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Propofol
Propofol Injection Emulsion is a sterile, white, isotonic emulsion, pH 7.0 - 8.5.
Propofol Injection Emulsion contains propofol, soya oil, glycerol, lecithin - egg, sodium hydroxide and water for injections.
Propofol (2, 6-diisopropylphenol) is short-acting general anaesthetic agent with a rapid onset of action of approximately 30 seconds. Recovery from anaesthesia is usually rapid. The mechanism of action, like all general anaesthetics, is poorly understood. The majority of pharmacodynamic properties exhibited by propofol are proportional to the dose or concentration in the blood. These dose or dose rate dependent properties include the desired therapeutic effects of mild sedation through to anaesthesia, but also include the increasing incidence of cardiac and respiratory depression seen with increasing dose.
The cardiovascular effects of propofol range from a minimal reduction in blood pressure through to arterial hypotension, and a decrease in heart rate. However, the haemodynamic parameters normally remain relatively stable during maintenance and the incidence of untoward haemodynamic changes is low.
Although ventilatory depression can occur following administration of propofol, any effects are qualitatively similar to those of other intravenous anaesthetic agents and are readily manageable in clinical practice.
Preliminary findings in patients with normal intraocular pressure indicate that propofol anaesthesia produces a decrease in intra-ocular pressure, which may be associated with a concomitant decrease in systemic vascular resistance.
In combination with hyporcarbia, propofol increases cerebro-vascular resistance, decreases cerebal blood flow, cerebral metabolic oxygen consumption, and intracranial pressure; but does not affect cerebro-vascular reactivity to changes in arterial carbon dioxide tension.
Limited experience in susceptible patients does not indicate any propensity of propofol to induce malignant hyperthermia.
Propofol does not suppress the adrenal response to ACTH.
The pharmacokinetics of propofol follow a three compartment open model with compartments representing the plasma, rapidly equilibrating tissues, and slowly equilibrating tissues. Following an IV bolus dose, there is rapid equilibration between the plasma and the highly perfused tissue of the brain, thus accounting for the rapid onset of anaesthesia. Plasma levels initially decline rapidly as a result of both distribution and metabolic clearance. The initial (distribution) half -life is between 2 and 4 minutes, followed by a rapid elimination phase with a half-life of 30-60 minutes and followed by a slower final phase, representative of redistribution of propofol from poorly perfused tissue. Accumulation may occur if higher than necessary infusion rates are used.
Adult propofol clearance ranges from 1.5-2litres/minute (21-29mL/kg/min). Propofol is primarily metabolised by the liver to, predominately glucuronide conjugates and their corresponding quinols, which are inactive. These are excreted renally. The pharmacokinetics of propofol are linear over the recommended range of infusion rates of propofol. Moderate hepatic or renal impairment do not alter these pharmacokinetics. Patients with severe hepatic or renal impairment have not been adequately studied.
The distribution and clearance in children down to the age of three years are similar to those of adults.
In older patients for a given dose, a higher peak plasma concentration is observed. The Volume of Distribution and clearance are also decreased; this may explain the decreasing dose requirement with increasing age and the sensitivity of older patients to the other dose related effects of propofol.
Discontinuation of propofol after the maintenance of anaesthesia for approximately one hour, or of ICU sedation for one day, results in a prompt decrease in blood propofol concentrations and rapid awakening, usually within 5 minutes. Longer infusions (10 days of ICU sedation) result in accumulation of significant tissue stores of propofol, such that the reduction in circulating propofol is slowed and the time to awakening may be increased by up to 15 minutes.
Short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and in children aged 3 years and older. Propofol Injection Emulsion has no analgesic properties.
Although the safety and efficacy of Propofol Injection Emulsion in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded.
Propofol Injection Emulsion may be used in adults for sedation of ventilated patients receiving intensive care.
Propofol Injection Emulsion may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.
For general anaesthesia or monitored anaesthesia care sedation, Propofol Injection Emulsion should be administered only by persons trained in the administration of general anaesthesia and not involved in the conduct of the surgical/diagnostic procedure. Patients should be continuously monitored, and facilities for maintenance of a patient airway, artificial ventilation, and oxygen enrichment and circulatory resuscitation must be immediately available.
For sedation of intubated, mechanically ventilated adult patients in the intensive care unit, Propofol Injection Emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Propofol Injection Emulsion may be used to induce anaesthesia by slow bolus injection or infusion. In unpremedicated and in premedicated patients, it is recommended that Propofol Injection Emulsion should be titrated (approximately 4 mL (40 mg) every 10 seconds in an average healthy adult) against the response of the patient until the clinical signs show the onset of anaesthesia. Most adult patients aged less than 55 years are likely to require Propofol Injection Emulsion 2.0 to 2.5 mg/kg. Over this age, the requirement will generally be less. In patients of ASA grades Ill and IV, lower rates of administration should be used (approximately 2 mL (20 mg) every 10 seconds). In general, slower rates of infusion at induction results in a lower induction dose, requirement and greater haemodynamic stability.
Recovery from induction doses usually occurs within five to ten minutes.
Anaesthesia can be maintained by administering Propofol Injection Emulsion either by continuous infusion or by repeat bolus injections to maintain the depth of anaesthesia required. Experience in procedures lasting more than one hour is limited.
Continuous infusion. The required rate of administration varies considerably between patients, but rates in the region of 0.067 to 0.2 mg/kg/minute (4 to 12 mg/kg/hour) usually maintain satisfactory anaesthesia.
Repeat bolus injections. If a technique involving repeat bolus injections is used, increments of 25 mg (2.5 mL) to 50 mg (5 mL) may be given according to clinical need.
Titration to clinical response and daily evaluation of sedation levels are important during use of Propofol Injection Emulsion for intensive care unit sedation, especially of long duration.
When used to provide sedation for ventilated adult patients undergoing intensive care, it is recommended that Propofol Injection Emulsion be given by continuous infusion. The infusion rate should be adjusted according to the depth of sedation required but rates in the region of 1.0 to 3.0 mg/kg/hour should achieve satisfactory sedation. Infusion rates greater than 4.0 mg/kg are not recommended.
There are limited data on propofol safety at high dosage (> 4 mg/kg/h) for extended periods of greater than 48 hours (see Warnings and Precautions).
Propofol Injection Emulsion is contraindicated for sedation in children as safety and efficacy have not been demonstrated. Although no causal relationship has been established, serious adverse events (including fatalities) have been observed from spontaneous reports of unregistered use. These events were seen more frequently in children with respiratory tract infections (including croup) given doses in excess of those recommended for adults. Lipaemia and an evolving acidosis may be precursors of fatal outcomes.
Propofol Injection Emulsion is contraindicated for sedation in children as safety and efficacy have not been demonstrated.
To provide sedation for surgical and diagnostic procedures rates of administration should be individualised and titrated to clinical response. Most patients will require 0.5 to 1 mg/kg over one to five minutes for onset of sedation.
Maintenance of sedation may be accomplished by titrating Propofol Injection Emulsion infusion to the desired level of sedation; most patients will require 1.5 to 3.0 mg/kg/hour. In addition to the infusion, bolus administration of 10 to 20 mg may be used if a rapid increase in the depth of sedation is required. In patients in ASA grades Ill or IV and in the elderly, the rate of administration and dosage may need to be reduced. Patients should not be discharged for at least three hours after the procedure.
Monitored conscious sedation in patients should be continuously monitored by persons not involved in the conduct of the surgical or diagnostic procedure. Oxygen supplementation should be immediately available and provided where clinically indicated; oxygen saturation should be monitored in all patients. Patients should be continuously monitored for early signs of hypotension, apnoea, airway obstruction and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid initiation (loading) boluses or during supplemental maintenance boluses, especially in the elderly, debilitated or ASA grade Ill or IV patients. Patients should be monitored during sedation and recovered according to the standards of the Australian and New Zealand College of Anaesthetists.
In elderly patients the dose requirement for induction of anaesthesia with propofol is reduced. The reduction should take account of the physical status and age of the patient. The reduced dose should be given at a slower rate and titrated against the response. Induction infusion rates of 300 mL/hour (50mg/min) are associated with less hypotension and apnoea in elderly patients. Where Propofol is used for the maintenance of anaesthesia or sedation the rate of infusion or 'target concentration' should also be reduced. Patients of ASA grades III and IV will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in the elderly unventilated patient as this may lead to apnoea.
A rapid bolus may also depress cardiac function.
Propofol Injection Emulsion is not recommended for use in children under 3 years of age (see Warnings and Precautions). When used to induce anaesthesia in children, it is recommended that Propofol Injection Emulsion be given slowly until the clinical signs show the onset of anaesthesia. The dose should be adjusted for age and/or weight. Most patients over 8 years of age are likely to require approximately 2.5 mg/kg for induction of anaesthesia. Under this age the requirement may be more. Lower dosage is recommended for children of ASA grades Ill or IV.
Propofol Injection Emulsion is not recommended for use in children under 3 years of age.
Anaesthesia can be maintained by administering Propofol Injection Emulsion by infusion or repeat bolus injection to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients but rates in the region of 9 to 15 mg/kg/hour usually achieve satisfactory anaesthesia.
Propofol is contraindicated for sedation in children as safety and efficacy have not been demonstrated. Although no casual relationship has been established, serious adverse events (including fatalities) have been observed from spontaneous reports of unregisterd use. These events were seen more frequently in children with respiratory tract infections (including croup) given doses in excess of those recommended for adults. Lipaemia and evolving metabolic acidosis may be precursors of fatal outcomes.
Propofol is contraindicated for sedation in children as safety and efficacy have not been demonstrated.
Propofol Injection Emulsion can be infused undiluted from plastic syringes, glass infusion bottles or Propofol Injection Emulsion prefilled syringes. It can be diluted with Glucose 5% Intravenous Infusion BP only, and used from glass or PVC infusion bags/bottles. Dilutions should be prepared aseptically immediately before administration and must be used within six hours of preparation. Such dilutions must not be more dilute than one volume of Propofol Injection Emulsion to four volumes of diluent (Propofol Injection Emulsion 2 mg/mL).
It is recommended that in order to prepare diluted Propofol Injection Emulsion, the volume of Glucose 5% Intravenous Infusion BP removed from the infusion bag during the dilution process be totally replaced in volume by Propofol Injection Emulsion.
The dilution may be used with a variety of infusion control techniques but a giving set used alone will not avoid the risk of accidental, uncontrolled infusion of large volumes of diluted Propofol Injection Emulsion. A burette, drop counter or volumetric pump must be included in the infusion line. The risk of uncontrolled infusion must be taken into account when deciding the maximum amount of Propofol Injection Emulsion in the burette.
When Propofol Injection Emulsion is used undiluted to maintain anaesthesia, it is recommended that drop counters, syringe pumps or volumetric infusion pumps should always be used to control infusion rates. The glass prefilled syringe has a lower frictional resistance than plastic disposable syringes and operates more easily. Therefore if Propofol Injection Emulsion is administered using a handheld prefilled syringe, the line between the syringe and the patient must not be left open if unattended.
When the prefilled syringe presentation is used in a syringe pump, appropriate compatibility should be ensured. In particular, the pump should be designed to prevent syphoning and should have an occlusion alarm set no greater than 1,000 mmHg. If using a programmable or equivalent pump that offers options for use of different syringes, choose only the B-D 50/60 mL Plastipak setting when using the Propofol Injection Emulsion prefilled syringe.
Changes to the haemodynamic parameters such as systolic arterial pressure, diastolic arterial pressure, cardiac output and systemic vascular resistance appear to be independent of changes to the rate of infusion of Propofol.
Propofol Injection Emulsion may be administered via a Y-piece close to the injection site, into infusions of Glucose 5% Intravenous Infusion BP, Sodium Chloride 0.9% Intravenous Infusion BP, or Glucose 4% with Sodium Chloride 0.18% Intravenous Infusion BP. Propofol Injection Emulsion should not be mixed, prior to administration, with other therapeutic agents or infusion fluids other than Glucose 5% Intravenous Infusion BP.
Strict aseptic technique must always be maintained during handling. Propofol Injection Emulsion injection is a single-use parenteral product, contains no antimicrobial preservatives, and can support rapid growth of micro-organisms. There have been reports in which failure to use aseptic technique when handling Propofol Injection Emulsion was associated with microbial contamination of the product and with fever, infection/sepsis, septicaemia, other life-threatening illness, and/or death. Do not use if contamination is suspected.
When Propofol Injection Emulsion is to be aspirated, it must be drawn aseptically into a sterile syringe or giving set immediately after breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both Propofol Injection Emulsion and the infusion equipment throughout the infusion period. Any drugs or fluids added to the infusion line must be administered close to the cannula site. Propofol Injection Emulsion must not be administered via a microbial filter.
Containers of Propofol Injection Emulsion and any syringe containing Propofol Injection Emulsion are for single use in an individual patient. In accordance with established guidelines for other lipid emulsions, a single infusion of Propofol Injection Emulsion must not exceed twelve hours. At the end of the procedure or at twelve hours, whichever is the sooner, both the reservoir of Propofol Injection Emulsion and the infusion line must be discarded and replaced as appropriate.
Each vial or prefilled syringe should be shaken before use. Do not use if the emulsion is separated or discoloured. Any portion of the contents remaining after use should be discarded.
The emulsion should not be mixed, prior to administration, with other therapeutic agents or infusion fluids other than Glucose 5% Intravenous Infusion BP.
The neuromuscular blocking agents atracurium and mivacurium should not be given through the same intravenous line as Propofol Injection Emulsion without prior flushing.
The glass syringe has a lower frictional resistance than plastic disposable syringes and operates more easily. Therefore, if Propofol Injection Emulsion is administered using a hand held prefilled syringe, the line between the syringe and the patient must not be left open if unattended.
Known allergy to propofol or any other ingredient contained in Propofol Injection Emulsion, namely egg lecithin, glycerol, soya oil and sodium Hydroxide.
Propofol is contraindicated in children 16 years of age or younger for sedation during intensive care and for monitored conscious sedation for surgical and diagnostic procedures.
As with all anaesthetic procedures, Propofol Injection Emulsion should be given by those trained in anaesthesia or where appropriate, doctors trained in the care of patients in Intensive Care. Patients should be continuously monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitation facilities should be readily available at all times. Propofol Injection Emulsion should not be administered by the person conducting the diagnostic or surgical procedure.
When Propofol Injection Emulsion is administered as a sedative for surgical or diagnostic procedures, patients should be continuously monitored by persons not involved in the conduct of the surgical/diagnostic procedures. Oxygen supplementation should be immediately available and provided when clinically indicated; oxygen saturation should be monitored in all patients. Patients should be continuously monitored for early signs of hypotension, apnoea, airway obstruction and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid initiation (loading) boluses or during supplemental maintenance boluses, especially in the elderly, debilitated and American Society of Anesthesiologists (ASA) grade Ill or IV patients, and with co-administration of other sedatives and opioid agents. Monitoring during the procedure and during the recovery period should be in accordance with the needs of the patient.
Special caution should be exercised if infusion rates in prolonged sedation (> 48 hours) exceed 4 mg/kg/h. In severely head injured patients also receiving inotropic support, fatal metabolic acidosis or cardiac failure have been reported in association with propofol infusion rates > 5 mg/kg/h for > 58 hours. Review of the sedation regime should be conducted in the presence of unexplained acidosis or cardiovascular compromise.
During induction of anaesthesia, hypotension and apnoea, similar to effects with other intravenous anaesthetic agents, commonly occur and may be influenced by the rate of administration, the use of premedicants and other agents including benzodiazepines.
Propofol Injection Emulsion lacks vagolytic activity and 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 bradycardia. (See also Interactions with other drugs.)
Occasionally hypotension may require use of intravenous fluids and reduction in the rate of administration of Propofol Injection Emulsion during the period of anaesthetic maintenance.
Ventilatory depression can occur following administration of propofol.
Propofol reduces cerebral blood flow, intracranial pressure and cerebral metabolism. This reduction in intracranial pressure is greater in patients with an elevated baseline intracranial pressure.
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 unconsciousness after the period when recovery from anaesthesia should have occurred. This may be accompanied by an increase in muscle tone and may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered.
As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients.
Appropriate care should be used in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.
One mL of Propofol Injection Emulsion carries a calorific value of 1.1 kcals.
Because Propofol Injection Emulsion is formulated in an oil-in-water emulsion, elevations in serum triglycerides may occur when Propofol Injection Emulsion is administered for extended periods of time. Patients at risk of hyperlipidaemia should be monitored for increases in serum triglycerides or serum turbidity. Administration of Propofol Injection Emulsion should be adjusted if lipids are being inadequately cleared from the body. A reduction in the quantity of concurrently administered lipids is indicated to compensate for the amount of lipid infused as part of the Propofol Injection Emulsion; Propofol Injection Emulsion 1.0 mL contains approximately 0.1 g of lipid. (See also Dosage and Administration, Sedation during intensive care.)
Propofol has been found to have no effect on electroshock seizure threshold in animals. When Propofol Injection Emulsion is administered to an epileptic patient, there may be a risk of seizure during the recovery phase. Perioperative myoclonia, less frequently including convulsions and opisthotonus, has occurred in temporal relationship to cases in which propofol has been administered.
As with thiopentone, in vitro studies have shown that propofol is much less potent than etomidate in the inhibition of synthesis of adrenocortical hormones. At concentrations of propofol likely to be encountered in anaesthetic practice, no clinically significant effect on adrenocortical hormones has been noted in studies to date.
Propofol has been reported to occasionally cause clinical anaphylactic/anaphylactoid type of reactions with angioedema, bronchospasm, erythema and hypotension. These reactions have been reported to respond to adrenaline.
Life threatening adverse events, occurring together or in combinations, of cardiac failure, arrhythmias, metabolic acidosis, rhabdomyolysis and renal failure have been associated with propofol when used for sedation during intensive care.
There have been very rare reports of metabolic acidosis, rhabdomyolysis, hyperkalaemia, and/or rapidly progressive cardiac failure (in some cases with a fatal outcome) in adults treated for more than 58 hours with propofol infusions in excess of 5 mg/kg/hour. These reports have mainly (but not exclusively) been in patients with serious head injuries associated with raised intracranial pressure. Consideration should be given to decreasing the propofol dosage or switching to an alternative sedative if these events occur. In the event of propofol dosage modification patients with raised intracranial pressure should continue to be monitored and treated appropriately as should patients with metabolic, respiratory and/or haemodynamic disturbances. The maximum dose of propofol for adult sedation during intensive care should not exceed 4.0 mg/kg/hour [see Dosage and Administration]. The use of propofol for sedation in children 16 years of age and younger during intensive care and for monitored conscious sedation for surgical and diagnostic procedures is contraindicated [see Contraindications]
Strict aseptic technique must always be maintained during handling. See Dosage and Administration and Pharmaceutical Precautions, for important handling information.
All general anaesthetics cross the placenta and carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem, however, in the compromised foetus, careful consideration should be given to this potential depression, and to the selection of anaesthetic drugs, doses and techniques.
Propofol Injection Emulsion should not be used in pregnancy. Teratology studies in rats and rabbits show some evidence of delayed ossification or abnormal cranial ossification with an increase in the incidence of subcutaneous haematomas. Reproductive studies in rats suggest that administration of propofol to the dam adversely affects perinatal survival of the offspring.
Obstetric Anaesthesia. Propofol crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anaesthesia.
Propofol Injection Emulsion is not recommended for use in women who are breast feeding because propofol has been reported to be excreted in human milk and the effects of oral absorption of small amounts of propofol are not known.
Propofol is not recommended for induction and maintenance of anaesthesia in neonates (See Adverse Effects). There are no data to support the use of propofol for sedation of premature neonates receiving intensive care (see Contraindications).
Propofol Injection Emulsion is not recommended for use in children under 3 years of age for induction and maintenance of general anaesthesia. There are no clinical trials to support the use of propofol for the sedation of children with croup or epiglottitis receiving intensive care. The use of propofol for sedation in children 16 years of age and younger during intensive care and for monitored conscious sedation for surgical and diagnostic procedures is contraindicated [see Contraindications].
Children are at particular risk of fat overload. Therefore serum lipids should be monitored in children receiving propofol.
Supplementary analgesic agents are generally required in addition to propofol. Following infusion of propofol, discontinuation of these analgesic agents should be gradual to minimise the risk of withdrawal symptoms.
Patients should be advised that performance of skilled tasks, such as driving and operating machinery, may be impaired for some time after general anaesthesia.
Animal carcinogenicity studies have not been performed with propofol. Propofol was not genotoxic in a series of assays for gene mutations (Salmonella typhimurium, saccharomyces cerevisiae), chromosomal damage (dominant lethal, micronucleus and cytogenetics assays) and other genotoxic effects (saccharomyces cerevisiae gene conversion). Studies in female rats at intravenous doses up to 15 mg/kg/day for 2 weeks before pregnancy to day 7 of gestation did not show impaired fertility. Male fertility in rats was not affected in a dominant lethal study at intravenous doses up to 15 mg/kg/day for 5 days.
It is reported that during induction in clinical trials, hypotension and apnoea occurred in up to 75% of patients. Excitatory phenomena such as involuntary movements, twitches, tremors, hypertonus and hiccup occurred in 14% of patients. Bradycardia responsive to atropine has been reported.
| Very common (>10%) |
Body as a whole: Pain during injection (burning, tingling/stinging) |
| Common (>1/100<1/10) | Body as a whole: Pain during injection (burning, tingling/stinging), elation/euphoria, Headache, shivering. Cardiovascular: Hypotension, hypertension. bradycardia Gastrointestinal: Nausea, vomiting. Respiratory: Transient apnoea, cough. Skin: Flush/rash. |
| Uncommon (>1/1000, <1/100) |
Cardiovascular: Arrhythmias. tachycardia, extrasystole. Blood: Thrombosis, phlebitis |
| Rare (<1/1000) |
Body as a whole: Fever CNS: Convulsions and seizures of the epileptic type. Urogenital: Discolouration of the urine on prolonged use. Other: anaphylactoid reactions, in some cases with angio-oedema, bronchospasm, erythema and hypotension. (These reactions have been reported to respond to adrenaline.) |
| Very Rare (<1/1000) | Musculoskeletal and connective tissue: Rhabdomyolysis (when Propofol has
been administered at doses greater than 4 mg/ Kg/hr for ICU sedation),
metabolic acidosis and cardiac failure. CNS: Postoperative unconsciousness Cardiovascular: Pulmonary odema, cardiac failure Gastrointestinal: Pancreatitis, abdominal cramps Renal: Renal failure, discolouration of urine following prolonged administration Metabolic: Hyperkalaemia, metabolic acidosis Other: Hiccup, postoperative fever. |
Occasionally, hypotension may require use of intravenous fluids and reduction of
the rate of administration of Propofol Injection Emulsion during the period of
anaesthetic maintenance or sedation. Epileptiform movements, including
convulsions and opisthotonus, have occurred. As with other anaesthetic agents,
depression of cardiac output may occur. Depression, crying, confusion,
restlessness and bronchospasm or laryngospasm were also observed. As with other
anaesthetics, sexual disinhibition may occur during recovery.
The occurrence of local pain has been reported during intravenous injection of Propofol Injection Emulsion at an incidence of 28% when veins of the dorsum of the hand are used and 5% when the larger veins of the forearm and antecubital fossa are used. Thrombosis and phlebitis are sequelae with 0.5 and 0.6% incidences. Burning, tingling/stinging and coldness have also been reported. Following abrupt discontinuation of Propofol Injection Emulsion in children receiving intensive care, withdrawal symptoms and flushing have been noted [see Contraindications]. Cardiorespiratory depression may occur in neonates if the paediatric dosage regimen is used for induction of anaesthesia [see Warnings and Precauctions, Use in neonates]. Accidental clinical extravasation and animal studies have shown minimal tissue reaction. lntra-arterial injection in animals did not induce local tissue effects.
As with other intravenous sedative agents, when Propofol Injection Emulsion is given with CNS depressants, eg potent analgesics, the sedative effect may be intensified and the possibility of severe respiratory or cardiovascular depression should be considered.
The induction dose requirements of Propofol Injection Emulsion may be reduced in patients with intramuscular or intravenous premedication (see Precautions, Premedication), particularly with narcotics (eg morphine, pethidine and fentanyl) and combinations of opioids and sedatives (eg benzodiazepines, barbiturates, chloral hydrate, droperidol). These agents may increase the anaesthetic or sedative effects of propofol and may also result in more pronounced decreases in systolic, diastolic and mean arterial pressures and cardiac output. Decreased oxygen saturation has been reported when propofol is administered with fentanyl; for this reason oxygen supplementation should be used.
During maintenance of anaesthesia or sedation, the rate of Propofol Injection Emulsion administration should be adjusted according to the desired level of anaesthesia or sedation and may be reduced in the presence of supplemental analgesic agents (eg nitrous oxide or opioids). The concurrent administration of potent inhalational agents (eg isoflurane, enflurane and halothane) during maintenance with propofol has not been extensively evaluated. These inhalational agents can also be expected to increase the anaesthetic or sedative and cardiorespiratory effects of propofol.
Propofol Injection Emulsion does not cause a clinically significant change in onset, intensity or duration of action of the commonly used neuromuscular blocking agents (eg suxamethonium and nondepolarising muscle relaxants).
No significant adverse interactions with commonly used premedications or drugs used during anaesthesia or sedation (including a range of muscle relaxants, inhalational agents, analgesic agents and local anaesthetic agents) have been observed.
Lower doses of Propofol Injection Emulsion may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques.
No information available.
Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression would require lowering of the patient's head, and if severe, use of plasma expanders and pressor agents.
No information available.
Store at or below 25°C. Do not freeze.
Prescription Medicine.
Vials: 10 mg/mL, 20 mL 10's, 50 mL 1's and 100 mL 1's.
Syringes: 10 mg/mL, 20 mL
The molecular formula of propofol is: C12H18O
Molecular weight: 178.27
Chemical name: 2,6-diisopropylphenol.
CAS Registry Number: 2078-54-8
Chemical Structure:
Mayne Pharma Limited
23 Haining Street
Te Aro
Wellington
New Zealand
31 May 2006