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DIPRIVAN should be given by those trained in anaesthesia or, where appropriate, doctors trained in the care of patients in Intensive Care. Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. DIPRIVAN should not be administered by the person conducting the diagnostic or surgical procedure.
When DIPRIVAN is administered for conscious sedation for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation.
As with other sedative agents, when DIPRIVAN is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility these movements may be hazardous to the operative site.
As with other intravenous anaesthetic and sedative agents, patients should be instructed to avoid alcohol before and for at least 8 hours after administration of DIPRIVAN.
DIPRIVAN should be used with caution when used to sedate patients undergoing some procedures where spontaneous movements are particularly undesirable, such as ophthalmic surgery.
As with other intravenous sedative agents, when DIPRIVAN is given along with central nervous system depressants, such as potent analgesics, the sedative effect may be intensified and the possibility of severe respiratory or cardiovascular depression should be considered.
During bolus administration for operative procedures, extreme caution should be exercised in patients with acute pulmonary insufficiency or respiratory depression.
Concomitant use of central nervous system depressants e.g., alcohol, general anaesthetics, narcotic analgesics will result in accentuation of their sedative effects. When DIPRIVAN is combined with centrally depressant drugs administered parenterally, severe respiratory and cardiovascular depression may occur. It is recommended that DIPRIVAN is administered following the analgesic and the dose should be carefully titrated to the patient's response (see Interactions).
During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedicants and other agents.
Occasionally, hypotension may require use of intravenous fluids and reduction of the rate of administration of DIPRIVAN during the period of anaesthetic maintenance.
An adequate period is needed prior to discharge of the patient to ensure full recovery after general anaesthesia. Very rarely the use of DIPRIVAN may be associated with the development of a period of post-operative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered.
When DIPRIVAN is administered to an epileptic patient, there may be a risk of convulsion.
As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic, elderly or debilitated patients.
The risk of relative vagal over activity may be increased because DIPRIVAN lacks vagolytic activity; it has been associated with reports of bradycardia (occasionally profound) and also asystole. The intravenous administration of an anticholinergic agent before induction or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to predominate, or when DIPRIVAN is used in conjunction with other agents likely to cause a bradycardia.
Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.
It is recommended that blood lipid levels should be monitored if DIPRIVAN is administered to patients thought to be at particular risk of fat overload. Administration of DIPRIVAN should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other intravenous lipid concurrently, a reduction in quantity should be made in order to take account of the amount of lipid infused as part of the DIPRIVAN formulation; 1.0 ml of DIPRIVAN contains approximately 0.1 g of fat. Use is not recommended with electroconvulsive treatment.
As with other anaesthetics, sexual disinhibition may occur during recovery.
DIPRIVAN is not advised for general anaesthesia in children younger than 1 month of age. The safety and efficacy of DIPRIVAN for (background) sedation in children younger than 16 years of age have not been demonstrated.
Although no causal relationship has been established, serious undesirable effects with (background) sedation in patients younger than 16 years of age (including cases with fatal outcome) have been reported during unlicensed use. In particular these effects concerned occurrence of metabolic acidosis, hyperlipidemia, rhabdomyolysis and/or cardiac failure. These effects were most frequently seen in children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in the intensive care unit.
DIPRIVAN is not recommended for use in neonates for induction and maintenance of anaesthesia. Data from 'off-label' use have indicated that if the paediatric (1 month to 16 years of age) dose regimen is applied in neonates, a relative overdose could occur which may result in cardiorespiratory depression.
There are no clinical trials data to support the use of DIPRIVAN for the sedation of children with croup or epiglottitis receiving intensive care.
Advisory statement concerning Intensive Care Unit management: Very rare reports of metabolic acidosis, rhabdomyolysis, hyperkalaemia, ECG changes*, and/or cardiac failure, in some cases with a fatal outcome, have been received concerning seriously ill patients receiving DIPRIVAN for ICU sedation. The following appear to be the major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents - vasoconstrictors, steroids, inotropes and/or propofol. All sedative and therapeutic agents used in the ICU (including DIPRIVAN) should be titrated to maintain optimal oxygen delivery and haemodynamic parameters.
*Coved ST segment elevation (similar to ECG changes of the Brugada syndrome).
ADDITIONAL PRECAUTIONS: DIPRIVAN contains no antimicrobial preservatives and supports growth of microorganisms. DIPRIVAN contains disodium edetate 0.005% w/v (EDTA) as a microbial inhibitor. EDTA is a chelator of metal ions, including zinc; during prolonged administration of DIPRIVAN the need for supplemental zinc should be considered in patients predisposed to zinc deficiency, such as those with burns, diarrhoea and/or sepsis. When DIPRIVAN is to be aspirated, it must be drawn aseptically into a sterile syringe or giving set immediately after opening the ampoule or breaking the vial seal.
Administration must commence without delay. Asepsis must be maintained for both DIPRIVAN and infusion equipment throughout the infusion period. Any infusion fluids added to the DIPRIVAN line must be administered close to the cannula site. DIPRIVAN must not be administered via a microbiological filter. DIPRIVAN and any syringe containing DIPRIVAN are for single use in an individual patient. For use in long term maintenance of anaesthesia or sedation in intensive care it is recommended that the infusion line and reservoir of DIPRIVAN be discarded and replaced at regular intervals.
There have been very rare reports of epileptiform movement in epileptics and non-epileptics occurring during induction orbemergence from anaesthesia induced by propofol.
Effects on Ability to Drive and Use Machines: Patients should be advised that performance at skilled tasks, such as driving and operating machinery, may be impaired for some time after use of DIPRIVAN.
