Classes
DEA Class; Rx
Common Brand Names; Romazicon
- Benzodiazepine Toxicity Antidotes
Description
Parenteral benzodiazepine antagonist
Treats benzodiazepine overdose, reverses benzodiazepine-induced sedation, and antagonizes the actions of zolpidem
Does not reverse the actions of barbiturates, opiate agonists, or tricyclic antidepressants
Indications
Indicated for sedation reversal when sedation is secondary to benzodiazepine therapy.
Contraindications
Hypersensitivity to flumazenil or benzodiazepines
Possible concomitant: Cyclic antidepressant overdose
Chronic benzodiazepine user; patients receiving a benzodiazepine for life-threatening condition (eg, intracranial pressure control, status epilepticus)
Adverse Effects
- Nausea and vomiting (11%)
- Dizziness (10%)
- Abnormal/blurred vision (3-9%)
- Agitation (3-9%)
- Dyspnea (3-9%)
- Hyperventilation (3-9%)
- Pain at injection site (3-9%)
- Xerostomia (3-9%)
- Diaphoresis (1-3%)
- Emotional lability (1-3%)
- Fatigue (1-3%)
- Headache (1-3%)
- Paresthesia (1-3%)
- Tremor (1-3%)
- Weakness (1-3%)
- Delirium
- Abnormal hearing
- Junctional tachycardia
- Thick tongue
- Tinnitus
- Coldness sensation
- Generalized seizure
Warnings
Head trauma
History of seizures
Chronic alcoholism
Not for reversal of respiratory depression (need to establish an airway, assist ventilation, and continue to observe patient)-monitor for return of respiratory depression/sedation
May not reverse amnesia
May cause CNS depression and impair ability to perform hazardous tasks
Resedation occurs frequently in patients who have received a large single dose or cumulative dose of a benzodiazepine administered along with a neuromuscular blocker and multiple anesthetic agents
Agitation produced in some patients
Patients rarely seize with 0.2 mg dose
If seizure after flumazenil, recommend valium 20-30 mg, then immediately to barbiturates
Use caution in patients with head injury
Use caution in patients with hepatic dysfunction
Use caution in patients with panic disorder
Unmasking of seizures, precipitation of benzodiazepine withdrawal
Not for diagnosis of benzodiazepine-induced sedation
Pregnancy and Lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; use with caution
Maximum Dosage
5 mg IV total cumulative dose for suspected benzodiazepine overdose. If patient unresponsive at this dose, cause of sedation not likely to be benzodiazepine. Max dose for reversal of conscious sedation is 1 mg IV.
5 mg IV total cumulative dose for suspected benzodiazepine overdose. If patient unresponsive at this dose, cause of sedation not likely to be benzodiazepine. Max dose for reversal of conscious sedation is 1 mg IV.
Single doses of 10 mcg/kg IV (Max: 200 mcg/dose); doses may be repeated as necessary up to a total cumulative dose of 50 mcg/kg IV (Max: 1 mg). Alternatively, 10 mcg/kg/hour via continuous IV infusion has been used off-label.
Single doses of 10 mcg/kg IV (Max: 200 mcg/dose); doses may be repeated as necessary up to a total cumulative dose of 50 mcg/kg IV (Max: 1 mg). Alternatively, 10 mcg/kg/hour via continuous IV infusion has been used off-label.
Safety and efficacy have not been established. However, single doses of 30 mcg/kg IV (Max: 200 mcg/dose) have been used off-label; doses may be repeated as necessary up to a total cumulative dose of 50 mcg/kg IV (Max: 1 mg). Alternatively, 10 mcg/kg/hour via continuous IV infusion has been used off-label.
Safety and efficacy have not been established. However, single doses of 20 mcg/kg IV have been used off-label; doses may be repeated as necessary up to a total cumulative dose of 50 mcg/kg IV. Alternatively, 20 mcg/kg/hour via continuous IV infusion has been used off-label.
How supplied
Flumazenil
injectable solution
- 0.1mg/mL