DEXMEDETOMIDINE- dexmedetomidine hydrochloride injection, solution, concentrate

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Dexmedetomidine Hydrochloride (UNII: 1018WH7F9I) (Dexmedetomidine - UNII:67VB76HONO)

Prieinama:

Akorn

INN (Tarptautinis Pavadinimas):

Dexmedetomidine Hydrochloride

Sudėtis:

Dexmedetomidine 100 ug in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. None Teratogenic Effects. Pregnancy Category C There are no adequate and well controlled studies of dexmedetomidine hydrochloride 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, and dexmedetomidine hydrochloride injection should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intra

Produkto santrauka:

Dexmedetomidine Hydrochloride Injection, 200 mcg/2 mL (100 mcg/mL), is a sterile, nonpyrogenic, clear, colorless solution. It is available in a 2 mL clear glass vial. Vials are intended for single use only. NDC 17478-055-02         2 mL single-dose vial in box of 10 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DEXMEDETOMIDINE- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION,
CONCENTRATE
AKORN
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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
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Dexmedetomidine hydrochloride injection is a relatively selective
alpha -adrenergic agonist indicated for:
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 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 monitor patients while receiving
dexmedetomidine hydrochloride injection.
(5.1)
Bradycardia and sinus arrest: Have occurred in young healthy
volunteers with high vagal tone or with
different routes of administration, e.g., rapid intravenous or bolus
administration. (5.2)
Hypotension and bradycardia: May necessitate medical intervention. May
be more pronounced in
patients with hypovolemia, diabetes mellitus, or chronic hyperten