PRECEDEX DEXMEDETOMIDINE HCI CHLORIDE- dexmedetomidine hydrochloride, sodium chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fareva Amboise

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours. PRECEDEX has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue PRECEDEX prior to extubation. Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. None. Risk Summary Available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not i

Product summary:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Do not use if product is discolored or if precipitate matter is present. PRECEDEX (dexmedetomidine hydrochloride in 0.9% Sodium Chloride) injection (4 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base. Discard unused portion. Unit of Sale Concentration NDC 0409-3301-10 Carton of 10 single‑dose clear glass vials 80 mcg/20 mL (4 mcg/mL) NDC 0409-1454-20 Tray of 20 single‑dose clear glass bottles 200 mcg/50 mL (4 mcg/mL) NDC 0409-1174-10 Tray of 10 single‑dose clear glass bottles 400 mcg/100 mL (4 mcg/mL) NDC 0409-2815-01 Carton containing 1 single‑dose clear glass bottle 1,000 mcg/250 mL (4 mcg/mL)

Authorization status:

New Drug Application

Summary of Product characteristics

PRECEDEX DEXMEDETOMIDINE HCI CHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE, SODIUM CHLORIDE INJECTION, SOLUTION
FAREVA AMBOISE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRECEDEX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRECEDEX.
PRECEDEX™ (DEXMEDETOMIDINE HYDROCHLORIDE) IN SODIUM CHLORIDE
INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Dosage and Administration, Preparation of Solution ( 2.4)
08/2022
Warnings and Precautions, Hyperthermia or Pyrexia ( 5.7)
08/2022
INDICATIONS AND USAGE
PRECEDEX is a alpha2-adrenergic receptor agonist indicated for:
• Sedation of initially intubated and mechanically ventilated
patients during treatment in an intensive care
setting. Administer PRECEDEX 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) (1)
DOSAGE AND ADMINISTRATION
• Individualize and titrate PRECEDEX dosing to desired clinical
effect. (2.1)
• Administer PRECEDEX using a controlled infusion device. (2.1)
• The 80 mcg/20 mL single-dose vial, and 200 mcg/50 mL, and 400
mcg/100 mL, and 1,000 mcg/
250 mL single-dose bottles do not require further dilution 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) (2)
DOSAGE FORMS AND STRENGTHS
• PRECEDEX in 0.9% Sodium Chloride Injection, 80 mcg/20 mL (4
mcg/mL) in a single-dose vial. Ready to
use. (3)•PRECEDEX in 0.9% Sodium Chloride Injection, 200 mcg/50 mL,