Gluvan Plus (Vildagliptin + Metformin Hydrochloride)

Therapeutic Group : Antidiabetic

Presentation:

Gluvan Plus 500 Tablet: Each film coated tablet contains Vildagliptin INN 50 mg & Metformin Hydrochloride BP 500 mg.
Gluvan Plus 850 Tablet: Each film coated tablet contains Vildagliptin INN 50 mg & Metformin Hydrochloride BP 850 mg.

Indications:

Gluvan Plus is indicated as an adjunct to diet and exercises to improve glycaemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on Metformin Hydrochloride or Vildagliptin alone or who are already treated with the combination of Vildagliptin and Metformin Hydrochloride, as separate tablets.

Dosage & Administration:

Adults: Based on the patient’s current dose of Metformin, Gluvan Plus may be initiated at either 50 mg/500 mg or 50 mg/850 mg twice daily, 1 tablet in the morning and the other in the evening. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to Gluvan Plus containing the same doses of each component. Doses higher than 100 mg of vildagliptin are not recommended. There is no clinical experience of Vildagliptin and Metformin in triple combination with other antidiabetic agents. Taking Gluvan Plus with or just after food may reduce gastrointestinal symptoms associated with Metformin.

Contrainidications:

This combination is contraindicated in patients with known hypersensitivity to Vildagliptin or Metformin Hydrochloride or to any of the excipients. It is contraindicated in patients with renal disease or renal dysfunction, acute myocardial infarction, and septicaemia. It is also contraindicated in patients with congestive heart failure patients and in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

Side effects:

The most common side effects are headache, tremor, dizziness, nausea, hypoglycaemia etc.

Drug interaction:

No clinically relevant pharmacokinetic interaction was observed when Vildagliptin (100 mg once daily) was co-administered with Metformin Hydrochloride (1,000 mg once daily). Vildagliptin has a low potential for drug interactions. Since Vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate nor does it inhibit nor induces CYP 450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes. As a result of these studies no clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin hydrochloride), amlodipine, digoxin, ramipril, Simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. On the other hand, Furosemide, Nifedipine and glyburide increase Cmax and blood AUC of Metformin with no change in renal clearance of Metformin.

Use in special groups:

Use in pregnancy:
There are no adequate and well controlled studies in pregnant women and therefore, Gluvan Plus should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.

Use in lactation:
No studies have been conducted with the components of this combination. As it is not known whether Vildagliptin and/or Metformin Hydrochloride is excreted in human milk this combination should not be administered to breast-feeding women.

Use in pediatric patients:
The safety and effectiveness of this combination in pediatric patients have not been established. Therefore, this combination is not recommended for use in children below 18 years of age.

Use in geriatric patients:
As Metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking this combination should have their renal function monitored regularly. This combination should only be used in elderly patients with normal renal function.

Patients with renal impairment:
This combination should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels > 1.5 mg/dL (>135 micro mol/L) in males and > 1.4 mg/dL (>110 micro mol/L) in females.

Patients with hepatic impairment:
This combination is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >3 X the upper limit of normal.

Packing:

Gluvan Plus 500 Tablet: Each box contains 20’s tablets in alu-alu blister pack.
Gluvan Plus 850 Tablet: Each box contains 20’s tablets in alu-alu blister pack.