Patients with renal or hepatic impairment 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. To avoid withdrawal symptoms in patients treated for a long period of time with high doses of benzodiazepines in the intensive care unit, the dosage of flumazenil has to be titrated individually and the injection has to be administered slowly (see section 4.4). Infusion should be discontinued every 6 hours to verify whether re-sedation occurs. If a significant improvement in consciousness or respiratory function is not obtained after repeated doses of flumazenil, a non-benzodiazepine aetiology must be assumed. The dosage and rate of infusion should be adjusted individually to achieve the desired level of consciousness. An intravenous infusion of 100 – 400 micrograms/hour may be useful. If drowsiness recurs, a second bolus injection of flumazenil may be administered. If the required level of consciousness is not obtained within 60 seconds, a further dose of 100 micrograms can be injected and repeated at 60-second intervals, up to a total dose of 2000 micrograms or until the patient awakes. The recommended starting dose is 300 micrograms administered intravenously. The usual dose is 300 to 600 micrograms, but may deviate depending on the patient's characteristics and the benzodiazepine used. If the required level of consciousness is not obtained within 60 seconds, a further dose of 100 micrograms can be injected and repeated at 60-second intervals, up to a maximum dose of 1000 micrograms. The recommended starting dose is 200 micrograms administered intravenously over 15 seconds. Date of first authorisation/renewal of the authorisation 6.6 Special precautions for disposal and other handling.4.7 Effects on ability to drive and use machines.4.5 Interaction with other medicinal products and other forms of interaction.4.4 Special warnings and precautions for use.4.2 Posology and method of administration.Show table of contents Hide table of contents
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