Glyurenorm tab 30mg 60 pc

Description

Composition
Active substance:
1 tablet contains: gliquidone – 30 mg.
Excipients:
Lactose monohydrate – 134.6 mg, dried corn starch – 70 mg maize starch soluble – 5 mg magnesium stearate – 0.4 mg.
Description:
Smooth, round, white tablets with beveled edges; with Valium on one party and chasing “57C” on both sides of the risks; on the other side is engraved with company logo.
Product form:
Tablets 30 mg. 10 tablets in blisters (blister) PVC / Al. At 3, 6 or 12 blisters with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to sulfonamides; type 1 diabetes; diabetic acidosis and ketoacidosis, precoma, coma; state after resection of the pancreas; acute intermittent porphyria; severe hepatic failure; some acute state (e.g., infectious diseases or large surgical operations); pregnancy, breast-feeding; rare inherited disorders such as galactosemia, lactase deficiency, malabsorption glyukozogalaktoznaya, lactose intolerance; age 18 years (due to lack of data on efficacy and safety in this age group).
Precautions: febrile syndrome; thyroid disease (with impaired function); glyukozo6fosfatdegidrogenazy deficit; alcoholism.
Dosage
30 mg
Indications
Type 2 diabetes in middle-aged and elderly patients (with poor diet).
Interaction with other drugs
Intensifying hypoglycemic action while appointing gliquidone and angiotensin-converting enzyme inhibitors, allopurinol, analgesics and non-steroidal antiinflammatory drugs, antifungal drugs, chloramphenicol, clarithromycin, clofibrate, coumarin derivatives, fluoroquinolone, Heparin, monoamine oxidase inhibitors, sulfinpirazona, sulfonamides, tetracyclines and tricyclic antidepressants , cyclophosphamide and its derivatives, insulin and oral hypoglycemic agents. Beta-blockers, sympatholytics (including clonidine), reserpine and guanethidine may enhance the hypoglycemic effect and at the same time masking the symptoms of hypoglycemia. May decrease hypoglycemic action while appointing gliquidone and aminoglutethimide, sympathomimetics, corticosteroids, thyroid hormone, glucagon, thiazide and “loop” diuretics, oral contraceptives, diazoxide, phenothiazine and preparations containing nicotinic acid. Barbiturates, phenytoin, and rifampin may also reduce the hypoglycemic effect gliquidone. Strengthening or weakening gliquidone hypoglycemic effect has been described while taking blockers histamine H2 receptor (cimetidine, ranitidine), and alcohol.
Overdose
Overdosing sulfonylureas can cause hypoglycemia.
Symptoms: tachycardia, sweating, hunger, palpitations, tremor, headache, insomnia, irritability, impaired speech and vision, restlessness and loss of consciousness.
Treatment: In case of symptoms of hypoglycemia should be taken into glucose (dextrose) or foods rich in carbohydrates. When severe hypoglycemia (loss of consciousness, coma) intravenous dextrose. After recovery of consciousness – carbohydrate intake (to avoid a recurrence of hypoglycemia).
pharmachologic effect
Pharmacological group:
Hypoglycemic agent for oral administration group II generation sulfonylureas.
Pharmacodynamics:
GLYURENORM – hypoglycemic agent for oral application relates to derivatives II generation sulfonylureas and has vnepankreaticheskim pancreatic effects. It stimulates the secretion of insulin potentiating glucose-mediated pathway of insulin. In animal experiments it was shown that GLYURENORM reduces insulin resistance in the liver and adipose tissue by increasing insulin receptors, as well as stimulation of post-receptor mechanism mediated by insulin. Hypoglycemic effect develops after 60 – 90 minutes after ingestion, maximum action occurs within 2-3 hours and lasts for about 8-10 hours.
Pharmacokinetics:
Absorption: after ingestion gliquidone single dose (15 mg or 30 mg) of drug is rapidly and almost completely (80 – 95%) is absorbed from the gastrointestinal tract to reach plasma concentration of 0.65 ug / ml (range 0.12 – 2 , 14 ug / ml). The mean time to maximum drug concentration in plasma was 2 hours 15 minutes (range: 1.25 – 4.75 h). The value of the area under the curve “concentration – time» (AUC 0- ~) h is 5.1 .mu.g / ml (range: 1.5 – 10.1 mcg hr / ml). There are no differences in pharmacokinetic parameters in patients with diabetes and in healthy individuals.
Distribution: gliquidone has high affinity to plasma proteins (> 99%). No data on the possible passage gliquidone or its metabolites through the blood-brain barrier or the placenta. No information about the possibility of penetration gliquidone into breast milk.
Metabolism: gliquidone completely metabolized in the liver, principally by demethylation and hydroxylation. Gliquidone metabolites have no or only mild pharmacological activity compared to the starting material.
Excretion: The majority of the metabolites derived through the intestine. The kidneys remove only a small portion of the metabolites. The studies have shown that after oral administration around 86% of the drug-labeled (14C) is output through the intestine. Regardless of the dose and mode of administration, kidneys displayed about 5% (as metabolites) of the introduced amount of the drug. GLYURENORMA excretion by the kidneys is minimal even with regular appointment. half-life is 1.2 hours (in the range – 0.4 – 3.0 hours), terminal half-life of approximately 8 hours (in the range – 5.7 – 9.4 hours).
Elderly patients: elderly patients and patients of middle age pharmacokinetic parameters are similar.
Patients with impaired renal and hepatic function: the bulk of the drug is excreted through the intestines. There is evidence that the metabolism of the drug is not altered in patients with hepatic insufficiency. Gliquidone excretion by the kidneys slightly in patients with impaired drug does not accumulate in renal function.
Pregnancy and breast-feeding
No data on the use of gliquidone in women during pregnancy and breastfeeding. In pregnancy, with concomitant diabetes requires careful monitoring of plasma glucose concentration. Use of oral hypoglycemic agents in women during pregnancy does not provide adequate glycemic control. Therefore, the use GLYURENORMA during pregnancy is contraindicated. In case of pregnancy or when planning a pregnancy during the period of application GLYURENORMA, the drug should be discontinued and a switch to insulin therapy. No data on the penetration gliquidone or its metabolites in breast milk. Application GLYURENORMA during breast-feeding is contraindicated.
Conditions of supply of pharmacies
On prescription.
side effects
From the blood and lymphatic system: thrombocytopenia, leukopenia, agranulocytosis.
From a metabolism: hypoglycaemia.
From the nervous system: headache, dizziness, somnolence, paresthesia, fatigue.
From a sight organ: accommodation disturbances.
Cardio-vascular system: angina, arrythmia, cardiovascular failure, hypotension.
On the part of the gastrointestinal tract: nausea, vomiting, constipation, diarrhea, abdominal discomfort, dry mouth, decreased appetite.
Of the liver and biliary tract: cholestasis.
Skin and subcutaneous tissue: skin rashes, pruritus, urticaria, Stevens-Johnson syndrome, photosensitivity reactions.
Other: pain in the chest.
special instructions
Patients with diabetes need to strictly comply with the doctor’s recommendation. Especially careful control is needed in the selection of a dose or when switching from another hypoglycemic drug. Oral hypoglycemic agents should not replace medical diet that allows you to monitor the patient’s body weight. Skipping meals or failure to follow the doctor’s recommendations can significantly lower blood glucose concentrations and lead to loss of consciousness. When taken before a meal tablets, and not as recommended at the beginning of a meal, the effect of the drug on the blood glucose concentration is more pronounced, thus increasing the risk of hypoglycemia. When the symptoms of hypoglycemia, you must take immediate food containing sugar. In the case of persistent hypoglycemic condition should consult a doctor immediately. Physical activity can enhance the hypoglycemic effect. Alcohol or stress may enhance or decrease the hypoglycemic action of sulfonylureas. Use of sulfonylureas in patients suffering from deficiency of glucose-6-phosphate dehydrogenase deficiency can lead to the development of hemolytic anemia. Since GLYURENORM relates to derivatives of sulfonylureas, care must be taken when using the drug in patients with deficiency of glucose-6-phosphate dehydrogenase and, if possible, it is necessary to take the decision to change the drug. GLYURENORMA One tablet contains 134.6 mg lactose (538.4 mg lactose maximum daily dose). Patients with rare hereditary disorders: galactosemia, lactase deficiency, glucose-galactose malabsorption and lactose intolerance should not take GLYURENORM. Gliquidone relates to short-acting sulphonylurea derivatives and therefore used in patients with type 2 diabetes with an increased risk of hypoglycemia, e.g., in older patients and patients with impaired renal function. Since the removal of the kidneys gliquidone slightly GLYURENORM can be used in patients with renal impairment and diabetic nephropathy. However, patients with severe renal insufficiency should be under close medical supervision. There is evidence that the use of gliquidone in patients with type 2 diabetes having liver related disease, effectively and safely. Only the removal of inactive metabolites in these patients somewhat delayed. However, patients with diabetes and concomitant severe hepatic impairment use of the drug is not recommended. During clinical studies revealed that the application GLYURENORMA for 18 and 30 months did not lead to an increase in body weight, even cases of weight loss were observed in 1 – 2 kg. In comparative studies with other sulfonylureas was proved that patients taking GLYURENORM more than a year no significant changes in body weight.
Effect on the ability to drive mechanisms and
No data on the effect of the drug on the ability to drive vehicles and mechanisms. However, patients should be warned about such manifestations of hypoglycemia as drowsiness, dizziness, disturbance of accommodation, which can occur in patients receiving the drug. Caution should be exercised when driving and mechanisms. If hypoglycemic states should avoid driving vehicles and mechanisms.
Storage conditions
Stored in a dry place at a temperature not higher than 25 C.
Keep out of the reach of children!.
Dosing and Administration
The drug is administered orally. It is necessary to comply with the doctor’s recommendation regarding dose and adherence to diet. You should not stop taking the drug without consulting your doctor.
The initial dose is typically 2.1 GLYURENORMA tablets (15 mg) at breakfast. The drug should be taken at the beginning of the meal. After receiving GLYURENORMA, eating should not be missed. If reception 1/2 tablet (15 mg) did not lead to an improvement, after consultation with the physician the dose should be gradually increased. If GLYURENORMA daily dose does not exceed 2 tablets (60 mg), it can be administered at once, during breakfast. When assigning a higher dose, the best effect can be achieved when receiving a daily dose, divided into 2-3 doses. In this case, the highest dose should be taken at breakfast. Increasing the dose to 4 tablets (120 mg) per day normally does not lead to further increases in efficacy. The maximum daily dose – 4 tablets (120 mg).
Acceptance of the drug in patients with impaired renal function. About 5% of the drug metabolites excreted by the kidneys. In patients with impaired renal function dose adjustment is not required
Acceptance of the drug in patients with impaired hepatic function. Receiving doses exceeding 75 mg in patients with impaired liver function requires careful monitoring of the patient. The drug should not be administered to patients with severe hepatic impairment, since 95% of the dose is metabolized in liver and excreted through the intestines.
combination therapy
If insufficient clinical effect GLYURENORM monotherapy can be recommended only additional metformin.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist