DEXMEDETOMIDINE HYDROCHLORIDE injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Medical Purchasing Solutions, LLC

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

Dexmedetomidine hydrochloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine hydrochloride injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine hydrochloride injection prior to extubation. Dexmedetomidine hydrochloride 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 dexmedetomidin

製品概要:

Dexmedetomidine Hydrochloride Injection Dexmedetomidine Hydrochloride Injection is a sterile, nonpyrogenic, clear, colorless, isotonic solution, free from visible particles and is available in 2 mL clear glass vials. The strength is based on the dexmedetomidine base. Vials are intended for single-dose only. Dexmedetomidine Hydrochloride Injection is supplied as follows: 200 mcg (base) per 2 mL (100 mcg (base) / mL):     2 mL single-dose vials  packaged in Cartons of 25 Vials                                       NDC 55150-209-02 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Preservative Free The vial stoppers are not made with natural rubber latex.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION.
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
FOR INTRAVENOUS USE ONLY.
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Dexmedetomidine hydrochloride 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 hydrochloride 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 hydrochloride injection
dosing to desired clinical effect. ( 2.1)
Administer dexmedetomidine hydrochloride 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
Dexmedetomidine Hydrochloride Injection, 200 mcg/2 mL (100 mcg/mL) in
a glass vial. To be used after
dilution. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Monitoring: Continuously monit