DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE- dexmedetomidine hydrochloride injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Dexmedetomidine Hydrochloride (UNII: 1018WH7F9I) (dexmedetomidine - UNII:67VB76HONO)

Fáanlegur frá:

TAGI Pharma, Inc.

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Dexmedetomidine HCl 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 HCl in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine HCl 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 HCl in 0.9% sodium chloride injection prior to extubation. Dexmedetomidine HCl 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 HCl in 0.9% sodium chloride injection use in pregnant women. In an in vitro human placenta study, placental transfer of dexmedetomidine occurred. In a study in the p

Vörulýsing:

Dexmedetomidine HCl in 0.9% sodium chloride injection Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is clear and colorless, 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 glass vials, 50 mL and 100 mL clear glass bottles, respectively. The strength is based on the dexmedetomidine base. Containers are intended for single-dose only. Discard unused portion. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE-
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION
TAGI PHARMA, INC.
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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 (HCL) 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 HCl 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)
DOSAGE AND ADMINISTRATION
Individualize and titrate dexmedetomidine HCl in 0.9% sodium chloride
injection dosing to desired
clinical effect. (2.1)
Administer dexmedetomidine HCl in 0.9% sodium chloride injection using
a controlled infusion device.
(2.1)
The 80 mcg/20 mL single-dose vial, and 200 mcg/50 mL 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)
DOSAGE FORMS AND STRENGTHS
Dexmedetomidine HCl in 0.9% sodium chloride injection 80 mcg/20 mL (4