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Romazicon (Flumazenil) - Summary


Boxed Warning




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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Published Studies Related to Romazicon (Flumazenil)

A controlled trial of flumazenil and gabapentin for initial treatment of methylamphetamine dependence. [2011.02]
Drug use has been associated with craving, which may be described as a powerful and sometimes overwhelming urge to use the drug. Patients seeking treatment for methylamphetamine dependence must cope with drug cravings as they engage in psychosocial treatments... Decreased methylamphetamine use was also observed, as measured by urine drug screens and self-reports.

Flumazenil expedites recovery from sevoflurane/remifentanil anaesthesia when administered to healthy unpremedicated patients. [2010.11]
BACKGROUND AND OBJECTIVE: To investigate the hypothesis that 0.3 mg flumazenil administered to healthy unpremedicated patients at the end of deep surgical sevoflurane/remifentanil anaesthesia would expedite recovery. Flumazenil, an imidazobenzodiazepine derivative, antagonizes the hypnotic/sedative effects of benzodiazepines on gamma-aminobutyric acid receptors. However, endogenous benzodiazepine ligands (endozepines) were isolated in mammalian tissues of individuals who had not received benzodiazepines... CONCLUSION: Administration of a single dose of 0.3 mg flumazenil to healthy unpremedicated patients at the end of sevoflurane/remifentanil anaesthesia results in earlier emergence from anaesthesia and significantly expedites recovery. This could redefine the role of flumazenil in general anaesthesia, implicating endozepine-dependent mechanisms.

A controlled trial of flumazenil and gabapentin for initial treatment of methylamphetamine dependence. [2009.11.25]
Drug use has been associated with craving, which may be described as a powerful and sometimes overwhelming urge to use the drug. Patients seeking treatment for methylamphetamine dependence must cope with drug cravings as they engage in psychosocial treatments... Decreased methylamphetamine use was also observed, as measured by urine drug screens and self-reports.

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.

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Clinical Trials Related to Romazicon (Flumazenil)

Treatment of Hepatic Encephalopathy With Flumazenil and Change in Cortical GABA Levels in MRS [Recruiting]
The purpose of this study is to test feasibility of measuring flumazenil-induced changes in cortical GABA levels observed with localized 1H-MRS in relation to changes in severity of hepatic encephalopathy (HE) in subjects with non-alcoholic liver cirrhosis. This study is a double-blind, placebo-controlled, randomized, cross-over design.

Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults [Completed]
The purpose of this study is to evaluate the safety and effectiveness of treatment with sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability data. In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed to monitor the degree and the duration of action in a single use of Flumazenil.

Flumazenil for the Treatment of Primary Hypersomnia [Completed]
The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is caused by a problem with the quality of sleep occurring at night, for instance when nighttime sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a symptom of brain dysfunction, and so are referred to as hypersomnias of central (i. e., brain) origin, or primary hypersomnias. The causes of most of these primary hypersomnias are not known. However, our group has recently identified a problem with the major brain chemical responsible for sedation, known as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance that causes the GABA receptor to be hyperactive. In essence, it is as though these patients are chronically medicated with Valium (or Xanax or alcohol, all substances that act through the GABA system), even though they do not take these medications. Current treatment of central hypersomnias is limited. For the fraction of cases with narcolepsy, there are FDA-approved, available treatments. However, for the remainder of patients, there are no treatments approved by the FDA. They are usually treated with medications approved for narcolepsy, but sleep experts agree that these medications are often not effective for this group of patients. Based on our understanding of the GABA abnormality in these patients, we evaluated whether flumazenil (an medication approved by the FDA for the treatment of overdose of GABA medications or the reversal of GABA-based anesthesia) would reverse the GABA abnormality in our patients. In a test tube model of this disease, flumazenil does in fact return the function of the GABA system to normal. The investigators have treated a few patients with flumazenil and most have felt that their hypersomnia symptoms improved with this treatment. To determine whether flumazenil is truly beneficial for primary hypersomnia, this study will compare flumazenil to an inactive pill (the placebo). All subjects will receive both flumazenil and the placebo at different times, and their reaction times and symptoms will be compared on these two treatments to determine if one is superior. Currently, flumazenil can only be given through an injection into a vein (i. e., intravenously). This study will evaluate this intravenous dosing as well as a new form of flumazenil, which is taken as a lozenge to be dissolved under the tongue. If this study shows that flumazenil is more effective than placebo in the treatment of hypersomnia, it will identify a potential new therapy for this difficult-to-treat disorder.

Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane [Completed]
Background and objectives: The inhalational anesthetic isoflurane is widely used in general anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil, benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early anesthetic recovery reduce morbidity and incidence of complications. The objective of this trial is to determine whether the use of flumazenil may contribute to faster recovery from anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were enrolled in this prospective, double-blind, randomized trial. Patients were randomized to receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The anesthetic technique was standardized. The groups were compared concerning values of Cerebral State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation, time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10) was also collected. ANOVA test was applied to analyze the results, considering p <0. 05.

Characterization of [11C]Flumazenil to Image GABA Transmission in Healthy Adult Subjects and Subjects With Alcohol Dependence [Terminated]

- This study is being done to examine the role of a chemical GABA in the brain of alcohol

dependent patients. GABA is the chief inhibitory neurotransmitter in the central nervous system. It helps induce relaxation and sleep and balances the brain by inhibiting over-excitation. Several studies have reported that anxiety disorders such as panic attacks, seizure disorders, and numerous other conditions including addiction, are all related to low GABA activity. Therefore, we will examine differences in GABA levels between healthy controls and subjects with alcohol addiction. Studies such as this are important to the understanding of the role of GABA in alcohol addiction.

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Page last updated: 2011-12-09

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