Application Nr Approved Date Route Status External Links
NDA206628 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dexmedetomidine Hydrochloride Injection Is A Central Alpha-2 Adrenergic Agonist Indicated For: • Sedation Of Initially Intubated And Mechanically Ventilated Patients During Treatment In An Intensive Care Setting. Administer Dexmedetomidine Hydrochloride Injection By Continuous Infusion Not To Exceed 24 Hours. (1.1) • Sedation Of Non-Intubated Patients Prior To And/or During Surgical And Other Procedures. (1.2) 1.1 Intensive Care Unit Sedation Dexmedetomidine Hydrochloride Injection Is Indicated For Sedation Of Initially Intubated And Mechanically Ventilated Patients During Treatment In An Intensive Care Setting. Dexmedetomidine Hydrochloride Injection Should Be Administered By Continuous Infusion Not To Exceed 24 Hours. Dexmedetomidine Hydrochloride Injection Has Been Continuously Infused In Mechanically Ventilated Patients Prior To Extubation, During Extubation, And Post-Extubation. It Is Not Necessary To Discontinue Dexmedetomidine Hydrochloride Injection Prior To Extubation. 1.2 Procedural Sedation Dexmedetomidine Hydrochloride Injection Is Indicated For Sedation Of Non-Intubated Patients Prior To And/or During Surgical And Other Procedures.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE ZINC4632106

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