DEXMEDETOMIDINE injection, solution DEXMEDETOMIDINE HYDROCHLORIDE- dexmedetomidine hydrochloride in 0.9% sodium chloride inject

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eugia US LLC

INN (International Name):

DEXMEDETOMIDINE HYDROCHLORIDE

Composition:

DEXMEDETOMIDINE 100 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated adult 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 adult 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 adult patients prior to and/or during surgical and other procedures. Pediatric use information is approved for Hospira Inc.’s PRECEDEXTM (dexmedetomidine hydrochloride) injection and PRECEDEXTM (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. None. Risk Summary Available data from published randomized controll

Product summary:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not Freeze. Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine injection, USP is supplied as follows: Dexmedetomidine Injection, USP 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. 200 mcg per 2 mL (100 mcg/mL): 2 mL single-dose vials packaged in a Carton of 25 Vials                                                                     NDC 55150-209-02 Preservative Free The vial stoppers are not made with natural rubber latex. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection (4 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base. Discard unused portion. 200 mcg per 50 mL (4 mcg/mL) 50 mL Single-Dose Flexible Containers packaged in a Carton of 10                                                                             NDC 55150-296-10 400 mcg per 100 mL (4 mcg/mL) 100 mL Single-Dose Flexible Containers packaged in a Carton of 10                                                                             NDC 55150-297-10 Preservative Free

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXMEDETOMIDINE - DEXMEDETOMIDINE INJECTION, SOLUTION
DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE HYDROCHLORIDE IN
0.9% SODIUM CHLORIDE INJECTION, SOLUTION
EUGIA US LLC
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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
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 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 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 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)
The 200 mcg/50 mL and 400 mcg/100 mL single-dose flexible containers
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 pa