Application Nr Approved Date Route Status External Links
ANDA208532 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 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 Hydrochloride In 0.9% Sodium Chloride 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 In 0.9% Sodium Chloride Injection Is Indicated For Sedation Of Initially Intubated And Mechanically Ventilated Patients During Treatment In An Intensive Care Setting. Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride Injection Should Be Administered By Continuous Infusion Not To Exceed 24 Hours. Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 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 In 0.9% Sodium Chloride Injection Prior To Extubation. 1.2 Procedural Sedation Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 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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