Glibenclamide, Metformin

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Glibenclamide, Metformin

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The dose of the drug is determined by the doctor individually for each patient, depending on the level of glycemia. The initial dose is 1 tablet of Gluconorm® Plus 2.5 mg + 500 mg once a day. To avoid hypoglycemia, the initial dose should not exceed the daily dose of glibenclamide (or an equivalent dose of another previously taken sulfonylurea drug) or metformin, if they were used as first-line therapy. It is recommended to increase the dose by no more than 5 mg of glibenclamide + 500 mg of metformin per day every 2 or more weeks to achieve adequate control of blood glucose.

Substitution of previous combination therapy with metformin and glibenclamide: the initial dose should not exceed the daily dose of glibenclamide (or the equivalent dose of another sulfonylurea drug) and metformin previously taken. Every 2 or more weeks after the start of treatment, the dose of the drug is adjusted depending on the level of glycemia.

The maximum daily dose is 6 pills of Gluconorm® Plus 2.5 mg + 500 mg.

Dosing regimen

Dosing regimen depends on the individual purpose:

For dosages of 2.5 mg + 500 mg

- once a day, in the morning during breakfast, with the appointment of 1 tablet per day;

- twice a day, morning and evening, with the appointment of 2 or 4 pills per day.

For dosage of 2.5 mg + 500 mg

- three times a day, in the morning, in the afternoon and in the evening, with the appointment of 3, 5 or 6 pills per day.

pills should be taken with meals. Each drug intake should be accompanied by a meal with a sufficiently high carbohydrate content to prevent the onset of hypoglycemia.

Elderly patients

The dose of the drug is selected based on the state of renal function. The initial dose should not exceed 1 tablet of Gluconorm® Plus 2.5 mg + 500 mg. Regular assessment of renal function is necessary.

Children

The drug Gluconorm Plus is not recommended for use in children.

Adverse reactions

The following side effects may be observed during the course of treatment with Gluconorm Plus.

Side effects are presented depending on the impact on organs and organ systems.

The adverse events listed below, noted during the use of Gluconorm® Plus, are distributed according to the frequency of occurrence according to the following gradation: very often (≥ 1/10), often (≥ 1/100 to 1/10), infrequently (≥ 1/1000 to <1/100), rarely (≥ 1/10000 to <1/1000), very rarely (<1/10000).

In each group, unwanted effects are presented in order of decreasing severity.

Metabolism and nutrition:

Hypoglycemia (see "Overdose", "Special instructions").

Seldom: attacks of a liver porphyria and skin porphyria.

Very rarely: lactic acidosis (see "Special Instructions").

The decrease in the absorption of vitamin B12, accompanied by a decrease in its concentration in serum with prolonged use of Metformin. If megaloblastic anemia is detected, the possibility of such an etiology must be considered. Disulfiramopodobnaya reaction when drinking alcohol.

Laboratory indicators:

Infrequently: an increase in serum urea and creatinine concentrations from moderate to moderate.

Very rare: hyponatremia.

From the side of blood and lymphatic system:

Rarely: leukopenia, thrombocytopenia.

Very rarely: agranulocytosis, hemolytic anemia, bone marrow aplasia and pancytopenia.

These adverse events disappear after drug withdrawal.

From the nervous system:

Often: a violation of taste (metallic taste in the mouth).

On the part of the organ of vision: a temporary visual impairment may occur at the beginning of treatment due to a decrease in blood glucose.

From the gastrointestinal tract:

Very often: nausea, vomiting, diarrhea, abdominal pain and lack of appetite. These symptoms are more common at the beginning of treatment and in most cases disappear on their own. To prevent the development of these symptoms, it is recommended to take the drug in 2 or 3 doses; a slow increase in the dose also improves its tolerability.

From the rut and subcutaneous tissues:

Seldom: skin reactions, such as: itch, urticaria, maculopapular rash.

Very rare: skin or visceral allergic vasculitis, polymorphic erythema, exfoliative dermatitis, photosensitivity.

On the part of the immune system:

Very rare: anaphylactic shock.

Cross-hypersensitivity reactions to sulfanilamides and their derivatives may occur.

Liver and biliary tract:

Very rarely: impaired liver function or hepatitis, requiring discontinuation of treatment.

Contraindications

- Hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives, as well as to excipients;

- diabetes mellitus type 1;

- diabetic ketoacidosis, diabetic precoma, diabetic coma;

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

- Acute conditions that can lead to a change in renal function: dehydration, severe infection, shock, intravascular administration of iodine-containing contrast media (see "Special Instructions");

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

- liver failure;

- porphyria;

- pregnancy, breastfeeding period;

- simultaneous reception of miconazole;

- extensive surgery;

- chronic alcoholism, acute alcohol intoxication;

- lactic acidosis (including in history);

- observance of a low-calorie diet (less than 1000 calories / day).

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

Carefully:

Feverish syndrome, adrenal insufficiency, hypofunction of the anterior pituitary gland, thyroid disease with uncompensated impairment of its function.

Drug interactions

Contraindications

Related to the use of glibenclamide

Miconazole can trigger the development of hypoglycemia (up to the development of coma).

Related to the use of metformin

Iodine-containing contrast agents: Depending on the kidney function, the drug should be stopped 48 hours before or after the intravenous administration of iodine-containing contrast media.

Combinations not recommended

Related to the use of sulfonylurea derivatives

Alcohol: a disulfiram-like reaction is very rare (alcohol intolerance) while taking alcohol and glibenclamide. Taking alcohol can increase the hypoglycemic effect (by inhibiting compensatory reactions or delaying its metabolic inactivation), which can contribute to the development of hypoglycemic coma. During the period of treatment with Gluconorm® Plus, alcohol intake and drugs containing alcohol should be avoided.Phenylbutazone increases the hypoglycemic effect of sulfonylurea derivatives (replacing sulfonylurea derivatives at the sites of their binding to protein and / or reducing their elimination). It is preferable to use other anti-inflammatory drugs that detect lesser effects, or to warn the patient about the need to independently control the level of glycemia; if necessary, the dose should be adjusted when the anti-inflammatory agent is used together and after it is discontinued.

Related to the use of glibenclamide

Bozentan in combination with glibenclamide increases the risk of hepatotoxic action. It is recommended to avoid taking these drugs at the same time. The hypoglycemic effect of glibenclamide may also be reduced.

Related to the use of metformin

Alcohol: the risk of lactic acidosis increases with acute alcohol intoxication, especially in case of fasting or poor nutrition, or liver failure.During the period of treatment with Gluconorm® Plus, alcohol and drugs containing ethanol should be avoided.

Combinations that require caution

Associated with the use of all hypoglycemic agents

Chlorpromazine: in high doses (100 mg / day) causes an increase in glycemia (reducing insulin release).

Precautions: the patient should be warned about the need for self-monitoring of blood glucose; if necessary, the dose of the hypoglycemic agent should be adjusted during the simultaneous use of the neuroleptic and after discontinuation of its use.

Glucocorticosteroids (GCS) and tetrakozaktid: an increase in blood glucose, sometimes accompanied by ketosis (GCS causes a decrease in glucose tolerance).

Precautions: the patient should be warned about the need for self-monitoring of blood glucose; if necessary, the dose of the hypoglycemic agent should be adjusted during the simultaneous use of corticosteroids and after discontinuation of their use.

Danazol has a hyperglycemic effect. If necessary, treatment with danazol and discontinuation of the latter requires dose adjustment of the drug Gluconorm Plus plus under the control of glycemia.

β2adrenomimetics: due to the stimulation of β2-adrenoreceptors, they increase the concentration of glucose in the blood.

Precautionary measures: it is necessary to warn the patient and establish the control of glucose in the blood, it is possible to transfer to insulin therapy.

Diuretics: increase in blood glucose.

Precautions: the patient should be warned about the need for self-monitoring of blood glucose; It may be necessary to adjust the dose of the hypoglycemic agent during simultaneous use with diuretics and after discontinuation of their use.

Angiotensin-converting enzyme (ACE) inhibitors (captopril, enalapril): the use of ACE inhibitors helps reduce blood glucose. If necessary, the dose of Gluconorm® Plus should be adjusted during simultaneous use with ACE inhibitors and after discontinuing their use.

Related to the use of metformin

Diuretics: lactic acidosis, which occurs when taking metformin on the background of functional renal failure caused by diuretics, especially "loop".

Related to the use of glibenclamide

β-adrenergic blockers, clonidine, reserpine, guanethidine and sympathomimetics mask some of the symptoms of hypoglycemia: palpitations and tachycardia; most non-selective β-blockers increase the incidence and severity of hypoglycemia.

The patient should be warned about the need for self-monitoring of blood glucose, especially at the beginning of treatment.

Fluconazole: an increase in the half-life of glibenclamide with the possible occurrence of manifestations of hypoglycemia. The patient should be warned about the need for self-monitoring of blood glucose; It may be necessary to adjust the dose of hypoglycemic drugs during simultaneous treatment with fluconazole and after discontinuation of its use.

Bile acid sequestrants: Simultaneous use with Gluconorm® Plus reduces the plasma concentration of glibenclamide, which can lead to a decrease in the hypoglycemic effect. You should take the drug Glukonorm® Plus at least 4 hours before taking bile acids sequestrants.

Other interactions: combinations to take into account

Related to the use of glibenclamide

Desmopressin: glibenclamide can reduce the antidiuretic effect of desmopressin.

Antibacterial drugs from the group of sulfonamides, fluoroquinolones, anticoagulants (coumarin derivatives), monoamine oxidase inhibitors (MAO), chloramphenicol, pentoxifylline, hypolipidermal drugs from the group of fibrates, disopyramide - the risk of developing hypoglycemia on the use of glybate.

Pregnancy and Lactation

Special instructions

Overdosage