As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or hypovolaemic or debilitated patients. Propofol clearance is blood flow dependent; therefore, concomitant medication which reduces cardiac output will also reduce propofol clearance.
Cardiac, circulatory or pulmonary insufficiency and hypovolaemia should be compensated before administration of Propofol.
Before anaesthesia of an epileptic patient, it should be checked that the patient has received the antiepileptic treatment. Although several studies have demonstrated efficacy in treating status epilepticus, administration of propofol in epileptic patients may also increase the risk of seizure.
Propofol should not be administered in patients with advanced cardiac failure or other severe myocardial disease except with extreme caution and intensive monitoring.
The risk of relative vagotonia 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 with Propofol 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
Use of NIRFOL MCT-LCT is not recommended with electroconvulsive therapy.
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.
Special care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used with caution. If patients receive parenteral nutrition it is necessary to take account of the amount of lipid infusion as part of the Propofol 1% formulation: 1.0 ml NIRFOL MCT-LCT contains 0.1 gram of fat.
Lipids should be monitored in the Intensive Care Unit treatment every 2 days.
Due to a higher dosage in patients with severe overweight the risk of haemodynamic effects on the cardiovascular system should be taken into consideration.
Special care should be recognised in patients with a high intracranial pressure and a low mean arterial pressure as there is a risk of a significant decrease of the intracerebral perfusion pressure.
To reduce pain on the injection site during induction of anaesthesia with NIRFOL MCT-LCT, lidocaine can be injected prior to the propofol emulsion. Lidocaine must not be used in patients with hereditary acute porphyria.
Pregnancy and lactation: Pregnancy Category B
The safety of propofol during pregnancy has not been established, so it should propofol not be given to pregnant women unless absolutely necessary. Propofol crosses placenta and could cause neonatal depression. High doses (more than 2.5 mg propofol / kg body weight for induction of anesthesia, or 6 mg propofol/kg bw/hr as maintenance dose for anesthesia) should not be serving.
Studies in lactating women with propofol showed that a small amount is excreted in breast milk, therefore mothers should discontinue breast-feeding and not to use breast milk for 24 hours after administration of propofol.