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ROMAZICON
Poisoning/overdose
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Drug Name:

ROMAZICON Rx

Generic Name and Formulations:
Flumazenil 0.1mg/mL; IV inj.

Company:
Roche Diagnostics Corp.

Therapeutic Use:

Indications for ROMAZICON:

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

Adult:

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.

Children:

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

Contraindications:

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

Warnings/Precautions:

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.

Interactions:

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

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