Description
Release form
Film-coated tablets from light yellow to yellow, oval, biconvex. On a slice of white or almost white.
Pharmacological action of
Hypoglycemic agent for oral administration (2nd generation sulfonylurea derivative + biguanide)
Indications
Type 2 diabetes mellitus in adults:
with ineffective diet therapy and previous monotherapy with metformin or a sulfonylurea derivative
to replace the previous therapy with two drugs (metformin and a sulfonylurea derivative) we control well with stable levels.
Contraindications
– Hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives, as well as
excipients – type 1 diabetes mellitus
– diabetic ketoacidosis, diabetic precoma or diabetes mellitus – coma ml / min)
– acute conditions that can lead to a change in kidney function: dehydration, severe infection, shock, intravascular administration of iodine-containing contrast agents (see Special instructions)
– acute or chronic diseases, which are accompanied by tissue hypoxia: heart or respiratory failure, recent myocardial infarction, shock
– liver failure
– porphyria
– pregnancy, breastfeeding
– concomitant use of miconazole
– extensive surgery
x acute – chronic – lactic acidosis (including a history)
– adherence to a low-calorie diet (less than 1000 cal / day).
It is not recommended to use the drug for people over 60 years old who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis in them.
Precautions:
Fever, adrenal insufficiency, hypofunction of the anterior pituitary, thyroid disease with uncompensated dysfunction.
Use during pregnancy and lactation
The use of the drug is contraindicated during pregnancy. The patient should be warned that that during the period of treatment with Gluconorm ® Plus, it is necessary to inform the doctor about the planned pregnancy and the onset of pregnancy. When planning pregnancy, as well as in the case of pregnancy during the period of taking the drug Gluconorm ® Plus, the drug should be canceled and insulin treatment prescribed.
The drug Gluconorm ® Plus is contraindicated in breastfeeding, as there is no evidence of its ability to pass into breast milk.
Special instructions
During treatment with Gluconorm ® Plus, regular fasting and post-meal glycemia should be monitored. Lactic acidosis Lactic acidosis is an extremely rare but serious (high mortality rate if there is no emergency treatment) complication that may occur due to cumulation of metformin. Cases of lactic acidosis in patients treated with metformin occurred mainly in patients with diabetes mellitus with severe renal failure. Other associated risk factors should be considered, such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol consumption, liver failure, and any condition associated with severe hypoxia. You should take into account the risk of lactic acidosis with the appearance of nonspecific signs, such as muscle cramps, accompanied by dyspeptic disorders, abdominal pain and severe malaise. In severe cases, acidotic shortness of breath, hypoxia, hypothermia, and coma may occur. Diagnostic laboratory parameters are: low blood pH, plasma lactate concentration above 5 mmol / l, increased anionic interval and lactate / pyruvate ratio. Hypoglycemia Since the drug Gluconorm ® Plus contains glibenclamide, then taking the drug is accompanied by a risk of hypoglycemia in the patient. Gradual titration of the dose after the start of treatment can prevent the occurrence of hypoglycemia. This treatment can only be prescribed to a patient who adheres to a regular meal (including breakfast). It is important that carbohydrate intake is regular, as the risk of developing hypoglycemia increases with a late meal, inadequate or unbalanced carbohydrate intake. The development of hypoglycemia is most likely with a hypocaloric diet, after intense or prolonged physical activity, with alcohol or with a combination of hypoglycemic agents. Sweating, fear, tachycardia, hypertension, palpitations, angina pectoris and arrhythmia can occur due to compensatory reactions caused by hypoglycemia. The latter symptoms may be absent if hypoglycemia develops slowly, in case of autonomic neuropathy or while taking -Adrenoblockers, clonidine, reserpine, guanethidine or sympathomimetics. Other symptoms of hypoglycemia in patients with diabetes can be headache, hunger, nausea, vomiting, severe fatigue , sleep disorder, excited state, aggression, impaired concentration and psychomotor reactions, depression, confusion, speech impairment, visual impairment, trembling, couple lich and paresthesia, dizziness, delirium, convulsions, doubt, unconsciousness, shallow breathing and bradycardia. Careful prescribing, dose selection and proper instructions for the patient are important to reduce the risk of hypoglycemia. If the patient recurs attacks of hypoglycemia, which are either severe or associated with ignorance of the symptoms, consideration should be given to treatment with other hypoglycemic agents. Factors contributing to the development of hypoglycemia: – the simultaneous use of alcohol, especially during fasting – the patient’s refusal or inability to interact with the doctor and follow the recommendations set out in the instructions for use (especially for elderly patients) – poor nutrition, irregular food intake, starvation or a change in diet – an imbalance between physical activity and iemom carbohydrates – kidney failure – severe liver failure – drug overdose Glyukonorm ® Plus – some endocrine disorders: failure thyroid, pituitary and adrenal glands – simultaneous reception of individual drugs. Renal and hepatic impairment Pharmacokinetics and / or pharmacodynamics may change in patients with hepatic impairment or severe renal impairment. Hypoglycemia arising in such patients may be prolonged, in which case appropriate treatment should be initiated. Blood glucose instability In case of surgical intervention or other cause of decompensation diabetes, it is recommended to provide a temporary transition to insulin therapy. Symptoms of hypoglycemia are frequent urination, severe thirst, dry skin. 48 hours before the planned surgery or intravenous administration of an iodine-containing radiopaque agent, the drug Gluconorm Plus should be discontinued. Treatment is recommended to resume after 48 hours, and only after how renal function was assessed and recognized as normal. Renal function Since metformin is excreted by the kidneys, before starting treatment and regularly thereafter, creatinine clearance and / or serum creatinine must be determined: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients, as well as in patients with creatinine clearance at the upper limit of normal. It is recommended to be especially careful in cases where kidney function may be impaired, for example, in elderly patients, or in case of antihypertensive therapy, diuretics or non-steroidal anti-inflammatory drugs (NSAIDs). Other Precautions The patient should inform the doctor about the appearance of a bronchopulmonary infection or an infectious disease of the genitourinary organs.
Composition
Active ingredients: glibenclamide – 5.00 mg, metformin hydrochloride – 500 mg.
Excipients: microcrystalline cellulose – 57.20 mg, hyprolose (hydroxypropyl cellulose) – 13.80 mg, croscarmellose sodium – 18.00 mg, magnesium stearate – 6.00 mg.
Dosage coat 5 mg + 500 mg: VIVACOAT ® PM-2P-050 [hypromellose (hydroxypropyl methylcellulose 6 cPs) – 9.00 mg, hyporolose (hydroxypropyl cellulose) – 0.90 mg, polyethylene glycol 3350 – 0.90 mg, guitana – 4.75 mg, talc – 1.80 mg, iron oxide yellow oxide (E172) – 0.26 mg, quinoline yellow color (E104) – 0.37 mg, sunset sunset yellow color (E110) – 0.02 mg] – 18.00 mg.
Dosage and administration of
The dose of the drug is determined by the doctor individually for each patient, depending on the level of glycemia. The initial dose is 1 tablet of the drug Gluconorm® Plus 2.5 mg + 500 mg 1 time per day. To avoid hypoglycemia, the initial dose should not exceed the daily dose of glibenclamide (or the equivalent dose of another previously taken sulfonylurea) or metformin, if they were used as first-line therapy. It is recommended to increase the dose by no more than 5 mg of glibenclamide + 500 mg of metformin per day every 2 or more weeks to achieve adequate control of blood glucose.
Substitution of previous combination therapy with metformin and glibenclamide: the initial dose should not exceed the daily dose of glibenclamide (or the equivalent dose of another sulfonylurea) and metformin taken previously. Every 2 or more weeks after the start of treatment, the dose is adjusted depending on the level of glycemia.
The maximum daily dose is 6 tablets of the drug Gluconorm® Plus 2.5 mg + 500 mg.
Dosage regimen
The dosage regimen depends on the individual purpose:
For dosages of 2.5 mg + 500 mg
– once a day, in the morning during breakfast, with 1 tablet per day
– twice a day, morning and evening, with the appointment of 2 or 4 tablets per day.
For a dosage of 2.5 mg + 500 mg
– three times a day, in the morning, afternoon and evening, with the appointment of 3, 5 or 6 tablets per day.
Tablets should be taken with meals. Each meal should be accompanied by a meal with a high enough carbohydrate content to prevent the occurrence of hypoglycemia.
Elderly patients
The dose of the drug is selected based on the state of renal function. The initial dose should not exceed 1 tablet of the drug Gluconorm® Plus 2.5 mg + 500 mg. Regular assessment of renal function is necessary.
Children
Gluconorm® Plus is not recommended for use in children.
Side effects of
The following side effects may occur during treatment with Gluconorm ® Plus.
Side effects are presented depending on the effect on organs and organ systems.
The following adverse events noted with the use of the drug Gluconorm ® Plus are distributed according to the frequency of occurrence according to the following gradation: very often (? 1/10), often (? 1/100 to 1/10), infrequently (? 1 / 1000 to <1/100), rarely (? 1/10000 to <1/1000), very rarely (<1/10000). In each group, unwanted effects are presented in decreasing order of severity. From the side of metabolism and nutrition: Hypoglycemia (see Overdose, Special Instructions). Rarely: bouts of hepatic porphyria and cutaneous porphyria. Very rare: lactic acidosis (see Special instructions). Decreased absorption of vitamin B12, accompanied by a decrease in its concentration in serum with prolonged use of metformin. If megaloblastic anemia is detected, the possibility of such an etiology must be considered. Disulfiram-like reaction with alcohol. Laboratory data: Infrequently: moderate to moderate increase in serum urea and creatinine concentrations. Very rare: hyponatremia. From the blood and lymphatic system: Rarely: leukopenia, thrombocytopenia. Very rare: agranulocytosis, hemolytic anemia, bone marrow aplasia, and pancytopenia. These adverse events disappear after discontinuation of the drug. From the nervous system: Often: taste disturbance (metallic taste in the mouth). From the side of the organ of vision: at the beginning of treatment, temporary visual impairment may occur due to a decrease in blood glucose. From the gastrointestinal tract: Very often: nausea, vomiting, diarrhea, abdominal pain and lack of appetite. These symptoms are more common at the beginning of treatment and in most cases pass on their own. To prevent the development of these symptoms, it is recommended to take the drug in 2 or 3 doses, a slow increase in the dose of the drug also improves its tolerance. From the side of the rut and subcutaneous tissue: Rarely: skin reactions such as: itching, urticaria, maculopapular rash. Very rare: skin or visceral allergic vasculitis, polymorphic erythema, exfoliative dermatitis, photosensitivity. On the part of the immune system: Very rare: anaphylactic shock. Cross-hypersensitivity reactions to sulfonamides and their derivatives may occur. From the liver and biliary tract: Very rare: impaired liver function or hepatitis requiring discontinuation of treatment. Storage conditions At a temperature not exceeding 25 ° ¡. Keep out of the reach of children. Expiration 2 years. Do not use after the expiration date indicated on the package. Active ingredient Hydrochlorothiazide, Metformin Pharmacy conditions Pharmacies prescription Dosage form tablets
