Universal reference book for medicines
Product name: BAGOMET PLUS ® (BAGOMET PLUS)

Active substance: glibenclamide, metformin

Type: Oral hypoglycemic drug

Manufacturer: VALEANT (Russia) manufactured by QUIMICA MONTPELLIER (Argentina)
Composition, form of production and packaging
The tablets covered with a film shell of
white color, oblong, biconcave, with a stamped company logo on each side;
on the bend - white.
1 tab.

glibenclamide 2.5 mg

metformin hydrochloride 500 mg

Excipients: croscarmellose sodium, magnesium stearate, starch, microcrystalline cellulose, povidone, lactose monohydrate.

The composition of the film shell: opadrai II white YS-30-18056 (hypromellose, lactose monohydrate, titanium dioxide, triacetin in a ratio of 40: 40: 10: 10), opadray transparent YS-1-7006 (hypromellose, macrogol in the ratio 90:10) , sodium saccharinate, vanillin.

10 pieces.
- blisters (3) - packs of cardboard.
The tablets covered with a film cover of blue color, oblong, biconcave, with a stamped company logo on each side;
on the bend - white.
1 tab.

glibenclamide 5 mg

metformin hydrochloride 500 mg

Excipients: croscarmellose sodium, magnesium stearate, starch, microcrystalline cellulose, povidone, lactose monohydrate.

The composition of the film shell: opadrai II white YS-30-18056 (hypromellose, lactose monohydrate, titanium dioxide, triacetin in a ratio of 40: 40: 10: 10), opadray transparent YS-1-7006 (hypromellose, macrogol in the ratio 90:10) , sodium saccharinate, vanillin, brilliant blue.

10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

A fixed combination of two oral hypoglycemic agents of various pharmacological groups: metformin and glibenclamide.

Metformin belongs to the biguanide group and reduces serum glucose levels by increasing the sensitivity of peripheral tissues to insulin action and enhancing glucose uptake.
Metformin reduces the absorption of carbohydrates in the gastrointestinal tract and inhibits gluconeogenesis in the liver. The drug also has a beneficial effect on the lipid composition, reducing the level of total cholesterol, LDL and triglycerides.
Glibenclamide belongs to the group of derivatives of sulfanil urea of ​​the second generation.
The glucose level when taking glibenclamide is reduced as a result of stimulation of insulin secretion by β-cells of the pancreas.
PHARMACOKINETICS

Metformin after intake is absorbed from the gastrointestinal tract quite fully.
Absolute bioavailability is from 50 to 60%. With simultaneous intake of food, absorption of metformin is reduced and delayed.
Metformin is rapidly distributed into tissues, practically does not bind to plasma proteins.
Metabolzimu is exposed to a very weak degree and is excreted by the kidneys. T 1/2 is approximately 6.5 hours.
Glibenclamide: ingestion of absorption from the gastrointestinal tract is 48-84%.
The time to reach C max is 1-2 hours, V d is 9-10 liters. The connection with plasma proteins is 95%. Almost completely metabolized in the liver with the formation of two inactive metabolites, one of which is excreted by the kidneys, and the other - with bile. The value of T 1/2 is from 3 to 10-16 hours.
INDICATIONS

Diabetes mellitus type 2 in adults:

- as a second-line drug with ineffectiveness of diet therapy, exercise and previous therapy with metformin or glibenclamide;

- to replace the previous therapy with two drugs (metformin and glibenclamide) in patients with a stable and well-controlled level of glycemia.

DOSING MODE

The drug is used inside.
The dose of the drug is determined by the doctor individually for each patient, depending on the level of blood glucose.
Usually the initial dose is 1 tablet of Bagomet Plus 500 mg / 2.5 mg or 500 mg / 5.0 mg 1 time / day.
If necessary, every 1-2 weeks after the start of treatment, the dose of the drug is corrected depending on the level of glucose in the blood.
When replacing the previous combination therapy with metformin and glibenclamide, 1-2 tablets of Bagomet Plus 500 mg / 2.5 mg or 500 mg / 5 mg (depending on the previous dose) are prescribed 2 times / day - morning and evening.

The maximum daily dose is 4 tablets of the drug (500 mg / 2.5 mg or 500 mg / 5 mg, which is 2 g metformin / 20 mg glibenclamide).

Tablets should be taken with meals.

SIDE EFFECT

Due to metformin:

- nausea, vomiting, abdominal pain, loss of appetite are frequent symptoms at the beginning of treatment and in most cases pass on their own and do not require special treatment.
To prevent the development of these symptoms, it is recommended to take the drug in 2 divided doses; a slow increase in the dose of the drug also improves its tolerability;
- "metallic" taste in the mouth;

erythema;

- megaloblastic anemia;

lactate acidosis.

Conditioned by glibenclamide:

- hypoglycemia, hypoglycemic coma (with a dosing regimen and an inadequate diet);

- nausea, vomiting, pain in the epigastric region;

- Increased activity of "liver" enzymes, cholestatic jaundice;

- Lakopenia, thrombocytopenia, rarely - agranulocytosis, hemolytic anemia, pancytopenia;

- "antabuse effect" when taking alcohol.

CONTRAINDICATIONS

- Type 1 diabetes mellitus;

- diabetic ketoacidosis, diabetic precoma, diabetic coma;

- hypoglycemia;

- Renal failure or renal dysfunction (creatinine level is above 135 mml / l for men and more than 110 mmol / l for women);

- acute conditions that can lead to a change in kidney function: dehydration, severe infection, shock, simultaneous intravascular injection of iodine-containing contrast agents;

- acute or chronic diseases that are accompanied by tissue hypoxia: cardiac or respiratory failure, recent myocardial infarction, shock;

- liver failure;

- porphyria;

- pregnancy, the period of breastfeeding;

- simultaneous administration of miconazole;

- infectious diseases, large surgical interventions, traumas, extensive burns and other conditions requiring insulin therapy;

- chronic alcoholism, acute alcohol intoxication;

- Lactate 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;

- adherence to a hypocaloric diet (less than 1000 calories / day);

- Hypersensitivity to the components of the drug, other derivatives of sulfonylurea, as well as to auxiliary substances.

- It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Caution Bagomet Plus should be used when:

febrile syndrome;

- diseases of the thyroid gland (with impaired function);

- hypofunction of the anterior lobe of the pituitary gland or the adrenal cortex.

PREGNANCY AND LACTATION

During the treatment with Bagometh Plus, the doctor should be informed of the planned pregnancy and the onset of pregnancy.
When planning pregnancy, as well as in case of pregnancy during the period of taking the drug Bagomet Plus, the drug should be canceled and insulin treatment is prescribed.
Bagomet Plus is contraindicated during breastfeeding, as there is no evidence of its ability to penetrate breast milk.

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated in renal failure or impaired renal function (creatinine levels above 135 mml / l for men and more than 110 mmol / l for women).

Contraindicated in acute conditions that can lead to a change in kidney function: dehydration, severe infection, shock, simultaneous intravascular injection of iodine-containing contrast agents;

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated for use in liver failure.

APPLICATION FOR CHILDREN

Data on the use of Bagometh Plus in children are not available.

APPLICATION IN ELDERLY PATIENTS

It is not recommended to use the drug in people over 60 who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

SPECIAL INSTRUCTIONS

Special instructions for the patient

Against the background of treatment with Bagometh Plus, you need to regularly check your blood glucose level on an empty stomach after eating.

Dose correction is necessary in case of physical and emotional overstrain, changes in diet.

If during the treatment with Bagometh Plus, vomiting and abdominal pain accompanied by muscle cramps or general malaise, it is necessary to stop taking the drug and immediately consult a doctor, as these symptoms may be signs of lactate acidosis.

It is necessary to inform the doctor about the appearance of bronchopulmonary infection or urinary tract infection.

48 hours before the surgery or / in the introduction of iodine-containing radiopaque, Bagomet Plus should be discontinued.
Treatment with the drug Bagomet Plus is recommended to resume after 48 hours.
When taking the drug Bagomet Plus, the risk of hypoglycemia in cases of taking ethanol, non-steroidal anti-inflammatory drugs, and fasting is increased.
During treatment, it is not recommended to take alcohol.
During treatment with Bagometh Plus, it is not recommended to engage in activities requiring increased attention and speed of psychomotor reactions.

OVERDOSE

Overdose or presence of risk factors can provoke the development of lactic acidosis, since the drug includes metformin.
Lactate acidosis is a condition requiring urgent medical attention; treatment of lactate-acidosis should be conducted in the clinic. The most effective method of treatment is hemodialysis.
Overdose can also lead to the development of hypoglycemia due to the presence of glibenclamide in the formulation.
Symptoms of hypoglycemia: hunger, sweating, weakness, palpitations, pallor of the skin, paresthesia in the mouth, tremors, general anxiety, headache, abnormal drowsiness, fatigue, sleep disorders, fear, coordination of movements, dizziness, temporary neurologic disorders (paresis, sensitivity disorders). With the progression of hypoglycemia, patients may lose self-control and consciousness.
With mild or moderate hypoglycemia, glucose or sugar solution is taken orally.
In case of severe hypoglycemia (loss of consciousness), a 40% solution of dextrose (glucose) or glucagon IV, IM, n / k is administered. After the restoration of consciousness, the patient needs to give food rich in carbohydrates, in order to avoid the re-development of hypoglycemia.
DRUG INTERACTION

ACE inhibitors (captopril, enalapril), H2-histamine receptor blockers (cimetidine), antifungal medications (miconazole, fluconazole), non-steroidal anti-inflammatory drugs (phenylbutazone, azapropane, oxyphenbutazone), fibrates (clofibrate, bezafibrate), antituberculous ( ethionamide), salicylates, coumarinic anticoagulants, anabolic steroids, β-adrenoblockers, MAO inhibitors, long-acting sulfonamides, cyclophosphamide, biguanides, chloramphenic
l, fenfluramine, acarbose, fluoxetine, guanethidine, pentoxifylline, tetracycline, theophylline, tubular secretion blockers, reserpine, bromocriptine, disopyramide, pyridoxine, insulin, allopurinol.
Weaken the effect of barbiturates, glucocorticosteroids, adrenostimulators (epinephrine, clonidine), antiepileptic drugs (phenytoin), BCCC, inhibitors of carbonic anhydrase (acetazolamide), thiazide diuretics, chlorthalidone, furosemide, triamterene, asparaginase, baclofen, danazol, diazoxide, isoniazid, morphine, ritodrin, salbutamol, terbutaline, glucagon, rifampicin, thyroid hormones, lithium salts, in high doses - nicotinic acid, chlorpromazine, oral contraceptives and estrogens.

Urine acidifying drugs (ammonium chloride, calcium chloride, ascorbic acid in high doses) enhance the effect by reducing the degree of dissociation and increasing the reabsorption of glibenclamide.

Ethanol increases the likelihood of developing lactic acidosis.

Furosemide increases the C max of metformin in the blood by 22%.

Nifedipine increases absorption and C max , slows the excretion of metformin.

Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene and vancomycin) secreted in tubules compete for tubular transport systems and, with prolonged therapy, can increase C max of metformin by 60%.

Metformin reduces C max and T 1/2 furosemide by 31 and 42.3%, respectively.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Storage conditions:

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

Keep out of the reach of children!

Shelf life:

2 years.
Do not use after the expiration date.
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