Metglib Force

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Metglib Force: instructions for use and reviews

1.production and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Metglib Force

ATX code: A10BD02

Active ingredient: metformin (Metformin) + glibenclamide (Glibenclamide)

Producer: CJSC "Raduga Production" (Russia), LLC "Kanonpharma Production" (Russia), LLC NPO "FarmVILAR" (Russia)

Description and photo update: 2019-08-07

Prices in pharmacies: from 81 rubles.

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Metglib Force is a combined oral hypoglycemic agent.

Release form and composition

The drug is produced in the form of film-coated tablets: oval, convex on both sides, brownish-orange (dosage 2.5 mg + 500 mg) or almost white with a risk (dosage 5 mg + 500 mg); the cross-section shows a core of almost white color (dosage 2.5 mg + 500 mg: in a cardboard box 3, 4, 6 or 9 cell contour packs of 10 tablets each, or 1 polymer jar containing 30, 40, 60 or 90 tablets; dosage of 5 mg + 500 mg: in a carton pack of 3, 4, 6 or 9 blister contour packs of 10 tablets each, or 2, 4 or 6 blister contour packs of 15 tablets each, or 1 polymer can containing 30, 40, 60 or 90 Each pack also contains instructions for the use of Metglib Force).

Composition of 1 tablet:

active substances: glibenclamide - 2.5 or 5 mg, metformin hydrochloride - 500 mg;
auxiliary components: sodium stearyl fumarate, calcium hydrogen phosphate dihydrate, corn starch, microcrystalline cellulose, croscarmellose sodium, povidone K-30, macrogol (polyethylene glycol 6000);
film shell: tablets 2.5 mg + 500 mg - Opadrai orange, including hyprolose (hydroxypropyl cellulose), titanium dioxide, talc, hypromellose (hydroxypropyl methylcellulose), iron dye red oxide, iron dye yellow oxide; tablets 5 mg + 500 mg - Opadray white, including hyprolose (hydroxypropyl cellulose), titanium dioxide, talc, hypromellose (hydroxypropyl methyl cellulose).

Pharmacological properties

Pharmacodynamics

Metglib Force is a combined preparation containing two oral hypoglycemic agents from different pharmacological groups:

glibenclamide is a second generation sulfonylurea derivative. The mechanism of action is due to the stimulation of insulin secretion by beta cells of the pancreas, which leads to a decrease in glucose content. The drug increases insulin sensitivity and increases the degree of its binding to target cells, enhances the effect of insulin on the absorption of glucose by the muscles and liver, inhibits lipolysis in adipose tissue;
metformin is a drug from the biguanide group that reduces the content of basal and postprandial glucose in blood plasma. It is characterized by three mechanisms of action: I - a decrease in the production of glucose by the liver due to inhibition of gluconeogenesis and glycogenolysis; II - increased sensitivity of peripheral receptors to insulin, increased consumption and utilization of glucose by cells in the muscles; III - decreased absorption of glucose in the gastrointestinal tract (gastrointestinal tract). Does not stimulate insulin secretion, therefore does not cause hypoglycemia. Stabilizes or reduces body weight. It has a beneficial effect on the lipid composition of the blood, reducing the content of total cholesterol, triglycerides and low density lipoproteins (LDL).

Glibenclamide and metformin have different mechanisms of action and mutually complement each other's hypoglycemic effect.

Due to the combination of active substances, Metglib Force has a synergistic activity in reducing glucose levels.

Pharmacokinetics

Glibenclamide, getting into the gastrointestinal tract, is absorbed in an amount exceeding 95% of the dose taken. The maximum concentration (C _max) reaches within 4 hours. The volume of distribution (V _d) is approximately 10 liters. Plasma proteins bind about 99%. It is almost completely metabolized in the liver, as a result of which two inactive metabolites are formed, which are excreted through the intestines (60%) and kidneys (40%). The half-life (T _½) is 4-11 hours.

Metformin, entering the gastrointestinal tract, is well absorbed. Simultaneous food intake reduces and delays the absorption of the drug. The time to reach C _max is approximately 2.5 hours. The absolute bioavailability is 50-60%. It is quickly distributed in tissues, almost does not bind to plasma proteins. It is metabolized to a very weak extent. In healthy volunteers, the clearance of metformin is 400 ml / min, which indicates the presence of active tubular secretion. It is excreted mainly by the kidneys. About 20–30% of the dose is excreted unchanged through the intestines. T _½ - an average of 6.5 hours. With functional impairment of the kidneys, renal clearance decreases in proportion to creatinine clearance (CC), while T _½ increases and, as a consequence, the plasma concentration of metformin.

The bioavailability of each of the active substances when combined in one tablet is similar to that when using drugs containing metformin or glibenclamide in isolation. With food intake, the bioavailability of Metglib Force does not change, but the rate of absorption of glibenclamide increases.

Indications for use

Metglib Force is used to treat type 2 diabetes in the following cases:

ineffectiveness of diet therapy, physical activity and prior therapy with metformin or sulfonylurea derivatives;
the need to replace previous therapy with two drugs (metformin and a sulfonylurea derivative) in patients with stable and well-controlled glycemic levels.

Contraindications

Absolute:

diabetic ketoacidosis, diabetic precoma, diabetic coma;
type 1 diabetes mellitus;
liver failure;
acute conditions that can cause functional changes in the kidneys: shock, severe infection, dehydration, intravascular administration of iodine-containing contrast media;
creatinine clearance less than 60 ml / min (impaired renal function or renal failure);
acute and chronic diseases accompanied by tissue hypoxia: respiratory or heart failure, recent myocardial infarction;
porphyria;
lactic acidosis (including history);
acute alcohol intoxication or chronic alcoholism;
extensive burns, trauma, major surgical interventions, infectious diseases and other conditions requiring insulin therapy;
adherence to a hypocaloric diet (less than 1000 kcal / day);
pregnancy and the period of breastfeeding;
age up to 18 years;
simultaneous administration of miconazole;
hypersensitivity to any component of the drug or other sulfonylurea derivatives.

Metglib Force tablets are not recommended for patients over 60 years of age who are engaged in heavy physical labor (there is a high risk of lactic acidosis).

With caution, a hypoglycemic agent is used in patients with febrile syndrome, adrenal insufficiency, thyroid diseases (uncompensated dysfunction), hypofunction of the anterior pituitary gland, as well as in the elderly.

Metglib Force, instructions for use: method and dosage

Metglib Force tablets are taken orally. The optimal dose is determined by the doctor depending on the level of glycemia.

The initial dose is 1 tablet once a day at a dosage of 2.5 mg + 500 mg or in a dosage of 5 mg + 500 mg. If the patient took a sulfonylurea derivative or metformin as a first-line therapy, when Metglib Force is prescribed, the initial dose of the corresponding active substance in its composition should not exceed the daily dose of the previously received drug (in order to avoid the development of hypoglycemia).

If necessary, the dose of Metglib Force is increased, but by no more than 5 mg glibenclamide + 500 mg metformin, at intervals of at least 2 weeks. This allows you to achieve adequate blood glucose control.

In case of replacement of previous therapy with two separate agents, the initial dose should not exceed the daily dose of metformin and glibenclamide (or another sulfonylurea drug) taken previously.

If necessary, at intervals of at least 2 weeks, the dose of Metglib Force is adjusted depending on the level of glycemia.

The maximum permissible daily dose is 4 tablets at a dosage of 5 mg + 500 mg or 6 tablets at a dosage of 2.5 mg + 500 mg.

Recommended frequency of admission, depending on the individual prescription:

dosages of 2.5 mg + 500 mg and 5 mg + 500 mg: with the appointment of 1 tablet per day - 1 time per day (in the morning during breakfast); with the appointment of 2 or 4 tablets a day - 2 times a day (morning and evening);
dosage 2.5 mg + 500 mg: with the appointment of 3, 5 or 6 tablets per day - 3 times a day (morning, afternoon and evening);
dosage 5 mg + 500 mg: with the appointment of 3 tablets per day - 3 times a day (morning, afternoon and evening).

To prevent the development of hypoglycemia, Metglib Force should be taken with a meal with a sufficiently high carbohydrate content.

For elderly patients, the dose of Metglib Force is determined taking into account the state of renal function. The initial recommended dose is 1 tablet at a dosage of 2.5 mg + 500 mg. Renal function should be assessed regularly during therapy.

Side effects

During the period of hypoglycemic therapy with the drug, the following side effects can be observed (according to the frequency of occurrence, they are classified as follows: very often - ≥ 1/10 appointments, often - from ≥ 1/100 to <1/10 appointments, infrequently - from ≥ 1/1000 to < 1/100 appointments, rarely - from ≥ 1/10 000 to <1/1000 appointments, very rarely - <1/10 000 appointments):

on the part of metabolism and nutrition: often - hypoglycemia; rarely - attacks of cutaneous or hepatic porphyria; very rarely - a disulfiram-like reaction (in the case of alcohol consumption), lactic acidosis, decreased absorption of vitamin B ₁₂, which, with prolonged use of metformin, causes a decrease in its content in blood serum;
from the immune system: very rarely - anaphylactic shock, cross-hypersensitivity reactions to sulfonamides and their derivatives;
on the part of the blood and lymphatic system (disappear after the abolition of Metglib Force): rarely - thrombocytopenia, leukopenia; very rarely - hemolytic anemia, agranulocytosis, pancytopenia, bone marrow aplasia;
from the liver and biliary tract: very rarely - impaired liver function indicators, hepatitis;
from the gastrointestinal tract: very often - lack of appetite, abdominal pain, diarrhea, nausea, vomiting (these disorders usually occur at the beginning of treatment, in most cases, with continued therapy, they pass on their own); infrequently - belching, feeling of fullness and heaviness in the stomach;
from the nervous system: often - a feeling of a metallic taste in the mouth;
on the part of the organ of vision: often - temporary visual impairment (usually noted at the beginning of treatment due to a decrease in blood glucose);
on the part of the skin and subcutaneous tissues: rarely - maculopapular rash, urticaria, itching; very rarely - cutaneous or visceral allergic vasculitis, exfoliative dermatitis, erythema polymorphism, photosensitivity;
laboratory data: infrequently - a moderate increase in serum urea and creatinine concentrations; very rarely - hyponatremia.

Overdose

An overdose of Metglib Force is usually manifested by hypoglycemia (due to the presence of glibenclamide in the tablets).

Hypoglycemia of mild to moderate severity, without neurological symptoms and loss of consciousness, can be stopped on their own by immediate glucose intake. In the future, you need to consult a doctor who will decide on changing the diet and / or adjusting the dose of the drug.

Severe hypoglycemic reactions, accompanied by neurological disorders, convulsions and coma, require immediate medical attention. Until hospitalization, if hypoglycemia is established or there are strong suspicions of its development, intravenous administration of a dextrose solution is indicated. After recovery of consciousness, in order to avoid a second attack of hypoglycemia, the patient should be offered food rich in easily digestible carbohydrates.

In patients with impaired liver function, an increase in the clearance of glibenclamide in the blood plasma is possible. The drug binds to plasma proteins, so it is not excreted from the body through dialysis.

Due to the presence of Metglib Force metformin in the composition, an overdose of the drug and the presence of associated risk factors can lead to the development of lactic acidosis, a condition that requires urgent medical attention. The patient is hospitalized and treated accordingly. To remove metformin and lactate from the body, hemodialysis is prescribed.

special instructions

Hypoglycemic therapy should be carried out under close medical supervision.

Patients should strictly follow all doctor's recommendations regarding adherence to dietary therapy and self-monitoring of blood glucose concentration. Regular monitoring of fasting and post-meal glycemic levels is required.

To avoid the development of side effects from the gastrointestinal tract allows the use of the drug in 2-3 doses. With a slow increase in the dose, the tolerance of Metglib Force improves.

Hypoglycemia

Due to the presence of glibenclamide in Metglib Force, its intake is accompanied by the risk of hypoglycemia. Gradual titration of the dose helps to prevent its appearance.

The drug can only be taken by those patients who adhere to a regular diet, including breakfast. It is important to systematically consume carbohydrates. This is due to the fact that the risk of hypoglycemia increases with late meals, unbalanced nutrition, insufficient carbohydrate intake, adherence to a hypocaloric diet, drinking alcoholic beverages, performing intense and prolonged physical activity, and taking a combination of hypoglycemic agents.

The first signs of hypoglycemia: increased sweating, palpitations, arrhythmia, increased blood pressure, angina pectoris, fear. However, it should be borne in mind that the listed symptoms may be absent in the case of slow development of hypoglycemia, as well as with autonomic neuropathy or the simultaneous use of beta-blockers, sympathomimetics, reserpine, clonidine or guanethidine.

Other possible symptoms of hypoglycemia in patients with diabetes mellitus: hunger, nausea, vomiting, sleep disorders, severe fatigue, headache, impaired concentration, tremors, confusion, agitation, speech and visual impairment, aggression, dizziness, depression, drowsiness, violation of psychomotor reactions, convulsions, paresthesia, delirium, paralysis, unconsciousness, bradycardia, shallow breathing.

Careful dose selection, correct use of Metglib Force, and strict adherence to doctor's instructions are important measures to reduce the risk of hypoglycemia. If the patient has repeated attacks of hypoglycemia, and they are severely impaired or associated with ignorance of the symptoms, the doctor should consider the appropriateness of prescribing another hypoglycemic agent.

The following factors may accompany the onset of hypoglycemia:

refusal or inability of the patient to interact with the doctor and follow his recommendations (especially for the elderly);
irregular food intake, changes in diet, poor nutrition, fasting;
imbalance between exercise and carbohydrate intake;
drinking alcoholic beverages, especially during fasting;
overdose of Metglib Force;
severe liver failure;
renal failure;
some endocrine disorders such as insufficient thyroid, adrenal, and pituitary gland function;
simultaneous use of certain drugs.

Lactic acidosis

Lactic acidosis is an extremely rare but very serious complication (with a high mortality rate in case of failure to provide emergency care) that can develop as a result of the accumulation of metformin in the body. Cases of lactic acidosis during the use of metformin were registered mainly in patients with diabetes mellitus and severe renal failure. However, other associated risk factors must be considered, such as poorly controlled diabetes mellitus, prolonged fasting, liver failure, ketosis, excessive alcohol consumption and any condition accompanied by hypoxia.

The development of lactic acidosis should be assumed with the appearance of such nonspecific signs as muscle cramps, accompanied by severe malaise, abdominal pain and dyspeptic disorders. In severe cases, hypothermia, hypoxia, acidotic dyspnea, coma are possible.

Diagnostic laboratory indicators of lactic acidosis are: plasma lactate concentration above 5 mmol / L, low blood pH, an increase in the anion gap, and an increase in the lactate / pyruvate ratio.

Instability of blood glucose

For any condition suggesting decompensation of diabetes mellitus, including surgery, it is recommended that a temporary switch to insulin therapy be considered. Symptoms of hyperglycemia: dry skin, severe thirst, frequent urination.

Reception of Metglib Force should be discontinued 48 hours before the planned operation or intravenous administration of an iodine-containing radiopaque contrast agent. It is possible to resume taking the drug no earlier than after 48 hours, provided that renal function during the assessment was found to be normal.

Metformin is excreted from the body by the kidneys, therefore it is required to control creatinine clearance and / or serum creatinine before Metglib Force is prescribed and periodically during treatment: at least once a year in patients with normal renal function, 2-4 times a year in patients with CC at the upper limit of the norm and in the elderly.

It is recommended to take special precautions for conditions fraught with impaired renal function, for example, when prescribing non-steroidal anti-inflammatory drugs or diuretics, the need for concomitant antihypertensive therapy, as well as in the elderly.

Renal / hepatic impairment

In patients with severe renal failure and hepatic insufficiency, the pharmacological parameters of the active substances of Metglib Force may change. Hypoglycemia in these patients can last for a long time, which requires adequate treatment.

Other precautions

If an infectious disease of the genitourinary organs or a bronchopulmonary infection appears during the treatment period, you should inform your doctor about it.

Influence on the ability to drive vehicles and complex mechanisms

Taking Metglib Force is associated with the risk of hypoglycemia - a condition in which dizziness, impaired concentration, severe fatigue and other symptoms that can negatively affect the ability to drive and work with complex mechanisms are possible. In this regard, vehicle drivers and persons employed in potentially hazardous industries should be especially careful.

Application during pregnancy and lactation

Metglib Force is contraindicated during pregnancy. Women of childbearing age should be warned that it is necessary to inform the doctor about planning and the onset of pregnancy - in these cases, the drug is canceled and insulin therapy is prescribed.

There is no information on the ability of the active substances of the drug to penetrate into breast milk, therefore, Metglib Force is contraindicated during lactation. If therapy is clinically justified, breastfeeding is discontinued.

Pediatric use

Metglib Force is not used in children and adolescents under 18 years of age.

With impaired renal function

Metglib Force is contraindicated in patients with functional impairment of the kidneys and renal failure, if the CC is less than 60 ml / min.

Treatment with caution is carried out in the presence of adrenal insufficiency.

For violations of liver function

In liver failure, Metglib Force is contraindicated.

Use in the elderly

The elderly are more likely to develop hypoglycemia, therefore, Metglib Force must be used with precautions. The dose of the drug for them is determined, taking into account the state of renal function. The initial recommended dose is 1 tablet at a dosage of 2.5 mg + 500 mg. Renal function should be assessed regularly during therapy.

It is not recommended to prescribe Metglib Force to elderly patients over 60 years of age who perform heavy physical work, since under such circumstances the risk of developing lactic acidosis is increased.

Drug interactions

Contraindicated combinations

miconazole in combination with glibenclamide can cause hypoglycemia, up to coma;
Intravenous iodine contrast media can cause renal failure, which contributes to the accumulation of metformin, which increases the risk of lactic acidosis.

Combinations not recommended

When interacting with glibenclamide:

bosentan increases the likelihood of hepatotoxic action, may reduce the activity of glibenclamide;
phenylbutazone enhances the hypoglycemic effect (it is recommended to use other anti-inflammatory drugs or carefully monitor the level of glycemia; glibenclamide dose adjustment may be required during the period of phenylbutazone administration);
ethanol (including ethanol-containing drugs) in rare cases causes a disulfiram-like reaction (alcohol intolerance), can enhance the hypoglycemic effect of glibenclamide, which is fraught with the development of hypoglycemic coma.

When interacting with metformin, alcohol (in case of acute intoxication) increases the risk of developing lactic acidosis, especially in liver failure, poor nutrition and fasting.

Combinations requiring caution

Diuretics can cause renal failure, which contributes to the accumulation of metformin, which increases the risk of lactic acidosis.

When interacting with glibenclamide:

fluconazole increases the risk of hypoglycemia. Patients should independently monitor blood glucose levels. Dose adjustment of Metglib Force may be required during the period of taking fluconazole and after its withdrawal;
guanethidine, reserpine, clonidine, sympathomimetics and β ₂ -adrenergic blockers can mask some symptoms of hypoglycemia (tachycardia and palpitations). Most nonselective β-blockers increase the incidence and severity of hypoglycemic conditions. Patients should be monitored for blood glucose, especially at the beginning of therapy;
antibiotics from the sulfonamide group, monoamine oxidase inhibitors, anticoagulants (coumarin derivatives), hypolipidemic agents from the fibrate group, fluoroquinolones, disopyramide, pentoxifylline, chloramphenicol increase the risk of hypoglycemia.

When interacting with all hypoglycemic agents:

ACE (angiotensin converting enzyme) inhibitors, such as enalapril and captopril, reduce blood glucose levels;
tetracosactide and glucocorticosteroids (GCS) increase blood glucose and can lead to ketosis. GCS reduce glucose tolerance;
β ₂ -adrenomimetics and diuretics increase the concentration of glucose in the blood;
Danazol enhances the hyperglycemic effect;
chlorpromazine in high doses (100 mg per day) reduces the release of insulin, which increases the level of glycemia.

In all cases, it is necessary to carefully monitor the blood glucose level, if necessary, adjust the dose of Metglib Force and / or a concomitantly used drug.

Other interactions

Metglib Force, when used simultaneously with desmopressin, can reduce its antidiuretic effect.

Analogs

Metglib Force analogs are: Avandamet, Astrozon, Bagomet, Galvus, Glibomet, Gliclazid MV, Glimepirid, Glyformin, Diabetalong, Invokana, Xelevia, Langerin, Meglimid, Metformin, NovoNorm, Ongliza, Piono, Yufametglin, Formetinu,

Terms and conditions of storage

Storage conditions: dry, dark place, out of reach of children, temperature - up to 25 ° C.

Expiration date: 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Metglib Force

Reviews of Metglib Force are few, but positive. The drug lowers blood sugar and helps control glucose levels, but an appropriate diet is essential for effective therapy. Its additional advantage is considered to be relatively low cost compared to most combined hypoglycemic agents. Despite the large list of possible side effects, if all the doctor's recommendations are followed, the drug is well tolerated.

The main problem, according to patients, is the absence of Metglib Force in many pharmacies.

Price for Metglib Force in pharmacies

Approximate prices for Metglib Force for a package of 30 tablets: dosage 2.5 mg + 500 mg - 159 rubles, dosage 5 mg + 500 mg - 165 rubles.

Metglib Force: prices in online pharmacies

Drug name

Price

Pharmacy

Metglib Force 2.5 mg + 500 mg film-coated tablets 30 pcs.

RUB 81

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Metglib Force tablets p.o. 2.5mg + 500mg 30 pcs.

155 RUB

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!