DEXMEDETOMIDINE HYDROCHLORIDE injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Gland Pharma Limited

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 PRECEDEXTM (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusivity rights

Огляд продуктів:

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. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not use if product is discolored or if precipitate matter is present.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION
GLAND PHARMA LIMITED
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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 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 hydrochloride in 0.9% sodium chloride 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 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 200 mcg/50 mL and 400 mcg/100 mL single-dose vials 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 patients over 65 years of age and
awake fiberoptic intu