DEXMEDETOMIDINE HYDROCHLORIDE- 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:

Actavis Pharma, Inc.

INN (International Name):

DEXMEDETOMIDINE HYDROCHLORIDE

Composition:

DEXMEDETOMIDINE 100 ug in 1 mL

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 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

Product summary:

Dexmedetomidine Hydrochloride Injection, Concentrate 200 mcg (dexmedetomidine)/2 mL (100 mcg (dexmedetomidine)/mL) is available in 2 mL clear glass vials. Vials are intended for single-dose only. NDC 45963-906-42, 2 mL vials in a carton of 25 Store at controlled room temperature, 25°C (77°F) with excursions allowed from 15 to 30°C (59 to 86°F). [See USP.] Sterile, Nonpyrogenic, Preservative-free. The vial stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE HYDROCHLORIDE
INJECTION,
SOLUTION
ACTAVIS PHARMA, INC.
----------
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, CONCENTRATE, 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 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, CONCENTRATE, 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 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 wit