DEXMEDETOMIDINE B. BRAUN CONCENTRATE FOR SOLUTION FOR INFUSION 100 MICROGRAMS/ML [SIN16861P]

Product Info

DEXMEDETOMIDINE B. BRAUN CONCENTRATE FOR SOLUTION FOR INFUSION 100 MICROGRAMS/ML

[SIN16861P]

4.1 Therapeutic indications

Intensive Care Unit Sedation

Dexmedetomidine is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine should be administered by continuous infusion not to exceed 24 hours.

Dexmedetomidine has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexetomidine prior to extubation.

Procedural Sedation

For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

4.2 Posology and method of administration

Dosing Guidelines

• Dexmedetomidine B. Braun dosing should be individualized and titrated to desired clinical response.

• Dexmedetomidine B. Braun is not indicated for infusions lasting longer than 24 hours.

• Dexmedetomidine B. Braun should be administered using a controlled infusion device.

For sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting

For hospital use only. Dexmedetomidine B. Braun should be administered by healthcare professionals skilled in the management of patients requiring intensive care.

Posology

Initiation of Intensive Care Unit Sedation

For adult patients, a loading infusion of 1.0 mcg/kg over 10 minutes may be used. A dose reduction should be considered for patients over 65 years of age and adult patients with impaired hepatic function.

Maintenance of Intensive Care Unit Sedation

A maintenance infusion of 0.2 to 0.7 micrograms/kg/hr may be used, and may then be adjusted step-wise within the dose range in order to achieve the desired level of sedation, depending on the patient's response. A dose reduction should be considered for patients over 65 years of age and adult patients with impaired hepatic function. Dexmedetomidine B. Braun dosing should be individualized and titrated to desired clinical response.

For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

Initiation of Procedural Sedation

A loading infusion of 1.0 microgram/kg over 10 minutes. For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 micrograms/kg given over 10 minutes may be suitable. For patients over 65 years of age, a loading infusion of 0.5 micrograms/kg over 10 minutes can be given. A dose reduction should be considered for adult patients with impaired hepatic function.

For awake fiberoptic intubation in adult patients: a loading infusion of one mcg/kg over 10 minutes.

Maintenance of Procedural Sedation

The maintenance infusion is generally initiated at 0.6 microgram/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 microgram/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation. For awake fiberoptic intubation in adult patients, a maintenance infusion of 0.7 mcg/kg/hr is recommended until the endotracheal tube is secured. A dose reduction should be considered for patients over 65 years of age and adult patients with impaired hepatic function.

Dosage adjustments:

Due to possible pharmacodynamic interactions, a reduction in dosage of Dexmedetomidine B. Braun or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered.

Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients.

Special populations

Elderly

Elderly patients over 65 years of age appear to have an increased risk for hypotension (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). A dose reduction should be considered.

• Intensive Care Unit Sedation:

  A total of 729 patients in the clinical studies were 65 years of age and over. A total of 200 patients were 75 years of age and over. In patients greater than 65 years of age, a higher incidence of bradycardia and hypotension was observed following administration of Dexmedetomidine. Therefore, a dose reduction may be considered in patients over 65 years of age.

• Procedural Sedation:

  A total of 131 patients in the clinical studies were 65 years of age and over. A total of 47 patients were 75 years of age and over. Hypotension occurred in a higher incidence in Dexmedetomidine -treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). A reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age.

Renal impairment

No dose adjustment is required for patients with renal impairment.

Hepatic impairment

Dexmedetomidine is metabolised in the liver and should be used with caution in patients with hepatic impairment. A reduced maintenance dose may be considered (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

Safety and efficacy have not been established for Procedural or ICU Sedation in pediatric patients. One assessor-blinded trial in pediatric patients and two open-label studies in neonates were conducted to assess efficacy for ICU sedation. These studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of Dexmedetomidine for this patient population. One open-label study conducted in pediatric patients for procedural sedation also did not meet its efficacy endpoint.

Additional safety data from pediatric patients became available following completion of an open-label ICU sedation study (Japan). In the Japan ICU study, the safety profile of Dexmedetomidine was generally similar to that of adults, although increased frequencies of adverse events of bradycardia, hypotension, and respiratory depression were seen. Therefore, Dexmedetomidine is not recommended in this population.

Method of administration

Intravenous use.

Dexmedetomidine B. Braun must be administered only as a diluted intravenous infusion using a controlled infusion device. Dexmedetomidine B. Braun should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of Dexmedetomidine B. Braun, patients should be continuously monitored while receiving Dexmedetomidine B. Braun. For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Advanced heart block (grade 2 or 3) unless paced

• Uncontrolled hypotension

• Acute cerebrovascular conditions