- Approval Id
- 87af1486137f87dd
- Drug Name
- Dapavid Film-Coated Tablets 10mg
- Product Name
- Dapavid Film-Coated Tablets 10mg
- Approval Number
- SIN17389P
- Approval Date
- 2025-11-10
- Registrant
- HOVID PTE. LTD.
- Licence Holder
- HOVID 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>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><u><em><strong>Renal impairment</strong></em></u></p>
<p>No dosage adjustment is required based on renal function.</p>
<p>It is not recommended to initiate treatment with Dapagliflozin in patients with GFR <25 mL/min due to limited experience. 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> (see sections 4.4 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). 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><u><em><strong>Hepatic impairment</strong></em></u></p>
<p>No dosage adjustment is required for patients with mild and moderate hepatic impairment. Dapagliflozin should not be used in patients with severe hepatic impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u><em><strong>Paediatric</strong></em></u></p>
<p>The safety and efficacy of Dapagliflozin in children aged 0 to < 18 years have not yet been established. No data are available.</p>
<p><u><em><strong>Elderly</strong></em></u></p>
<p>No dosage adjustment 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>). However, older population is more likely to have impaired renal function, therefore recommendations related to renal function 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>Dapagliflozin is indicated in adults aged 18 years and older 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 and 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 hypersensitivity to the active substances or to any of the excipients of DAPAVID.</p>
