If necessary, the dosage of Eucreas may need to be adjusted during concomitant therapy and on its discontinuation.Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels. Eucreas may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.- For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy:The starting dose of Eucreas should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.- For patients switching from co-administration of vildagliptin and metformin as separate tablets:Eucreas should be initiated at the dose of vildagliptin and metformin already being taken.- For patients inadequately controlled on dual combination with metformin and a sulphonylurea:The doses of Eucreas should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
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Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. Findings were only observed in association with maternal toxicity at ≥ 150 mg/kg and included a transient decrease in body weight and reduced motor activity in the F1 generation.A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose).
Sono stati osservati effetti solo in associazione a tossicità materna con ≥ 150 mg/kg e comprendenti una transitoria riduzione di peso corporeo ed una ridotta attività motoria nella generazione F1.E’ stato eseguito uno studio di carcinogenesi nei ratti della durata di due anni con dosi orali fino a 900 mg/kg (circa 200 volte l’esposizione nell’uomo alla dose massima raccomandata). Cada comprimido recubierto con película de Eucreas 50 mg/850 mg contiene 50 mg de vildagliptina y 850 mg de hidrocloruro de metformina (correspondientes a 660 mg de metformina). Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:- a significant reduction in the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034;- a significant reduction in the absolute risk of diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017;- a significant reduction in the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021);- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years (p=0.01).Vildagliptin added to patients whose glycaemic control was not satisfactory despite treatment with metformin monotherapy resulted after 6-month treatment in additional statistically significant mean reductions in HbAIn a 24-week trial, vildagliptin (50 mg twice daily) was compared to pioglitazone (30 mg once daily) in patients inadequately controlled with metformin (mean daily dose: 2020 mg).
A no-effect level was not established.A fertility and early embryonic development study in rats revealed no evidence of impaired fertility, reproductive performance or early embryonic development due to vildagliptin. Per prevenirli si raccomanda di assumere la metformina in 2 dosi giornaliere, durante o dopo i pasti. To prevent them, it is recommended that metformin be taken in 2 daily doses during or after meals.
Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.Use of vildagliptin has been associated with a risk of developing acute pancreatitis. These were consistently located on the extremities (hands, feet, ears and tail). Flaking skin, peeling skin, scabs and tail sores with correlating histopathological changes were noted at doses ≥ 20 mg/kg/day (approximately 3 times human AUC exposure at the 100 mg dose). After 1 year, mean reductions in HbAIn a 24-week trial the efficacy of the fixed dose combination of vildagliptin and metformin (gradually titrated to a dose of 50 mg/500 mg twice daily or 50 mg/1000 mg twice daily) as initial therapy in drug-naïve patients was evaluated. Eucreas 50 mg… However, vildagliptin cannot be removed by haemodialysis, although the major hydrolysis metabolite (LAY 151) can. Eucreas 50 mg/850 mg филмирани таблетки са жълти, елипсовидни таблетки с “NVR” от едната страна и “SEH” от другата. The mean volume of distribution (VMetformin is excreted unchanged in the urine. Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/kg (59-fold human exposure) and 100 mg/kg (16-fold human exposure), respectively.
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