DEXMEDETOMIDINE HCL injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Medical Purchasing Solutions, LLC

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 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 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 intraven

Огляд продуктів:

Dexmedetomidine Hydrochloride Injection is available as: NDC 0143-9532-25 - 200 mcg/2 mL (100 mcg/mL) in 2 mL clear glass vial, carton of 25. The strength is based on the dexmedetomidine base. Vials are intended for single use only. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DEXMEDETOMIDINE HCL- DEXMEDETOMIDINE HCL INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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. (1.1)
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/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 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 HCl. (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,