Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)
Gland Pharma Limited
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. Pediatric use information is approved for Hospira Inc.’s PRECEDEXTM (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusivity rights
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. 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 GLAND PHARMA LIMITED ---------- 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/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: 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 fiberoptic intu Baca dokumen lengkap