Bagomet - instructions for use, dose, side effects, contraindications

Double-convex capsule capsules of white color with a risk on one side and the logo of the firm on the other, coated with a film sheath.
View of the fracture: a rough surface of white color.

Pharmacotherapeutic group:Hypoglycemic agent for oral administration of the biguanide group

ATX: & nbsp

A.10.B.A.02 Metformin

Pharmacodynamics:

Bagomet ® lowers the concentration of glucose in the blood in patients with diabetes by suppressing gluconeogenesis in the liver, reducing the absorption of glucose from the gastrointestinal tract (GIT) and increasing its utilization in tissues.

Does not cause hypoglycemic reactions. Does not stimulate the secretion of insulin and does not cause hypoglycemia.

Reduces body weight in patients with high body weight, suffering from diabetes, by reducing hyperinsulinemia. Has a lipolytic effect. Bagomet ® lowers the concentration of total cholesterol in blood plasma, low-density lipoproteins and triglycerides.

Pharmacokinetics:

After oral administration, it is quickly and sufficiently absorbed from the digestive tract. Absolute bioavailability with fasting is 50-60%. The maximum plasma concentration in the plasma (Cmax) is 4 μg / ml. The time to reach the maximum concentration (TCmax) is 1-3 hours. With the simultaneous administration of the drug with food, the absorption of metformin is reduced and delayed. Metformin quickly distributed into tissues, practically does not bind to plasma proteins, it is able to accumulate in erythrocytes. The volume of distribution is 1951.7 liters.Exposed to a very weak degree of metabolism. It is excreted by the kidneys, mainly in unchanged form. The clearance of metformin in healthy subjects is 400 ml / min. The half-life (T1 / 2) is approximately 6 hours. With violations of kidney function, cumulation of the drug is possible.

Indications:

Type 2 diabetes mellitus, especially when combined with obesity (including in the inability of the sulfonylurea group) in monotherapy or as part of combination therapy with other oral hypoglycemic agents or insulin.

Contraindications:

- Hypersensitivity to metformin or to any auxiliary substance;

- diabetic ketoacidosis, diabetic precoma, coma;

- renal failure or impaired renal function (creatinine clearance less than 60 ml / min);

- acute conditions that occur with a risk of developing renal dysfunction;

- Dehydration (with diarrhea, vomiting), fever, severe infectious diseases;

- the state of hypoxia (shock, sepsis, kidney infections, broncho-pulmonary diseases);

- clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including cardiac or respiratory failure, acute myocardial infarction);

- extensive surgery and trauma, when insulin therapy is indicated;

- liver failure, a violation of liver function;

- chronic alcoholism, acute alcohol poisoning;

- pregnancy, the period of breastfeeding;

- lactic acidosis (including in the anamnesis);

- use for at least 48 hours before and within 48 hours after carrying out radioisotope or X-ray studies with the introduction of iodine-containing contrast medium;

- compliance with the hypocaloric diet (less than 1000 kcal / day);

- Children under 18 years.

Carefully:

Age is more than 60 years old, performing hard physical work (increased risk of lactic acidosis).

Dosing and Administration:

Inside

The dose of the drug is determined by the doctor individually depending on the concentration of glucose in the blood.

The initial dose is 1000 mg (1 tablet) 1 time per day with meals or immediately after meals, with enough liquid. After 10-15 days in the absence of adverse effects on the part of the gastrointestinal tract, a further gradual increase in the dose, depending on the concentration of glucose in the blood, is possible. The maintenance dose of the drug is usually 1000-2000 mg / day (1-2 tablets). The maximum dose is 2000 mg / day (2 tablets).To reduce side effects from the GIT, the dose of 2000 mg should be divided into 2 doses.

A slow increase in the dose may help improve the gastrointestinal tolerance of the drug.

In the combination therapy with insulin:

The usual recommended dose of Bagometh ® is 1000 mg (1 tablet) once a day. The dose of insulin is selected based on the glucose values in the blood.

Side effects:

Disorders from the digestive tract: nausea, vomiting, "metallic" taste in the mouth, lack of appetite, flatulence, diarrhea, abdominal pain. These symptoms are sometimes found at the beginning of treatment and tend to go away on their own: Typically, these side effects are minimized by taking the drug during or after a basic meal.

From the central nervous system: headache, dizziness, fatigue, weakness.

Allergic reactions: erythema, itching, rash.

From the side of metabolism: lactoacidosis (requires withdrawal of the drug)

Other: with prolonged use develops hypovitaminosis B12.

Overdose:

In case of an overdose, lactoacidosis may develop.Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, fever, abdominal pain, muscle pain, there may be more rapid breathing, dizziness, impaired consciousness and coma development. Treatment: in case of signs of lactic acidosis, metformin treatment should be stopped immediately, the patient immediately hospitalized. The most effective measure for excretion from the body of lactate and metformin is hemodialysis. Symptomatic therapy is also performed.

If you accidentally take a large amount of the drug, you need to wash the stomach. The concentration of glucose, urea, creatinine, lactate and electrolytes in the blood should be monitored.

Interaction:

When used simultaneously with glucocorticosteroids, hormonal contraceptives, epinephrine, glycagon, sympathomimetics, phenytoin, thyroid hormones, phenothiazine derivatives, thiazide diuretics, nicotinic acid derivatives, slow calcium channel blockers, and isoniazid, a decrease in the hypoglycemic effect of metformin is possible.

When used simultaneously with sulfonylurea derivatives, acarbose, insulin, non-steroidal anti-inflammatory drugs (NSAIDs), monoamine oxidase inhibitors, oxytetracycline, angiotensin converting enzyme inhibitors, clofibrate derivatives, cyclophosphamide, β-blockers, hypoglycemic effect of metformin is possible.

Alcohol intake increases the risk of developing lactic acidosis during acute alcohol intoxication, especially in cases of fasting or low-calorie diet, as well as in liver failure. When taking the drug should avoid drinking alcohol and drugs containing alcohol.

Metformin can reduce the absorption of cyanocobalamin (vitamin B12).

Cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis.

Nifedipine slows the excretion of metformin. Metformin can weaken the effect of anticoagulants (coumarin derivatives).

Special instructions:

During the treatment with Bagometh®, the concentration of glucose in the blood should be regularly monitored on an empty stomach and after eating.

The patient should be warned about the need to stop taking the drug and see a doctor if there is vomiting, abdominal pain, muscle pain, general weakness and severe malaise. These symptoms can be a sign of beginning lactic acidosis.

Bagomet ® should be discontinued 48 hours before and within 48 hours after X-ray examination (including urography, intravenous angiography) using radiopaque means.

Bagomet ® should be discontinued 48 hours before and within 48 hours after surgery under general anesthesia, spinal or epidural anesthesia. Because the metformin is excreted by the kidneys, the concentration of creatinine in the blood serum should be determined before starting treatment and regularly thereafter: in patients with preserved kidney function, once a year; in patients with a reduced serum creatinine concentration and in elderly patients -2-4 times a year. Particular caution should be exercised in cases of impaired renal function, for example, during the initial period of therapy with antihypertensive agents, diuretics, NSAIDs.

It is necessary to inform the patient about the need to consult a doctor if symptoms of bronchopulmonary infection or infectious disease of the genito-urinary organs appear.

Against the background of the use of the drug Bagomet ® should refrain from drinking alcohol, in connection with the possibility of developing lactic acidosis.

Hypovitaminosis B12 when taking Bagometh® is caused by a malabsorption. It has a reversible character - the content of vitamin B12 is quickly restored when the drug Bagomet ® is withdrawn. Reducing the concentration of vitamin B12 should be taken into account in patients with megaloblastic anemia.

Effect on the ability to drive transp. cf. and fur:

Data on the adverse effects of Bagomet ® in the recommended doses on the ability to drive or work with machines are not present.

However, patients who report side effects when taking the drug, especially when using Bagometh ® with other hypoglycemic agents (sulfonylureas, insulin, etc.), should be careful when practicing potentially dangerous activities that require increased concentration and attention the speed of psychomotor reactions.

Form release / dosage:

Tablets of prolonged action, film-coated 1000 mg.

Packaging:

10 tablets per blister.For 1, 3, 6 or 12 blisters in a cardboard box together with instructions for medical use.

Storage conditions:

Store in a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008009/10

Date of registration:12.08.2010 / 27.08.2013

Expiration Date:Unlimited

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

QUIMICA MONTPELLIER, S.A. Argentina

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp11.01.17

Illustrated instructions

Instructions

Bagomet® (Bagomet®)