Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)
Slayback Pharma LLC
INTRAVENOUS
PRESCRIPTION DRUG
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult 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 hav
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride injection is a clear colorless solution. The strength is based on the dexmedetomidine base. Discard unused portion.
Abbreviated New Drug Application
DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE HYDROCHLORIDE INJECTION SLAYBACK PHARMA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% 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 Dexmedetomidine hydrochloride in 0.9% sodium chloride 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 in 0.9% sodium chloride 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) DOSAGE AND ADMINISTRATION • Individualize and titrate dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing to desired clinical effect. (2.1) • Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection using a controlled infusion device. (2.1) • The 200 mcg/50mL and 400 mcg/100 mL single-dose bottles, do not require further dilution prior to administration. (2.4) • For Adult Intensive Care Unit Sedation: 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: 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 fi Baca dokumen lengkap