- Approval Id
- 9ca580cbc0dd1b1f
- Drug Name
- DAPIFLOZIN 10 TABLET 10MG
- Product Name
- DAPIFLOZIN 10 TABLET 10MG
- Approval Number
- SIN17276P
- Approval Date
- 2025-07-04
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Type 2 diabetes mellitus</strong></p>
<p>The recommended dose of Dapagliflozin is 10 mg taken orally once daily at any time of the day regardless of meals.</p>
<p><strong>Special populations</strong></p>
<p><em><u><strong>Patients with renal impairment</strong></u></em></p>
<p>No dosage adjustment is required based on renal function.</p>
<p>Due to limited experience, it is not recommended to initiate treatment with Dapagliflozin in patients with GFR < 25 mL/min, however patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, end-stage kidney disease and CV death.</p>
<p>The glucose lowering efficacy of Dapagliflozin is reduced in patients with eGFR <45 mL/min/1.73 m<sup>2</sup>. Therefore, if eGFR falls below 45 mL/min/1.73 m<sup>2</sup>, additional glucose lowering treatment should be considered in patients with diabetes mellitus.</p>
<p><em><u><strong>Patients with hepatic impairment</strong></u></em></p>
<p>No dosage adjustment for Dapagliflozin is necessary for patients with mild and moderate hepatic impairment. Dapagliflozin should not be used in patients with severe hepatic impairment.</p>
<p><em><u><strong>Pediatric and adolescent patients</strong></u></em></p>
<p>Safety and effectiveness of Dapagliflozin in pediatric and adolescent patients have not been established.</p>
<p><em><u><strong>Geriatric patients</strong></u></em></p>
<p>No dosage adjustment for Dapagliflozin is required based on age (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Older patients are more likely to have impaired renal function. The renal function recommendations provided for all patients also apply to elderly patients (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><strong>Type 2 diabetes mellitus</strong></p>
<p>Dapiflozin is indicated in adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise. Dapagliflozin can be given as monotherapy or in combination with other medicinal products indicated for the treatment of type 2 diabetes mellitus.</p>
<p>For study results with respect to combination of therapies, effects on glycemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Dapagliflozin is not indicated for use in patients with type 1 diabetes.</p>
<p>Dapagliflozin should not be used for the treatment of diabetic ketoacidosis.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Dapagliflozin is contraindicated in patients with a history of any serious hypersensitivity reaction to the active substance or to any of the excipients.</p>
