DEXMEDETOMIDINE HYDROCHLORIDE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

AuroMedics Pharma LLC

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. Pregnancy Category C There are no adequate and well-controlled studies of dexmedetomidine use in pregnant women. In an in vitro human placenta study, placental transfer of dexmedetomidine occurred. In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. Thus, fetal exposure should be expect

Descriptif du produit:

Dexmedetomidine Injection, USP Dexmedetomidine injection, USP is a sterile, nonpyrogenic, clear, colorless, isotonic solution and is available in 2 mL clear glass vials. The strength is based on the dexmedetomidine base. Vials are intended for single-dose only. Discard unused portion. Dexmedetomidine injection, USP is supplied as follows: 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 is a clear, colorless, isotonic solution and is available as 50 mL and 100 mL flexible containers. The strength is based on the dexmedetomidine base. Containers are intended for single-dose, 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 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not Freeze. Preservative Free

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE HYDROCHLORIDE
INJECTION,
SOLUTION
AUROMEDICS PHARMA LLC
----------
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
INDICATIONS AND USAGE
Dexmedetomidine 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 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)
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: 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 injection, 200 mcg/2 mL (100 mcg/mL) in a glass vial.
To be used after dilution. (3)
Dexme