Dexmedetomidine HCl

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Overview

What is Dexmedetomidine HCl?

Dexmedetomidine hydrochloride Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as 4-[()-a,2,3-trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the molecular formula is CHN• HCl and the structural formula is:

Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride equivalent to 100 mcg (0.1 mg) of dexmedetomidine and 9 mg of sodium chloride in water and is to be used after dilution. The solution is preservative-free and contains no additives or chemical stabilizers.

What does Dexmedetomidine HCl look like?

What are the available doses of Dexmedetomidine HCl?

Dexmedetomidine Hydrochloride Injection 200 mcg/2 mL (100 mcg/mL) in a glass vial. To be used after dilution.

What should I talk to my health care provider before I take Dexmedetomidine HCl?

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 04/2016

How should I use Dexmedetomidine HCl?

Dexmedetomidine hydrochloride injection is a relatively selective alpha-adrenergic agonist indicated for:

Individualize and titrate dexmedetomidine hydrochloride injection dosing to desired clinical effect.

Administer dexmedetomidine hydrochloride injection using a controlled infusion device.

Dilute the 200 mcg/2mL (100 mcg/mL) vial contents in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) prior to administration.

For Adult Procedural Sedation:

minutes

hour

hour

Alternative doses

What interacts with Dexmedetomidine HCl?

Sorry No Records found

What are the warnings of Dexmedetomidine HCl?

Sorry No Records found

What are the precautions of Dexmedetomidine HCl?

Sorry No Records found

What are the side effects of Dexmedetomidine HCl?

Sorry No records found

What should I look out for while using Dexmedetomidine HCl?

None

What might happen if I take too much Dexmedetomidine HCl?

The tolerability of dexmedetomidine hydrochloride was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute.

One patient who received a loading bolus dose of undiluted dexmedetomidine hydrochloride (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

How should I store and handle Dexmedetomidine HCl?

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].Dexmedetomidine Hydrochloride Injection is available as:NDC 0143-9532-25 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dexmedetomidine Hydrochloride Injection is available as:NDC 0143-9532-25 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dexmedetomidine Hydrochloride Injection is available as:NDC 0143-9532-25 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Dexmedetomidine hydrochloride is a relatively selective alpha-adrenergic agonist with sedative properties. Alpha selectivity is observed in animals following slow intravenous infusion of low and medium doses (10 to 300 mcg/kg). Both alpha and alpha activity is observed following slow intravenous infusion of high doses (≥1000 mcg/kg) or with rapid intravenous administration.

Non-Clinical Toxicology

None

Cyclobenzaprine HCl may have life-threatening interactions with MAO inhibitors. (See .) Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).

Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.

Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.

† ULTRAM (tramadol hydrochloride tablets, Ortho-McNeil Pharmaceutical)

† ULTRACET (tramadol hydrochloride and acetaminophen tablets, Ortho-McNeil Pharmaceutical)

Dexmedetomidine hydrochloride 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, patients should be continuously monitored while receiving dexmedetomidine hydrochloride.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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