Glumedex - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate, cellulose microcrystalline, povidone (K 25), sodium carboxymethyl starch, magnesium stearate, sodium lauryl sulfate, iron dye oxide yellow, indigocarmine.

Description:

Tablets from bluish-green with a grayish hue to a green with a grayish hue of color, a dumbbell, with a chamfer, with an engraving S / P divided by risk from one side and engraving G/ M divided risk on the other side.

Pharmacotherapeutic group:Hypoglycemic agent for oral use of the sulfonylurea group of the third generation

ATX: & nbsp

A.10.B.B.12 Glimepiride

Pharmacodynamics:

Hypoglycemic agent, derivative of sulfonylureas of the third generation. It stimulates beta-cells of the pancreas, contributing to the mobilization and enhancement of the release of endogenous insulin, increases the number of insulin-sensitive receptors in target cells, inhibits glukogenesis. Reduces hyperglycemia without increasing the level of insulin on an empty stomach. Extrapancreatic effects consist in increasing the sensitivity of peripheral tissues to insulin. Glimepiride has anti-aggregation, anti-atherogenic and antioxidant effect.

The maximum effect is achieved after 2-3 hours, the hypoglycemic effect lasts longer than 24 hours.

Pharmacokinetics:

Absorption is high. When ingested at a daily dose of 4 mg, the maximum concentration in the blood (309 ng / ml) is achieved after 2.5 hours. The volume of the distribution is 8.8 l (113 ml / kg). Bioavailability is about 100%. Communication with proteins - 99%, clearance - 48 ml / min. Metabolised in the liver. The half-life is 5-8 hours. It is excreted mainly in the form of metabolites by the kidneys (58% of the administered dose) and the intestine (35%). Do not cumulate. It is excreted in breast milk and penetrates the placental barrier. The drug does not penetrate the hemato-encephalic barrier poorly.

Indications:

Diabetes mellitus type 2 with ineffectiveness of diet and exercise.

Contraindications:

diabetes mellitus type 1;
diabetic ketoacidosis, diabetic precoma and coma;
hypersensitivity to glimepiride or to drug components, to other derivatives of sulfonylurea or to sulfonamide preparations;
severe violations of liver function;
severe renal dysfunction;
conditions requiring the transfer of a patient to insulin therapy (extensive burns,severe injuries, major surgical interventions, as well as impaired absorption in the gastrointestinal tract - intestinal obstruction, paresis of the stomach, etc.);
leukopenia;
pregnancy and the period of breastfeeding.

Carefully:

Feverish syndrome, alcoholism, adrenal insufficiency, thyroid disease (hypothyroidism or thyrotoxicosis).

Pregnancy and lactation:

Glimepiride is contraindicated for use in pregnant women. In the case of a planned pregnancy or when pregnancy occurs, insulin therapy is recommended.

As glimepiride penetrates into breast milk, it should not be prescribed to women during breastfeeding. In this case, it is necessary to perform insulin therapy or stop breastfeeding.

Dosing and Administration:

The dose of glimepiride is determined individually based on the results of regular monitoring of glucose in the blood.

The drug is taken orally, without liquid, with a sufficient amount of liquid, before an abundant breakfast, at an initial dose of 1 mg once a day. If necessary, the daily dose can be increased gradually (by 1 mg every 1-2 weeks) to 2, 3 or 4 mg / day. Only in individual patients, the effect of therapy is achieved with daily doses above 4 mg.The maximum daily dose is 6 mg.

Treatment: prolonged.

Side effects:

From the side of metabolism: In rare cases it is possible to develop hypoglycemic reactions. These reactions mainly occur shortly after taking the drug, and they can not always be easily stopped.

From the side of the organs of sight: during treatment (especially at the beginning), transient visual impairments due to changes in the concentration of glucose in the blood can be observed.

On the part of the digestive system: sometimes there may be nausea, vomiting, a feeling of heaviness or discomfort in the epigastrium, abdominal pain, diarrhea, very rarely leading to discontinuation of treatment; in rare cases - increased activity of "liver" enzymes, cholestasis, jaundice, hepatitis (until the development of liver failure).

On the part of the hematopoiesis system: rarely possible thrombocytopenia (from moderate to severe), leukopenia, hemolytic or aplastic anemia, erythrocytopenia, granulocytopenia, agranulocytosis and pancytopenia.

Allergic reactions: Sometimes it is possible the appearance of symptoms of urticaria (itching, skin rash).Such reactions are, as a rule, moderately expressed, but can progress, accompanied by a drop in blood pressure, dyspnea, until the development of anaphylactic shock. When symptoms of urticaria appear, consult a doctor immediately. A cross-allergy with other derivatives of sulfonylurea, sulfonamides, or similar substances is possible, and development of allergic vasculitis is also possible.

Other side effects: at exceptional cases, it is possible to develop photosensitivity, hyponatremia. If the patient discovers any of the above side effects, other unwanted effects, he should consult a doctor.

Overdose:

In case of an overdose it is possible to develop hypoglycemia (manifestations: hunger, tachycardia, nausea, vomiting, apathy, drowsiness, depression, sleep disturbances, severe weakness, anxiety, decreased concentration, speech disorders (aphasia) and vision, tremor, impaired sensation, paresis, dizziness, convulsions, shallow breathing, impaired consciousness, hypoglycemic coma).

Treatment: if the patient is conscious - ingestion of carbohydrates, with the impossibility of taking carbohydrates - injections of dextrose (intravenously bolus - 40% solution, then infusion 5-10% solution), 1-2 mg glucagon intramuscularly or subcutaneously. It is necessary to constantly monitor and maintain vital functions, blood glucose (at a level of 5.5 mmol / l) for at least 24-48 hours (there may be repeated episodes of hypoglycemia). After the restoration of consciousness it is necessary to give the patient food that is rich in easily assimilated carbohydrates (in order to avoid the re-development of hypoglycemia).

Interaction:

Increase the effect of glimepiride angiotensin converting enzyme (captopril, enalapril), H2-histamine-receptor blockers (cimetidine), antifungal medicines (miconazole, fluconazole), non-steroidal anti-inflammatory drugs (phenylbutazone, azapresene, oxyphenbutazone), fibrates (clofibrate, bezafibrate), antituberculous (ethionamide), salicylates (paracetamol), coumarin anticoagulants, anabolic steroids, beta-adrenoblockers, monoamine oxidase inhibitors, sulfonamides, hypoglycemic agents (acarbose, biguanides, insulin), cyclophosphamide, chloramphenicol, fenfluramine, fluoxetine, guanethidine, pentoxifylline, tetracycline, theophylline, tubular secretion blockers, reserpine, bromocriptine, disopyramide, pyridoxine, allopurinol.

Weaken the effect of glimepiride barbiturates, glucocorticosteroids, adrenostimulants (epinephrine, clonidine), antiepileptic drugs (phenytoin), blockers of "slow" calcium channels, inhibitors of carbonic anhydrase (acetazolamide), thiazide diuretics, chlorthalidone, furosemide, triamterene, asparaginase, baclofen, danazol, diazoxide, isoniazid, morphine, ritodrin, salbutamol, terbutaline, glucagon, rifampicin, hormone preparations thyroid gland, lithium salt, in high doses - a nicotinic acid, chlorpromazine, oral contraceptives and estrogens.

Glimepiride reduces (slightly) the hypocoagulation caused by warfarin. With simultaneous use with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.

Special instructions:

Regular monitoring of glucose in the blood is necessary.

If glomepiride monotherapy is ineffective, its use in combination therapy with metformin or with insulin is possible.

In the case of surgical interventions or when decompensating diabetes, it is necessary to consider the possibility of using insulin.

Patients should be warned about the increased risk of hypoglycemia in cases of taking ethanol (including the development of disulfiram-like reactions: abdominal pain, nausea, vomiting, headache), with fasting.

Dose correction is necessary in case of physical and emotional overstrain, changes in diet.

Clinical manifestations of hypoglycemia can be masked when taking beta-blockers, clonidine, reserpine, guanetidine.

At the beginning of treatment, during the selection of a dose for patients prone to hypoglycemia, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 2 mg.

Packaging:

10 tablets per blister of PVC-aluminum foil film. For 3 blisters with instructions for use are placed in a cardboard box.

For 100 tablets in a white bottle of polyethylene with a vinyl filler of 30 ml. One bottle together with the instruction for use is placed in a cardboard bundle

Storage conditions:

The drug should be stored in a dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-003007/08

Date of registration:22.04.2008

Expiration Date:Unlimited

The owner of the registration certificate:Shin Pung Pharmaceutical Co., Ltd.Shin Pung Pharmaceutical Co., Ltd. The Republic of Korea

Manufacturer: & nbsp

SHIN POONG PHARMACEUTICAL, Co. Ltd. The Republic of Korea

Representation: & nbspPharmInform Ltd.PharmInform Ltd.Russia

Information update date: & nbsp23.04.2017

Illustrated instructions

Instructions

Gliuimex (Glumedex)