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

Excipients: croscarmellose sodium, magnesium stearate, starch, microcrystalline cellulose, povidone, lactose monohydrate, Opadrai II white YS-30-18056 (a ready-made shell mixture consisting of lactose monohydrate, hydroxypropyl methylcellulose (hypromellose), titanium dioxide and triacetin in a ratio of 40: 40: 10: 10), Opaprai transparent YS 1-7006 (ready-mixed for the shell, consisting of hydroxypropylmethylcellulose (hypromellose) and polyethylene glycol (macrogol) in a ratio of 90:10), sodium saccharinate, vanillin.

Dosage 500 mg + 5.0 mg

Active substances: metformin hydrochloride 500 mg, glibenclamide 5.0 mg

Excipients: croscarmellose sodium, magnesium stearate, starch, microcrystalline cellulose, povidone, lactose monohydrate, Opadrai II white YS-30-18056 (ready-mix for the shell, consisting of lactose monohydrate, hydroxypropylmethylcellulose (hypromellose), titanium dioxide and triacetin in a ratio of 40: 40: 10: 10), opadrai transparent YS 1-7006 (a ready-made shell mixture consisting of hydroxypropyl methylcellulose (hypromellose) and polyethylene glycol (macrogol) in 90:10 ratio), sodium saccharinate, vanillin, brilliant blue.

Description:

Tablets 500 mg + 2.5 mg

White, oblong, biconvex tablets, covered with a shell, with a dent. logo of the company on each side. View of the break: white surface.

Tablets 500 mg + 5 mg

Blue, oblong, biconvex tablets, covered with a shell, with a stamped company logo on each side. View of the break: surface of white color.

Pharmacotherapeutic group:Combined hypoglycemic agent for oral administration (derivative of sulfonylurea of the second generation + biguanide).

ATX: & nbsp

A.10.B.D.02 Metformin and sulfonamides

Pharmacodynamics:

Bagomet Plus is a fixed combination of two oral hypoglycemic agents of various pharmacological groups: metformin and glibenclamide.

Metformin belongs to the biguanide group and lowers 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 of the blood, reducing the level of total cholesterol, LDL and triglycerides. Glibenclamide belongs to the group of sulfanylurea derivatives of the second generation. The glucose level in the intake of glibenclamide is reduced as a result of stimulation of the secretion of insulin by beta cells of the pancreas.

Pharmacokinetics:

Metformin after oral 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 quickly distributed into tissues, practically does not bind to plasma proteins.Exposed to a very weak degree of metabolism and excreted by the kidneys. The elimination half-life (T1) is approximately 6.5 hours.

Glibenclamide. When administered, absorption from the gastrointestinal tract is 48- 84%. The time to reach the maximum concentration is 1-2 hours, the volume of distribution 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 T1 is from 3 to 10-16 hours.

Indications:

Diabetes mellitus type 2 in adults:

as a second-line drug in the 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.

Contraindications:

increased sensitivity to metformin, glibenclamide or other sulfonylurea derivatives, as well as to auxiliary substances;
Type 1 diabetes;
Diabetic ketoacidosis, diabetic precoma, diabetic coma;
hypoglycemia;
renal failure or renal dysfunction (creatinine level above 135 moles / 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, trauma interventions extensive burns and other conditions requiring insulin therapy;
chronic alcoholism, acute alcohol intoxication;
lactoacidosis (including in the anamnesis);
application 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);

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

Carefully:

Baguette Plus should be used when:

febrile syndrome;

thyroid disease (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 in breastfeeding, as there is no evidence of its ability to enter breast milk.

Dosing and Administration:

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 500mg / 2.5 mg or 500 / 5.0 mg once a 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 pibeclamide, 1-2 tablets Bagomet Plus 500 mg / 2.5 mg or 500 mg / 5 mg (depending on the previous dose) 2 times a day - in the morning and in the evening.

The maximum daily dose is 4 tablets of the drug. (500 mg / 2.5 mg or 500 mg / 5 mg, which is 2000 mg of metformin / 20 mg of glibenclamide)

Tablets should be taken with meals.

Side effects:

Metformin-related:

nausea, vomiting, abdominal pain, loss of appetite are frequent symptoms at the beginning of treatment and in most cases go away 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;
interregional anemia;
lactic acidosis.

Due to glibenclamide:

hypoglycaemia, hypoglycemic coma (with a dosing regimen and an inadequate diet);
skin allergic reactions: urticaria, rash, itchy skin, photosensitization; in some cases - severe generalized allergic reactions with skin rash, fever, arthralgia, proteinuria;
nausea, vomiting, pain in the epigastric region;
increased activity of "liver" enzymes, cholestatic jaundice;
leukopenia, thrombocytopenia, rarely - agranulocytosis, hemolytic anemia, pancytopenia;
"antabuse effect" when taking alcohol.

Overdose:

Overdose or presence of risk factors can provoke the development of lactic acidosis, since the composition of the drug includes metformin. Lactic acidosis is a condition requiring urgent medical attention: treatment of lactic acidosis should be performed at 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, trembling, 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 the case of severe hypoglycemia (loss of consciousness), a 40% solution of dextrose (glucose) or intravenously glucagon intravenously, intramuscularly, subcutaneously. After the restoration of consciousness, the patient needs to give food rich in carbohydrates, in order to avoid the re-development of hypoglycemia.

Interaction:

Increase the hypoglycemic effect of the drug inhibitors of the angiotensin-converting enzyme (captopril, enalapril), H2-histamine receptor blockers (cimetidine), antifungal medicines (miconazole, fluconazole), non-steroidal anti-inflammatory drugs (NSAIDs) (phenylbutazone, azapresene, oxyphenbutazone), fibrates (clofibrate, bezafibrate), antituberculous (ethionamide), salicylates, coumarinic anticoagulants, anabolic steroids, beta adrenoblock locators, monoamine oxidase inhibitors, long-acting sulfonamides, cyclophosphamides, biguanides, chloramphenicol, fenfluramine, acarbose, fluoxetine, guanethidine, pentoxifylline, tetracycline, theophylline, tubular secretion blockers, reserpine, bromocriptine, disopyramide, pyridoxine, insulin, allopurinol.

Weaken the effect of barbiturates, glucocorticosteroids, adrenostimulants (epinephrine, clonidine), antiepileptic drugs (phenytoin), BCCI, 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 - a 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 lactic acidosis.

Furosemide increases the maximum concentration in the blood (Cmax) of metformin by 22%. Nifedipine increases absorption, Cmax, 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 Cmax metformin by 60%.

Metformin reduces C max and T ½ furosemide by 31 and 42.3%, respectively.

Special instructions:

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 medication and consult a doctor immediately, as these symptoms may be signs of lactic acidosis.

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

48 hours prior to surgery or intravenous iodine-containing radiopaque, Bagometh Plus should be discontinued. Treatment with the drug Bagomet Plus is recommended to resume after 48 hours.

Patients should be warned about the increased risk of hypoglycemia in cases of taking ethanol, NSAIDs, with fasting.During treatment, it is not recommended to take alcohol.

Effect on the ability to drive transp. cf. and fur:During treatment with Bagometh Plus, it is not recommended to engage in activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets 500 mg + 2.5 mg and 500 mg + 5 mg.

Packaging:For 10 tablets in a blister of PVC / aluminum. For 3 or 6 blisters in a cardboard box with instructions for use.

Storage conditions:

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006460/09

Date of registration:13.08.2009 / 31.12.2013

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 Plus® (Bagomet Plus® )