DEXMEDETOMIDINE HYDROCHLORIDE injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

CIVICA, INC.

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 h

Ringkasan produk:

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.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION
CIVICA, INC.
----------
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) (1)
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 fiber