DEXMEDETOMIDINE HYDROCHLORIDE injection, solution, concentrate DEXMEDETOMIDINE HYDROCHLORIDE IN DEXTROSE- dexmedetomidine hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

WG Critical Care, LLC

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 initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine Hydrochloride Injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine Hydrochloride Injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine Hydrochloride Injection prior to extubation. Dexmedetomidine Hydrochloride Injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. None. Risk Summary There are no studies conducted with dexmedetomidine hydrochloride in pregnant women to inform any drug-associated risks. A published in vitro human placenta study reported placental transfer of dexmedetomidine hydrochloride. Rats subcutaneously administered dexmedetomidine HCl during organogenesis showed pregnancy loss and reduced live pups at doses equivalent to the maximum recommended human dose (MRHD). Reduced fetal weights were observed in rats administered subcutaneously dexmedetomidine HCl at a dose that is less than one-half of the MRHD during gestation and lactation. In this study, elevated fetal and embryocidal toxicity and delayed motor development were observed in second generation offspring. No fetal malformations were observed in animal reproduction studies with subcutaneous administration of dexmedetomidine HCl during organogenesis in rats and rabbits at doses approximately equal to and one-half the MRHD, respectively [see Data]. The background risk in the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Animal Data Teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine HCl 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 MRHD based on body surface area) or in rabbits following intravenous administration of dexmedetomidine HCl 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 MRHD 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 MRHD based on a body surface area comparison). In another reproductive toxicity study when dexmedetomidine HCl was administered subcutaneously to pregnant rats at 8 mcg/kg and 32 mcg/kg (representing a dose less than the MRHD 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. Risk Summary There is no information regarding the presence of dexmedetomidine hydrochloride in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Radio-labeled dexmedetomidine administered subcutaneously to lactating female rats was excreted in milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmedetomidine hydrochloride and any potential adverse effects on the breastfed infant from dexmedetomidine hydrochloride or from the underlying maternal condition. Clinical Considerations A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 half-lives) after receiving dexmedetomidine hydrochloride in order to minimize potential drug exposure to a breastfed infant. Safety and efficacy of dexmedetomidine HCl have not been established for Procedural or ICU Sedation in pediatric patients. 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 HCl [see Warnings and Precautions (5.1, 5.2)]. Therefore a dose reduction may be considered in patients over 65 years of age [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. Procedural Sedation A total of 131 patients in the procedural sedation 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 HCl-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients less than 65 years (47%). In patients greater than 65 years of age, reduce the loading infusion dosage for initiation of procedural sedation and consider reducing the maintenance infusion dosage for maintenance of procedural sedation [see Dosage and Administration (2.3) and Clinical Pharmacology ( 12.3)] . Since dexmedetomidine HCl clearance decreases with increasing severity of hepatic impairment, consider dosage reduction in patients with hepatic impairment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)] . The dependence potential of dexmedetomidine HCl has not been studied in humans. However, since studies in rodents and primates have demonstrated that dexmedetomidine HCl exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine HCl may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see Warnings and Precautions (5.5) ].

Product summary:

Dexmedetomidine Hydrochloride Injection is clear and colorless, and is available in a 100 mcg/mL strength in clear glass, multiple-dose vials as follows: NDC No. Strength Package 44567-600-04 400 mcg/4 mL 4 vials/carton 44567-601-04 1000 mcg/10 mL 4 vials/carton Dexmedetomidine Hydrochloride Injection is available in single-dose, single-port, ready-to-use flexible plastic infusion bags in a foil laminate overwrap as follows: NDC No. Strength Package 44567-602-24 200 mcg/50 mL 24 bags/carton 44567-603-24 400 mcg/100 mL 24 bags/carton Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. It is recommended that the infusion bags be kept in the overwrap until ready to use. PROTECT INFUSION BAGS FROM FREEZING.

Authorization status:

New Drug Application

Summary of Product characteristics

DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE
DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION
WG CRITICAL CARE, LLC
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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 central alpha-2
adrenergic agonist indicated for: (1)
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DOSAGE AND ADMINISTRATION
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Initiation of Intensive Care Unit Sedation (2.2) (2)
Procedure (2)
Recommended Loading Infusion Dosage (2)
ICU Sedation (2)
1 mcg/kg over 10 minutes (2)
Maintenance of Intensive Care Unit Sedation (2.2) (2)
Procedure (2)
Recommended Maintenance Infusion Dosage (2)
Maintenance (2)
0.2 to 0.7 mcg/kg/hour. (2)
Initiation of Procedural Sedation (2.2) (2)
Procedure (2)
Recommended Loading Infusion Dosage (2)
More invasive procedures or
awake fiberoptic intubation (2)
1 mcg/kg over 10 minutes (2)
Less invasive procedures such
as ophthalmic surgery (2)
0.5 mcg/kg over 10 minutes (2)
MAINTENANCE OF PROCEDURAL SEDATION (2.2) (2)
PROCEDURE (2)
RECOMMENDED MAINTENANCE INFUSION
DOSAGE (2)
Generally, initiate at 0.6 mcg/kg/hour and titrate
to achieve desired clinical effect with dosages
ranging from 0.2 to 1 mcg/kg/hour. (2)
Administer 0.7 mcg/kg/hour until the
endotracheal tube is secured (2)
Sedation of initially intubated and mechanically ventilated patients
during treatment in an intensive
care setting. Administer Dexmedetomidine Hydrochloride 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)
Dilute in 0.9% Sodium Chloride Injection to concentration of 4 mcg/mL
prior to administration. (2.1,
2.6)
The 200 mcg/50 mL and