DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Sandoz Inc.

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine hydrochloride in 0.9% sodium chloride 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 in 0.9% sodium chloride injection prior to extubation. Dexmedetomidine hydrochloride in 0.9% sodium chloride 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 in sodium chloride injection). However, due to Hospira, Inc.’s marketing exclusivity righ

Огляд продуктів:

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (4 mcg per mL) is clear and colorless. The strengths are based on the dexmedetomidine base. Discard unused portion. 0781-3493-95 Carton of 10 single-dose clear glass vials 80 mcg per 20 mL (4 mcg per mL) 0781-3494-95 Carton of 10 single-dose clear glass bottles 200 mcg per 50 mL (4 mcg per mL) 0781-3495-95 Carton of 10 single-dose clear glass bottles 400 mcg per 100 mL (4 mcg per mL) Sterile, Nonpyrogenic, Preservative-free.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE-
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION
SANDOZ 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 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 hydrochloride in 0.9% sodium chloride injection is a
alpha
-adrenergic receptor agonist
indicated for: (1)
Sedation of initially intubated and mechanically ventilated adult
patients during treatment in an
intensive care setting. Administer dexmedetomidine hydrochloride in
0.9% sodium chloride 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 in 0.9% sodium
chloride injection dosing to
desired clinical effect. (2.1)
Administer dexmedetomidine hydrochloride in 0.9% sodium chloride
injection using a controlled infusion
device. (2.1)
The 80 mcg per 20 mL single-dose vial, 200 mcg per 50 mL, and 400 mcg
per 100 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 10
MINUTES, followed by a
maintenance infusion of 0.2 mcg/kg/ HOUR 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 mcg/kg/ HOUR to 1 mcg/kg/ HOUR. (2.2)
ALTER