DEXMEDETOMIDINE HYDROCHLORIDE injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)

Sẵn có từ:

Sandoz Inc

INN (Tên quốc tế):

DEXMEDETOMIDINE HYDROCHLORIDE

Thành phần:

DEXMEDETOMIDINE 100 ug in 1 mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

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].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE HYDROCHLORIDE
INJECTION,
SOLUTION
SANDOZ INC
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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:
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DOSAGE AND ADMINISTRATION
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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
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ADVERSE REACTIONS
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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