Each tablet contain :
- 50 mg vildagliptin and 1,000 mg metformin hydrochloride. yellow, ovaloid beveled edge, film-coated tablet.
ICANDRA Plus is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control:
- As initial therapy when diabetes is not adequately controlled by diet and exercise alone
- As therapy in patients inadequately controlled with metformin hydrochloride or vildagliptin alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets
- As combination therapy- in combination with other medicinal products(other OADs except GLP-I agonist ), including insulin,SGLT2,SUs& TZDs when these do not provide adequate glycemic control.
should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings
- Based on the patient’s current dose of vildagliptin and/or metformin, ICANDRA Plus may be initiated at either the 50 mg/500 mg or 50mg/850mg or 50mg/1000mg tablet strength twice daily, one tablet in the morning and the other in the evening. The recommended daily dose is 100mg vildagliptin plus 2000mg metformin hydrochloride.
- Patients receiving vildagliptin and metformin from separate tablets may be switched to ICANDRA Plus containing the same doses of each component.
- In treatment naïve patients, ICANDRA Plus may be initiated at 50mg/500 mg once daily and gradually titrated to a maximum dose of 50mg/1000 mg twice daily after assessing the adequacy of therapeutic response.
- The dose of ICANDRA Plus used in combination therapy with sulfonylurea (SU) or insulin would provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When used in combination with a sulfonylurea, a lower dose of the sulfonylurea may be considered to reduce the risk of hypoglycaemia. Initial combination therapy or maintenance of combination therapy should be individualized and are left to the discretion of the health care provider.
- Doses higher than 100mg of vildagliptin are not recommended.
- The use of antihyperglycaemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability.
- The recommended starting dose of ICANDRA Plus should be based on the patient’s current regimen of vildagliptin and/or metformin hydrochloride
- Hypersensitivity to the active substance
A box containing 30 film coated tablets.
combines two antihyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes:
- vildagliptin, a member of the DPP-4 (dipeptidyl-peptidase-4) inhibitor class
- metformin hydrochloride, a member of the biguanide class.
- Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl- peptidase4 (DPP-4) inhibitor that improves glycemic control. Vildagliptin inhibition of DPP4 results in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon- like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
- Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin hydrochloride stimulates intracellular glycogen synthesis by acting on glycogen synthase and increase the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4)