50 mg Uncoated Tablets
Each Tablet Contains 50 mg Vildagliptin.
Pack Size: 3*10 Blister
Therapeutic Indications
Vildagliptin is indicated in the Treatment of Type 2 Diabetes Mellitus in Adults:
As Monotherapy
As dual oral therapy in combination with
As triple oral therapy in combination with
Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycemic control.
Posology And Method Of Administration
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 Vildagliptin 50 mg once daily.
When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycemia.
Doses higher than 100 mg are not recommended.
If a dose of VGLIP 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.
Additional Information on Special Populations
Elderly (≥ 65 years)
No dose adjustments are necessary in elderly patients.
Renal Impairment
No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min). In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of VGLIP is 50 mg once daily.
Hepatic Impairment
VGLIP should not be used in patients with hepatic impairment, including patients with pretreatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN).
Pediatric Population
VGLIP is not recommended for use in children and adolescents (< 18 years). The safety and efficacy of VGLIP in children and adolescents (< 18 years) have not been established. No data are available.
Method of Administration
Oral Use
VGLIP can be administered with or without a meal.
Hypersensitivity to the active substance or to any of the excipients.
General
VGLIP is not a substitute for insulin in insulin-requiring patients. VGLIP 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 hemodialysis. Therefore VGLIP should be used with caution in these patients.
Hepatic Impairment
VGLIP should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN.
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 VGLIP in order to know the patient's baseline value. Liver function should be monitored during treatment with VGLIP 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 3x ULN or greater persist, withdrawal of VGLIP therapy is recommended.
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue VGLIP.
Following withdrawal of treatment with VGLIP and LFT normalization, treatment with VGLIP 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. Clinical experience in patients with NYHA functional class III treated with Vildagliptin is still limited and results are inconclusive.
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.
Skin Disorders
Skin lesions, including blistering and ulceration have been reported in extremities of monkeys in non-clinical toxicology studies (see section 5.3). Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications. 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.
Hypoglycemia
Sulphonylureas are known to cause hypoglycemia. Patients receiving Vildagliptin in combination with a sulphonylurea may be at risk for hypoglycemia. Therefore, a lower dose of sulphonylurea may be considered to reduce the risk of hypoglycemia.
Vildagliptin has a low potential for interactions with co-administered medicinal products. Since Vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.
Combination with Pioglitazone, Metformin and Glyburide
Results from studies conducted with these oral antidiabetics have shown no clinically relevant pharmacokinetic interactions.
Digoxin (Pgp Substrate), Warfarin (CYP2C9 Substrate)
Clinical studies performed with healthy subjects have shown no clinically relevant pharmacokinetic interactions. However, this has not been established in the target population.
Combination with Amlodipine, Ramipril, Valsartan or Simvastatin
Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin. In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with Vildagliptin.
Combination with ACE-Inhibitors
There may be an increased risk of angioedema in patients concomitantly taking ACE-inhibitors.
As with other oral antidiabetic medicinal products the hypoglycemic effect of Vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetic.
Pregnancy
There are no adequate data from the use of Vildagliptin in pregnant women. Studies in animals have shown reproductive toxicity at high doses. The potential risk for humans is unknown. Due to lack of human data, VGLIP should not be used during pregnancy.
Breast-Feeding
It is unknown whether Vildagliptin is excreted in human milk. Animal studies have shown excretion of Vildagliptin in milk. VGLIP should not be used during breast-feeding.
Fertility
Nostudies on the effect on human fertility have been conducted for VGLIP.
Effects on Ability to Drive and Use Machines
No studies on the effects on the ability to drive and use machines have been performed. Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines.