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VILDAGLIPTIN is a brand name for Vildagliptin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults: As monotherapy • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. As dual oral therapy in combination with • metformin, in patients with…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than 50 mg vildagliptin once daily.
When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia. Doses higher than 100 mg are not recommended. If a dose of Vildagliptin Kappler is missed, it should be taken as soon as the patient remembers.
A double dose should not be taken on the same day. The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established. 2). Renal impairment No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min).
2). 2). Paediatric population Vildagliptin Kappler is not recommended for use in children and adolescents (< 18 years). The safety and efficacy of Vildagliptin Kappler in children and adolescents (< 18 years) have not been established.
1). 2).
Summary of the safety profile Safety data were obtained from a total of 3,784 patients exposed to vildagliptin at a daily dose of 50 mg (once daily) or 100 mg (50 mg twice daily or 100 mg once daily) in controlled trials of at least 12 weeks duration.
Of these patients, 2,264 patients received vildagliptin as monotherapy and 1,520 patients received vildagliptin in combination with another medicinal product. 2,682 patients were treated with 100 mg vildagliptin daily (either 50 mg twice daily or 100 mg once daily) and 1,102 patients were treated with 50 mg vildagliptin once daily.
The majority of adverse reactions in these trials were mild and transient, not requiring treatment discontinuations. No association was found between adverse reactions and age, ethnicity, duration of exposure or daily dose. Rare cases of hepatic dysfunction (including hepatitis) have been reported.
In these cases, the patients were generally asymptomatic without clinical sequelae and liver function returned to normal after discontinuation of treatment. 2% for 50 mg vildagliptin once daily, 50 mg vildagliptin twice daily and all comparators, respectively.
These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice. Rare cases of angioedema have been reported on vildagliptin at a similar rate to controls. A greater proportion of cases were reported when vildagliptin was administered in combination with an angiotensin converting enzyme inhibitor (ACE-Inhibitor).
The majority of events were mild in severity and resolved with ongoing vildagliptin treatment. Tabulated list of adverse reactions Adverse reactions reported in patients who received vildagliptin in double- blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
General Vildagliptin is not a substitute for insulin in insulin-requiring patients. Vildagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Renal impairment There is limited experience in patients with ESRD on haemodialysis.
2). 2). Liver enzyme monitoring Rare cases of hepatic dysfunction (including hepatitis) have been reported. In these cases, the patients were generally asymptomatic without clinical sequelae and liver function test results returned to normal after discontinuation of treatment.
Liver function tests should be performed prior to the initiation of treatment with vildagliptin in order to know the patient’s baseline value. Liver function should be monitored during treatment with vildagliptin at three-month intervals during the first year and periodically thereafter.
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality(ies) return(s) to normal.
Should an increase in AST or ALT of 3 x ULN or greater persist, withdrawal of vildagliptin therapy is recommended. Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue vildagliptin. Following withdrawal of treatment with vildagliptin and LFT normalisation, treatment with vildagliptin should not be reinitiated.
Cardiac failure A clinical trial of vildagliptin in patients with New York Heart Association (NYHA) functional class I-III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo.
1). There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class IV and therefore use is not recommended in these patients. 3). Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Combination with metformin Table 1 Adverse reactions reported in patients who received 100 mg vildagliptin daily in combination with metformin in double-blind studies (N=208) Metabolism and nutrition disorders Common Hypoglycaemia.
Nervous system disorders Common Tremor, headache, dizziness. Uncommon Fatigue. Gastrointestinal disorders Common Nausea. Description of selected adverse reactions In controlled clinical trials with the combination of 100 mg vildagliptin daily + metformin, no withdrawal due to adverse reactions was reported in either the 100 mg vildagliptin daily + metformin or the placebo + metformin treatment groups.
4 %). No severe hypoglycaemic events were reported in the vildagliptin arms. 0 kg for vildagliptin and placebo, respectively). Clinical trials of up to more than 2 years’ duration did not show any additional safety signals or unforeseen risks when vildagliptin was added on to metformin.
Combination with a sulphonylurea Table 2 Adverse reactions reported in patients who received 50 mg vildagliptin in combination with a sulphonylurea in double-blind studies (N=170) Infections and infestations Very rare Nasopharyngitis.
Metabolism and nutrition disorders Common Hypoglycaemia. Nervous system disorders Common Tremor, headache, dizziness, asthenia. Gastrointestinal disorders Uncommon Constipation. 6 % in the 50 mg vildagliptin + sulphonylurea vs 0 % in the placebo + sulphonylurea treatment group.
6 % for placebo + glimepiride. No severe hypoglycaemic events were reported in the vildagliptin arms. 4 kg for vildagliptin and placebo, respectively). Combination with a thiazolidinedione Table 3 Adverse reactions reported in patients who received 100 mg vildagliptin daily in combination with a thiazolidinedione in double-blind studies (N=158) Metabolism and nutrition disorders Common Weight increase.
Uncommon Hypoglycaemia. Nervous system disorders Uncommon Headache, asthenia. Vascular disorders Common Oedema peripheral. Description of selected adverse reactions In controlled clinical trials with the combination of 100 mg vildagliptin daily+ a thiazolidinedione, no withdrawal due to adverse reactions was reported in either the 100 mg vildagliptin daily + thiazolidinedione or the placebo + thiazolidinedione treatment groups.
9 %). No severe hypoglycaemic events were reported in the vildagliptin arms. 7 kg, respectively. The incidence of peripheral oedema when 100 mg vildagliptin daily was added […]
Furthermore, there have been post-marketing reports of bullous and exfoliative skin lesions. Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Acute pancreatitis Use of vildagliptin has been associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis. If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted.
Caution should be exercised in patients with a history of acute pancreatitis. Hypoglycaemia Sulphonylureas are known to cause hypoglycaemia. Patients receiving vildagliptin in combination with a sulphonylurea may be at risk for hypoglycaemia.
Therefore, a lower dose of sulphonylurea may be considered to reduce the risk of hypoglycaemia. Excipients Vildagliptin Kappler contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Vildagliptin Kappler contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.