Pharmaniaga Flumazenil

Pharmaniaga Flumazenil



Pharmaniaga LifeScience


Pharmaniaga Logistics
Concise Prescribing Info
Complete or partial reversal of central sedative effects of benzodiazepines. Termination of hypnosedative effects in general anaesth induced &/or maintained w/ benzodiazepines in hospitalised patients; reversal of benzodiazepine sedation in short-term diagnostic & therapeutic procedures in ambulatory & hospitalised patients. Diagnosis of intoxication w/ benzodiazepines; diagnostic measure in unconsciousness of unknown origin to differentiate between involvement of benzodiazepines, other drugs or brain damage; specific reversal of benzodiazepines central effects in drug overdose.
Dosage/Direction for Use
Adult Anaesth Initially 0.2 mg IV over 15 sec. Further dose of 0.1 mg repeated at 60-sec intervals up to max dose: 1 mg may be given if required level of consciousness is not obtained w/in 60 sec. Intensive care Initially 0.3 mg IV. Further dose repeated at 60-sec intervals up to total dose 2 mg or until patient awakes may be given if required level of consciousness is not obtained w/in 60 sec. Recurring drowsiness 0.1-0.4 mg/hr IV infusion. Childn >1 yr Reversal of benzodiazepine-induced conscious sedation Initially 0.01 mg/kg (up to 0.2 mg) IV over 15 sec. Follow-up inj of 0.01 mg/kg (up to 0.2 mg) repeated at 60-sec intervals (up to max: 4 times) to max dose: 0.05 mg/kg or 1 mg may be given if required level of consciousness is not obtained after an additional 45-sec waiting period.
Hypersensitivity. Patients receiving benzodiazepines for control of potentially life-threatening condition eg, intracranial pressure or status epilepticus. Not to be used in mixed intoxications w/ benzodiazepines, tri- & tetracyclic antidepressants; in presence of autonomic (anticholinergic), neurological (motor abnormalities), CV symptoms of severe intoxication w/ tri-/tetracyclics.
Special Precautions
Avoid rapid inj. Not to be given in post-op anaesth until peripheral muscle relaxant effects have been fully reversed. Not recommended in epileptic patients; for benzodiazepine-dependence or long-term benzodiazepine-abstinence syndromes. Patients w/ cardiac problems; pre-op anxiety, history of chronic or episodic anxiety; post-op pain; severe brain injury &/or instable intracranial pressure; history of panic disorder. Alcoholism & other drug dependencies. Adequately monitor ECG, pulse, oximetry, patient alertness & other vital signs. Periodically monitor resedation, resp depression or other residual benzodiazepine effects. Long-period use w/ high-dose benzodiazepines. May affect ability to drive & use machines. Hepatic impairment. Pregnancy & lactation. Not recommended to use for other indications other than reversal of conscious sedation in childn. Childn <1 yr. Monitor childn previously sedated w/ midazolam at least 2 hr after administration due to potential for resedation & resp depression. Elderly.
Adverse Reactions
Nausea (during anaesth). Allergic reactions; anxiety, emotional lability, insomnia, somnolence; vertigo, headache, agitation, tremor, dry mouth, hyperventilation, speech disorder, paresthesia; diplopia, strabismus, increased lacrimation; palpitations; flushing, hypotension, orthostatic hypotension, transient increased BP (on awakening); vomiting (during anaesth), hiccup; sweating; inj site pain.
Drug Interactions
Reversed central effects of benzodiazepines. Antagonized effects of non-benzodiazepine agonists eg, zopiclone, triazolopyridazine. Increased toxic effects of other psychotropic medicinal products eg, TCAs in accidental overdose.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AB25 - flumazenil ; Belongs to the class of antidotes. Used in the management of hypnotics and sedatives overdose.
Pharmaniaga Flumazenil soln for inj 0.1 mg/mL
5 mL x 10 × 1's
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