Flumazenil

ROMAZICON

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Flumazenil ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Flumazenil ballicule

Flumazenil ROMAZICON mascot mnemonic cartoon — Visual mnemonic: Flumazenil mascot
**“Flume a -zepine”**

What it isCompetitive benzodiazepine-site antagonist; benzodiazepine reversal.

Why this oneRapidly 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.

Flumazenil molecular structure (skeletal formula) — Molecular structure: Flumazenil

FDA-approved for

benzodiazepine reversal (1991)

Principal riskIt precipitates seizures in the benzodiazepine-dependent

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger3 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryUnknown / historical label unavailable

Defining liabilityAgent-specific cardiovascular, neurologic or metabolic toxicity requires monitored use in poisoning or overload.

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Seizures, most frequent after long-term benzodiazepine sedation or in overdose with signs of serious cyclic antidepressant overdose; individualize dosage and be prepared to manage seizures.

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

Available strengths

inj 0.1 mg/mL

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

Cost

Flumazenil (ROMAZICON)

What pharmacies pay · NADAC 9/30/26

Strength		#/mo	generic $/unit	CostPlus
0.1 mg/mL	inj	per unit	$1.18/mL	not offered

Generic entry2004

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Self-check

Why can sedation recur after flumazenil?
Its effect is brief.
Which co-ingestion raises flumazenil-triggered seizure risk?
Tricyclic antidepressants.