- Approval Id
- bbd3a7f314a57bad
- Drug Name
- DEXMEDETOMIDINE EVER PHARMA CONCENTRATE FOR SOLUTION FOR INFUSION 100 μG/ML
- Product Name
- DEXMEDETOMIDINE EVER PHARMA CONCENTRATE FOR SOLUTION FOR INFUSION 100 μG/ML
- Approval Number
- SIN17393P
- Approval Date
- 2025-11-12
- Registrant
- ALLIANCE PHARM PTE. LTD.
- Licence Holder
- ALLIANCE PHARM PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<ul>
<li>DEXMEDETOMIDINE EVER PHARMA dosing should be individualized and titrated to desired clinical response.</li>
<li>DEXMEDETOMIDINE EVER PHARMA is not indicated for infusions lasting longer than 24 hours.</li>
<li>DEXMEDETOMIDINE EVER PHARMA should be administered using a controlled infusion device.</li>
</ul>
<p><strong>Intensive Care Unit Sedation</strong></p>
<p>DEXMEDETOMIDINE EVER PHARMA should be administered by continuous infusion not to exceed 24 hours.</p>
<p>DEXMEDETOMIDINE EVER PHARMA has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue DEXMEDETOMIDINE EVER PHARMA prior to extubation.</p>
<p><u>Loading dose</u></p>
<p>For adult patients, it is recommended that administration of dexmedetomidine hydrochloride starts with a 1.0 mcg/kg loading dose administered over 10 minutes followed by a maintenance dose.</p>
<p>For adult patients already intubated and sedated who are being converted from alternate sedative therapy, a loading dose may not be required.</p>
<p><u>Maintenance dose</u></p>
<p>For adult patients, a maintenance infusion of 0.2 to 0.7 mcg/kg/hour is recommended. The rate of the maintenance infusion should be adjusted to achieve the desired level of sedation for optimal clinical effect.</p>
<p><u>Elderly patients</u></p>
<p>A dose reduction for both the loading and maintenance doses should be considered for patients over 65 years of age (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>).</p>
<p><u>Patients with renal impairment</u></p>
<p>No dose adjustment is required for patients with renal 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>Patients with hepatic impairment</u></p>
<p>Dexmedetomidine hydrochloride should be used with caution in adult patients with hepatic impairment. A dose reduction should be considered for both the loading and maintenance doses (see sections 4.4 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Procedural Sedation</strong></p>
<p><u>Loading dose</u></p>
<p>For adult patients, it is recommended that administration of dexmedetomidine hydrochloride starts with a 1.0 mcg/kg loading dose administered over 10 minutes followed by a maintenance dose.</p>
<p>For awake fiberoptic intubation in adult patients: a loading infusion of 1.0 mcg/kg over 10 minutes may be suitable.</p>
<p>For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable.</p>
<p><em>Elderly patients:</em> For patients over 65 years of age, a dose reduction in the loading dose to 0.5 mcg/kg over 10 minutes should be considered (see sections 4.4, 5.1 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Maintenance dose</u></p>
<p>The maintenance infusion is generally initiated at 0.6 mcg/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1.0 mcg/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation.</p>
<p>For awake fiberoptic intubation in adult patients: a maintenance infusion of 0.7 mcg/kg/hour is recommended until the endotracheal tube is secured.</p>
<p><em>Elderly patients:</em> A maintenance dose reduction should be considered in patients over 65 years of age (see sections 4.4, 5.1 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Patients with renal impairment</u></p>
<p>No dose adjustment is required for patients with renal 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>Patients with hepatic impairment</u></p>
<p>Dexmedetomidine hydrochloride should be used with caution in adult patients with hepatic impairment. A dose reduction should be considered for both the loading and maintenance doses (see sections 4.4 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Pediatric Use</strong></p>
<p>The efficacy and safety of dexmedetomidine in pediatric patients less than 18 years of age have not been established for Procedural or ICU Sedation. Therefore, dexmedetomidine is not recommended in this population (see sections 4.8 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><strong>Intensive Care Unit (ICU) Sedation</strong></p>
<p>DEXMEDETOMIDINE EVER PHARMA is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting.</p>
<p><strong>Procedural Sedation</strong></p>
<p>DEXMEDETOMIDINE EVER PHARMA is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to dexmedetomidine hydrochloride or to any of the excipients.</p>
