DEXMEDETOMIDINE HYDROCHLORIDE injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)

Beszerezhető a:

Slayback Pharma LLC

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult 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 adult 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. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. None Risk Summary Available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy hav

Termék összefoglaló:

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride injection is a clear colorless solution. The strength is based on the dexmedetomidine base. Discard unused portion.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION
SLAYBACK PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMEDETOMIDINE
HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9%
SODIUM
CHLORIDE INJECTION.
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION FOR
INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Dosage and Administration, Preparation of Solution (2.4) 08/2022
Warnings and Precautions, Hyperthermia or Pyrexia (5.7) 08/2022
INDICATIONS AND USAGE
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a
alpha -adrenergic receptor agonist
indicated for:
• Sedation of initially intubated and mechanically ventilated adult
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 adult patients prior to and/or during
surgical and other procedures. (1.2)
DOSAGE AND ADMINISTRATION
• Individualize and titrate dexmedetomidine hydrochloride in 0.9%
sodium chloride injection dosing to
desired clinical effect. (2.1)
• Administer dexmedetomidine hydrochloride in 0.9% sodium chloride
injection using a controlled infusion
device. (2.1)
• The 200 mcg/50mL and 400 mcg/100 mL single-dose bottles, do not
require further dilution prior to
administration. (2.4)
• For Adult Intensive Care Unit Sedation: Initiate at one mcg/kg
over 10 _minutes_, followed by a
maintenance infusion of 0.2 to 0.7 _mcg/kg/hour_. (2.2)
• For Adult Procedural Sedation: Initiate at one mcg/kg over 10
_minutes_, followed by a maintenance
infusion initiated at 0.6 _mcg/kg/hour_ and titrated to achieve
desired clinical effect with doses ranging from
0.2 to 1 _mcg/kg/hour_. (2.2)
• Alternative Doses: Recommended for patients over 65 years of age
and awake fi