DEXMEDETOMIDINE HYDROCHLORIDE injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Slayback Pharma LLC

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. 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. None Pregnancy Category C There are no adequate and well-controlled studies of dexmedetomidine hydrochloride in 0.9% sodium chloride injection use in pregnant women. In an in vitro human placenta study, placent

Povzetek izdelek:

Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection Dexmedetomidine hydrochloride in 0.9% Sodium Chloride injection is a clear colorless solution and available as 80 mcg/20 mL (4 mcg/mL), 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 20 mL clear single-dose vial, 50 mL and 100 mL clear single-dose bottles, respectively. The strength is based on the dexmedetomidine base. Containers are intended for single-dose only. Discard unused portion.      Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION
SLAYBACK PHARMA LLC
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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
INDICATIONS AND USAGE
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a
relatively selective alpha -
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)
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 80 mcg/20 mL single-dose vial, 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: Generally 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: Generally 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 fiberoptic intubation
patients. (2.2) (2)
DOSAGE FORMS AND STRENGTHS
Dexmedetomidine hydrochloride in 0.9% Sodium Chlo