What is Romazicon used to treat?
Romazicon is a prescription medicine used as reversal of Conscious Sedation and General Anesthesia. Romazicon may be used alone or with other medications. Romazicon belongs to a class of drugs called Benzodiazepine Toxicity Antidotes. What are the possible side effects of Romazicon? Romazicon may cause serious side effects including:
Can Romazicon be used to reverse versed?
PDR 2003). Romazicon (Flumazenil) is a benzodiazepine antogonist used to reverse Versed (Midazolam) and Valium (Diazepam). It also has a rapid onset of action, producing a reversal in less than one minute.
Does Romazicon have any effect on benzodiazepines?
Romazicon has no effect in cases where benzodiazepines are not responsible for sedation. Once doses of 3 mg to 5 mg have been reached without clinical response, additional Romazicon is likely to have no effect.
How should I use Flumazenil (Romazicon)?
Use Flumazenil (Romazicon) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Flumazenil is given as an infusion into a vein. A healthcare provider will give you this injection.
What meds does Romazicon reverse?
Romazicon (Flumazenil) is a benzodiazepine antogonist used to reverse Versed (Midazolam) and Valium (Diazepam). It also has a rapid onset of action, producing a reversal in less than one minute. A dose of 0.2 – 1 mg is given slowly intravenously with a dose not exceeding 0.2 mg/min.
What is Romazicon used for?
Romazicon (flumazenil) is a benzodiazepine receptor antagonist used to reverse the sedative effects of a benzodiazepine when used during surgery or other medical procedure. Romazicon is also used to treat benzodiazepine overdose.
What is flumazenil the antidote for?
Flumazenil injection is indicated for a complete or partial reversal of the sedative effects of benzodiazepines in conscious sedation and general anesthesia in adult and pediatric populations.
What is the antidote for midazolam?
Conclusion: Flumazenil in a dose of 0.15 mg is a safe drug that reverses the sedative effect of midazolam.
When should you not take flumazenil?
Flumazenil should not be used routinely Flumazenil is contraindicated in patients with unknown or mixed overdose, benzodiazepine tolerance, seizure disorders or a prolonged QRS interval.
When should you administer flumazenil?
Initial dose: 0.2 mg IV one time over 15 seconds. Repeated doses: 0.2 mg may be given every minute until the desired level of consciousness is achieved. Maximum total dose 1 mg.
What is the antidote for opioid?
Naloxone is a life-saving medication that can reverse an overdose from opioids—including heroin, fentanyl, and prescription opioid medications—when given in time. Naloxone is easy to use and small to carry.
What is the antidote for alcohol?
Antidotes for Toxic-alcohol Poisoning. The use of ethanol or, preferably, fomepizole for alcohol dehydrogenase (ADH) inhibition is a mainstay in the management of toxicity due to ingestion of methanol, ethylene glycol, or diethylene glycol.
What is the antidote for aspirin?
Aspirin crosses the blood-brain barrier in acidic blood. Administer IV sodium bicarbonate to achieve a blood pH between 7.45-7.5. [Many physicians will use D5W with 150 mEq HCO3/L as an initial crystalloid infusion]. Aspirin poisoning causes hyperventilation which helps to maintain alkalemia.
What is the antidote for propofol?
In summary, we have shown that physostigmine reverses the propofol-induced unconsciousness and associated depression of the ASSR and BIS in human volunteers. The reversal of the unconsciousness and depression of the ASSR and BIS was blocked by pretreatment with scopolamine.
What is the reversal for propofol?
Reversal agents exist for each class of drugs used in sedative procedures (unfortunately, propofol does not have a reversal agent). The current reversal agents, flumazenil for benzodiazepines and naloxone for opioids, work by binding to the same receptors that the sedative or opiate drug attaches to.
What is antidote of atropine?
The antidote to atropine is physostigmine or pilocarpine. A common mnemonic used to describe the physiologic manifestations of atropine overdose is: "hot as a hare, blind as a bat, dry as a bone, red as a beet, and mad as a hatter".
How do you administer Romazicon?
For initial management of a known or suspected benzodiazepine overdose, the recommended initial dose of ROMAZICON is 0.2 mg (2 mL) administered intravenously over 30 seconds.
Is Romazicon a controlled substance?
Although flumazenil has a benzodiazepine-like structure it does not act as a benzodiazepine agonist in man and is not a controlled substance.
How do you administer a flumazenil injection?
The recommended starting dose is 200 micrograms administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 100 micrograms can be injected and repeated at 60-second intervals, up to a maximum dose of 1000 micrograms.
Does flumazenil reverse respiratory depression?
Conclusions: Flumazenil effectively reverses the benzodiazepine component of ventilatory depression during combined administration of a benzodiazepine and an opioid.
How many patients have taken Romazicon?
Romazicon was studied in two trials in 497 patients who were presumed to have taken an overdose of a benzodiazepine, either alone or in combination with a variety of other agents. In these trials, 299 patients were proven to have taken a benzodiazepine as part of the overdose, and 80% of the 148 who received Romazicon responded by an improvement in level of consciousness. Of the patients who responded to flumazenil, 75% responded to a total dose of 1 mg to 3 mg.
Why should you be cautious when administering Romazicon to a nursing woman?
Caution should be exercised when deciding to administer Romazicon to a nursing woman because it is not known whether flumazenil is excreted in human milk.
How much clearance does Romazicon have?
The clearance of Romazicon is reduced to 40% to 60% of normal in patients with mild to moderate hepatic disease and to 25% of normal in patients with severe hepatic dysfunction (see CLINICAL PHARMACOLOGY: Pharmacokinetics ). While the dose of flumazenil used for initial reversal of benzodiazepine effects is not affected, repeat doses of the drug in liver disease should be reduced in size or frequency.
How long does flumazenil last?
Flumazenil is extensively distributed in the extravascular space with an initial distribution half-life of 4 to 11 minutes and a terminal half-life of 40 to 80 minutes.
How long does it take for flumazenil to be eliminated?
Elimination. Elimination of radiolabeled drug is essentially complete within 72 hours, with 90% to 95% of the radioactivity appearing in urine and 5% to 10% in the feces. Clearance of flumazenil occurs primarily by hepatic metabolism and is dependent on hepatic blood flow.
Can Romazicon cause withdrawal symptoms?
Romazicon may cause benzodiazepine withdrawal symptoms in individuals who have been taking benzodiazepines long enough to have some degree of tolerance. Patients who had been taking benzodiazepines prior to entry into the Romazicon trials, who were given flumazenil in doses over 1 mg, experienced withdrawal-like events 2 to 5 times more frequently than patients who received less than 1 mg.
Is Romazicon an induction agent?
Romazicon was studied in four trials in 644 patients who received midazolam as an induction and/or maintenance agent in both balanced and inhalational anesthesia. Midazolam was generally administered in doses ranging from 5 mg to 80 mg, alone and/or in conjunction with muscle relaxants, nitrous oxide, regional or local anesthetics, narcotics and/or inhalational anesthetics. Flumazenil was given as an initial dose of 0.2 mg IV, with additional 0.2 mg doses as needed to reach a complete response, up to a maximum total dose of 1 mg. These doses were effective in reversing sedation and restoring psychomotor function, but did not completely restore memory as tested by picture recall. Romazicon was not as effective in the reversal of sedation in patients who had received multiple anesthetic agents in addition to benzodiazepines.
How to administer romazicon?
To minimize the likelihood of pain at the injection site, ROMAZICON should be administered through a freely running intravenous infusion into a large vein.
How long does it take to take romazicon?
For the reversal of the sedative effects of benzodiazepines administered for general anesthesia, the recommended initial dose of ROMAZICON is 0.2 mg (2 mL) administered intravenously over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, a further dose of 0.2 mg (2 mL) can be injected and repeated at 60-second intervals where necessary (up to a maximum of 4 additional times) to a maximum total dose of 1 mg (10 mL). The dosage should be individualized based on the patient's response, with most patients responding to doses of 0.6 mg to 1 mg (see INDIVIDUALIZATION OF DOSAGE ).
Can you give ROMAZICON as a single bolus?
It is recommended that ROMAZICON be administered as the series of small injections described (not as a single bolus injection) to allow the practitioner to control the reversal of sedation to the approximate endpoint desired and to minimize the possibility of adverse effects (see INDIVIDUALIZATION OF DOSAGE ).
Is ROMAZICON safe to inject?
ROMAZICON is supplied in sealed dosage forms and poses no known risk to the healthcare provider. Routine care should be taken to avoid aerosol generation when preparing syringes for injection, and spilled medication should be rinsed from the skin with cool water.
Is flumazenil 0.1mg in 1mL?
Generic name : flumazenil 0.1mg in 1mL. Dosage form: injection, solution. ROMAZICON is recommended for intravenous use only. It is compatible with 5% dextrose in water, lactated Ringer's and normal saline solutions. If ROMAZICON is drawn into a syringe or mixed with any of these solutions, it should be discarded after 24 hours.
Can you rush romazicon?
Do not rush the administration of ROMAZICON. Patients should have a secure airway and intravenous access before administration of the drug and be awakened gradually (see PRECAUTIONS ).
Can romazicon be given at 20 min intervals?
If a patient has not responded 5 minutes after receiving a cumulative dose of 5 mg of ROMAZICON, the major cause of sedation is likely not to be due to benzodiazepines, and additional ROMAZICON is likely to have no effect. In the event of resedation, repeated doses may be given at 20-minute intervals if needed.
What is the best antidote for acetaminophen?
Acetylcysteine (Mucomyst ®) is the antidote for acetaminophen accumulation and overdose, administered either in oral or intravenous form. Management of pain and anxiety, and providing conscious sedation can also put our patients at risk. Naloxone (Narcan®) is the antidote for narcotics, such as morphine, dilaudid, and fentanyl.
What is the best antidote for morphine?
Naloxone (Narcan®) is the antidote for narcotics, such as morphine, dilaudid, and fentanyl. Intravenous administration is preferred, although intramuscular injection can be given. Flumazenil (Romazicon®) is the antidote for benzodiazepines, such as diazepam (Valium®), lorazepam (Ativan®), and midazolam (Versed®), ...
What is the best reversal agent for benzodiazepines?
Flumazenil (Romazicon®) is the reversal agent of choice for an overdose of benzodiazepines (diazepam or midazolam).
What is the best reversal agent for morphine overdose?
There are two important reversal agents to remember: Naloxone (Narcan®) is the reversal agent of choice for narcotic / opioid (morphine) over-dosage. Flumazenil (Romazicon®) is the reversal agent of choice for an overdose of benzodiazepines (diazepam or midazolam).
Is flumazenil an antidote?
Flumazenil: an antidote for benzodiazepine toxic ity. Flumazenil, a specific benzodiazepine antagonist, is useful in reversing the sedation and respiratory depression that often occur when benzodiazepines are administered to patients undergoing anesthesia or when patients have taken an intentional benzodiazepine overdose.
Is flumazenil a benzodiazepine antagonist?
Flumazenil, a specific benzodiazepine antagonist, is useful in reversing the sedation and respiratory depression that often occur when benzodiazepines are administered to patients undergoing anesthesia or when patients have taken an intentional benzodiazepine overdose. Judicious use of flumazenil ma …. Flumazenil: an antidote for benzodiazepine ...
What is the brand name of Romazicon?
Flumazenil (Romazicon) Brand Names: Romazicon. Last Updated: June 23, 2020. Flumazenil is used to reverse the effects of a benzodiazepine (BENZ-oh-dye-AYZ-e-peen) sedative such as Valium, Versed, Xanax, Tranxene, and others. Flumazenil is used to help you wake up after a surgery or medical procedure in which a benzodiazepine was used as a sedative.
Why do you need flumazenil?
Flumazenil is used to help you wake up after a surgery or medical procedure in which a benzodiazepine was used as a sedative.
Where is flumazenil given?
Flumazenil is given as an infusion into a vein. A healthcare provider will give you this injection.
Can flumazenil cause seizures?
Flumazenil may cause seizures. especially: in people withdrawing from sedative addiction; in people who have recently taken an antidepressant overdose; in people who have recently received injectable benzodiazepines; or. in people who had seizure-like symptoms just before receiving flumazenil.
Can you take Flumazenil in larger amounts?
Use Flumazenil (Romazicon) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Flumazenil is given as an infusion into a vein. A healthcare provider will give you this injection.
Can you miss flumazenil?
Because you will receive flumazenil in a clinical setting, you are not likely to miss a dose.
Can you take flumazenil if you are allergic to it?
You should not receive this medicine if you are allergic to flumazenil or any type of benzodiazepine sedative, or if you have taken an overdose of certain antidepressant medication. if you have been using benzodiazepine long-term. Tell your doctor if you are pregnant or breastfeeding.
What is Narcan used for?
Narcan (Naloxone) is used to reverse medications like Morphine, Methadone and Nalbuphine.
How does Narcan work?
Narcan (Naloxone) is used to reverse medications like Morphine, Methadone and Nalbuphine. It is a competitive opiate antagonist that binds with opiate receptors in the central nervous system (CNS) and spinal cord, and blocks out the binding of opiates to these receptor sites. The opiates are then metabolized in the liver and excreted. When therapeutic blood levels of Naloxone are maintained, opiates cannot affect the CNS. The therapeutic dose of Naloxone is 0.4 – 1 mg titrated intravenously. It has a rapid onset of action, producing reversal in less than one minute and can be repeated at half to one hour intervals, if signs of re-sedation appear (Gahart & Nazareno, 2003. PDR 2003).
Description
Pharmacology
- Flumazenil, an imidazobenzodiazepine derivative, antagonizes the actions of benzodiazepines on the central nervous system. Flumazenil competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex. Flumazenil is a weak partial agonist in some animal models of activity, but has little or no agonist activity in man. Flumazeni…
Other animals
- In animals pretreated with high doses of benzodiazepines over several weeks, Romazicon elicited symptoms of benzodiazepine withdrawal, including seizures. A similar effect was seen in adult human subjects.
Uses
- Intravenous Romazicon has been shown to antagonize sedation, impairment of recall, psychomotor impairment and ventilatory depression produced by benzodiazepines in healthy human volunteers.
Prognosis
- The duration and degree of reversal of sedative benzodiazepine effects are related to the dose and plasma concentrations of flumazenil as shown in the following data from a study in normal volunteers.
Interactions
- Ingestion of food during an intravenous infusion of the drug results in a 50% increase in clearance, most likely due to the increased hepatic blood flow that accompanies a meal.
Research
- Romazicon has been administered in adults to reverse the effects of benzodiazepines in conscious sedation, general anesthesia, and the management of suspected benzodiazepine overdose. Limited information from uncontrolled studies in pediatric patients is available regarding the use of Romazicon to reverse the effects of benzodiazepines in conscious sedatio…
Adverse effects
- Seventy-eight percent of patients receiving flumazenil responded by becoming completely alert. Of those patients, approximately half responded to doses of 0.4 mg to 0.6 mg, while the other half responded to doses of 0.8 mg to 1 mg. Adverse effects were infrequent in patients who received 1 mg of Romazicon or less, although injection site pain, agitation, and anxiety did occur. Reversal …
Toxicity
- Eighty-one percent of patients sedated with midazolam responded to flumazenil by becoming completely alert or just slightly drowsy. Of those patients, 36% responded to doses of 0.4 mg to 0.6 mg, while 64% responded to doses of 0.8 mg to 1 mg.
Side effects
- Resedation in patients who responded to Romazicon occurred in 10% to 15% of patients studied and was more common with larger doses of midazolam (>20 mg), long procedures (>60 minutes) and use of neuromuscular blocking agents (see PRECAUTIONS). Romazicon is well tolerated at the recommended doses in individuals who have no tolerance to (or dependence on) benzodiaz…
Treatment
- In patients who may have tolerance to benzodiazepines, as indicated by clinical history or by the need for larger than usual doses of benzodiazepines, slower titration rates of 0.1 mg/min and lower total doses may help reduce the frequency of emergent confusion and agitation. In such cases, special care must be taken to monitor the patients for resedation because of the lower d…
Medical uses
- 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 ind…
Contraindications
- Romazicon is contraindicated: Romazicon is not recommended in cases of serious cyclic antidepressant poisoning, as manifested by motor abnormalities (twitching, rigidity, focal seizure), dysrhythmia (wide QRS, ventricular dysrhythmia, heart block), anticholinergic signs (mydriasis, dry mucosa, hypoperistalsis), and cardiovascular collapse at presentation. In such cases Romazico…
Causes
- The reversal of benzodiazepine effects may be associated with the onset of seizures in certain high-risk populations. Possible risk factors for seizures include: concurrent major sedative-hypnotic drug withdrawal, recent therapy with repeated doses of parenteral benzodiazepines, myoclonic jerking or seizure activity prior to flumazenil administration in overdose cases, or con…
Safety
- Overdose cases should always be monitored for resedation until the patients are stable and resedation is unlikely.