DEXMEDETOMIDINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medical Purchasing Solutions, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 intraveno

Product summary:

Dexmedetomidine hydrochloride injection, 200 mcg (dexmedetomidine)/2 mL (100 mcg (dexmedetomidine) /mL) is available as clear and colorless solution in 2 mL clear glass vial. Vials are intended for single dose only. Discard unused portion. NDC No. Container Package Description This package is contained within the BOX (57664-596-50) Vial 2 mL In 1 VIAL 25 VIAL In 1 BOX Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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 200mcg/2mL (100mcg/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 (dexmedetomidine)/2
mL [100 mcg
(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 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
patient