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FLUMAZENIL KABI is a brand name for Flumazenil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Flumazenil is indicated for the complete or partial reversal of the central sedative effects of benzodiazepines. It may therefore be used in anaesthesia and in the intensive care in the following situations: In anaesthesia − Termination of hypnosedative effects in general anaesthesia induced and/or maintained with…
Verbatim from this product's MHRA label. Tap a section to expand.
2 mg administered intravenously over 15 seconds. 0 mg. 6 mg, but may deviate depending on the patient’s characteristics and the benzodiazepine used. 3 mg administered intravenously over 15 seconds. 1 mg can be injected and repeated at 60-second intervals, up to a total dose of 2 mg or until the patient awakes.
If drowsiness recurs, a second bolus injection may be administered. 4 mg/h has also been shown to be useful. The dosage and rate of infusion should be adjusted individually to achieve the desired level of consciousness. If no clear effect on awareness and respiration is obtained after repeated dosing, it should be considered that the intoxication is not due to benzodiazepines.
Infusion should be discontinued every 6 hours to verify whether resedation occurs. 4). Elderly In the absence of data on the use of flumazenil in elderly patients, it should be noted that this population is generally more sensitive to the effects of medicinal products and should be treated with due caution.
Patients with hepatic impairment Since flumazenil is primarily metabolized in the liver, careful titration of dosage is recommended in patients with impaired hepatic function. Patients with renal impairment No dosage adjustments are required in patients with renal impairment.
Paediatric population Children above 1 year of age For the reversal of conscious sedation induced by benzodiazepines in children > 1 year of age, the recommended initial dose is 10 micrograms/kg (up to 200 micrograms), administered intravenously over 15 seconds.
If the desired level of consciousness is not obtained after waiting an additional 45 seconds, further injection of 10 micrograms//kg may be administered (up to 200 micrograms) and repeated at 60 second intervals where necessary (a maximum of 4 times) to a maximum total dose of 50 micrograms/kg or 1 mg, whichever is lower.
The dose should be individualised based on the patient’s response. No data are available on the safety and efficacy of repeated administration of flumazenil to children for re-sedation. Children under the age of 1 year There are insufficient data on the use of flumazenil in children under 1 year.
Therefore, flumazenil should only be administered in children under 1 year if the potential benefits to the patient outweigh the possible risk. Method of administration Flumazenil should be administered intravenously by an anaesthetist or experienced physician.
The following convention has been used for the classification of the adverse reactions: Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known cannot be estimated from the available data Immune systems disorders Common Allergic reactions.
Not known Hypersensitivity reactions, including anaphylaxis Psychiatric disorders Common Anxiety*, emotional lability, insomnia, somnolence. Uncommon Fear Not known Withdrawal symptoms (see below); panic attacks (in patients with a history of panic reactions); abnormal crying, agitation, aggressive reactions Nervous system disorders Common Vertigo, headache, agitation*, tremor, dry mouth, hyperventilation, speech disorder, paresthesia.
4)). Ear and labyrinth disorders Uncommon Abnormal hearing. Eye disorders Common Diplopia, strabismus, lacrimation increased. Cardiac disorders Common Palpitations*. Uncommon Tachycardia or bradycardia, extrasystole. Vascular disorders Common Flushing, hypotension, orthostatic hypotension, transient increased blood pressure (on awakening).
Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea, cough, nasal congestion, chest pain. Gastrointestinal disorders Very common Nausea (during postoperative use). Common Vomiting (during postoperative use), hiccup. Skin and subcutaneous tissue disorders Common Sweating.
General disorders and administration site conditions Common Fatigue, injection site pain. Uncommon Shivering*. *: after rapid injection, not requiring treatment Following rapid injection of doses of 1 mg or more or in patients treated for long periods and/or high dose with benzodiazepines flumazenil can induce withdrawal symptoms.
The symptoms are: tension, agitation, anxiety, emotional lability as well as confusion and sensory distortions, hallucinations, tremor and convulsions. In general the undesirable effect profile in children is generally similar to that in adults.
Use in children for other indications than reversal of conscious sedation is not recommended as no controlled studies are available. - The patient should be monitored for an adequate period of time (ECG, pulse, oximetry, patient alertness and other vital signs such as heart rate, respiratory rate and blood pressure).
- Flumazenil specifically reverses benzodiazepines. Therefore, if the patient does not wake up, another aetiology should be considered. - When used in anaesthesiology at the end of surgery, flumazenil should not be given until the effects of peripheral muscle relaxants have been fully reversed.
- As the action of flumazenil is usually shorter than that of benzodiazepines and sedation may possibly recur the patient should remain closely monitored, preferably in the intensive care unit, until the effect of flumazenil has presumably worn off.
- In patients at increased risk the advantages of sedation by means of benzodiazepines should be weighed against the drawbacks of rapid awakening. g. with cardiac problems) maintenance of a certain level of sedation may be preferable to being fully awake.
- Rapid injection of high doses (more than 1 mg) flumazenil should be avoided. In patients who receive high dose and/or chronic treatment with benzodiazepines at any time within the weeks preceding flumazenil administration, rapid injection of doses equal or higher than 1 mg has led to withdrawal symptoms including palpitations, agitation, anxiety, emotional lability as well as mild confusion and sensory distortions.
- In patients suffering from pre-operative anxiety or having a history of chronic or episodic anxiety the dosage of flumazenil should be adjusted carefully. - Postoperative pain must be taken into account. It may be preferable to keep the patient lightly sedated.
- In patients treated for long periods with high doses of benzodiazepines, the advantages of the use of flumazenil should be carefully weighed against the risk of withdrawal symptoms. If withdrawal symptoms occur despite careful dosing an individually titrated dose of 5 mg diazepam or 5 mg midazolam should be given by slow intravenous injection.
1. g. control of intracranial pressure or status epilepticus). - In mixed intoxications with benzodiazepines and tricyclic and/or tetracyclic antidepressants, the toxicity of the antidepressants can be masked by protective benzodiazepine effects.
In the presence of autonomic (anticholinergic), neurological (motor abnormalities) or cardiovascular symptoms of severe intoxication with tricyclics/tetracyclics, Flumazenil should not be used to reverse benzodiazepine effect.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6). Flumazenil may be used concomitantly with other resuscitative measures. 6.
When using flumazenil for the reversal of conscious sedation abnormal crying, agitation and aggressive reactions have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
- Patients who have received flumazenil for the reversal of benzodiazepine effects should be monitored for resedation, respiratory depression or other residual benzodiazepine effects for an appropriate period based on the dose and duration of effect of the benzodiazepine employed.
Because patients with underlying hepatic impairment may experience delayed effects as described above, an extended observation period may be required. - Because of the potential for resedation and respiratory depression children previously sedated with midazolam should be monitored at least 2 hours after flumazenil administration.
In case of other sedating benzodiazepines, the monitoring time must be adjusted according to their expected duration. - Until sufficient data are available flumazenil should not be used in children of 1 year or younger unless the risks for the patient (especially in case of accidental overdose) have been weighed against the advantages of the therapy.
- The use of the antagonist is not recommended in patients with epilepsy, who have been treated with benzodiazepines for a prolonged period of time. Although flumazenil has some intrinsic anti-epileptic effects, the abrupt antagonising effect can cause convulsions in patients with epilepsy.
- In patients with serious brain damage (and/or instable intracranial pressure) receiving flumazenil – to reverse the effects of benzodiazepines – an increased intracranial pressure may develop. - Flumazenil is not recommended for the treatment of benzodiazepine-dependence or for the treatment of long-term benzodiazepine-abstinence-syndromes.
- Panic attacks have been reported after the use of flumazenil in patients with a history of panic disorder. - Due to the increased frequency of benzodiazepines tolerance and dependence in patients with alcoholism and other drug dependencies, flumazenil should be used with caution in this population.
- Particular caution is necessary when using flumazenil in cases of mixed-drug overdose. In particular in the case of an intoxication with benzodiazepines and cyclic antidepressants, certain toxic effects such as convulsions and cardiac arrhythmias, which are caused by these antidepressants but which emerge less readily on concomitant administration with benzodiazepines, are exacerbated on administration of flumazenil.
- Elimination may be delayed in patients with hepatic impairment. - Each 5 ml ampoule contains less than 1 mmol sodium (or 23 mg), that is to say essentially ‘sodium-free’. 9% of the WHO recommended maximum daily intake of 2 g sodium for an adult.