Troypofol Special Precautions



Troikaa Pharma


Full Prescribing Info
Special Precautions
Propofol 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 patient airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol should not be administered by the person conducting the diagnostic or surgical procedure.
When propofol is administered for 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 propofol 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 propofol.
Propofol 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 propofol 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 propofol is combined with centrally depressant drugs administered parenterally, severe respiratory and cardiovascular depression may occur. It is recommended that propofol is administered following the analgesic and the dose should be carefully titrated to the patient's response.
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 propofol 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 propofol 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 propofol is administered to an epileptic patient, there may be a risk of convulsion.
There have been very rare reports of epileptiform movement in epileptics and non-epileptics occuring during induction orbemergence from anaesthesia induced by propofol.
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 overactivity may be increased because propofol 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 propofol 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.
Use is not recommended with electroconvulsive treatment.
As with other anaesthetics, sexual disinhibition may occur during recovery.
Propofol is not recommended for paediatric general anaesthesia and sedation because its safety and effectiveness in these patients have not been established. There have been recent reports of adverse cardiac events and deaths associated with its use in paediatric intensive care. Although there is no evidence of a causal link of death with propofol in these cases, the drug could not be ruled out as a contributing factor. Until further data establishing its safety and delineating its appropriate dose range are available, propofol should not be used in paediatric intensive care. 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.
Propofol 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.
Similarly very rare reports have been received of occurrence of metabolic acidosis, rhabdomyolysis, hyperkalaemia and/or rapidly progressive cardiac failure (in some cases with fatal outcome) in adults who were treated for more than 58 hours with dosages in excess of 5 mg/kg/h. This exceeds the maximum dosage of 4 mg/kg/h currently advised for sedation in the intensive care unit. The patients affected were mainly (but not only) seriously head-injured patients with raised ICP. The cardiac failure in such cases was usually unresponsive to inotropic supportive treatment. If possible, the dosage should not exceed 4 mg/kg/h. Alertness is advised to these possible undesirable effects and consider decreasing the propofol dosage or switching to an alternative sedative at the first sign of occurrence of symptoms. Patients with raised ICP should be given appropriate treatment to support the cerebral perfusion pressure during these treatment modifications.
Additional Precautions: Troypofol contains no antimicrobial preservatives and supports growth of micro-organisms. When propofol is to be aspirated, it must be drawn aseptically into a sterile syringe. Administration must commence without delay. Asepsis must be maintained for both propofol and infusion equipment throughout the infusion period. Any drugs or fluids added to the propofol line must be administered close to the cannula site. Propofol must not be administered via a microbiological filter.
Propofol and any syringe containing propofol 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 propofol be discarded and replaced at regular intervals.
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 general anaesthesia.
Use in Pregnancy: The safety of propofol during pregnancy has not been established. Therefore propofol should not be used in pregnancy unless clearly necessary. Propofol has been used, however, during termination of pregnancy in the first trimester.
Obstetrics: Propofol crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anaesthesia unless clearly necessary.
Use in Lactation: Safety to the neonate has not been established following the use of propofol in mothers who are breast feeding.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in