DEXMEDETOMIDINE HYDROCHLORIDE injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Fresenius Kabi USA, LLC

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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. There are no adequate and well-controlled studies of Dexmedetomidine Injection 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 expected in humans, an

Produkto santrauka:

Dexmedetomidine Injection, USP, is a clear, colorless solution available as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex. Discard unused portion.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, 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
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Dexmedetomidine hydrochloride 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 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/ 2mL (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 Injection, USP, 200 mcg (dexmedetomidine)/2 mL [100mcg
(dexmedetomidine)/mL] in
a glass vial. To be used after dilution. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Monitoring: Continuously monitor patients while receiving
dexmedetomidine hydrochloride. (5.1)
Bradycardia and Sinus Arr