- Approval Id
- 10b2bb5dd3aa755c
- Drug Name
- SITAVITAE FILM-COATED TABLETS 50 MG
- Product Name
- SITAVITAE FILM-COATED TABLETS 50 MG
- Approval Number
- SIN17161P
- Approval Date
- 2025-01-08
- Registrant
- NOVEM HEALTHCARE PTE LTD
- Licence Holder
- NOVEM HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>4.2.1 Recommended Dosing</strong><br>
The recommended dose of Sitavitae is 100 mg once daily. Sitavitae can be taken with or without food.</p>
<p><strong>4.2.2 Patients with Renal Impairment</strong><br>
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sitavitae and periodically thereafter.</p>
<p>For patients with mild renal impairment (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m<sup>2</sup> to < 90 mL/min/1.73 m<sup>2</sup>), no dosage adjustment for SITAVITAE is required.</p>
<p>For patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m<sup>2</sup> to < 60 mL/min/1.73 m<sup>2</sup>), no dosage adjustment for Sitavitae is required.</p>
<p>For patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m<sup>2</sup> to < 45 mL/min/1.73 m<sup>2</sup>), the dose of Sitavitae is 50 mg once daily.</p>
<p>For patients with severe renal impairment (eGFR ≥ 15 mL/min/1.73 m<sup>2</sup> to < 30 mL/min/1.73 m<sup>2</sup>) or with end-stage renal disease (ESRD) (eGFR < 15 mL/min/1.73 m<sup>2</sup>), including those requiring hemodialysis or peritoneal dialysis, the dose of Sitavitae is 25 mg once daily. Sitavitae may be administered without regard to the timing of dialysis.</p>
<p><strong>4.2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin</strong><br>
When Sitavitae 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.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 INDICATIONS AND USAGE</strong></p>
<p><strong>4.1.1 Monotherapy</strong><br>
Sitavitae is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</p>
<p><strong>4.1.2 Combination with Metformin</strong><br>
Sitavitae 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.</p>
<p><strong>4.1.3 Combination with a Sulfonylurea</strong><br>
Sitavitae 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.</p>
<p><strong>4.1.4 Combination with a PPARγ agonist</strong><br>
Sitavitae 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.</p>
<p><strong>4.1.5 Combination with Metformin and a Sulfonylurea</strong><br>
Sitavitae 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.</p>
<p><strong>4.1.6 Combination with Insulin</strong><br>
Sitavitae 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.</p>
<p><strong>4.1.7 Important Limitations of Use</strong><br>
Sitavitae 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.<br>
Sitavitae 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 Sitavitae.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- A10BH01
- Pharma Manufacturer Name
- NOVEM HEALTHCARE PTE LTD
