Country: United States
Language: English
Source: NLM (National Library of Medicine)
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)
Par Pharmaceutical, Inc.
DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE 100 ug in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION PAR PHARMACEUTICAL, INC. ---------- 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 Read the complete document