Flumazenil
ROMAZICON
What it isCompetitive benzodiazepine-site antagonist; benzodiazepine reversal.
Why this oneIt rapidly reverses benzodiazepine sedation, which supportive care cannot.
What limits it⚑ It can precipitate seizures in benzodiazepine dependence or tricyclic co-ingestion. Its brief effect allows re-sedation.
FDA-approved for
- benzodiazepine reversal (1991)
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Reversal of conscious sedation | Adults | 0.2 mg IV over 15 s | repeat 0.2 mg q60s PRN | 1 mg total |
| Reversal of general anesthesia | Adults | 0.2 mg IV over 15 s | repeat 0.2 mg q60s PRN | 1 mg total |
| Suspected benzodiazepine overdose | Adults | 0.2 mg IV over 30 s, then 0.3 mg, then 0.5 mg q1min | titrate to response | 3 mg cumulative (occasionally up to 5 mg) |
| Reversal of conscious sedation | Peds >1y | 0.01 mg/kg (up to 0.2 mg) IV over 15 s | repeat 0.01 mg/kg q60s PRN | 0.05 mg/kg or 1 mg, whichever is lower |
Renal Undefined
Hepatic Undefined
Resedation: repeat doses at 20-min intervals; no more than 1 mg per treatment and no more than 3 mg per hour.
Instructions
- IV use only; administer into a freely running IV in a large vein
- Give as a series of small injections, not a single bolus
Contraindications
- Patients given a benzodiazepine to control a potentially life-threatening condition (e.g., raised intracranial pressure or status epilepticus)
- Signs of serious cyclic antidepressant overdose
Cautions
- Convulsions — esp. benzodiazepine-dependent patients, mixed-drug overdose, or severe hepatic impairment
- Resedation
- Benzodiazepine withdrawal symptoms after rapid injection
- Deaths reported, mainly with serious underlying disease or cyclic-antidepressant overdose
Adverse reactions
- Dizziness
- Injection site pain
- Increased sweating
- Headache
- Abnormal/blurred vision
- Nausea and vomiting
- Agitation
- Convulsions
Pregnancy Undefined
Lactation Undefined
NO BOXED WARNINGS
Principal riskIt precipitates seizures in the benzodiazepine-dependent
Cost, est. cash$20–$2,000/month
Generic entry2004
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityAgent-specific cardiovascular, neurologic or metabolic toxicity requires monitored use in poisoning or overload.
Mechanism of action: Flumazenil ballicule
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