Glemaz

Glemaz – derivative generation sulphonylurea III, peroral hypoglycemic drug.

Form of release and structure

Dosage form – tablets: rectangular, flat, light green color, with 3 parallel notches put on tablet width on both sides and dividing it into 4 equal parts (on 5 or 10 pieces in blisters, in a pack of cardboard 3 or 6 blisters).

Active ingredient: глимепирид, in 1 tablet – 4 mg.

Additional components: cellulose microcrystallic, magnesium stearate, cellulose, croscarmellose sodium, dye diamond blue, dye quinolinic yellow.

Indications to use

Glemaz – drug for treatment of a diabetes mellitus 2 types (including as a part of complex therapy with insulin or metformin).

Contraindications

Absolute:

• Diabetes mellitus of 1 type;
• Leukopenia;
• Heavy renal failures (including it is contraindicated to the patients who are on a hemodialysis);
• Heavy abnormal liver functions;
• Diabetic prekoma and coma, diabetic ketoacidosis;
• The states which are followed by disturbance of absorption of food and development of a hypoglycemia (including infectious diseases);
• Age up to 18 years;
• Pregnancy and lactation;
• Hypersensitivity to components of drug or other derivatives of sulphonylurea and sulfanamide drugs.

Glemaz it is necessary to appoint with care at the states demanding transfer of the patient into an insulin therapy such as disturbances of absorption of food and medicines in digestive tract (including paresis of a stomach and intestinal impassability), big surgical interventions, severe multiple injuries, extensive burns.

Route of administration and dosage

Glemaz accept inside. The daily dose should be accepted in one step to or during a big breakfast or the first main meal. It is necessary to swallow of tablets, without chewing, washing down with enough liquid (about ½ glasses). After reception of a tablet it is not recommended to miss meal.

The initial and supporting doses are defined individually depending on results of regular definition of concentration of glucose in blood.

In an initiation of treatment usually appoint 1 mg of a glimepirid (^1/4 tablets) of 1 times a day. If it is possible to reach optimum therapeutic effect, drug continues to be accepted in the same dose (as supporting).

In case of lack of glycemic control, the daily dose is increased step by step, constantly controlling concentration of glucose in blood: each 1-2 weeks, at first to 2 mg, then – to 3 mg, further – to 4 mg (the dose over 4 mg is effective only in exceptional cases). The most admissible daily dose makes 8 mg.

Time and frequency rate of administration of drug are defined by the doctor on the basis of a way of life of the patient. Prolonged treatment, under control of content of glucose in blood.

Use in a combination with Metforminum

If at the patients accepting Metforminum it is not possible to reach glycemic control, the combination therapy with Glemaz can be appointed. In this case the dose of Metforminum is kept at the previous level, and глимепирид appointed in the minimum dose then it is gradually raised up to maximum daily (depending on concentration of glucose in blood). The combination therapy is carried out under careful observation of the doctor.

Use in a combination with insulin

If at the patients receiving Glemaz in the maximum dose as monodrug or in a combination with the maximum dose of Metforminum it is not possible to reach glycemic control, the combination therapy with insulin can be appointed. In this case the last appointed dose of a glimepirid leave invariable, and appoint insulin in the minimum dose and if necessary gradually increase it under control of concentration of glucose in blood. The combined treatment is carried out under careful observation of the doctor.

Transfer of the patient on Glemaz from other peroral hypoglycemic drug

At transfer of the patient from other peroral hypoglycemic means the initial dose of a glimepirid has to make 1 mg even if other drug was accepted in the maximum dose. In need of further Glemaz's dose is raised step by step according to the general recommendations described above and taking into account efficiency, by doses and durations of effect of the used hypoglycemic drug. In certain cases, especially when using hypoglycemic means with a big elimination half-life, there can be a need for the temporary termination of treatment (for several days) to avoid the additive effect increasing risk of development of a hypoglycemia.

Transfer of the patient from insulin on глимепирид

In exceptional cases, when performing insulin therapy at patients with a diabetes mellitus 2 types, at compensation of a disease and the kept secretory function of β-cells of a pancreas, insulin can be replaced glimepiridy. Glemaz's reception begin 1 mg with the minimum dose, make a transfer under careful medical control.

Side effects

• Metabolism: the hypoglycemic reactions arising preferential soon after administration of drug (can have the heavy form and a current, they not always manage to be stopped easily);
• Alimentary system: an abdominal pain, heavy feeling or discomfort in epigastriums, nausea, vomiting, diarrhea, jaundice, a cholestasia, increase in activity of hepatic transaminases, hepatitis (up to a liver failure);
• System of a hemopoiesis: aplastic or hemolitic anemia, an erythrocytopenia, a leukopenia, a granulocytopenia, a pancytopenia, an agranulocytosis, thrombocytopenia (from moderated to heavy);
• Organ of sight: to a thicket at the beginning of therapy – tranzitorny vision disorders;
• Allergic reactions: urticaria, skin rash, an itch (are usually expressed moderately, but can progress, being followed by short wind and a lowering of arterial pressure, to lead to an acute anaphylaxis), a cross allergy with streptocides and other derivatives of sulphonylurea or similar to them substances, an allergic vasculitis;
• Others: in some cases – a hyponatremia, an adynamy, a photosensitization, a headache, a late skin porphyria.

Special instructions

Glemaz it is necessary to accept strictly according to recommendations of the doctor. Reception errors (for example, the admission of the next dose) can never be eliminated by means of the following reception of higher dose. The patient has to discuss in advance with the doctor of a measure which should be undertaken in case of similar mistakes or in situations when the next administration of drug is impossible at the scheduled time. The patient has to inform immediately the doctor if accepted too high dose.

Means development of a hypoglycemia after Glemaz's reception in a daily dose of 1 mg that the glycemia can be controlled only by means of a diet.

After achievement of compensation of a diabetes mellitus 2 types raise sensitivity to insulin therefore the dose decline of a glimepirid can be required. Not to allow development of a hypoglycemia, it is necessary to lower temporarily a dose or at all to cancel Glemaz. Dose adjustment needs also to be carried out at change of body weight of the patient, his way of life or at emergence of other factors which can lead to development hypo - or a hyperglycemia.

Especially careful observation of the patient is necessary in the first weeks of treatment since during this period the risk of development of a hypoglycemia increases. The similar situation arises at the admission of meal or irregular food.

It must be kept in mind that symptoms of a hypoglycemia can be maleficiated or at all be absent at the elderly people sick with a vegetative neuropathy and the patients receiving at the same time beta adrenoblockers, Reserpinum, a clonidine, гуанетидин. The hypoglycemia almost always manages to be stopped quickly immediate reception of carbohydrates (sugar or glucose, for example, in the form of a piece of sugar, sweet tea or fruit juice). For this reason for patients it is always recommended to have at itself at least 20 g of glucose (4 pieces of lump sugar). Sweeteners in treatment of a hypoglycemia are inefficient.

The entire period of treatment by Glemaz it is regularly necessary to control concentration of glucose in blood, level of glikozilirovanny hemoglobin, function of a liver, a picture of peripheral blood (especially number of thrombocytes and leukocytes).

In stressful situations (for example, at infectious diseases with fever, surgical intervention or an injury) temporary transfer of the patient on insulin can be required.

During therapy it is necessary to be careful at occupations potentially dangerous types of activity which performance requires the speed of reactions and special attention (including when driving vehicles).

Medicinal interaction

At simultaneous use of Glemaz with other drugs change of its action – strengthening or easing is possible. Therefore it is necessary to agree on possibility of reception of any other medicine with the attending physician.

Strengthening of hypoglycemic action of Glemaz and, as a result, development of a hypoglycemia can cause joint reception with the following drugs: insulin, metformin, other peroral hypoglycemic drugs, inhibitors of an angiotensin-converting enzyme, anabolic steroids and male sex hormones, monoamine oxidase inhibitors, salicylates (including aminosalicylic acid), antimicrobic means – derivatives of a hinolon, tetracyclines, sympatholytics (including гуанетидин), some streptocides of the prolonged effect derivative of coumarin, fibrata, Allopyrinolum, трофосфамид, фенфлурамин, ифосфамид, fluoxetine, Miconazolum, cyclophosphamide, chloramphenicol, оксифенбутазон, тритоквалин, азапропазон, флуконазол, Sulfinpyrazonum, phenylbutazone, пентоксифиллин (entered parenterally in high doses).

Weakening of hypoglycemic action of Glemaz and, as a result, increase in concentration of glucose in blood, can cause joint reception with the following drugs: glucocorticosteroids, thiazide diuretics, purgatives (at long reception), estrogen and progestogens, barbiturates, Epinephrinum and other sympathomimetic means, saluretics, niacin (in high doses) and its derivatives, a glucagon, diazoxide, acetazoleamide, derivatives of a fenotiazin, including Chlorpromazinum, rifampicin, Phenytoinum, lithium salts, hormones of a thyroid gland.

Reserpinum, clonidine, blockers histamine _{H2 receptors} can both weaken, and to exponentiate hypoglycemic action of a glimepirid. Under the influence of these drugs and a guanetidin easing or total absence of clinical signs of a hypoglycemia is possible.

Glimepirid can weaken or strengthen action of derivatives of coumarin.

In case of simultaneous use of the drugs oppressing a marrowy hemopoiesis the risk of development of a miyelosupressiya increases.

The single or chronic use of alcoholic beverages can both strengthen, and to weaken hypoglycemic action of Glemaz.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 2 years.