Dexmedetomidine HCl

1 INDICATIONS AND USAGE Dexmedetomidine injection 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. Pediatric use information is approved for Hospira Inc.’s PRECEDEX TM (dexmedetomidine hydrochloride) injection and PRECEDEX TM (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 1.2 Procedural Sedation Dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Pediatric use information is approved for Hospira Inc.’s PRECEDEX TM (dexmedetomidine hydrochloride) injection and PRECEDEX TM (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.