dexmedetomidine hydrochloride
dexmedetomidine hydrochloride is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand names including Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride, Dexmedetomidine Hydrochloride, DEXMEDETOMIDINE HYDROCHLORIDE. Available dosage forms: injection, solution, injection, solution, concentrate, injection, powder.
Drug Details
- Generic Name
- dexmedetomidine hydrochloride
- Brand Names
- Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride, Dexmedetomidine Hydrochloride, DEXMEDETOMIDINE HYDROCHLORIDE
- Application Number
- ANDA217308
- Sponsor
- Sagent Pharmaceuticals
- NDC Codes
- 11
- Dosage Forms
- INJECTION, SOLUTION, INJECTION, SOLUTION, CONCENTRATE, INJECTION, POWDER
- Routes
- INTRAVENOUS
- Active Ingredients
- DEXMEDETOMIDINE 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.