DEXMEDETOMIDINE HYDROCHLORIDE injection, solution, concentrate

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Zydus Pharmaceuticals USA Inc.

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Dexmedetomidine hydrochloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine hydrochloride 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 injection prior to extubation. Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Pediatric use information is approved for Hospira Inc.'s PRECEDEX TM (dexmedetomidine hydrochloride) injection and PRECEDEX TM  (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.'s marketing exclusivity rights, this drug product is not labeled with that informatio

Rezumat produs:

Dexmedetomidine hydrochloride Injection Dexmedetomidine hydrochloride injection 200 mcg/2 mL (100 mcg/mL) is available in 2 mL clear glass vials. The strength is based on the dexmedetomidine base. Vials are intended for single dose only. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION.
DEXMEDETOMIDINE HYDROCHLORIDE 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 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
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 injection
dosing to desired clinical effect. (2.1)
Administer dexmedetomidine hydrochloride injection using a controlled
infusion device. (2.1)
Dilute the 200 mcg/2 mL (100 mcg/mL) vial contents in 0.9% sodium
chloride solution to achieve
required concentration (4 mcg/mL) prior to administration. (2.4)
The 80 mcg/20 mL single-dose vial, and 200 mcg/50 mL,400 mcg/100 mL,
and 1,000 mcg/250 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
10MINUTES, 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 patien