DEXMEDETOMIDINE injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Accord Healthcare Inc.

INN (Internationale Bezeichnung):

DEXMEDETOMIDINE HYDROCHLORIDE

Zusammensetzung:

DEXMEDETOMIDINE 100 ug in 1 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine injection prior to extubation. Dexmedetomidine injection is indicated for sedation of non-intubated 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 have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures t

Produktbesonderheiten:

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.] Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine injection, USP 200 mcg/2 mL (100 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base. Discard unused portion 16729-239-30 Vial 2 mL Single Dose Vial 16729-239-93 Vial 25 Units of 2 mL Single Dose Vial in a Carton

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DEXMEDETOMIDINE- DEXMEDETOMIDINE INJECTION, SOLUTION
ACCORD HEALTHCARE INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMEDETOMIDINE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DEXMEDETOMIDINE
INJECTION.
DEXMEDETOMIDINE 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 injection is a alpha
-adrenergic receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients
during treatment in an intensive
care setting Administer dexmedetomidine 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 injection dosing to desired
clinical effect. ( 2.1)
Administer dexmedetomidine 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)
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
2
DOSAGE FORMS AND STRENGTHS
Dexmedetomidine injection, USP, 200 mcg/2 mL (100 mcg/mL) in a single
vial. To be used after dilution.
(3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Monitoring: Cont