DEXMEDETOMIDINE HYDROCHLORIDE injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sun Pharmaceuticals Industries, Inc.

INN (mednarodno ime):

DEXMEDETOMIDINE HYDROCHLORIDE

Sestava:

DEXMEDETOMIDINE 100 ug in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 intravenous dose based on body surface

Povzetek izdelek:

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].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE HYDROCHLORIDE
INJECTION,
SOLUTION
SUN PHARMACEUTICALS INDUSTRIES, INC.
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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:
•
DOSAGE AND ADMINISTRATION
•
•
• 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/HO UR.(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
•
•
•
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC. AT 1-800-818-4555
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of
pharmacodynamic effects. Reduction in dosage of
Dexmedetomidine hydrochloride or the concomitant medication may be
required. (7.1)
2
Sedation of non-intubated patients prior to and/or during surgical and
other procedures. (1.2)
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/