PANSIPTIN FILM COATED TABLETS 100MG

SAG MANUFACTURING, S.L.U. (SPAIN)🇸🇬 Health Sciences Authority

Approval Date: Mar 4, 2025
Approval ID: 2c940de62ec06201
Company: SAG MANUFACTURING, S.L.U. (SPAIN)
Type: Therapeutic

Approval Details

Approval Id: 2c940de62ec06201
Drug Name: PANSIPTIN FILM COATED TABLETS 100MG
Product Name: PANSIPTIN FILM COATED TABLETS 100MG
Approval Number: SIN17192P
Approval Date: 2025-03-04
Registrant: GOLDPLUS UNIVERSAL PTE LTD
Licence Holder: GOLDPLUS UNIVERSAL PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Dosage: DOSAGE AND ADMINISTRATION Recommended Dosing The recommended dose of Sitagliptin is 100 mg once daily. Sitagliptin can be taken with or without food. Recommendations For Use In Renal Impairment Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sitagliptin 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 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 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 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 is 25 mg once daily. Sitagliptin may be administered without regard to the timing of dialysis. Concomitant use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin When Sitagliptin 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.
Route Of Administration: ORAL
Indication Info: INDICATIONS: Monotherapy Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Combination with Metformin Sitagliptin 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 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 is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a PPARY 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 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 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 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 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.
Contraindications: CONTRAINDICATION History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
Atc Code: A10BH01
Pharma Manufacturer Name: GOLDPLUS UNIVERSAL PTE LTD

Active Ingredients

Sitagliptin HCl monohydrate eqv Sitagliptin

100.00mg

Sitagliptin HCl monohydrate eqv Sitagliptin

100.00mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 4, 2025

Approval ID

2c940de62ec06201

Type

Therapeutic

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