Icunes Special Precautions

Monitoring: Dexmedetomidine injection is intended for use in an intensive care setting and use in other environments is not recommended. All patients should have continuous cardiac monitoring during Dexmedetomidine infusion. Respiration should be monitored in non-intubated patients due to the risk of respiratory depression and in some case apnoea.
General precautions: Since Dexmedetomidine injection should not be administered by loading or bolus dose, users should be ready to use an alternative sedative for acute control of agitation or during procedures, especially during the first few hours of treatment.
Some patients receiving Dexmedetomidine injection have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.
Dexmedetomidine injection should not be used as an induction agent for intubation or to provide sedation during muscle relaxant used. Dexmedetomidine lacks the anticonvulsant action of some other sedatives and so will not suppress underlying seizure activity.
Care should be taken if combining dexmedetomidine with other substances with sedative or cardiovascular actions as additive effects may occur.
Cardiovascular effects and precautions: Dexmedetomidine reduces heart rate and blood pressure through central sympatholysis but at higher concentrations causes peripheral vasoconstriction leading to hypertension.
Dexmedetomidine normally does not cause deep sedation and patients may be easily roused. Dexmedetomidine is therefore not suitable in patients who will not tolerate this profile of effects, for example, those requiring continuous deep sedation or with severe cardiovascular instability.
Caution should be exercised when administering dexmedetomidine to patients with pre-existing bradycardia. Data on the effects of Dexmedetomidine injection in patients with a heart rate <60 are very limited and particular care should be taken with such patients. Bradycardia does not normally require treatment but has commonly responded to anticholinergic medicine or dose reduction where needed. Patients with high physical fitness and slow resting heart rate may be particularly sensitive to bradycardic effects of alpha-2 receptor agonists and cases of transient sinus arrest have been reported.
The hypotensive effects of dexmedetomidine may be of greater significance in those patients with pre-existing hypotension (especially if not responsive to vasopressors), hypovolaemia, chronic hypotension or reduced functional reserve such as patients with severe ventricular dysfunction and the elderly and special care is warranted in these cases. Hypotension does not normally require specific treatment but, where needed, users should be ready to intervene with dose reduction, fluids and/or vasoconstrictors.
Patients with impaired peripheral autonomic activity (e.g. due to spinal cord injury) may have more pronounced haemodynamic changes after starting dexmedetomidine and so should be treated with care.
Transient hypertension has been observed primarily during the loading dose in association with the peripheral vasoconstrictive effects of dexmedetomidine and a loading dose is not recommended. Treatment of hypertension has generally not been necessary but decreasing the continuous infusion rate may be advisable.
Local vasoconstriction at higher concentration may be of greater significance in patients with ischaemic heart disease or severe cerebrovascular disease who should be monitored closely. Dose reduction or discontinuation should be considered in a patient developing sign of myocardial or cerebral ischaemia.
Patients with neurological disorders: Experience of dexmedetomidine in severe neurological disorders such as head injury and after neurosurgery is limited and it should be used with caution here, especially if deep sedation is required. Dexmedetomidine may reduce cerebral blood flow and intracranial pressure and this should be considered when selecting therapy.
Patients with hepatic impairment: Since Icunes clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function. Care should be taken in severe hepatic impairment as excessive dosing may increase the risk of adverse reactions, over-sedation or prolonged effect as a result of reduced dexmedetomidine clearance.
Other: Alpha-2 agonists have rarely been associated with withdrawal reactions when stopped abruptly after prolonged use. This possibility should be considered if the patient develops agitation and hypertension shortly after stopping dexmedetomidine.
It is not known whether dexmedetomidine is safe to use in malignant hyperthermia-sensitive individuals, therefore, it is not recommended. Dexmedetomidine injection treatment should be discontinued in the event of a sustained unexplained fever.
Effect on Ability to Drive and Use Machine: Patients should be advised to refrain from driving or other hazardous tasks for a suitable period of time after receiving Icunes for procedural sedation.