Medetomidine hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Medetomidine hydrochloride is {{{aOrAn}}} sedative that is FDA approved for the procedure of sedation of non-intubated patients prior to and/or during surgical and other procedures.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Medetomidine hydrochloride FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Medetomidine hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Medetomidine hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Medetomidine hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Medetomidine hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Medetomidine hydrochloride in pediatric patients.
Contraindications
None
Warnings
Drug Administration
Dexmedetomidine hydrochloride injection should be administered only by persons skilled in the management of patients in the operating room setting. Due to the known pharmacological effects of dexmedetomidine hydrochloride injection, patients should be continuously monitored while receiving dexmedetomidine hydrochloride injection.
Hypotension, Bradycardia, and Sinus Arrest
Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine hydrochloride injection 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 injection infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of dexmedetomidine hydrochloride injection, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because dexmedetomidine hydrochloride injection has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., 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 injection to patients with advanced heart block and/or severe ventricular dysfunction. Because dexmedetomidine hydrochloride injection 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.
In clinical trials where other vasodilators or negative chronotropic agents were coadministered with dexmedetomidine hydrochloride injection an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with dexmedetomidine hydrochloride injection.
Transient Hypertension
Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of dexmedetomidine hydrochloride injection. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.
Arousability
Some patients receiving dexmedetomidine hydrochloride 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.
Withdrawal
Procedural Sedation
In adult subjects, withdrawal symptoms were not seen after discontinuation of short term infusions of dexmedetomidine hydrochloride injection (< 6 hours).
Tolerance and Tachyphylaxis
Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose related increase in adverse reactions [see ADVERSE REACTIONS (6.1)].
Hepatic Impairment
Since dexmedetomidine clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic functio
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Medetomidine hydrochloride Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Medetomidine hydrochloride Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Medetomidine hydrochloride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Medetomidine hydrochloride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Medetomidine hydrochloride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Medetomidine hydrochloride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Medetomidine hydrochloride in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Medetomidine hydrochloride in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Medetomidine hydrochloride in geriatric settings.
Gender
There is no FDA guidance on the use of Medetomidine hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Medetomidine hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Medetomidine hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Medetomidine hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Medetomidine hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Medetomidine hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Medetomidine hydrochloride Administration in the drug label.
Monitoring
There is limited information regarding Medetomidine hydrochloride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Medetomidine hydrochloride and IV administrations.
Overdosage
There is limited information regarding Medetomidine hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Medetomidine hydrochloride Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Medetomidine hydrochloride Mechanism of Action in the drug label.
Structure
There is limited information regarding Medetomidine hydrochloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Medetomidine hydrochloride Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Medetomidine hydrochloride Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Medetomidine hydrochloride Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Medetomidine hydrochloride Clinical Studies in the drug label.
How Supplied
There is limited information regarding Medetomidine hydrochloride How Supplied in the drug label.
Storage
There is limited information regarding Medetomidine hydrochloride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Medetomidine hydrochloride Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Medetomidine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Medetomidine hydrochloride Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Medetomidine hydrochloride Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.