Application Nr Approved Date Route Status External Links
ANDA205867 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dexmedetomidine Injection Is A Relatively Selective Alpha 2 -Adrenergic Agonist Indicated For: Sedation Of Initially Intubated And Mechanically Ventilated Patients During Treatment In An Intensive Care Setting. Administer Dexmedetomidine 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 Injection Is Indicated For Sedation Of Initially Intubated And Mechanically Ventilated Patients During Treatment In An Intensive Care Setting. Dexmedetomidine Injection Should Be Administered By Continuous Infusion Not To Exceed 24 Hours. Dexmedetomidine Injection Has Been Continuously Infused In Mechanically Ventilated Patients Prior To Extubation, During Extubation, And Post-Extubation. It Is Not Necessary To Discontinue Dexmedetomidine Injection Prior To Extubation. 1.2 Procedural Sedation Dexmedetomidine 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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