SITAGLIPTIN SANDOZ FILM COATED TABLET 50MG [SIN17123P]

Product Info

SITAGLIPTIN SANDOZ FILM COATED TABLET 50MG

[SIN17123P]

4.1 Therapeutic indications
Monotherapy
Sitagliptin Sandoz is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Combination with Metformin
Sitagliptin Sandoz is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycemic control.

Combination with a Sulfonylurea
Sitagliptin Sandoz is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control.

Combination with a PPARγ agonist
Sitagliptin Sandoz is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a PPARγ agonist (e.g., thiazolidinediones) when the single agent alone, with diet and exercise, does not provide adequate glycemic control.

Combination with Metformin and a Sulfonylurea
Sitagliptin Sandoz is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycemic control.

Combination with Insulin
Sitagliptin Sandoz is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycemic control.

Important Limitations of Use
Sitagliptin Sandoz 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.
Sitagliptin Sandoz has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin Sandoz (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
Recommended Dosing
The recommended dose of Sitagliptin Sandoz is 100 mg once daily.
Sitagliptin Sandoz can be taken with or without food.

Patients with Renal Impairment
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sitagliptin Sandoz and periodically thereafter.

For patients with mild renal impairment (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m² to < 90 mL/min/1.73 m²), no dosage adjustment for Sitagliptin Sandoz is required.

For patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m² to < 60 mL/min/1.73 m²), no dosage adjustment for Sitagliptin Sandoz is required.

For patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m² to < 45 mL/min/1.73 m²), the dose of Sitagliptin Sandoz is 50 mg once daily.

For patients with severe renal impairment (eGFR ≥ 15 mL/min/1.73 m² to < 30 mL/min/1.73 m²) or with end-stage renal disease (ESRD) (eGFR < 15 mL/min/1.73 m²), including those requiring hemodialysis or peritoneal dialysis, the dose of Sitagliptin Sandoz is 25 mg once daily. Sitagliptin Sandoz may be administered without regard to the timing of dialysis.

Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When Sitagliptin Sandoz is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric Use
Sitagliptin should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy.

A 54-week, double-blind study was conducted to evaluate the efficacy and safety of sitagliptin in pediatric patients (10 to 17 years of age) with type 2 diabetes who were not on anti-hyperglycaemic therapy for at least 12 weeks or were on a stable dose of insulin for at least 12 weeks. Patients were randomized and treated with sitagliptin 100 mg (N=95) or placebo (N=95) once daily for 20 weeks.

Treatment with sitagliptin 100 mg did not provide significant improvement in HbA_1c at 20 weeks.

In pediatric patients aged 10 to 17 years with type 2 diabetes, the profile of side effects was comparable to that observed in adults.

Sitagliptin has not been studied in pediatric patients under 10 years of age.

Geriatric Use
Of the total number of subjects (N=3884) in pre-approval clinical safety and efficacy studies of sitagliptin, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter (see sections 4.2 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
For oral administration.
Sitagliptin Sandoz can be taken with or without food.

4.3 Contraindications
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).