Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 0.1mg/mL
Reversal of Conscious Sedation and General Anesthesia
0.2 mg IV over 15 sec
IF after 45 sec no response, administer 0.2 mg again over 1 min; may repeat at 1 min intervals; not to exceed 4 doses (1 mg)
IF resedation occurs, may repeat doses at 20-min intervals; not to exceed 1 mg/dose or 3 mg/hr
Benzodiazepine Overdose
0.2 mg IV over 15-30 sec
IF no response after 30 sec, administer 0.3 mg over 30 sec 1 min later; IF no response, repeat dose of 0.5 mg IV over 30 sec at 1-min intervals to max cumulative dose of 3 mg/hr
In the event of resedation, may repeat dose at 20-min intervals if needed; not to exceed 1 mg (administered as 0.5 mg/min) administered at any one time and no more than 3 mg/hr
Rarely patient may require titration up to total dose 5 mg; IF no response after 5 min, sedation unlikely to be secondary to benzodiazepines
Dosing Considerations
Slow infusion of lowest dose required to decrease adverse effects
Dosing Modifications
Renal impairment: Not studied
Hepatic impairment: Initial dose adjustment not necessary; reduce dose or frequency of subsequent doses
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (1)
- amifampridine
flumazenil increases toxicity of amifampridine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Amifampridine can cause seizures. Coadministration with drugs that lower seizure threshold may increase this risk.
Minor (0)
Adverse Effects
>10%
Nausea and vomiting (11%)
1-10%
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%)
<1%
Delirium
Abnormal hearing
Junctional tachycardia
Thick tongue
Tinnitus
Coldness sensation
Generalized seizure
Warnings
Black Box Warnings
The use of flumazenil has been associated with seizures. These are most frequent in patients who have been on benzodiazepines for long-term sedation or in overdose cases where patients are showing signs of serious cyclic antidepressant overdose. Practitioners should individualize the dosage of flumazenil and be prepared to manage seizures.
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)
Cautions
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 & Lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; use with caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Competitive benzodiazepine receptor antagonist; inhibits activity at the benzodiazepine receptor site on the GABA/benzodiazepine receptor complex; does not reverse the effect of opioids
Absorption
Onset of action: 1-2 min; 80% response within 3 min
Peak effect: 6-10 min
Distribution
Protein bound: 40-50%
Vd: 0.5 L/kg
Elimination
Half-life: 53 min
Excretion: Feces, urine
First order elimination
Administration
IV Administration
Over 15-30 sec
To minimize pain, administer through a freely running IV infusion line into a large vein
Avoid extravasation
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  | |
| flumazenil intravenous - | 0.1 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
flumazenil intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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