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盐酸右美托咪定注射液
  • 盐酸右美托咪定注射液
ENGLISH NAME: Dexmedetomidine Hydrochloride Injection
SPECIFICATIONS: 2 ml : 0.2 mg (according Dexmedetomidine)
LICENSE NUMBER: 2 ml : 0.2 mg (according Dexmedetomidine) H20130027
PRODUCT PACKAGING: Glass Ampule; 1 vial/box, 2 vials/box, 5 vials/box
FORMULATION: Injection
STORAGE CONDITION: Shading, Closed, Preservation of the Shade
SHELF LIFE: 24 Months
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Description: Dexmedetomidine Hydrochloride Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7.0. Dexmedetomidine hydrochloride injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+) 4-(S)-[1-(2,3-dimethylphenyl) ethyl]-1H-imidazole monohydrochloride.

Pharmacological effects: Dexmedetomidine is a relatively selective alpha 2-adrenergic agonist with sedative properties. Alpha 2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10‑300 mcg/kg). Both alpha1 and alpha 2 activity is observed following slow intravenous infusion of high doses (≥1000 mcg/kg) or with rapid intravenous administration.

Pharmacokinetics: Following intravenous administration, dexmedetomidine exhibits the following pharmacokinetic parameters: a rapid distribution phase with a distribution half-life (t1/2) of approximately 6 minutes; a terminal elimination half-life (t1/2) of approximately 2 hours; and steady-state volume of distribution (Vss) of approximately 118 liters. Clearance is estimated to be approximately 39 L/h. The mean body weight associated with this clearance estimate was 72 kg. Dexmedetomidine exhibits linear pharmacokinetics in the dosage range of 0.2 to 0.7 mcg/kg/hr when administered by intravenous infusion for up to 24 hours. The steady-state volume of distribution (Vss) of dexmedetomidine was approximately 118 liters. Dexmedetomidine protein binding was assessed in the plasma of normal healthy male and female subjects. The average protein binding was 94% and was constant across the different plasma concentrations tested Dexmedetomidine undergoes almost complete biotransformation with very little unchanged dexmedetomidine excreted in urine and feces. Biotransformation involves both direct glucuronidation as well as cytochrome P450 mediated metabolism. The terminal elimination half-life (t1/2) of dexmedetomidine is approximately 2 hours and clearance is estimated to be approximately 39 L/h.

Indications: Intensive Care Unit Sedation,Procedural Sedation.

Precautions: Dexmedetomidine Hydrochloride Injection should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of dexmedetomidine, patients should be continuously monitored while receiving Dexmedetomidine Hydrochloride Injection. Reports of hypotension and bradycardia have been associated with dexmedetomidine infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Dexmedetomidine Hydrochloride Injection, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. In some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering Dexmedetomidine Hydrochloride Injection to patients with advanced heart block and/or severe ventricular dysfunction. Because dexmedetomidine decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients. Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of Dexmedetomidine Hydrochloride Injection. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable. In adult subjects, tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Dexmedetomidine Hydrochloride Injection supportive therapy is indicated. In adult subjects, withdrawal symptoms were not seen after discontinuation of short term infusions of Dexmedetomidine Hydrochloride Injection (<6 hours). Since dexmedetomidine clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function .

Adverse reaction: Hypotension, bradycardia and sinus arrest, Transient hypertension. The most frequent adverse reactions were hypotension, bradycardia and dry mouth. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia .
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