Flumazenil

A to Z Drug Facts

Flumazenil

	Action
	Indications
	Contraindications
	Route/Dosage
	Interactions
	Lab Test Interferences
	Adverse Reactions
	Precautions
Patient Care Considerations
	Administration/Storage
	Assessment/Interventions
	Patient/Family Education

(flew-MAZ-ah-nil)

Romazicon, Anexate

Class: Antidote

Action Antagonizes actions of benzodiazepines on CNS by blocking receptors.

Indications Complete or partial reversal of sedative effects of benzodiazepines where general anesthesia induced or maintained with benzodiazepines, where sedation produced with benzodiazepines for diagnostic or therapeutic procedures, and for the management of benzodiazepine overdose.

Contraindications Hypersensitivity to flumazenil or benzodiazepines; in patients given benzodiazepines for control of a potentially life-threatening condition (eg, status epilepticus); in patients showing signs of serious cyclic antidepressant overdose.

Route/Dosage

Reversal of conscious sedation or in general anesthesia

ADULTS: IV 0.2 mg over 15 sec. If desired level of consciousness is not achieved in 45 sec, additional 0.2 mg doses can be administered at 60 sec intervals (maximum 1 mg). In event of resedation, repeat doses (0.2 mg/min–maximum 1 mg) at 20 min intervals as needed (maximum 3 mg/hr).

Management of suspected benzodiazepine overdose

ADULTS: IV 0.2 mg over 30 sec. If desired level of consciousness is not achieved in 30 sec, an additional dose of 0.3 mg over 30 sec can be administered. Further doses of 0.5 mg over 30 sec can be administered at 1 min intervals as needed (maximum 3 mg).

Interactions

Toxic effects of other drugs taken in toxic doses may emerge with reversal of benzodiazepine effect.

Lab Test Interferences None well documented.

Adverse Reactions

CV: Cutaneous vasodilation (eg, sweating, flushing, hot flushes); palpitations. CNS: Convulsions; headache; dizziness; agitation; emotional lability; fatigue; paresthesia; insomnia; dyspnea; hypoesthesia. DERM: Sweating. EENT: Visual field defect; diplopia; blurred vision. GI: Nausea; vomiting. RESP: Hyperventilation. OTHER: Injection site pain; injection site reaction; dry mouth.

Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not determined. Labor and delivery: Not recommended; effects on newborn are unknown. Seizures: Reversal of benzodiazepine effects may be associated with the onset of seizures in certain high-risk populations including the following: Concurrent major sedative-hypnotic drug withdrawal; recent therapy with repeated doses of parenteral benzodiazepines; myoclonic jerking or seizure activity prior to flumazenil in overdose cases; concurrent cyclic antidepressant poisoning. Resedation/hypoventilation: Flumazenil may not fully reverse postoperative airway problems or ventilatory insufficiency induced by benzodiazepines; its effects may wear off before the effects of many benzodiazepines. Hepatic function impairment: Elimination of flumazenil is reduced in patients with liver disease. Intensive care unit: Use of flumazenil to diagnose benzodiazepine-induced sedation in the ICU is not recommended due to the risk of adverse effects. Head injury: Use with caution in patients with head injury due to risk of precipitating convulsions or altering cerebral blood flow in patients receiving benzodiazepines. Neuromuscular blocking agents: Do not use flumazenil until effects of neuromuscular blocking agents have been fully reversed. Psychiatric: Flumazenil may provoke panic attacks in patients with a history of panic disorder. Drug/alcohol dependence: Use with caution in patients with alcoholism and other drug dependencies due to the increased frequency of benzodiazepine tolerance and dependence observed in these patient populations. Overdose situations: Flumazenil is intended as an adjunct to, not a substitute for, proper management of overdose patients (eg, airway maintenance, decontamination, etc.). Benzodiazepine tolerance: Flumazenil may cause benzodiazepine withdrawal symptoms in individuals who have been taking benzodiazepines long enough to have some degree of tolerance or physical dependence. Ambulatory: The effects of flumazenil may wear off before a long-acting benzodiazepine is completely cleared from the body.

PATIENT CARE CONSIDERATIONS

Administration/Storage

For IV use only.
Compatible with D5W, LR, and NS.
Administer through a freely flowing IV in a large vein.
In high-risk patients, administer smallest amount effective. Wait 6 to 10 min between trial dose administration in high-risk patients.
Do not rush administration. Secure airway and IV access.
If patient does not respond after 5 min of a cumulative dose of 5 mg, sedation is probably not due to benzodiazepines.
Do not use if solution is discolored or has particulate matter.
Stable for 24 hr at room temperature after mixing. Best if used just after mixing.

Assessment/Interventions

Obtain patient history.
Determine reason for use prior to administration (eg, benzodiazepine overdose, reverse anesthesia, sedation). Use this information to select the proper dosing strategy.
Monitor level of consciousness during and after administration.
Resedation may take place in 15 to 30 min because half-life of many benzodiazepines is longer than flumazenil.
Monitor patient during and after administration for seizure activity and respiratory or cardiac arrest.
Monitor patient for confusion, agitation, emotional lability, and perceptual distorting after administration.

Patient/Family Education

Instruct patient that flumazenil does not reverse amnesia. Repeat patient instructions in post-procedure period.
Warn patient that despite feelings of alertness at time of discharge, effects of benzodiazepines may reoccur, affecting memory and judgment.
Instruct patient to avoid activities requiring complete alertness, such as operating hazardous machinery or driving, for at least 18 to 24 hr after discharge.
Warn patients to avoid alcohol or over-the-counter drugs for at least 18 to 24 hr after discharge.