Description
Each tablet contain :
- Vildagliptin 50MG film-Coated tablets
ICANDRA 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 insufficient glycemic control despite maximal tolerated dose of monotherapy with metformin
- Sulphonyl urea, in patients with insufficient glycemic control despite maximal tolerated dose of a sulphonyl urea and for whom metformin is inappropriate due to contraindications or intolerance,
- Thiazolidinedione ,in patients with insufficient glycemic control and for whom the use of TZDs is appropriate
As triple oral therapy in combination with:
- A Sulphonyl urea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycemic control .ICANDRA 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
Adults
(When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonyl urea, or in combination with insulin (with or without metformin))
- the recommended daily dose of ICANDRA
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 Sulphonyl urea , the recommended dose of ICANDRA is 50 mg once daily administered in the morning . in this patient population, Vildagliptin 100 mg daily was no more effective than ICANDRA 50 mg once daily.
- When used in combination with a sulphonyl urea, a lower dose of the sulphonyl urea may be considered to reduce the risk of hypoglycemia
Note:- ( If a dose of ICANDRA is missed, it should be taken as soon as the patient remembers A double dose should not be taken on the same day)
Elderly(65)
- 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 vildagliptin is 50 mg once daily
- Hypersensitivity to the active substance
A box containing 30 film coated tablets.
Pharmacodynamic effects (PD)
By increasing the endogenous levels of these incretin hormones,
- vildagliptin enhances the sensitivity of beta cells to glucose, resulting in improved glucose-dependent insulin secretion.
Treatment with vildagliptin 50/100- mg daily in patients with type 2 diabetes
- significantly improved markers of beta cell function including HOMA-ß (Homeostasis Model Assessment- ),
- proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Note:-In non-diabetic (normal glycemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels. By increasing endogenous GLP-1 levels.
- vildagliptin, also enhances the sensitivity of alpha cells to glucose, resulting in more glucose-appropriate glucagon secretion .
- The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia .
- The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment.
