Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)
Sandoz Inc
DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE 100 ug in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated 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 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 patients prior to and/or during surgical and other procedures. None There are no adequate and well-controlled studies of dexmedetomidine hydrochloride use in pregnant women. In an in vitro human placenta study, placental transfer of dexmedetomidine occurred. In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. Thus, fetal exposure should be expected in humans, and
Dexmedetomidine injection, USP 200 mcg/2 mL (100 mcg/mL) dexmedetomidine, is a clear, colorless solution and is available in 2 mL clear glass vials. The strength is based on the dexmedetomidine base. Vials are intended for single-dose only. Discard unused portion. 0781-3297-95 – 2 mL vials in boxes of 10. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION SANDOZ INC ---------- 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 INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE Dexmedetomidine injection is a relatively selective alpha -adrenergic agonist indicated for: • • DOSAGE AND ADMINISTRATION • • • FOR ADULT INTENSIVE CARE UNIT SEDATION: Generally 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: Generally 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 intubation patients. (2.2) DOSAGE FORMS AND STRENGTHS Dexmedetomidine injection, USP 200 mcg/2 mL (100 mcg/mL) dexmedetomidine in a glass vial. To be used after dilution. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS • • 2 Sedation of initially intubated and mechanically ventilated 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 patients prior to and/or during surgical and other procedures. (1.2) Individualize and titrate dexmedetomidine hydrochloride dosing to desired clinical effect. (2.1) Administer dexmedetomidine hydrochloride 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) Monitoring: Continuously monitor patients while receiving dexmedetomidine hyd Les hele dokumentet