev Х60 (20tab. Х3blist. 159.40) (R)

Glucofage 850mg №60

Glucophage 850mg №60 tab

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