BIOCON SITAGLIPTIN TABLETS USP 25MG [SIN17336P]

Product Info

BIOCON SITAGLIPTIN TABLETS USP 25MG

[SIN17336P]

Indication

4 INDICATION

4.1 Monotherapy
Sitagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

4.2 Combination with Metformin
Sitagliptin Tablets are 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.

4.3 Combination with a Sulfonylurea
Sitagliptin Tablets are 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.

4.4 Combination with a PPARγ agonist
Sitagliptin Tablets are 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.

4.5 Combination with Metformin and a Sulfonylurea
Sitagliptin Tablets are 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.

4.6 Combination with Insulin
Sitagliptin Tablets are 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.

4.7 Important Limitations of Use
Sitagliptin Tablets 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 Tablets have 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 Tablets. [See Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]

Dosing

5 DOSAGE AND ADMINISTRATION

5.1 Recommended Dosing
The recommended dose of Sitagliptin Tablets is 100 mg once daily. Sitagliptin Tablets can be taken with or without food.

5.2 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 Tablets 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 Tablets 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 Tablets 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 Tablets 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 Tablets is 25 mg once daily. Sitagliptin Tablets may be administered without regard to the timing of dialysis.

5.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When Sitagliptin Tablets are 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 Warnings and Precautions (5.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]

Contraindications

6 CONTRAINDICATIONS
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions (5.4); Adverse Reactions (6.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]