Chemical formula: C₁₂H₁₈O Molecular mass: 178.271 g/mol PubChem compound: 4943
Propofol interacts in the following cases:
It should be taken into consideration that concomitant use of propofol and medicinal products for premedication, inhalation agents or analgesic agents may potentiate anaesthesia and cardiovascular side effects. Concomitant use of central nervous system depressants (e.g. alcohol, general anaesthetics, narcotic analgesics) will result in intensification of their sedative effects. When propofol is combined with centrally depressant drugs administered parenterally, severe respiratory and cardiovascular depression may occur.
After additional premedication with opioids, the sedative effects of propofol may be intensified and prolonged, and there may be a higher incidence and longer duration of apnoea.
Concomitant use of benzodiazepines, parasympatholytic agents or inhalational anaesthetics has been reported to prolong the anaesthesia and to reduce the respiratory rate.
Leucoencephalopathy has been reported with administration of lipid emulsions as used for Propoven 1% in patients receiving cyclosporine.
After administration of fentanyl, the blood level of propofol may be temporarily increased with an increase in the rate of apnoea.
Bradycardia and cardiac arrest may occur after treatment with suxamethonium or neostigmine.
Profound hypotension has been reported following anaesthetic with propofol in patients treated with rifampicin.
A need for lower propofol doses has been observed in patients taking valproate. When used concomitantly, a dose reduction of propofol may be considered.
Use of propofol is not recommended with electroconvulsive therapy.
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.
Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.
When propofol is administered to an epileptic patient, there may be a risk of convulsion.
In epileptic patients delayed epileptiform attacks may occur, the delay period ranging from a few hours to several days.
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.
The safety of propofol during pregnancy has not been established. Studies in animals have shown reproductive toxicity. Propofol should not be given to pregnant women except when absolutely necessary. Propofol can, however, be used during an induced abortion.
Propofol crosses the placenta and can cause neonatal depression. It should not be used for obstetric anaesthesia unless clearly necessary.
Studies of breastfeeding mothers showed that small quantities of propofol are excreted in human milk. Women should therefore not breast-feed for 24 hours after administration of propofol. Milk produced during this period should be discarded.
Propofol has moderate influence on the 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.
Propofol induced impairment is not generally detectable beyond 12 hours.
Induction and maintenance of anaesthesia or sedation with propofol is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side effects of an anaesthetic/sedative agent, such as hypotension. The nature, severity and incidence of adverse events observed in patients receiving propofol may be related to the condition of the recipients and the operative or therapeutic procedures being undertaken.
Table of Adverse Drug Reactions:
| System Organ Class | Frequency | Undesirable Effects |
|---|---|---|
| Immune system disorders | Very rare (<1/10 000) | Anaphylaxis – may include angioedema, bronchospasm, erythema and hypotension |
| Metabolism and Nutritional disorder | Frequency not known (9) | Metabolic acidosis (5), hyperkalaemia (5), hyperlipidaemia (5) |
| Psychiatric disorders | Frequency not known (9) | Euphoric mood, sexual disinhibition. Drug abuse and drug dependence (8) |
| Nervous system disorders | Common (>1/100, <1/10) | Headache during recovery phase |
| Rare (>1/10 000, <1/1000) | Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recovery. Vertigo, shivering and sensation of cold during recovery | |
| Very rare (<1/10 000) | Postoperative unconsciousness | |
| Frequency not known (9) | Involuntary movements | |
| Cardiac disorders | Common (>1/100, <1/10) | Bradycardia (1) and tachycardia during induction |
| Very rare (<1/10 000) | Pulmonary oedema | |
| Frequency not known (9) | Cardiac arrhythmia (5), cardiac failure (5),(7) | |
| Vascular disorders | Common (>1/100, <1/10) | Hypotension (2) |
| Uncommon (>1/1000, <1/100) | Thrombosis and phlebitis | |
| Respiratory, thoracic and mediastinal disorders | Common (>1/100, <1/10) | Transient apnoea, coughing and singultus during induction |
| Frequency not known (9) | Respiratory depression (dose dependant) | |
| Gastrointestinal disorders | Common (>1/100, <1/10) | Nausea and vomiting during recovery phase |
| Very rare (<1/10 000) | Pancreatitis | |
| Hepatobiliary disorders | Frequency not known (9) | Hepatomegaly (5) |
| Musculoskeletal and connective tissue disorders | Frequency not known (9) | Rhabdomyolysis (3), (5) |
| Renal and urinary disorders | Very rare (<1/10 000) | Discolouration of urine following prolonged administration |
| Frequency not known (9) | Renal failure (5) | |
| Reproductive system and breast disorders | Not known | Priapism |
| General disorders and administration site conditions | Very common (>1/10) | Local pain on induction (4) |
| Very rare (<1/10 000) | Tissue necrosis (10) following accidental extravascular administration | |
| Frequency not known (9) | Local pain, swelling, following accidental extravascular administration | |
| Investigations | Frequency not known (9) | Brugada type ECG (5),(6) |
| Injury, poisoning and procedural complications | Very rare (<1/10 000) | Postoperative fever |
(1) Serious bradycardias are rare. There have been isolated reports of progression to asystole.
(2) Occasionally, hypotension may require use of intravenous fluids and reduction of the administration rate of propofol.
(3) Very rare reports of rhabdomyolysis have been received where propofol has been given at doses greater than 4 mg/kg/hr for ICU sedation.
(4) May be minimised by using the larger veins of the forearm and antecubital fossa. With propofol 1 % local pain can also be minimised by the co-administration of lidocaine.
(5) Combinations of these events, reported as “Propofol infusion syndrome”, may be seen in seriously ill patients who often have multiple risk factors for the development of the events.
(6) Brugada-type ECG – elevated ST-segment and coved T-wave in ECG.
(7) Rapidly progressive cardiac failure (in some cases with fatal outcome) in adults. The cardiac failure in such cases was usually unresponsive to inotropic supportive treatment.
(8) Abuse of and drug dependence on propofol, predominantly by health care professionals.
(9) Not known as it cannot be estimated from the available clinical trial data.
(10) Necrosis has been reported where tissue viability has been impaired.
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