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Generic Name and Formulations:

Flumazenil 0.1mg/mL; IV inj.

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Indications for ROMAZICON:

Reversal of benzodiazepine sedative effects in overdose, general anesthesia or conscious sedation.


Overdose: Give dose over 30 seconds by IV infusion. Initially: 0.2mg. After 30 seconds (if needed), 0.3mg. Then 0.5mg at 60 second intervals up to 3mg cumulative dose. Usual range: 1–3mg. If partial response occurs at 3mg cumulative dose, may titrate up to 5mg cumulative dose. Conscious sedation, general anesthesia, resedation: see literature.


<1yr: not recommended. 1–17yrs: for reversal of benzodiazepine-induced conscious sedation only. See literature.


Patients treated with benzodiazepines for life threatening conditions. Mixed overdose patients when seizures likely (esp. cyclic antidepressants).


Monitor for resedation (at least 2 hrs), respiratory depression, other residual benzodiazepine effects, seizures. Seizure disorders or risk. Drug or alcohol dependence. Head injury. Panic disorder. Hepatic disease. Counsel on post-procedure period (see literature). Labor & delivery: not recommended. Pregnancy (Cat.C). Nursing mothers.


Avoid use until neuromuscular blockade reversed. Avoid alcohol, sedatives for 18–24 hrs after treatment. Potentiates toxicity of cyclic antidepressant or mixed drug overdose.

Pharmacological Class:

Benzodiazepine antagonist.

Adverse Reactions:

Seizures, local reactions, dizziness, increased sweating, headache, blurred vision, GI upset, agitation, benzodiazepine withdrawal syndrome.

How Supplied:

Vials (5mL, 10mL)—10