BIOCON SITAGLIPTIN TABLETS USP 50MG

BIOCON PHARMA LIMITED (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Sep 19, 2025
Approval ID: 18c08d267b2082a7
Company: BIOCON PHARMA LIMITED (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 18c08d267b2082a7
Drug Name: BIOCON SITAGLIPTIN TABLETS USP 50MG
Product Name: BIOCON SITAGLIPTIN TABLETS USP 50MG
Approval Number: SIN17337P
Approval Date: 2025-09-19
Registrant: TAEVAS LIFE SCIENCES PTE LTD
Licence Holder: FREYR LIFE SCIENCES PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 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.]
Route Of Administration: ORAL
Indication Info: 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.]
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.]

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 19, 2025

Approval ID

18c08d267b2082a7

Type

Therapeutic

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