Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)
Eugia US LLC
DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE 100 ug in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine 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 injection prior to extubation. Dexmedetomidine 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) injection and PRECEDEXTM (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. None. Risk Summary Available data from published randomized controll
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not Freeze. Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine injection, USP is supplied as follows: Dexmedetomidine Injection, USP Dexmedetomidine injection USP, 200 mcg/2 mL (100 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base. Discard unused portion. 200 mcg per 2 mL (100 mcg/mL): 2 mL single-dose vials packaged in a Carton of 25 Vials NDC 55150-209-02 Preservative Free The vial stoppers are not made with natural rubber latex. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 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. 200 mcg per 50 mL (4 mcg/mL) 50 mL Single-Dose Flexible Containers packaged in a Carton of 10 NDC 55150-296-10 400 mcg per 100 mL (4 mcg/mL) 100 mL Single-Dose Flexible Containers packaged in a Carton of 10 NDC 55150-297-10 Preservative Free
Abbreviated New Drug Application
DEXMEDETOMIDINE - DEXMEDETOMIDINE INJECTION, SOLUTION DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION, SOLUTION EUGIA US LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEXMEDETOMIDINE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXMEDETOMIDINE 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 Dosage and Administration, Preparation of Solution (2.4) 08/2022 Warnings and Precautions, Hyperthermia or Pyrexia (5.7) 08/2022 INDICATIONS AND USAGE Dexmedetomidine 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 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 injection dosing to desired clinical effect. (2.1) Administer dexmedetomidine 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 flexible containers 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 pa Lestu allt skjalið