dexmedetomidine

FDA Drug Profile — Dexmedetomidine

dexmedetomidine is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Dexmedetomidine. Available dosage form: injection, solution, concentrate.

Drug Details

Generic Name
dexmedetomidine
Brand Names
Dexmedetomidine
Application Number
ANDA202881
Sponsor
Mylan Institutional LLC
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients
DEXMEDETOMIDINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE 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. 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 )