Universal reference book for medicines

Active substance: glimepiride

Type: Oral hypoglycemic drug

Manufacturer: KRKA (Slovenia) manufactured by SPECIFAR (Greece)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

Oral hypoglycemic agent, sulfonylureas.
Stimulates the secretion of insulin? -cellular pancreas, increases the release of insulin. Increases the sensitivity of peripheral tissues to insulin.
With repeated ingestion at a dose of 4 mg / day, C max in the blood serum is reached after about 2.5 hours and is 309 ng / ml;
there is a linear relationship between dose and C max , as well as between dose and AUC. Eating does not have a significant effect on absorption.
V d about 8.8 liters.
Binding to plasma proteins is more than 99%.
Clearance - about 48 ml / min.

Exposed to metabolism.
Hydroxylated and carboxylated metabolites of glimepiride are apparently formed due to metabolism in the liver and are found in urine and in feces.
T 1/2 is 5-8 hours. After taking glimepiride in high doses, T 1/2 is increased.
After a single dose of glimepiride labeled with radioactivity, 58% of radioactivity was detected in urine and 35% in feces. An unchanged active substance in the urine was not detected.
T 1/2 hydroxylated and carboxylated metabolites of glimepiride were, respectively, about 3 to 6 hours and 5 to 6 hours.

In patients with impaired renal function (with low QC), there was a tendency to increase the clearance of glimepiride and to reduce its mean serum concentrations.Thus, in this category of patients there is no additional risk of cumulating glimepiride.

Diabetes mellitus type 2 (insulin-independent) in the case of ineffectiveness of diet and exercise.

The initial and maintenance dose is set individually based on the results of regular monitoring of blood glucose and urine levels.

The initial dose is 1 mg 1 time / day.
If necessary, the daily dose can be gradually increased (by 1 mg for 1-2 weeks) to 4-6 mg.
The maximum dose is 8 mg / day.

On the part of metabolism: hypoglycemia, hyponatremia.

On the part of the digestive system: nausea, vomiting, a feeling of discomfort in the epigastrium, abdominal pain, diarrhea, increased activity of hepatic transaminases, cholestasis, jaundice, hepatitis (until the development of liver failure).

On the part of the hemopoietic system: thrombocytopenia, leukopenia, erythropenia, granulocytopenia, agranulocytosis, pancytopenia, hemolytic anemia.

From the side of the organ of vision: transient visual impairment.

Allergic reactions: itching, urticaria, skin rash;
rarely - dyspnea, falling blood pressure, anaphylactic shock, allergic vasculitis, photosensitization.
Diabetes mellitus type 1 (insulin-dependent), ketoacidosis, precoma, coma, liver failure, renal failure (including patients on hemodialysis), pregnancy, lactation, hypersensitivity to glimepiride, other derivatives of sulfonylurea and sulfonamides.

Contraindicated in pregnancy.
In the case of a planned pregnancy or when pregnancy occurs, a woman should be transferred to insulin.
During lactation, a woman should be transferred to insulin.

In experimental studies , it has been established that glimepiride is excreted in breast milk.

Contraindicated in renal failure (including patients who are on hemodialysis).

Contraindicated in liver failure.

With caution apply in patients with concomitant diseases of the endocrine system, affecting carbohydrate metabolism (including thyroid dysfunction, adenohypophysis or adrenocortical insufficiency).

In stressful situations (with trauma, surgical intervention, infectious diseases accompanied by fever), there may be a need for a temporary transfer of the patient to insulin.

It should be borne in mind that the symptoms of hypoglycemia can be smoothened or completely absent in elderly patients, patients with NCDs or receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanethidine or other sympatholytic drugs.

When the compensation for diabetes is reached, insulin sensitivity increases;
in this regard, the treatment process may reduce the need for glimepiride. To avoid the development of hypoglycemia, it is necessary to reduce the dose in a timely manner or to cancel glimepiride. Dose adjustment should also be carried out with a change in the body weight of the patient or with a change in his lifestyle, or with the appearance of other factors contributing to the development of hypo- or hyperglycemia.
When switching to glimepiride from another drug, it is necessary to take into account the extent and duration of the effect of the previous hypoglycemic agent.
It may be necessary to temporarily discontinue treatment in order to avoid an additive effect.
In the first weeks of treatment, the risk of developing hypoglycemia may increase, which requires particularly strict monitoring of the patient.
Factors contributing to the development of hypoglycemia include: irregular, malnutrition; changes in the habitual diet; use of alcohol, especially when combined with a skipping meal;changing the habitual mode of exercise; simultaneous use of other drugs. Hypoglycemia can be quickly stopped by immediate intake of carbohydrates.
During the period of treatment, regular monitoring of glucose levels in blood and urine, as well as the concentration of glycated hemoglobin, is necessary.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, one should refrain from engaging in potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

An increase in the hypoglycemic effect of glimepiride is possible with simultaneous use with insulin or other hypoglycemic drugs, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, phenyramidol, fibrates, fluoxetine, guanethidine, isophosphamide, MAO inhibitors , miconazole, PASK, pentoxifylline (when injected in high doses), phenylbutazone, azapropase, oxyphenbutazone
m, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides, tetracyclines.
Weakening of hypoglycemic action of glimepiride is possible with simultaneous use with acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetics, glucagon, laxatives (after prolonged use), nicotinic acid (in high doses), estrogens and progestogens, phenothiazine , phenytoin, rifampicin, thyroid hormones.

With simultaneous use of blockers of histamine H 2 -receptors, clonidine and reserpine are able both to potentiate and reduce the hypoglycemic effect of glimepiride.

Against the background of the use of glimepiride, it is possible to enhance or weaken the action of coumarin derivatives.

Ethanol may increase or decrease the hypoglycemic effect of glimepiride.

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