Monograph Details
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Poisoning & Drug Dependence
> Poisoning/overdose
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ROMAZICON |
| Manufacturer |
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Roche Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Benzodiazepine antagonist. |
| Generic Name |
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Flumazenil 0.1mg/mL; IV inj. |
| Indications |
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Reversal of benzodiazepine sedative effects in overdose, general anesthesia or conscious sedation. |
| Children |
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<1yr: not recommended. 1–17yrs: for reversal of benzodiazepine-induced conscious sedation only. See literature. |
| Adults |
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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. |
| Contraindications |
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Patients treated with benzodiazepines for life threatening conditions. Mixed overdose patients when seizures likely (esp. cyclic antidepressants). |
| Precautions |
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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 |
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Avoid use until neuromuscular blockade reversed. Avoid alcohol, sedatives for 18–24 hrs after treatment. Potentiates toxicity of cyclic antidepressant or mixed drug overdose. |
| Adverse Reactions |
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Seizures, local reactions, dizziness, increased sweating, headache, blurred vision, GI upset, agitation, benzodiazepine withdrawal syndrome. |
| How Supplied |
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Vials (5mL, 10mL)—10 |
| Additional Resources |
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• Related Prescribing Note |
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