DEXMEDETOMIDINE HYDROCHLORIDE injection, solution, concentrate DEXMEDETOMIDINE HYDROCHLORIDE injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Par Pharmaceutical, Inc.

INN (Jina la Kimataifa):

DEXMEDETOMIDINE HYDROCHLORIDE

Tungo:

DEXMEDETOMIDINE 100 ug in 1 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 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 trim

Bidhaa muhtasari:

D exmedetomidine Injection, USP NDC 42023-146-25:  200 mcg/2 mL (100 mcg/mL) is clear and colorless, and available in 2 mL clear glass vials supplied in packages of twenty-five. The strength is based on the dexmedetomidine base. Vials are intended for single-dose only. Discard unused portion. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection NDC 42023-186-20: 200 mcg/50 mL (4 mcg/mL) is clear and colorless, and available in 50 mL clear glass vials supplied in packages of twenty.    NDC 42023-187-10: 400 mcg/100 mL (4 mcg/mL) is clear and colorless, and available in 100 mL clear glass vials supplied in packages of ten.  The strength is based on the dexmedetomidine base.  Vials are intended for single-dose only.  Discard unused portion. Vial stoppers do not contain natural rubber latex. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature.) Do not use if product is discolored or if precipitate matter is present.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE
DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMEDETOMIDINE
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION.
DEXMEDETOMIDINE INJECTION, FOR INTRAVENOUS USE
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION, FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indication and Usage, Procedural Sedation (1.2) 12/2022
Dosage and Administration, Recommended Dosage (2.2) 12/2022
Dosage and Administration, Preparation of Solution (2.4) 08/2022
Warnings and Precautions, Withdrawal (5.5) 12/2022
Warnings and Precautions, Hyperthermia or Pyrexia (5.7) 08/2022
INDICATIONS AND USAGE
Dexmedetomidine hydrochloride injection is a alpha -adrenergic
receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated adult
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 adult patients prior to and/or during
surgical and other procedures. (1.2)
Sedation of non-intubated pediatric patients aged 1 month to less than
18 years prior to and during
non-invasive 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 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)
The 200 mcg/50 mL and 400 mcg/100 mL single-dose vials do not require
further dilution prior to
administration. (2.4)
For Adult Intensive Care Unit Sedation: Initi