Amaryl M

Write your review

Amaryl M

• Quality

Title for your review^* Your review^* Your name^*

^* Required fields

Send

As a rule, the dose of Amaryl® M is determined by the target concentration of glucose in the patient’s blood. The lowest dose should be applied, sufficient to achieve the necessary metabolic control.

During treatment with Amaryl® M, it is necessary to regularly determine the concentration of glucose in the blood. In addition, it is recommended to regularly monitor the percentage of glycated hemoglobin in the blood.

An incorrect drug intake, for example, skipping a regular dose, should never be replenished by the subsequent intake of a higher dose.

Patient's actions in case of errors when taking the drug (in particular when skipping the next dose or skipping the meal), or in situations where it is not possible to take the drug, should be discussed by the patient and the doctor in advance.

Since improvement of metabolic control is associated with increased sensitivity of tissues to insulin, then during treatment with Amaryl® M, the need for glimepiride may decrease. In order to avoid the development of hypoglycemia, it is necessary to promptly reduce the dose or stop taking Amaryl® M.

Amaril® M should be taken 1 or 2 times / day with meals.

The maximum dose of metformin at a time is 1000 mg.

The maximum daily dose: for glimepiride - 8 mg, for metformin - 2000 mg.

Only in a small number of patients a daily dose of glimepiride more than 6 mg is more effective.

In order to avoid the development of hypoglycemia, the initial dose of Amaryl® M should not exceed the daily doses of glimepiride and metformin that the patient is already taking. When transferring patients from taking a combination of individual drugs of glimepiride and metformin to Amaryl® M, its dose is determined on the basis of the doses of glimepiride and metformin already taken as separate drugs. If it is necessary to increase the dose, the daily dose of Amaryl® M should be titrated in increments of only 1 tablet of Amaryl® M 1 mg + 250 mg or 1/2 tablet of Amaryl® M 2 mg + 500 mg.

Duration of treatment: usually treatment with Amaryl® M is carried out for a long time.

The study of the safety and efficacy of the drug in children with type 2 diabetes was not conducted.

It is known that metformin is excreted mainly by the kidneys, and since the risk of severe adverse reactions to metformin in patients with impaired renal function is higher, it can only be used in patients with normal renal function. Due to the fact that kidney function decreases with age, in elderly patients, metformin should be used with caution. The dose should be carefully selected and careful and regular monitoring of renal function should be ensured.

Adverse reactions

Glimepiride + Metformin

Receiving a combination of glimepiride and metformin, both as a free combination made up of separate preparations of glimepiride and metformin, as well as a combined preparation with fixed doses of glimepiride and metformin, is associated with the same safety characteristics as the use of each of these drugs separately.

Glimepiride

Based on clinical experience with glimepiride and known data on other sulfonylurea derivatives, adverse reactions listed below may develop.

On the part of metabolism and nutrition: hypoglycemia may develop, which may be prolonged. Symptoms of developing hypoglycemia - headache, acute hunger, nausea, vomiting, weakness, lethargy, sleep disorders, anxiety, aggressiveness, decreased concentration, decreased alertness and slowed down psychomotor reactions, depression, confusion, speech disorders, aphasia, visual impairment, tremor, paresis, impaired sensitivity, dizziness, helplessness, loss of self-control, delirium, convulsions, drowsiness and loss of consciousness up to the development of coma, shallow breathing and bradycardia.In addition, adrenergic anti-glycemic regulation symptoms may develop in response to developing hypoglycemia, such as increased sweating, skin stickiness, increased anxiety, tachycardia, increased blood pressure, heart palpitations, angina and heart rhythm disturbances. The clinical picture of an attack of severe hypoglycemia may resemble acute cerebrovascular accident. Symptoms are almost always resolved after the elimination of hypoglycemia.

On the part of the organ of vision: temporary visual impairment, especially at the beginning of treatment, due to fluctuations in glucose concentration in the blood. The reason for the deterioration of vision is a temporary change in the swelling of the lens, depending on the concentration of glucose in the blood, and due to this change in their refractive index.

On the part of the digestive system: the development of gastrointestinal symptoms, such as nausea, vomiting, feeling of fullness in the stomach, abdominal pain and diarrhea.

On the part of the liver and biliary tract: hepatitis, increased activity of liver enzymes and / or cholestasis and jaundice, which can progress to life-threatening liver failure, but may be reversed after discontinuation of glimepiride.

From the hematopoietic system: thrombocytopenia, in some cases - leukopenia or hemolytic anemia, erythrocytopenia, granulocytopenia, agranulocytosis or pancytopenia. After the drug was released to the market, cases of severe thrombocytopenia (with platelet count less than 10,000 / μl) and thrombocytopenic purpura are described.

On the part of the immune system: allergic or pseudo-allergic reactions (for example, pruritus, urticaria, or rash). These reactions almost always have a mild form, but can turn into a severe form with shortness of breath or a decrease in blood pressure, up to the development of anaphylactic shock. If urticaria develops, you should immediately inform your doctor. Possible cross-allergy with other sulfonylurea derivatives, sulfonamides, or similar substances. Allergic vasculitis.

Other: photosensitivity, hyponatremia.

Metformin

Metabolism: lactacidosis.

On the part of the digestive system: gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, increased gas formation, flatulence and anorexia) - the most frequent reactions with metformin monotherapy - occur about 30% more often than when taking placebo, especially in the initial treatment period. These symptoms, mainly temporary, with continued treatment are spontaneously resolved. In some cases, a temporary dose reduction may be helpful. Due to the fact that the development of gastrointestinal symptoms in the initial period of treatment is dose-dependent, these symptoms can be reduced by gradually increasing the dose and taking the drug during meals. Since severe diarrhea and (or) vomiting can lead to dehydration and prerenal azotemia, when they appear, you should temporarily stop taking Amaryl® M. The appearance of non-specific gastrointestinal symptoms in patients with type 2 diabetes, with a stable condition against the background of taking Amaryl ® M may be associated not only with therapy, but also with intercurrent diseases or the development of lactic acidosis.

At the beginning of treatment with metformin, approximately 3% of patients may have an unpleasant or metallic taste in the mouth, which usually disappears spontaneously.

Liver and biliary tract: abnormal liver function tests or hepatitis, which were reversed when metformin was discontinued. With the development of the above or other adverse reactions, the patient should immediately inform your attending physician. As some undesirable reactions, incl.hypoglycemia, lactic acidosis, hematological disorders, severe allergic and pseudo-allergic reactions and liver failure can threaten the patient's life, in case of such reactions, the patient should immediately inform your doctor and stop taking the drug further before receiving instructions from the doctor.

On the part of the skin and subcutaneous tissues: erythema, pruritus, rash.

From the hemopoietic system: anemia, leukocytopenia or thrombocytopenia. In patients who take Metformin for a long time, usually asymptomatic, there is a decrease in the concentration of vitamin B₁₂ in serum due to a decrease in its intestinal absorption. If a patient has megaloblastic anemia, consider the possibility of reducing the absorption of vitamin B₁₂associated with taking metformin.

Contraindications

Carefully: in the first weeks of treatment with Amaryl® M, the risk of hypoglycemia increases, which requires particularly careful monitoring. In conditions that increase the risk of hypoglycemia (patients who are unwilling or unable to cooperate with the doctor, most often elderly patients; poorly nourished, not regularly eating, skipping patients; with a mismatch between exercise and carbohydrate consumption; when changing diets, when consuming ethanol-containing beverages, especially in combination with skipping meals, for liver and kidney dysfunction, for some uncompensated endocrine disorders, them as dysfunction of the thyroid gland, insufficiency of hormones of the anterior pituitary gland and adrenal cortex, affecting carbohydrate metabolism or activation of mechanisms aimed at increasing the concentration of glucose in the blood during hypoglycemia, with the development of intercurrent diseases during treatment or lifestyle changes (such Patients need more careful control of blood glucose concentrations and signs of hypoglycemia, they may need a dose adjustment of Amaril® M). With the simultaneous use of some other drugs. Elderly patients (they often have asymptomatic decline in renal function). In situations where kidney function may deteriorate, such as the start of their taking antihypertensive drugs or diuretics, as well as NSAIDs (an increased risk of developing lactic acidosis and other side effects of metformin). When performing heavy physical work (the risk of lactic acidosis increases when taking metformin). With erasure or the absence of symptoms of adrenergic anti-glycemic regulation in response to developing hypoglycemia (in elderly patients, with autonomic neuropathy or with simultaneous therapy with beta-adrenergic blockers, clonidine, guanethidine and other sympatholytic; in these patients more careful monitoring of glucose concentration in the blood is needed) . If glucose-6-phosphate dehydrogenase is deficient (in these patients, when taking sulfonylurea derivatives, hemolytic anemia may develop, therefore, the use of alternative hypoglycemic drugs that are not sulfonylurea derivatives should be considered in these patients).

Drug interactions

Interaction glimepirida with other drugs

When other drugs are prescribed or canceled at the same time to a patient taking glimepiride, undesirable reactions are possible: an increase or a decrease in the hypoglycemic action of glimepiride. Based on the clinical experience with glimepiride and other sulfonylurea drugs, the following drug interactions should be considered.

With drugs that are inducers and inhibitors of the isoenzyme CYP2C9: glimepiride is metabolized with the participation of the isoenzyme CYP2C9.Its metabolism is influenced by the simultaneous use of CYP2C9 isoenzyme inducers, for example, rifampicin (the risk of reducing the hypoglycemic effect of glimepiride with simultaneous use of the isoenzyme CYP2C9 with inducers and an increase in the risk of developing hypoglycemia if they are canceled without dose adjustment of glimepiride) and inhibitors of the CYP2C isofment of an isoenzyme. increased risk of hypoglycemia and side effects of glimepiride when it is taken simultaneously with inhibitors of the isoenzyme CYP2C9 and the risk of reducing its hypoglycemia chesky effect at their cancellation without dose adjustment of glimepiride).

With drugs that enhance hypoglycemia, glimepirida: insulin MAO inhibitors, miconazole, fluconazole, aminosalicylic acid, pentoxifylline (high parenteral doses), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, anti-cancer detail drugs quinolone derivatives, salicylates, sulfinpyrazone, clarithromycin, sulfa antimicrobials, tetracyclines, tritokvalin, trofosfamide: increased risk of hypoglycemia, while the use of these drugs with glimepiride and the risk of deterioration of glycemic control at their cancellation without correction dose of glimepiride.

With drugs that weaken the hypoglycemic effect: acetazolamide, barbiturates, GCS, diazoxide, diuretics, epinephrine (adrenaline) or other sympathomimetics, glucagon, laxatives (long-term use), nicotinic acid (high doses), estrogens, progestogens, phenothiazines, phenytocin, phenytocin, phenytocin, phenytocin, and phenytocin. , thyroid hormones: the risk of glycemic control deterioration when used together with these drugs and an increased risk of hypoglycemia if they are canceled without dose adjustment of glimepiride.

With histamine H blockers₂-receptors, beta-adrenergic blockers, clonidine, reserpine, guanetidinom: both strengthening and reducing the hypoglycemic effect of glimepiride is possible. Careful monitoring of blood glucose concentration is required. Beta-blockers, clonidine, guanethidine, and reserpine, by blocking the reactions of the sympathetic nervous system in response to hypoglycemia, can make the development of hypoglycemia more imperceptible to the patient and the physician and thereby increase the risk of its occurrence.

With ethanol: acute and chronic use of ethanol can unpredictably either weaken or enhance the hypoglycemic effect of glimepiride.

With indirect anticoagulants, coumarin derivatives: glimepiride can both increase and decrease the effects of indirect anticoagulants, coumarin derivatives.

With bile acid sequestrants: wheelworms bind to glimepiride and reduce the absorption of glimepiride from the gastrointestinal tract. In the case of glimepiride, at least 4 hours before ingestion of the wheelwheel, no interaction is observed. Therefore, glimepiride must be taken at least 4 hours before taking the wheelchair.

Interaction of metformin with other drugs

Combinations not recommended

With ethanol: with acute alcohol intoxication increases the risk of lactic acidosis, especially in the case of skipping or insufficient food intake, the presence of liver failure. Alcohol intake (ethanol) and preparations containing ethanol should be avoided.

With iodine-containing contrast agents: intravascular administration of iodine-containing contrast agents can lead to the development of renal failure, which in turn can lead to an accumulation of metformin and an increased risk of lactic acidosis.Metformin should be discontinued prior to or during the study and should not be resumed within 48 h after it; renewal of metformin is possible only after the study and obtain normal indicators of renal function.

With antibiotics with a pronounced nephrotoxic effect (gentamicin): an increased risk of lactic acidosis.

Combinations of drugs with metformin that require compliance with caution

With GCS (systemic and for local use), beta2-adrenostimulants and diuretics with internal hyperglycemic activity: the patient should be informed about the need for more frequent monitoring of the morning glucose concentration in the blood, especially at the beginning of the combination therapy. May require correction of doses of hypoglycemic therapy during the application or after the abolition of the above drugs.

With ACE inhibitors: ACE inhibitors can reduce the concentration of glucose in the blood. It may be necessary to adjust the doses of hypoglycemic therapy during the application or after discontinuation of ACE inhibitors.

With drugs that enhance the hypoglycemic effect of metformin: insulin, sulfonylurea drugs, anabolic steroids, guanethidine, salicylates (including acetylsalicylic acid), beta-adrenergic blockers (including propranolol), MAO inhibitors: in case of simultaneous use of these drugs with metformin, careful monitoring of the patient and control of the glucose concentration in the blood are necessary, since it is possible to enhance the hypoglycemic effect of metformin.

With drugs that weaken the hypoglycemic action of Metformin: epinephrine, corticosteroids, thyroid hormone, estrogen, pyrazinamide, isoniazid, nicotinic acid, phenothiazines, thiazide diuretics or diuretics other groups, oral contraceptives, phenytoin, sympathomimetics, blockers of the slow calcium channel: in the case of simultaneous application these drugs with metformin require careful monitoring of the patient and control of glucose concentration in the blood, because possibly weakening of hypoglycemic action.

Interaction that should be taken into account

With furosemide: in a clinical study on the interaction of metformin and furosemide when taken once in healthy volunteers, it was shown that the simultaneous use of these drugs affects their pharmacokinetic parameters. Furosemide increased C_max metformin in plasma by 22%, a AUC by 15% without any significant changes in renal clearance of metformin. When used with Metformin C_max and AUC of furosemide decreased by 31% and 12%, respectively, compared with furosemide monotherapy, and terminal T_1/2 decreased by 32% without any significant changes in the renal clearance of furosemide. Information about the interaction of metformin and furosemide with prolonged use is not available.

With nifedipine: in a clinical study of the interaction of metformin and nifedipine when taken once in healthy volunteers, it was shown that the simultaneous use of nifedipine increases C_max and AUC of metformin in the blood plasma by 20% and 9%, respectively, and also increases the amount of metformin excreted by the kidneys. Metformin had a minimal effect on the pharmacokinetics of nifedipine.

With cationic drugs (amiloride, dicogsin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin): cationic drugs that are derived by tubular secretion in the kidneys are theoretically able to interact with metformin as a result of competition for a common canalicular transport system. This interaction between metformin and oral cimetidine was observed in healthy volunteers in clinical studies of the interaction of metformin and cimetidine in single and multiple use, where there was a 60% increase in C_max in plasma and total blood concentration of metformin and 40% increase in plasma and total AUC of metformin. With a one-time acceptance of changes T_1/2 did not have. Metformin did not affect the pharmacokinetics of cimetidine.Although this interaction remains purely theoretical (with the exception of cimetidine), careful monitoring of patients should be ensured and the dose of metformin and / or the drug interacting with it should be adjusted in the event of simultaneous administration of cationic drugs excreted from the secretory system of the proximal tubules of the kidneys.

With propranolol, ibuprofen: healthy volunteers in single-dose studies with metformin and propranolol, as well as metformin and ibuprofen, did not show any changes in their pharmacokinetic parameters.

Pregnancy and Lactation

Special instructions

Studies and clinical trials of Amaryl M (Click to expand)