GLUCOPHAGE PILLS 850MG

Packaging

30 tablets.

Mechanism of action

Glucophage is an oral hypoglycemic drug from the biguanide group.

Glucophage reduces hyperglycemia, without leading to the development of hypoglycemia. It does not stimulate insulin secretion and does not have a hypoglycemic effect in healthy individuals.

Increases the sensitivity of peripheral receptors to insulin and stimulates glucose uptake by muscle cells. Inhibits gluconeogenesis in the liver. Delays the absorption of carbohydrates in the intestines. It has a beneficial effect on lipid metabolism: lowers total cholesterol, triglycerides and LDL.

Indications and usage

- Type 2 diabetes in adults.
- In combination with insulin - with type 2 diabetes, especially with a pronounced degree of obesity, accompanied by secondary insulin resistance.
- Type 2 diabetes in children from 10 years of age - both in monotherapy and in combination with insulin.

Contraindications

- Hypersensitivity to Metformin or to any of the excipients.
- Diabetic ketoacidosis, diabetic precoma, coma.
- Impaired renal function (creatinine clearance less than 60 ml / min).
- Acute diseases occurring with the risk of developing renal dysfunction:
- Dehydration (with diarrhea, vomiting).
- Fever.
- Severe infectious diseases.
- Conditions of hypoxia:
- Shock.
- Sepsis.
- Renal infections.
- Broncho-pulmonary diseases.

- Respiratory or heart failure.
- Acute myocardial infarction.

Pregnancy and Breastfeeding

When planning pregnancy, as well as in the event of pregnancy on the background of metformin, the drug should be canceled and insulin therapy prescribed.

For mother and newborn monitoring is established. Since there is no data on the penetration into breast milk, this drug is contraindicated during breastfeeding.

If you need to use metformin during breastfeeding, breastfeeding should be stopped.

Dosage and administration

Inside

Monotherapy and combination therapy in combination with other oral hypoglycemic agents The usual initial dose is 500 mg 2-3 times a day after or during the meal. A further gradual increase in the dose is possible depending on the level of glucose in the blood. Maintenance dose of the drug is usually 1500 - 2000 mg / day. To reduce the side effects of the gastrointestinal tract, the daily dose should be divided into 2-3 doses. The maximum dose is 3000 mg / day, divided into three doses.Slow increase in dose may contribute to improved gastrointestinal tolerance. Patients taking metformin in doses of 2000-3000 mg / day can be transferred to the reception of Glucophage ® 1000 mg. The maximum recommended dose is 3000 mg per day, divided into three doses. In the case of planning a transition from taking another hypoglycemic agent, it is necessary to stop taking another agent and start taking Glucophage ® at the dose indicated above.

Insulin combination To achieve better blood glucose control, metformin and insulin can be used as a combination therapy. The usual initial dose of Glucofage ® 500 mg and 850 mg is one pill 2-3 times a day. Glucophage ® 1000 mg - one pill 1 time per day, while the insulin dose is selected based on the results of blood glucose measurement.

In children from 10 years of age, Glucophage ® can be used both in monotherapy and in combination with insulin. The usual initial dose is 500 mg 2-3 times a day after or during the meal. After 10-15 days, the dose must be adjusted based on the results of blood glucose measurement. The maximum daily dose is 2000 mg, divided into 2-3 doses.

Because of the possible reduction in renal function, the dose of metformin must be selected under regular monitoring of indicators of renal function (serum creatinine at least two to four times a year).

Adverse reactions

From the side of the central nervous system Often: a violation of taste.

From the gastrointestinal tract Very often: nausea, vomiting, diarrhea, abdominal pain and lack of appetite. Most often they occur in the initial period of treatment and in most cases pass spontaneously. To prevent symptoms, it is recommended to take Metformin 2 or 3 times a day during or after a meal. Slow increase in dose may improve gastrointestinal tolerance.

Skin and subcutaneous tissue Very rarely: skin reactions such as erythema, pruritus, rash.

Metabolic disorders Very rare: lactic acidosis. In patients who received long-term treatment with metformin, there was a decrease in the absorption of vitamin B 12, accompanied by a decrease in its concentration in blood serum. These effects are quickly reversible with the abolition of metformin, and are usually clinically insignificant (

Hepato-biliary disorders There are isolated reports of impaired liver function or hepatitis. After the abolition of metformin, adverse events completely disappear.

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

If during treatment the patient has vomiting, abdominal pain, muscle pain, general weakness and severe discomfort, it is necessary to stop taking the drug and immediately consult a doctor.These symptoms may be a sign of incipient lactic acidosis.

48 hours before and within 48 hours after the radiopaque study (urography, intravenous angiography) should stop taking Glucophage.

Since metformin is eliminated by the kidneys, it is necessary to determine serum creatinine levels before starting treatment and regularly later.

Particular caution must be exercised in cases where kidney function may be impaired, for example, in the initial period of antihypertensive or diuretic therapy and during initial therapy with NSAIDs.

The patient must inform the doctor about the appearance of a bronchopulmonary infection or an infection of the urinary organs. During treatment, you must refrain from taking alcohol.

Influence on ability to drive and work with mechanisms
Monotherapy with the drug Glucophage does not cause hypoglycemia and therefore does not affect the ability to drive and work with mechanisms. However, patients should be wary of the risk of hypoglycemia when using metformin in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin, repaglinide, etc.).

Combinations not recommended
It is not recommended to take danazol at the same time in order to avoid hyperglycemic action of the latter.If necessary, treatment with danazol and after discontinuation of the latter requires a dose adjustment Glyukofazha under the control of glucose levels. Alcohol intake increases the risk of developing lactic acidosis during acute alcohol intoxication, especially in cases of starvation or low-calorie diets, as well as in liver failure. While taking the drug should avoid taking alcohol and medicines containing ethanol.

Combinations requiring special care
Chlorpromazine when taken in large doses (100 mg per day) increases glycemia, reducing insulin release. When treating neuroleptics and after discontinuation of the latter, a dose adjustment of the Glucophage under glycemic level control is required.

Glucocorticosteroids of systemic and local action reduce glucose tolerance, increase blood glucose, sometimes causing ketosis. In the treatment of corticosteroids, and after discontinuation of the latter, a dose adjustment of the Glucophage is required under glycemic control.

Simultaneous use of loop diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Glucophage should not be appointed if creatinine clearance below 60 ml / min.

Iodine-containing radiopaque agents. Radiological research with the use of iodine-containing radiopaque agents can cause the development of lactic acidosis in patients with diabetes mellitus on the background of functional renal failure.Appointment of Glucophage should be canceled 48 hours before and not renewed earlier 2 days after x-ray examination using radiopaque agents.

Appointed in the form of beta-2 injections, sympathomimetics increase glycemia due to stimulation of beta-2 receptors. In this case, glycemia control is necessary. If necessary, the appointment of insulin is recommended.

It should be appreciated that ACE inhibitors and other antihypertensive drugs can lower blood glucose levels. If necessary, adjust the dose of metformin.

With the simultaneous use of Glucophage with sulfonylurea derivatives, insulin, acarbose, salicylates, hypoglycemic action may be enhanced.

Symptoms: when using metformin at a dose of 85 g, hypoglycemia was not observed, however, the development of lactic acidosis was noted. The early symptoms of lactic acidosis are nausea, vomiting, diarrhea, fever, abdominal pain, muscle pain, and, in the future, rapid breathing, dizziness, impaired consciousness, and the development of coma.
Treatment: immediate cancellation of Glucophage, urgent hospitalization, determination of lactate concentration in the blood; if necessary, conduct symptomatic therapy. For removal of lactate and metformin from the body, hemodialysis is most effective.

Store at 15-25 ° C.

3 years.

Glucophage