Indications
This 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.
Therapeutic Class
Combination Oral hypoglycemic preparations
Dosage & Administration
Adults: Based on the patient’s current dose of Metformin, Vildagliptin and Metformin 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 Vildagliptin and Metformin 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 Vildagliptin and Metformin with or just after food may reduce gastrointestinal symptoms associated with Metformin.
Interaction
In pharmacokinetic studies, no interactions were seen with pioglitazone, metformin, glibenclamide, digoxin, warfarin, amlodipine, ramipril, valsartan or simvastatin. As with other oral antidiabetic medicinal products the glucose-lowering effect of Vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics. Close monitoring of glycemic control is required, when cationic drugs are co-administered. Glucocorticoids, beta 2 agonists, diuretics and ACE inhibitors may alter blood glucose. The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment. If necessary, the dosage of Vildagliptin & Metformin tablets may need to be
Side Effects
The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. Lactic acidosis can occur due to Metformin. Rare cases of hepatic dysfunction. Some common side effects like tremor, headache, dizziness, nausea, hypoglycaemia, fatigue are seen. Clinical trials of up to and more than 2 years duration did not show any additional safety signals or unforeseen risks when use this combinatin.
Pregnancy & Lactation
PREGNANCY: There are no adequate data on the use of Vildagliptin & Metformin in pregnant women; hence the potential risk for human is unknown.
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