ROMAZICON SUMMARY
ROMAZICON®
(flumazenil)
INJECTION
ROMAZICON (flumazenil) is a benzodiazepine receptor antagonist.
ADULT PATIENTS
ROMAZICON is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
PEDIATRIC PATIENTS (AGED 1 TO 17)
ROMAZICON is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use).
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NEWS HIGHLIGHTS
Published Studies Related to Romazicon (Flumazenil)
Efficacy of a combination of flumazenil and gabapentin in the treatment of alcohol dependence: relationship to alcohol withdrawal symptoms. [2009.08]
Improved treatment of alcohol dependence is a high priority, including defining subtypes that might respond differently. We evaluated a medication combination of intravenous flumazenil (FMZ) and oral gabapentin (GBP) in alcoholics who did and did not exhibit pretreatment alcohol withdrawal (AW) symptoms...
Flumazenil reversal of sublingual triazolam: a randomized controlled clinical trial. [2009.05]
BACKGROUND: Incremental sublingual (SL) dosing of triazolam has emerged as a popular sedation technique. Nevertheless, few studies have evaluated the technique's safety or efficacy. Given its popularity, an easily administered rescue strategy is needed... CONCLUSIONS: Deep sedation from incremental SL dosing of triazolam is incompletely reversed by a single intraoral injection of flumazenil. The reversal did not persist. The authors discharged the patients from the dental clinic at 360 minutes. CLINICAL IMPLICATIONS: A single intraoral injection of flumazenil (0.2 mg) cannot immediately reverse oversedation with triazolam. A higher dose might be effective. Reversal for the purpose of discharging the patient early is neither appropriate nor safe.
Effect of flumazenil on bispectral index monitoring in unpremedicated patients. [2009.05]
BACKGROUND: Flumazenil is an imidazobenzodiazepine that promptly reverses via competitive inhibition the hypnotic/sedative effects of benzodiazepines on gamma-aminobutyric acid receptors. Endogenous benzodiazepine ligands (endozepines) were isolated in urine, cerebrospinal fluid, and breast milk of women who had not received benzodiazepines. The bispectral index (BIS), an electroencephalographically derived parameter widely used for monitoring the effects of anesthetic/hypnotic drugs, was shown to correlate to various conditions that could influence electroencephalography. The authors examined the hypothesis that 0.5 mg of flumazenil administered to healthy unpremedicated patients during deep surgical remifentanil/propofol anesthesia would increase the BIS value and might expedite recovery from anesthesia... CONCLUSIONS: This study demonstrates that flumazenil given to healthy unpremedicated patients during propofol/remifentanil anesthesia significantly increased the BIS value and allowed earlier emergence from anesthesia. This may indicate that flumazenil could be used on a case-by-case basis to reverse endogenous or exogenous endozepines that might play a role during anesthesia.
Effect of intravenous flumazenil on oral midazolam pharmacokinetics and pharmacodynamics for use as a cytochrome P450 3A probe. [2009.02]
Phenotyping intestinal and hepatic cytochrome P450 (CYP) 3A activity with oral midazolam can be limited by midazolam-induced central nervous system (CNS) side effects. Determining methods to minimize CNS side effects optimizes use of midazolam as a CYP3A probe. OBJECTIVE: The objective of this study was to determine the effect of intravenous (i.v.) flumazenil on midazolam apparent oral clearance (a surrogate marker of CYP3A activity). Midazolam pharmacodynamics were also evaluated... CONCLUSION: i.v. flumazenil can be used in conjunction with oral midazolam for CYP3A phenotyping.
Effect of flumazenil on disturbance of equilibrium function induced by midazolam. [2008.09]
Benzodiazepines in intravenous sedation are useful, owing to their outstanding amnesic effect when used for oral surgery as well as dental treatments on patients with intellectual disability or dental phobia. However, compared with propofol, the effect of benzodiazepine lasts longer and may impede discharge, especially when it is administered orally because of fear of injections.
Clinical Trials Related to Romazicon (Flumazenil)
Rapid Benzodiazepine Detoxification Using Flumazenil - 1 [Completed]
The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist,
flumazenil, will reduce acute benzodiazepine withdrawal.
Rapid Benzodiazepine Detoxification Using Flumazenil - 2 [Completed]
The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist,
flumazenil, will reduce acute benzodiazepine withdrawal.
Flumazenil Reversal of Oral Triazolam [Completed]
An increase in the utilization of anesthesia and sedation medications by
non-anesthesiologists, including dentists, has grown dramatically. This has been prompted,
in part, by the need for pharmacological tools to address high levels of fear and anxiety
about dental care among the US population and the evidence of oral health disparities among
those who are fearful . Given the prevalence of dental fear in the general population and in
the various populations with the greatest burden of oral diseases, effective sedation
techniques are needed that are safe and effective in the hands of general dentists that make
up the "front line" in the efforts to reduce oral health disparities. This study is to
determine whether, when compared to a saline placebo, a single intraoral submucosal
administration of the benzodiazepine antagonist flumazenil (0. 2 mg) is capable of attenuating
in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of
stacked sublingual dosing of triazolam (3 doses of 0. 25 mg over 90 minutes).
A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder [Recruiting]
Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325 [Recruiting]
The study is carried out in order to determine the relationship between the dose of AZD7325
and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to
the GABAA receptors.
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