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Vildagliptin in combination with metformin and glimepiride significantly decreased HbAA 24-week randomised, double-blind, placebo-controlled trial was conducted in 449 patients to evaluate the efficacy and safety of vildagliptin (50 mg twice daily) in combination with a stable dose of basal or premixed insulin (mean daily dose 41 units), with concomitant use of metformin (N=276) or without concomitant metformin (N=173). Talk to your doctor if vomiting persists and you notice signs of dehydration, like dark colored and strong-smelling urine and a low frequency of urination. No severe hypoglycaemic events were reported in the vildagliptin arms.In the pioglitazone add-on study, the absolute weight increases with placebo, Galvus 100 mg daily were 1.4 and 2.7 kg, respectively.The incidence of peripheral oedema when vildagliptin 100 mg daily was added to a maximum dose of background pioglitazone (45 mg once daily) was 7.0%, compared to 2.5% for background pioglitazone alone.In addition, in controlled monotherapy trials with vildagliptin the overall incidence of withdrawals due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).Clinical trials of up to 2 years' duration did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy.There were no withdrawals due to adverse reactions reported in the vildagliptin + metformin + glimepiride treatment group versus 0.6% in the placebo + metformin + glimepiride treatment group.The incidence of hypoglycaemia was common in both treatment groups (5.1% for the vildagliptin + metformin + glimepiride group versus 1.9% for the placebo + metformin + glimepiride group). Galvus Met 50mg/1000mg Tablet should be used with caution in patients with kidney disease. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. 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). 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). The composite endpoint of adjudicated major adverse cardiovascular events (MACE) including acute myocardial infarction, stroke or cardiovascular death was similar for vildagliptin versus combined active and placebo comparators [Mantel–Haenszel risk ratio (M-H RR) 0.82 (95% CI 0.61-1.11)]. However, now I'm experiencing erectile dysfunction from past one month. 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Galvumet 50 mg/850 mg tablets Galvumet 50 mg/1000 mg tablets (vildagliptin/ metformin hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vildagliptin: (S)-1-[2-(3-Hydroxy-adamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile Of these patients, 2,264 patients received vildagliptin as monotherapy and 1,520 patients received vildagliptin in combination with another medicinal product. At 400 mg, there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels. Symptoms of lactic acidosis may include muscle pain or weakness, dizziness, tiredness, feeling of cold in arms and legs, difficulty in breathing, nausea, vomiting, stomach pain or slow heart rate. You can also order Ayurvedic, Homeopathic and other Over-The-Counter (OTC) health products. So, regular monitoring of blood sugar level is important. Macquarie Park, New South Wales: Novartis Pharmaceuticals Australia Pty Limited; 2010 [revised 8 Nov. 2018]. Nuremberg, Germany: Novartis Pharma GmbH; 2018. A MACE occurred in 83 out of 9,599 (0.86%) vildagliptin-treated patients and in 85 out of 7,102 (1.20%) comparator-treated patients. It lowers the glucose production in the liver, delays glucose absorption from the intestines and increases the body's sensitivity to insulin. Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications. More than 1,900 patients receiving vildagliptin 50 mg once daily or 100 mg daily were ≥ 65 years. More than 5,000 male and more than 4,000 female patients received vildagliptin 50 mg once daily or 100 mg daily. [Accessed 22 Jan. 2019] (online) Available from:Vildagliptin/metformin hydrochloride. The exposure to vildagliptin after a single dose in patients with mild and moderate hepatic impairment was decreased (20% and 8%, respectively), while the exposure to vildagliptin for patients with severe impairment was increased by 22%.

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