Medetomidine Hydrochloride

FDA Drug Profile

Medetomidine Hydrochloride is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: powder.

Drug Details

Generic Name
Medetomidine Hydrochloride
Brand Names
N/A
Application Number
Sponsor
Interquim, S.A. de C.V.
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
MEDETOMIDINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS & 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.