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Hypoglycemic agent for oral administration (sulfonylurea derivative II generation + biguanide)
Type 2 diabetes in adults:
- with the ineffectiveness of diet therapy, exercise and previous monotherapy with metformin or a sulfonylurea derivative;
- to replace the previous treatment with two drugs (metformin and a sulfonylurea derivative) in patients with a stable and well-controlled level of glycemia.
Active ingredients: glibenclamide - 5.00 mg, metformin hydrochloride - 500 mg.
Excipients: microcrystalline cellulose - 57.20 mg, hyprolosis (hydroxypropylcellulose) - 13.80 mg, croscarmellose sodium - 18.00 mg, magnesium stearate - 6.00 mg.
Shell for dosage 5 mg +500 mg: VIVACOAT® RM-2P-050 [hypromellose (hydroxypropylmethylcellulose 6 cPs) - 9.00 mg, hyprose (hydroxypropylcellulose) - 0.90 mg, polyethylene glycol 3350 - 0.90 mg, guitar dioxide - 4.75 mg, talc - 1, 80 mg, iron dye yellow oxide (E172) - 0.26 mg, quinoline yellow dye (E104) - 0.37 mg, sunset sunflower yellow (E110) - 0.02 mg] - 18.00 mg.
Glibenclamide, Metformin is marketed under different brands and generic names, and comes in different dosage forms:
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Dosage and Administration
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 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.
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.
The drug Gluconorm Plus is not recommended for use in children.
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.
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.
- 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;
- 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.
Feverish syndrome, adrenal insufficiency, hypofunction of the anterior pituitary gland, thyroid disease with uncompensated impairment of its function.
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
Use of the drug is contraindicated during pregnancy. The patient should be warned that during the period of treatment with Gluconorm Plus it is necessary to inform the doctor about the planned pregnancy and the onset of pregnancy. When planning pregnancy, as well as in the event of pregnancy in the period of taking the drug Gluconorm Plus, the drug should be canceled and insulin treatment prescribed.
The drug Gluconorm Plus is contraindicated in breastfeeding, because there are no data on its ability to penetrate into breast milk.
During treatment with Gluconorm Plus it is necessary to regularly monitor the level of fasting glucose and after meals.Lactic acidosisLactic acidosis is an extremely rare, but serious (high mortality in the absence of emergency treatment) complication that may occur due to cumulation of metformin. Cases of lactic acidosis in patients treated with metformin, occurred mainly in patients with diabetes mellitus with severe renal insufficiency. Other associated risk factors should be considered, such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol consumption, liver failure, and any condition associated with severe hypoxia. Consideration should be given to the risk of developing lactic acidosis in the event of non-specific signs, such as muscle cramps, accompanied by dyspeptic disorders, abdominal pain and severe malaise. In severe cases, acidotic dyspnea, hypoxia, hypothermia, and coma may occur. Diagnostic laboratory parameters are: low blood pH, plasma lactate concentration above 5 mmol / l, increased anion interval and lactate / pyruvate ratio.HypoglycemiaSince Gluconorm® Plus contains glibenclamide, taking the drug is accompanied by the risk of hypoglycemia in the patient. Gradual dose titration after starting treatment can prevent the onset of hypoglycemia. This treatment can only be prescribed to a patient adhering to a regular mealtime (including breakfast). It is important that carbohydrate intake is regular, as the risk of hypoglycemia increases with late meals, inadequate or unbalanced carbohydrate intake. The development of hypoglycemia is most likely with a hypocaloric diet, after an intense or prolonged exercise, while drinking alcohol or taking a combination of hypoglycemic drugs. Due to compensatory reactions caused by hypoglycemia, sweating, fear, tachycardia, hypertension, palpitations, angina and arrhythms can occur. The latter symptoms may be absent if hypoglycemia develops slowly, in the case of autonomic neuropathy or while taking β-blockers, clonidine, reserpine, guanethidine, or sympathomimetics. , sleep disorder, agitated state, aggression, impaired concentration of attention and psychomotor reactions, depression, confusion, speech disorder, impaired vision, tremors, couples Lich and paraesthesia, dizziness, delirium, convulsions, somnolence, unconsciousness, shortness of breath and bradikardiya.Ostorozhnoe use of the drug, dose selection and proper instructions for the patient are important to reduce the risk of hypoglycemia.If a patient has bouts of hypoglycemia, which are either severe or associated with ignorance of symptoms, the possibility of treatment with other hypoglycemic agents should be considered. Factors contributing to the development of hypoglycemia: - simultaneous drinking of alcohol, especially during fasting; follow the recommendations in the instructions for use (especially for elderly patients); - poor nutrition, irregular food intake, starvation or changes e in a diet; - an imbalance between physical activity and carbohydrate intake; - renal insufficiency; - severe liver failure; - overdose of Gluconorm® Plus; - isolated endocrine disorders: insufficiency of the thyroid gland, pituitary and adrenal glands;Kidney and liver failurePharmacokinetics and / or pharmacodynamics may vary in patients with liver failure or severe renal failure. The resulting hypoglycemia in these patients may be prolonged, in which case appropriate treatment should be initiated.Blood glucose instabilityIn the case of surgery or other causes of diabetes decompensation, it is recommended to provide a temporary transition to insulin therapy. Symptoms of hypoglycemia are frequent urination, severe thirst, dry skin. Within 48 hours of planned surgery or intravenous administration of iodine-containing radiopaque agents, taking Gluconorm® Plus should be stopped. Treatment is recommended to resume after 48 hours, and only after the kidney function has been evaluated and recognized as normal.Kidney functionSince metformin is eliminated by the kidneys, before starting treatment, and regularly later, it is necessary to determine creatinine clearance and / or serum creatinine level: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients , as well as in patients with creatinine clearance at the upper limit of the norm. It is recommended to take special care in cases where kidney function may be impaired, for example, in elderly patients, or in the case of the start of antihypertensive therapy, diuretic therapy or nonsteroidal antiinflammatory drugs (NSAIDs).Other precautionsThe patient should inform the doctor about the appearance of a bronchopulmonary infection or an infection of the urinary organs.
In case of overdose, hypoglycemia may develop due to the presence of a sulfonylurea derivative in the preparation (see "Special Instructions").
Mild and moderate symptoms of hypoglycemia without loss of consciousness and neurological manifestations can be corrected by immediate consumption of sugar. You must perform a dose adjustment and / or change the diet. The occurrence of severe hypoglycemic reactions in patients with diabetes mellitus, accompanied by coma, paroxysm or other neurological disorders, requires the provision of emergency medical care. Intravenous administration of a solution of dextrose is necessary immediately after the establishment of a diagnosis or the occurrence of a suspicion of hypoglycemia before the patient is hospitalized. After the restoration of consciousness, it is necessary to give the patient food rich in easily digestible carbohydrates (in order to avoid the recurrence of hypoglycemia).
A prolonged overdose or the presence of associated risk factors can trigger the development of lactic acidosis, as the drug contains metformin (see "Special Instructions").
Lactic acidosis is a condition requiring emergency medical care; lactic acidosis treatment should be carried out in the clinic.The most effective method of treatment, which allows to remove lactate and metformin, is hemodialysis.
Plasma glibenclamide clearance may increase in patients with liver disease. Since glibenclamide is actively associated with blood proteins, the drug is not eliminated during dialysis.
- The development and validation of liquid chromatography method for the simultaneous determination of metformin and glipizide, gliclazide, glibenclamide or glimperide in plasma
- Influence of initial hyperglycaemia, weight and age on the blood glucose lowering efficacy and incidence of hypoglycaemic symptoms with a single-tablet metformin–glibenclamide therapy (Glucovance®) in type 2 diabetes
- Vascular effects of glibenclamide vs. glimepiride and metformin in Type 2 diabetic patients
- Improved glycaemic control with metformin–glibenclamide combined tablet therapy (Glucovance®) in Type 2 diabetic patients inadequately controlled on metformin
- Prospective comparative study in NIDDM patients of metformin and glibenclamide with special reference to lipid profiles
- Comparative effects of phenformin, metformin and glibenclamide on metabolic rhythms in maturity-onset diabetics
- Metformin or gliclazide, rather than glibenclamide, attenuate progression of carotid intima-media thickness in subjects with type 2 diabetes
- Effects of glibenclamide and metformin (alone or in combination) on insulin release from isolated human pancreatic islets
- Nateglinide and glibenclamide metabolic effects in naïve type 2 diabetic patients treated with metformin
- Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy
- The effects of metformin and glibenclamide on glucose metabolism, counter-regulatory hormones and cardiovascular responses in women with Type 2 diabetes during exercise of moderate intensity
- Durable efficacy of metformin/glibenclamide combination tablets (Glucovance®) during 52 weeks of open-label treatment in type 2 diabetic patients with hyperglycaemia despite previous sulphonylurea monotherapy
- Beta-cell response to metformin–glibenclamide combination tablets (Glucovance®) in patients with type 2 diabetes
- In-vitro In-vivo Correlation Models for Glibenclamide after Administration of Metformin/Glibenclamide Tablets to Healthy Human Volunteers
- Effects of Acarbose Versus Glibenclamide on Glycemic Excursion and Oxidative Stress in Type 2 Diabetic Patients Inadequately Controlled by Metformin: A 24-Week, Randomized, Open-Label, Parallel-Group Comparison
- Efficacy of glimepiride/metformin combination versus glibenclamide/metformin in patients with uncontrolled type 2 diabetes mellitus
- Differential effect of glyburide (glibenclamide) and metformin on qt dispersion: a potential adenosine triphosphate sensitive k+ channel effect
- The effect of pioglitazone as add-on therapy to metformin or sulphonylurea compared to a fixed-dose combination of metformin and glibenclamide on diabetic dyslipidaemia
- Antioxidant effects of gliclazide, glibenclamide, and metformin in patients with type 2 diabetes mellitus
- Combination treatment with metformin and glibenclamide versus single-drug therapies in type 2 diabetes mellitus: a randomized, double-blind, comparative study
- Dose titration of new metformin-glibenclamide (glyburide) fixed combination in metformin-failure type 2 diabetics
- Betaxolol and glucose-insulin relationships: studies in normal subjects taking glibenclamide or metformin.
- PDB25 FIXED COMBINATION METFORMIN PLUS GLIBENCLAMIDE (GLUCOVANCE®) IS COST AND LIFE SAVING COMPARED TO METFORMIN PLUS ROSIGLITAZONE IN TYPE-2 DIABETES PATIENTS IN FRANCE
- Effects of glibenclamide, metformin and insulin on the incidence and latency of death by oubain-induced arrhythmias in mice