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Romazicon (Flumazenil) - Summary









ROMAZICON (flumazenil) is a benzodiazepine receptor antagonist.


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.


ROMAZICON is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use).

See all Romazicon indications & dosage >>


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)

Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults [Recruiting]
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 [Recruiting]
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.

Safety and Pharmacokinetic Study of Sublingual Flumazenil (CRLS035) in Healthy Adults [Recruiting]
This study compare the pharmacokinetic (PK) profile of sublingual CRLS035 (two doses) to I. V flumazenil administration.

Selection of study drug dosage: CRLS035 - sublingual Flumazenil will be administrated at a

final dosage of 1. 1 mg per 100 Ál and 2. 2 mg (200 Ál) in a sublingual spray administration.

Currently, Flumazenil is given as an IV drug with a repetitive administration of doses of 0. 2 mg up to 3 mg per hour. As the bioavailability of Flumazenil is expected to be lower than the IV administration, 1. 1 mg and 2. 2 mg will be tested in sublingual delivery. The suggested doses in this study are very safe according to the following data: first, sublingual and buccal administration of Flumazenil have been detailed previously with similar and higher doses with no side effects, secondly, IV dose may reach 3 mg and thirdly, oral administration has been reported as up to 600 mg/dose.

The purpose of this study is to determine the single dose PK profile of SL CRLS035. This study is designed to collect short-term safety data and to monitor the PK profile of CRLS035.

Primary Objective The primary objective is to determine the single dose safety and PK profile of SL CRLS035 using the marketed IV flumazenil formulation as the comparator.

Secondary Objectives The secondary objectives are to (1) characterize the concentration time course of two dose levels of SL CRLS035 to support dose selection for Phase 2 and 3 studies and to evaluate the safety and tolerability of flumazenil formulations; (2)To evaluate the effect of high fat diet and water consumption on the PK profile.

A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder [Recruiting]

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.

more trials >>

Page last updated: 2011-12-09

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