See Supplemental Patient Information
- Dexmedetomidine should be administered by persons skilled in the management of patients in the intensive care or operating room setting. Monitor patients continuously during therapy
- Incidence of clinically significant episodes of bradycardia and sinus arrest have been reported during therapy in young patients with high vagal tone or with different routes of administration including rapid IV or bolus administration
- Cases of hypotension and bradycardia have been associated with dexmedetomidine infusion
- Incidence of transient hypertension may occur in association with the initial peripheral vasoconstrictive effects of the drug, primarily during the loading dose
- Some patients may be arousable and alert when stimulated; this alone should not be considered as lack of efficacy in the absence of other clinical signs/symptoms
- Withdrawal symptoms such as agitation, hypertension, nausea, tachycardia, and vomiting, may occur up to 48 hrs after discontinuation of dexmedetomidine after prolonged usage. Supportive therapy must be given if tachycardia and/or hypertension occurs after discontinuation
- Tolerance, tachyphylaxis and a dose-related increase in adverse reactions may be associated with the use of this drug beyond 24 hrs
- Dose reduction should be considered in patients with hepatic impairment
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- Advanced heart block
- Severe ventricular dysfunction
- Hypovolemia
- Diabetes mellitus
- Cardiovascular disease
- Cerebrovascular disease
- Adrenal insufficiency
- Elderly patients
- Sick sinus syndrome
Supplemental Patient Information
- Instruct patients to promptly report any headaches, nervousness, and agitation that may occur for up to 48 hrs when dexmedetomidine is infused for >6 hrs
Pregnancy Category:C
Breastfeeding: Safety unknown; manufacturer advises caution.