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PRECEDEX is a brand name for Dexmedetomidine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Precedex® (Dexmedetomidine Hydrochloride for Injection, Dexmedetomidine Hydrochloride Injection) is indicated for: • Intensive Care Unit Sedation Precedex® is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting by continuous intravenous…
Verbatim from this product's HC label. Tap a section to expand.
0 Warnings and Precautions 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................
3 Reconstitution ......................................................................................................... 4 Administration .........................................................................................................
5 Missed Dose ............................................................................................................ 8 5 OVERDOSAGE...............................................................................................................
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2 Geriatrics Geriatrics (> 65 years of age): Dosage adjustment in this population is recommended (see 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS • Precedex® (Dexmedetomidine Hydrochloride for Injection, Dexmedetomidine Hydrochloride Injection) is contraindicated in patients who are hypersensitive to the active substance of this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
1 Dosing Considerations • Precedex® should be used only in facilities adequately staffed and equipped for anesthesia, resuscitation, and cardiovascular monitoring. • Precedex® is indicated for short-term intravenous sedation. Precedex® should not be generally used for duration longer than 24 hours.
Its continued use beyond 24 hours should be determined based on careful assessment of the patient’s conditions. • Precedex® should be administered using a controlled infusion device with adequate precision. • Respiration should be monitored in non-intubated patients because of the risk of respiratory depression and in some cases apnoea.
• Dosage must be individualized and titrated to the desired clinical effect. Patient Counselling Information • Patients should be informed blood pressure, heart rate and oxygen levels will be monitored both continuously during the infusion of Precedex® and as clinically appropriate after discontinuation.
• When Precedex® is infused for more than 6 hours, patients should be informed to report nervousness, agitation, and headaches that may occur for up to 48 hours after discontinuation of Precedex®. • Additionally, patients should be informed to report symptoms that may occur within 48 hours after the administration of Precedex® such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness, or light-headedness.
General Dexmedetomidine hydrochloride is for hospital use only. It 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 hydrochloride, patients should be continuously monitored (MAC: Monitored Anesthesia Care) for early signs of hypotension, hypertension, bradycardia, respiratory depression, airway obstruction, apnoea, dyspnoea and/or oxygen desaturation while receiving Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous infusion Solution, 100 mcg/mL dexmedetomidine hydrochloride (Concentrate) Sodium Chloride and Water for Injection Intravenous infusion Solution, 4 mcg/mL dexmedetomidine hydrochloride (Ready to Use) Sodium Chloride and Water for Injection PRECEDEX (dexmedetomidine hydrochloride for Injection; dexmedetomidine hydrochloride Injection) Page 10 of 34 Dexmedetomidine hydrochloride.
Supplemental oxygen should be immediately available and provided when indicated. Risk of mortality In a published pragmatic controlled trial (SPICE III), 3904 ventilated critically ill adult intensive care unit (ICU) patients were randomized to either dexmedetomidine hydrochloride as primary sedative or usual care.
1% in both groups), but heterogeneity of effect from age on mortality was observed. 9). 56) compared to usual care. Although the mechanism is not known, the heterogeneity of effect from age on mortality was most prominent in patients admitted for reasons other than post-operative care and increased with the increasing severity of disease as per Acute Physiology and Chronic Health Evaluation (APACHE) II scores (without the age component).
The significance of these findings is unknown, but they should be weighed against the clinical benefit expected from dexmedetomidine hydrochloride compared to alternative sedatives in younger patients.
• Precedex® (Dexmedetomidine Hydrochloride for Injection, Dexmedetomidine Hydrochloride Injection) is contraindicated in patients who are hypersensitive to the active substance of this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING PRECEDEX (dexmedetomidine hydrochloride for Injection; dexmedetomidine hydrochloride Injection) Page 5 of 34
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. • Precedex® is used for adult patients already intubated and sedated in an intensive care setting.
• An assessment of the level of sedation and the need for Precedex® should precede the initiation of Precedex®. PRECEDEX (dexmedetomidine hydrochloride for Injection; dexmedetomidine hydrochloride Injection) Page 6 of 34 Maintenance The rate of the maintenance infusion should be adjusted to achieve the optimal level of sedation for optimal clinical effect.
7 mcg/kg/hour is recommended. 7 mcg/kg/hr. 1 mcg/kg/hr. 4 mcg/kg/hr should not be attempted. • Precedex® use beyond 24 hours must be assessed individually. Patients must be assessed at regular intervals for the need to continuing sedation.
The experience of Precedex® longer than 4 days is limited. g. midazolam or propofol) may be added according to clinical assessment. Opioids or neuromuscular blocking agents may also be used, based on individual assessment. • The need for Precedex® continuous infusion post-extubation must be assessed individually.
In post- surgical ICU patients exposed for <24 hours, the dose of Precedex® should be reduced by half after extubation. 6 hours. Conscious Sedation • Based on the Ramsay and Observer’s Assessment of Alertness/Sedation Scales, the loading infusion provides clinically effective onset of sedation 10 to 15 minutes after start of infusion.
• For use in Monitored Anesthesia Care, an adequate nerve block and/or local infiltration should be used. • For Awake Fiberoptic Intubation, the upper airway should be topicalized with proper lidocaine formulations. 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 mcg/kg over 10 minutes may be suitable. 5 mcg/kg given over 10 minutes may be suitable. 5 mcg/kg over 10 minutes should be considered. Maintenance • The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation.
2 to 1 mcg/kg/hr. 7 mcg/kg/hr is recommended until the endotracheal tube is secured. Dosage Adjustment for ICU Sedation and Conscious Sedation Due to possible pharmacodynamic interactions, a reduction in dosage of Precedex® or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered.
Geriatric:
A dose reduction for both the loading and maintenance infusions should be […]
Cardiovascular Hypotension, Bradycardia and Sinus Arrest:
Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine hydrochloride administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration.
Reports of hypotension and bradycardia have been associated with dexmedetomidine hydrochloride infusion. Some of these cases have resulted in fatalities. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex®, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents.
Because dexmedetomidine hydrochloride has the potential to augment bradycardia induced by vagal stimuli; clinicians should be prepared to intervene. , glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of dexmedetomidine hydrochloride induced bradycardia.
However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering dexmedetomidine hydrochloride to patients with advanced heart block and/or severe ventricular dysfunction.
Because dexmedetomidine hydrochloride decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients.
PRECEDEX (dexmedetomidine hydrochloride for Injection; dexmedetomidine hydrochloride Injection) Page 11 of 34 In situations where other vasodilators or negative chronotropic agents are administered, co- administration of dexmedetomidine hydrochloride could have an additive pharmacodynamic effect and should be administered with caution.
Transient Hypertension:
Transient hypertension has been observed during the loading dose and maintenance period in association with the peripheral vasoconstrictive effects of dexmedetomidine hydrochloride in some patients. Transient hypertension is often referred to as paradoxical hypertension in the literature.
Reduction of the infusion rate may be desirable. Treatment with a vasodilator may be needed. The use of other concomitant medications with an effect on the cardiovascular system should be reviewed to rule out potential drug interactions.
Dependence/Tolerance Precedex® is not a controlled substance under the Controlled Drugs and Substances Act, but it is used only by health care professionals. The dependence potential of dexmedetomidine hydrochloride has not been studied in humans.
Precedex® exhibits pharmacologic actions similar to those of clonidine, it may be possible that dexmedetomidine hydrochloride produces a clonidine-like withdrawal syndrome upon discontinuation. Endocrine and Metabolism The available evidence is inadequate to confirm if dexmedetomidine hydrochloride is associated with significant adrenocortical suppression.
The adequacy of the adrenocortical function should be individually assessed and managed. Hyperthermia Dexmedetomidine hydrochloride may induce hyperthermia that may be resistant to traditional cooling methods. Precedex® should be discontinued in the event of a sustained […]