• Romazicon (flumazenil)

    Romazicon (flumazenil)

    Class:

    Benzodiazepine antagonist.

    Actions:
    Reverses effects of benzodiazepines.

    Indications:
    To reverse CNS, respiratory depression associated with Benzodiazepines.

    Contraindications:
    Romazicon (flumazenil) should not be used as a diagnostic agent for Benzodiazepine overdose in the same manner Naloxone is used for narcotic overdose. Known hypersensitivity to the drug.

    Precautions:
    Administer with caution to patients dependent upon Benzodiazepines as it may induce life-threatening Benzodiazepine withdrawal.

    Side Effects:
    Fatigue, headache, nervousness, dizziness.

    Dosage:
    0.2-0.3 mg IV over 30 seconds; repeated as needed to a maximum dose of 1.0 mg.

    Routes:
    IV.

    Pediatric Dosage:
    Pediatric data unavailable
    Comments 9 Comments
    1. Scotty McScottScott's Avatar
      Mike,
      I'm needing to review my Pharm stuff. If you want, I can write a few of them to the site since I have to be staring at them anyway. I'd need a walkthrough on how to get everything posted to the right sections and such.
      Thoughts?
      Scotty
    1. Dorkfish's Avatar
      Very interesting that I am reading this after a conversation I had with a ED nurse last night.

      Another crew brought in a Ambien OD. The nurse asked if they gave Narcan. They said they gave 4 with no change. He asked why they did not push another 4? They told him after they found out what she took, there was no need. Then the nurse asked why Narcan did not work. The medic from that crew, another ED nurse, and myself had to explain to him the difference in a opate blocker ( Narcan ) and a Benzo blocker ( Romazicon ) and that Ambien is a Benzo.

      Thanks for the post Mike. I will raise my hand in shame to admit my pharm knowledge is not what it needs to be.
    1. mike's Avatar
      Either is mine, I am just copying and pasting them over from the HTML portion of the site.
    1. scotttt's Avatar
      I find it interesting that that romazicon is even still taught to medic students. Further mind-blowing is that some EMS systems still carry it considering it has pretty much no indications in the prehospital setting, and it costs around 50-70$ per vial.
    1. Dorkfish's Avatar
      Quote Originally Posted by scotttt View Post
      I find it interesting that that romazicon is even still taught to medic students. Further mind-blowing is that some EMS systems still carry it considering it has pretty much no indications in the prehospital setting, and it costs around 50-70$ per vial.
      We were taught it, but do not carry it. Cost is one issue, but the way the powers that be see it, more people OD on opiates.
    1. Mogollon's Avatar
      Ambien is not a benzodiazepine. Ambien is part of a class of molecules know as imidazopyridines, which have a distinctly different molecular structure from benzodiazepines. However, flumazenil can reverse the effects of Ambien and the mechanism of Ambien's action regarding GABA is very similar to benzodiazepines.

      In general, I would not recommend routine field use of flumazenil. The risk of withdraw and difficult to manage seizures is a primary concern when utilising flumazenil to reverse people with dependancy and addiction issues. I can see using it to reverse benzo naive patients who are "oversedated" during certain procedure; however, this would not often apply to EMS services.
    1. scotttt's Avatar
      Ditto what Mogollon said. This drug has no indication other than reversal of conscious sedation in well controlled setting. Some time ago I found a pretty amazing case-study that serves as an example of one of the worst outcomes from administration of flumazenil.

      Ann Pharmacother. 1994 Dec;28(12):1347-9.
      Fatal seizures after flumazenil administration in a patient with mixed overdose.
      Haverkos GP, DiSalvo RP, Imhoff TE.
      Department of Pharmacy, Good Samaritan Hospital, Cincinnati, OH 45220.
      Abstract
      OBJECTIVE: To report a fatal case of refractory status epilepticus precipitated by flumazenil use in a mixed benzodiazepine-tricyclic antidepressant overdose. CASE SUMMARY: A 39-year-old woman was brought to the emergency room (ER) in a stupor from a suspected suicidal overdose of an unknown mixture of drugs. Past medical history included seizures and psychiatric disorders managed with benzodiazepine and tricyclic antidepressants. Initial ER electrocardiogram showed a QRS interval of 136 milliseconds. The patient developed refractory seizures after being given flumazenil. Lorazepam, phenytoin, and phenobarbital were administered; however, seizures persisted for 4 hours, resulting in rhabdomyolysis, acute renal failure, severe brain damage, and death. DISCUSSION: Flumazenil should be used with caution in patients with chronic benzodiazepine use, prior seizure history, or when a mixed overdose is suspected. Flumazenil may unmask tricyclic antidepressant-induced seizures by antagonizing the antiepileptic effect of concomitantly ingested benzodiazepine. In this patient seizures occurred within two minutes of flumazenil administration. As benzodiazepine-induced central nervous system depression is rarely life-threatening, the use of flumazenil must be balanced against potential risk. CONCLUSIONS: Seizure risk factors should be assessed in all patients in whom flumazenil use is considered. If risk factors are present, the benefit of flumazenil use is outweighed by the potential risk. If flumazenil is used, resulting seizures may require larger doses of benzodiazepine.
    1. PSYCtest040's Avatar
      Quote Originally Posted by Dorkfish View Post
      We were taught it, but do not carry it. Cost is one issue, but the way the powers that be see it, more people OD on opiates.
      This is the first time I have heard of this drug and I thought I was in a pretty progressive school. Shows I still have a lot to learn.

      Quote Originally Posted by Mogollon View Post
      Ambien is not a benzodiazepine. Ambien is part of a class of molecules know as imidazopyridines, which have a distinctly different molecular structure from benzodiazepines. However, flumazenil can reverse the effects of Ambien and the mechanism of Ambien's action regarding GABA is very similar to benzodiazepines.

      In general, I would not recommend routine field use of flumazenil. The risk of withdraw and difficult to manage seizures is a primary concern when utilising flumazenil to reverse people with dependancy and addiction issues. I can see using it to reverse benzo naive patients who are "oversedated" during certain procedure; however, this would not often apply to EMS services.
      Quote Originally Posted by scotttt View Post
      Ditto what Mogollon said. This drug has no indication other than reversal of conscious sedation in well controlled setting. Some time ago I found a pretty amazing case-study that serves as an example of one of the worst outcomes from administration of flumazenil.

      Ann Pharmacother. 1994 Dec;28(12):1347-9.
      Fatal seizures after flumazenil administration in a patient with mixed overdose.
      Haverkos GP, DiSalvo RP, Imhoff TE.
      Department of Pharmacy, Good Samaritan Hospital, Cincinnati, OH 45220.
      Abstract
      OBJECTIVE: To report a fatal case of refractory status epilepticus precipitated by flumazenil use in a mixed benzodiazepine-tricyclic antidepressant overdose. CASE SUMMARY: A 39-year-old woman was brought to the emergency room (ER) in a stupor from a suspected suicidal overdose of an unknown mixture of drugs. Past medical history included seizures and psychiatric disorders managed with benzodiazepine and tricyclic antidepressants. Initial ER electrocardiogram showed a QRS interval of 136 milliseconds. The patient developed refractory seizures after being given flumazenil. Lorazepam, phenytoin, and phenobarbital were administered; however, seizures persisted for 4 hours, resulting in rhabdomyolysis, acute renal failure, severe brain damage, and death. DISCUSSION: Flumazenil should be used with caution in patients with chronic benzodiazepine use, prior seizure history, or when a mixed overdose is suspected. Flumazenil may unmask tricyclic antidepressant-induced seizures by antagonizing the antiepileptic effect of concomitantly ingested benzodiazepine. In this patient seizures occurred within two minutes of flumazenil administration. As benzodiazepine-induced central nervous system depression is rarely life-threatening, the use of flumazenil must be balanced against potential risk. CONCLUSIONS: Seizure risk factors should be assessed in all patients in whom flumazenil use is considered. If risk factors are present, the benefit of flumazenil use is outweighed by the potential risk. If flumazenil is used, resulting seizures may require larger doses of benzodiazepine.
      I stand in awe of you gentlemen, pharmacology and bio chemistry will be the down fall of me right now.
    1. shockadin's Avatar
      Every once in a while someone brings up Flumazenil as something they'd like to get added to our rigs. They generally get pointed towards our medical director for a quick education and then drop it. In the field, a BVM is about as much of an agent as we need for benzo ODs, especially considering the risks of triggering seizures we may be unable to stop.
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