DEXMEDETOMIDINE 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:

Piramal Critical Care Inc

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

1.1 Intensive Care Unit Sedation Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine injection prior to extubation. 1.2 Procedural Sedation Dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. None. 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of dexmedetomidine 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 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 intravenous dose based on body surface area) or in rabbits following intravenous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 6 to 18) with doses up to 96 mcg/kg (representing approximately half the human exposure at the maximum recommended dose based on plasma area under the time-curve comparison). However, fetal toxicity, as evidenced by increased post-implantation losses and reduced live pups, was observed in rats at a subcutaneous dose of 200 mcg/kg. The no-effect dose in rats was 20 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison). In another reproductive toxicity study when dexmedetomidine was administered subcutaneously to pregnant rats at 8 and 32 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison) from gestation day 16 through weaning, lower offspring weights were observed. Additionally, when offspring of the 32 mcg/kg group were allowed to mate, elevated fetal and embryocidal toxicity and delayed motor development was observed in second generation offspring. 8.2 Labor and Delivery The safety of dexmedetomidine injection during labor and delivery has not been studied. 8.3 Nursing Mothers It is not known whether dexmedetomidine hydrochloride is excreted in human milk. Radio-labeled dexmedetomidine administered subcutaneously to lactating female rats was excreted in milk. Because many drugs are excreted in human milk, caution should be exercised when dexmedetomidine injection is administered to a nursing woman. 8.4 Pediatric Use Safety and efficacy have not been established for Procedural or ICU Sedation in pediatric patients. One assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for ICU sedation. These studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of dexmedetomidine injection for this patient population. The use of dexmedetomidine for procedural sedation in pediatric patients has not been evaluated. 8.5 Geriatric Use Intensive Care Unit Sedation A total of 729 patients in the clinical studies were 65 years of age and over. A total of 200 patients were 75 years of age and over. In patients greater than 65 years of age, a higher incidence of bradycardia and hypotension was observed following administration of dexmedetomidine injection [see Warnings and Precautions ( 5.2)]. Therefore, a dose reduction may be considered in patients over 65 years of age [see Dosage and Administration ( 2.2, 2.3), Clinical Pharmacology ( 12.3)]. Procedural Sedation A total of 131 patients in the clinical studies were 65 years of age and over. A total of 47 patients were 75 years of age and over. Hypotension occurred in a higher incidence in dexmedetomidine injection-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). A reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age. 8.6 Hepatic Impairment Since dexmedetomidine clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration ( 2.2, 2.3) and Clinical Pharmacology ( 12.3)]. 9.1 Controlled Substance Dexmedetomidine injection (dexmedetomidine hydrochloride) is not a controlled substance. 9.3 Dependence The dependence potential of dexmedetomidine injection has not been studied in humans. However, since studies in rodents and primates have demonstrated that dexmedetomidine injection exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine injection may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see Warnings and Precautions ( 5.5)].

Povzetek izdelek:

Dexmedetomidine Injection, USP Dexmedetomidine injection, USP (dexmedetomidine hydrochloride) 200 mcg/2 mL (100 mcg/mL) is clear and colorless, and available in 2 mL clear glass vials with pink caps, supplied in packages of 25. The strength is based on the dexmedetomidine base. Vials are intended for single-dose only. Discard unused portion. Store at controlled room temperature, 25°C (77°F) with excursions allowed from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DEXMEDETOMIDINE- DEXMEDETOMIDINE INJECTION, SOLUTION
PIRAMAL CRITICAL CARE INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMEDETOMIDINE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DEXMEDETOMIDINE
INJECTION.
DEXMEDETOMIDINE INJECTION, FOR INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Dexmedetomidine injection is a relatively selective alpha
-adrenergic agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients
during treatment in an intensive
care setting. Administer dexmedetomidine injection by continuous
infusion not to exceed 24 hours. (
1.1)
Sedation of non-intubated patients prior to and/or during surgical and
other procedures. ( 1.2)
DOSAGE AND ADMINISTRATION
Individualize and titrate dexmedetomidine injection dosing to desired
clinical effect. ( 2.1)
Administer dexmedetomidine 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 INTENSIVE CARE UNIT SEDATION: Generally initiate at one
mcg/kg over 10 MINUTES, followed
by a maintenance infusion of 0.2 to 0.7 mcg/kg/ HOUR. ( 2.2)
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 Injection, USP 200 mcg/2 mL (100 mcg/mL) in a glass
vial with pink cap. To be used
after dilution. ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Monitoring: Continuously monitor patients while receiving
dexmedetomidine injection. ( 5.1)
Bradycardia and Sinus Arrest: Have occurred in young healthy
volunteers