국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)
Sun Pharmaceuticals Industries, Inc.
DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE 100 ug in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. None Pregnancy Category C: 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 hydrochloride should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intravenous dose based on body surface
Dexmedetomidine hydrochloride injection, 200 mcg (dexmedetomidine)/2 mL (100 mcg (dexmedetomidine) /mL) is available as clear and colorless solution in 2 mL clear glass vial. Vials are intended for single dose only. Discard unused portion. NDC No. Container Package Description This package is contained within the BOX (57664-596-50) Vial 2 mL In 1 VIAL 25 VIAL In 1 BOX Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION SUN PHARMACEUTICALS INDUSTRIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEXMEDETOMIDINE HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE INJECTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE Dexmedetomidine hydrochloride injection is a relatively selective alpha -adrenergic agonist indicated for: • DOSAGE AND ADMINISTRATION • • • 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/HO UR.(2.2) ALTERNATIVE DOSES: Recommended for patients over 65 years of age and awake fiberoptic intubation patients. (2.2) DOSAGE FORMS AND STRENGTHS Dexmedetomidine Hydrochloride Injection, 200 mcg (dexmedetomidine)/2 mL [100 mcg (dexmedetomidine)/mL] in a glass vial. To be used after dilution (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL INDUSTRIES, INC. AT 1-800-818-4555 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH DRUG INTERACTIONS Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of Dexmedetomidine hydrochloride or the concomitant medication may be required. (7.1) 2 Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.2) 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 200mcg/2mL (100mcg/mL)vial contents in 0.9% sodium chloride solution to achieve required concentration (4 mcg/ 전체 문서 읽기