PRECEDEX CONCENTRATE FOR SOLUTION FOR INFUSION 100 MCG/ML (VIAL) [SIN11333P]

Product Info

PRECEDEX CONCENTRATE FOR SOLUTION FOR INFUSION 100 MCG/ML (VIAL)

[SIN11333P]

4.1 Therapeutic indications

Intensive Care Unit (ICU) Sedation

PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting.

Procedural Sedation

PRECEDEX is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

4.2 Posology and method of administration

• PRECEDEX dosing should be individualized and titrated to desired clinical response.

• PRECEDEX is not indicated for infusions lasting longer than 24 hours.

• PRECEDEX should be administered using a controlled infusion device.

Intensive Care Unit Sedation

PRECEDEX should be administered by continuous infusion not to exceed 24 hours.

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

Loading dose

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.

For adult patients already intubated and sedated who are being converted from alternate sedative therapy, a loading dose may not be required.

Maintenance dose

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.

Elderly patients

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal impairment

No dose adjustment is required for patients with renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Procedural Sedation

Loading dose

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.

For awake fiberoptic intubation in adult patients: a loading infusion of 1.0 mcg/kg over 10 minutes may be suitable.

For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable.

Elderly patients: 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Maintenance dose

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.

For awake fiberoptic intubation in adult patients: a maintenance infusion of 0.7 mcg/kg/hour is recommended until the endotracheal tube is secured.

Elderly patients: A maintenance dose reduction should be considered in patients over 65 years of age (see sections 4.4, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal impairment

No dose adjustment is required for patients with renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric Use

The efficacy and safety of PRECEDEX in pediatric patients less than 18 years of age have not been established for Procedural or ICU Sedation. Therefore, PRECEDEX is not recommended in this population (see sections 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to dexmedetomidine hydrochloride or to any of the excipients.