Propofol
Other General Anesthetics
Sold as DIPRIVAN 1%
- Drug class
- Other General Anesthetics
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 28
- FDA reports (12 mo)
- 2,332
Overview
Plain-language summary, compiled from the cited regulatory records
Propofol is an intravenous general anesthetic and sedation drug [1]. It belongs to the drug class of other general anesthetics [1].
Propofol is approved for use in patients 3 years of age and older for the induction of general anesthesia [1]. For patients 2 months of age and older, it is indicated for the maintenance of general anesthesia [1]. Additionally, propofol is used for monitored anesthesia care (MAC) sedation in adult patients, and for sedation in adult patients when combined with regional anesthesia [1]. It is also used for intensive care unit (ICU) sedation in intubated adult patients [1].
In the past 12 months, there have been 2,332 adverse event reports associated with propofol [2]. The most frequently reported adverse events include drug ineffectiveness, hypotension, acute kidney injury, anaphylactic shock, and off-label use [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 22 | May 15, 2026 |
| CA Canada | Health Canada | 5 | January 26, 2026 |
| US United States | FDA | 1 | May 26, 2025 |
GBUnited Kingdom· MHRA
22 products
Uses
Propofol 20mg/ml is a short-acting intravenous anaesthetic for the - induction and maintenance of anaesthesia in adults and children over 3 years of age, -sedation of ventilated patients over 16 years of age during intensive care, - sedation of adults and children over 3 years of age for surgical and diagnostic procedures, alone or in combination with local or regional anaesthesia.
How to take
Propofol 20 mg/ml may only be administered by doctors that have been trained in anaesthesiology or intensive care. Sedation or anaesthesia with Propofol 20 mg/ml and the surgical or diagnostic procedure Page 2 of 14 may not be performed by the same person.
g. ECG, pulse oxymetry). The customary equipment for possible accidents during anaesthesia or sedation must be ready for use at all times. The dosage should be adjusted individually while taking the premedication and the patient's reaction into consideration.
Normally, the additional administration of analgesics is necessary. Administration of boluses with Propofol 20 mg/ml is not recommended.
Anaesthesia for adults:
Induction of anaesthesia: For induction of anaesthesia, Propofol 20 mg/ml is administered, titrated at a speed of 20 - 40 mg Propofol every 10 seconds, by means of an infusion pump until unconsciousness occurs. 5 mg propofol/kg of body weight.
For patients in risk groups ASA III and IV, especially in the case of prior cardiac damage and elderly patients, it may be necessary to reduce the total dosage of Propofol 20 mg/ml down to 1 mg Propofol/kg of bodymass, Whereby Propofol 20 mg/ml is administered at slower infusion speed (approximately 20 mg propofol every 10 seconds).
Maintenance of anaesthesia:
For maintenance of anaesthesia by means continuous infusion, the dosage and infusion speed must be adjusted for each individual. Normally, the dosage is 4 -12 mg propofol/kg of body mass per hour in order to maintain a satisfactory level of anaesthesia.
In the case of elderly patients, in a poor general state of health or with hypovolemia and patients in the risk groups ASA III and IV, the dosage of Propofol 20 mg/ml may be reduced down to 4 mg Propofol/kg of body mass per hour. Anaesthesia in children from 3 years of age Induction of anaesthesia For the induction of anaesthesia, Propofol 20 mg/ml is titrated slowly until clinical signs can be seen that indicate the start of anaesthesia.
The dose should be adjusted based on the age and/or body weight. 5 mg Propofol/kg of body mass for induction of anaesthesia. 5 - 4 mg Propofol/kg of body mass). 4). Maintenance of anaesthesia Maintenance of the required depth of anaesthesia can be achieved with the administration of Propofol 20 mg/ml by means of an infusion.
The required dosage rates vary considerably among patients, however a satisfactory state of anaesthesia is normally achieved at doses in the range of 9 - 15 mg Propofol/kg of body mass per hour. In the case of younger children, the required dose may be higher.
4). Page 3 of 14 There is not sufficient information available yet regarding use in children under 3 years of age. Sedation of patients over 16 years of age during intensive care. For the sedation of ventilated patients during intensive care,, Propofol 20 mg/ml should be administered as a continuous infusion.
The dosage is based on the desired depth of sedation. 0 mg propofol/kg of body mass per hour. 4). Propofol 20 mg/ml may not be used for the sedation of children aged 16 years or younger as part of intensive care. The administration of Propofol 20 mg/ml by means of a TCI system is not recommended for sedation as part of intensive care.
Sedation of adults for surgical and diagnostic procedures. During the administration of Propofol 20 mg/ml, the patient must be continually monitored for signs of a decrease in blood pressure, respiratory tract obstruction and oxygen deficiency and the customary emergency equipment for accidents must be kept ready.
0 mg propofol/kg of body mass are administered for 1 to 5 minutes. 5 mg propofol/kg of body mass per hour. A lower dosage and slower administration may be necessary for patients in risk groups ASA III and IV. A lower dosage may also be necessary in patients over 55 years of age.
Note In the case of elderly patients, smaller doses are required for the induction of anaesthesia with Propofol 20 mg/ml. The patient's general state of health and age should be taken into account. The lowered dose should be administered more slowly and titrated according to the reaction.
Even when using Propofol 20 mg/ml for maintenance of anaesthesia and for sedation, the infusion rate and the selected Propofol concentration in the blood should be decreased. An additional lowering of the dosage and the infusion rate is necessary for patients in risk groups ASA III and IV.
Elderly patients should not be given any bolus injections (individual or multiple), since circulatory and respiratory depression may result. Sedation of children from 3 years of age for surgical and diagnostic procedures The dosage and the periods between doses are selected based on the required depth of sedation and the clinical response.
For the induction of sedation, a dose of 1 - 2 mg Propofol/kg of body weight is necessary for most paediatric patients. Maintenance of sedation is achieved with the titration of Propofol 20 mg/ml via an infusion until the desired depth of sedation is reached.
5 - 9 mg Propofol/kgof body mass per hour is required. Lower doses may be necessary for patients in the risk groups ASA III and IV. Propofol 20 mg/ml may not be used for the sedation of children aged […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
The induction and maintenance of anaesthesia and sedation with Propofol is normally gentle with only a few signs of excitation. The most frequently reported undesirable effects are pharmacologically foreseeable effects of anaesthetics / sedatives, such as, for example, hypotension and respiratory depression.
The type, severity and frequency of these effects which were observed in patients during the use of Propofol, are dependent on the patient's state of health, the type of procedure and the therapeutic measures taken. The indication of the frequency of undesirable effects is based on the following categories: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000); not known (the frequency cannot be assessed on the basis of the available data).
4) Not known Involuntary movements Common Bradycardia1 Very rare Pulmonary oedema Cardiac disorders Not known Arrhythmia5, heart failure 5,7 Common Hypotension2 Vascular disorders Uncommon Thrombosis and phlebitis Common Hyperventilation and coughing during induction of anaesthesia, temporary apnoea during induction of anaesthesia Uncommon Coughing during maintenance therapy Rare Coughing during the waking phase Respiratory, thoracic and mediastinal disorders Not known Respiratory depression (depending on the dosage) Common Singultation during the induction, nausea and vomiting during the waking phase Gastrointestinal tract disorders Very rare Pancreatitis Hepatomegaly5 Hepatobiliary disorders Not known Hepatitis, acute hepatic failure10 Musculoskeletal and connective tissue disorders Not known Rhabdomyolysis 3,5 Very rare Discolouration of urine after longer periods of administration of Propofol 20 mg/ml Renal and urinary disorders Not known Renal failure5 Very rare Sexual disinhibitionReproductive tract and breast disorders Not known Priapism Very common Local pain during the first injection4 Common Hot flushes during the induction of anaesthesia Very rare Severe tissue reactions and tissue necrosis9 after erroneous extravascular application General disorders and administration site conditions Not known Local pain, swelling following erroneous extravascular application Investigations Not known Brugada-type ECG5,6 Injury, poisoning and complications as a result of a procedure Very rare Postoperative fever After simultaneous administration of lidocaine, the following side effects can occur: dizziness, Page 10 of 14 vomiting, drowsiness, convulsions, bradycardia, arrhythmia and shock.
Soybean oil may trigger allergic reactions very rarely. 1 Severe bradycardia is rare; in some individual cases, progression up to and including asystole has been reported. 2 Occasionally, a decrease in blood pressure can make volume replacement therapy and a decrease in the speed of administering Propofol 20 mg/ml necessary.
3 Rhabdomyolysis was reported very rarely if Propofol 20 mg/ml was administered in high doses as 4 mg Propofol/kg of body mass per hour for sedation as part of intensive care. 4 This can be avoided for the most part by administering lidocaine simultaneously and by administering the drug in larger veins in the forearm or the cubital fossa.
4). 6 Brugada syndrome - elevated ST segment and concave T waves in the ECG. 7 Quickly progressing heart failure (in some cases with a deadly outcome) in adults, which was usually not able to be treated with supportive inotropic therapeutic measures.
8 Misuse and dependency on Propofol, primarily by healthcare personnel. 9 In cases where viability of the tissue was impaired, necrosis has been reported. 10 After both long- and short-term treatment and in patients without underlying risk factors.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions (see details below).
uk/yellowcard
During the use of Propofol 20 mg/ml for sedation for surgical and diagnostic procedures, the patient must be continually monitored for the first signs of a decrease in blood pressure, respiratory tract obstruction and oxygen deficiency.
As is also the case with other sedatives, spontaneous movements of the patient during surgical procedures may occur with the use of Propofol 20 mg/ml for sedation. For procedures that require an immobile patient, these movements may jeopardise the success of the operation.
Misuse and dependency on Propofol has been reported, primarily among healthcare personnel. As with all medications for general anaesthesia, it may not be used without securing an airway; Page 5 of 14 otherwise, there is the risk of deadly respiratory complications.
After the use of Propofol 20 mg/ml, it should be ensured that the patient has fully recovered from the anaesthesia prior to discharge. In individual cases, a postoperative unconsciousness phase can occur with the use of Propofol 20 mg/ml, which may be accompanied by increased muscle tone.
The occurrence of this is dependent on whether or not the patient was previously awake. Even though the patient will spontaneously regain consciousness, an unconscious patient should be kept under intensive observation. The impairments caused by Propofol 20 mg/ml are usually not observed for longer than 12 hours.
When explaining the effect of Propofol 20 mg/ml to the patient, and when making the following recommendations, the doctor should take into consideration the type of procedure, the concomitant medication, the age and the condition of the patient.
• The patient should only return home when accompanied by another person. g. operating a motor vehicle) can be carried out again. g. benzodiazepine, opiates, alcohol) may prolong and increase the impairments. 2). Heart, circulatory and respiratory insufficiency as well as hypovolaemia should be compensated prior to administration of the drug, if possible.
In the case of patients with severe cardiac damage, Propofol 20 mg/ml must be administered with corresponding caution and in combination with intensive monitoring. A pronounced drop in blood pressure may necessitate the administration of plasma substitutes, possibly of vasoconstrictors, and slower administration of Propofol 20 mg/ml.
The possibility of a massive drop in blood pressure should be taken into consideration for patients with reduced coronary or cerebral perfusion or with hypovolemia. The Propofol clearance is dependent on the blood flow. Therefore, if drugs are used at the same time that reduce the cardiac output, the Propofol clearance will also be reduced.
Propofol does not have a vagolytic effect. The use has been associated with the occurrence of bradycardia with an occasionally severe outcome (cardiac arrest). Therefore, in situations where there is pre-existing high vagal tone or Propofol 20 mg/ml is administered with other drugs, which may decrease the heart rate, intravenous administration of an anticholinergic agent should be considered before or during anaesthesia with Propofol 20 mg/ml.
When using Propofol 20 mg/ml in people with epilepsy, it is possible for a seizure to be triggered. 3. Page 6 of 14 Paediatric Population The use of Propofol 20 mg/ml in newborns is not recommended, since this patient group has not been sufficiently evaluated.
2) indicate that the clearance of Propofol is considerably reduced in newborns and varies widely per individual. 8). Propofol 20 mg/ml is not recommended for children under 3 years of age, since a corresponding titration of Propofol 20 mg/ml for small children can only be carried out with difficulty on account of the extraordinarily small volume required.
3). Notes regarding intensive medical care The use of infusions with Propofol emulsion for sedation as part of intensive care is associated with a series of metabolic disorders and organ failure, which may lead to death. In addition, combined occurrence of the following undesirable effects has also been reported: metabolic acidosis, rhabdomyolysis, hyperkalaemia hepatomegaly, renal failure, hyperlipidaemia, heart arrhythmia, Brugada-type ECG (saddle or tent shaped ST segment elevations in the right precordial leads [V1-V3] and concave T waves) and/or quickly progressing heart failure, which was usually not able to be treated with supportive inotropic therapeutic measures.
The combination of these events is also called "Propofol infusion syndrome". These events were most frequently observed in patients with severe head injuries and in children with respiratory tract infections, which had received higher doses than is foreseen for adults for the purpose of sedation during intensive care.
The following factors are believed to be significant risk factors for the development of this complication: Low oxygen […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
4).
This is not medical advice. Consult a qualified healthcare professional.
CACanada· Health Canada
5 products
Uses
3 WARNINGS AND PRECAUTIONS, Pediatrics). v. bolus injection. The patient’s clinical response will determine the infusion rate or the amount and frequency of incremental injections. When administering PROPOFOL INJECTION by infusion, drop counters, syringe pumps or volumetric pumps must be used to provide controlled infusion rates.
20 mg/kg/min (6 - 12 mg/kg/h) administered in a variable rate infusion with 60% - 70% nitrous oxide and oxygen provides anaesthesia for patients undergoing general surgery. Maintenance by infusion of PROPOFOL INJECTION should immediately follow the induction dose in order to provide satisfactory or continuous anaesthesia during the induction phase.
20 mg/kg/min; 9 - 12 mg/kg/h) for the first 10 to 15 minutes. Infusion rates should subsequently be decreased by 30% - 50% during the first half-hour of maintenance. 0 mL) incremental boluses and/or by increasing the infusion rate. If vital sign changes are not controlled after a 5 minute period,other means such as a narcotic, PROPOFOL INJECTION propofol Page 8 of 37 Unclassified / Non classifié barbiturate, vasodilator or inhalation agent therapy should be initiated to control these responses.
e. body surface) 60% to 70% nitrous oxide can be combined with a variable rate PROPOFOL INJECTION infusion to provide satisfactory anaesthesia. e. v. analgesic agentsshould be considered to provide a satisfactory anaesthetic and recovery profile.
When supplementation with nitrous oxide is not provided, administration rate(s) of PROPOFOL INJECTION and/or opioids should be increased in order to provide adequate anaesthesia. Infusion rates should always be titrated downward in the absence of clinical signs of light anaesthesia until a mild response to surgical stimulation is obtained in order to avoid administration of PROPOFOL INJECTION at rates higher than are clinically necessary.
10 mg/kg/min should be achieved during maintenance in order to optimize recoverytimes. 10 mg/kg/min and should be supplemented with analgesic levels of continuous opioid administration. 05 mg/kg/min. Higher doses of PROPOFOL INJECTION will reduce the opioid requirements.
25 mg/kg/min (6 - 15 mg/kg/h) should achieve satisfactory anaesthesia. These infusion ratesmay be subsequently reduced depending on patient response and concurrent medication. 0 mL) may be administered withnitrous oxide in patients undergoing general surgery.
The incremental boluses should be administered when changes in vital signs indicate a response to surgical stimulation or light anaesthesia. Propofol has been used in conjunction with a wide variety of agents commonly used in anaesthesia such as atropine, scopolamine, glycopyrrolate, diazepam, depolarizing and nondepolarizing muscle relaxants, and narcotic analgesics, as well as with inhalational and regional anaesthetic agents.
No pharmacological incompatibilities have been encountered. Lower doses of PROPOFOL INJECTION may be required when used as an adjunct to regional anaesthesia. 20 mg/kg/min (6 to 12 mg/kg/h). 10 mg/kg/min (3 to 6 mg/kg/h). 15 mg/kg/min (6 to 9 mg/kg/h).
10 mg/kg/min (3 to 6 mg/kg/h). 20 mg/kg/min (6 to 12 mg/kg/h). 25 mg/kg/min (6-15 mg/kg/h).
Intermittent Bolus:
Increments of 25 mg to 50 mg, as needed. Surgical/Diagnostic sedation During sedation, attention must be given to the cardiorespiratory effects of PROPOFOL INJECTION. Hypotension, apnea, airway obstruction, and/or oxygen desaturation can occur, especially with a rapid bolus injection.
During initiation of sedation, slow infusion or slow injection techniques are preferable over rapid bolus administration, and during maintenance of sedation, a variable rate infusion is preferable over intermittent bolus administration in order to minimize undesirable cardiorespiratory effects.
In the elderly, debilitated and ASA III or IV patients, rapid (single or repeated) bolus dose administration should not be used for sedation (See 7 WARNINGS AND PRECAUTIONS, General). Adults When PROPOFOL INJECTION is administered for sedation, rates of administration should be individualized and titrated to clinical response.
In most patients, the rates of PROPOFOL INJECTION administration will be approximately 25 to 30% of those used for […]
How to take
). (See 2 CONTRAINDICATIONS). AND PRECAUTIONS, Geriatrics and 4 DOSAGE AND ADMINISTRATION). 2. Contraindications PROPOFOL INJECTION (propofol) is contraindicated: • in patients who are hypersensitive or allergic to this drug, lipid emulsions or to any other ingredient in the formulation, including any non-medicinal ingredient, (including eggs or egg products, and soybeans or soy products), or component of the container.
For a complete listing, see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
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 doses of one or more of the following pharmacological agents – vasoconstrictors, steroids, inotropes and/or propofol.
All sedatives and therapeutic agents used in the ICU (including propofol) should be titrated tomaintain optimal oxygen delivery and haemodynamic parameters. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
PROPOFOL INJECTION propofol Page 14 of 37 Unclassified / Non classifié Patients should be followed up post-operatively after exposure to PROPOFOL INJECTION as appropriate to identify potential adverse effects. Cardiovascular Extreme care should be used in administering PROPOFOL INJECTION in patients with impaired left ventricular function because propofol injectable emulsion may produce a negative inotropic effect.
Extreme care should be used in administering PROPOFOL INJECTION in patients who are hypotensive, hypovolemic or in shock because propofol injectable emulsion may cause excessive arterial hypotension. Propofol lacks vagolytic activity and has been associated with reports of bradycardia,(occasionally profound) and also asystole.
v. 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 INJECTION is used in conjunction with other agents likely to cause bradycardia.
Patients should be monitored for early signs of significant hypotension and/or cardiovascular depression, which may be profound. v. fluid administration, and/or vasopressor therapy. Of these patients 85% were males (mean age 61, range 32-83) and 15% were females (mean age 65, range 42-86).
The majority of patients undergoing CABG had good left ventricular function. Experience in patients with poor left ventricular function, as well as, in patients with hemodynamically significant valvular or congenital heart disease is limited.
Slower rates of administration should be utilized in premedicated patients, geriatric patients, patients with recent fluid shift, or patients who are hemodynamically unstable. Any fluid deficitsshould be corrected prior to administration of PROPOFOL INJECTION.
g. elevation of lower extremities, or use of pressor agents, may be useful to offset the hypotension which is associated with the induction of anaesthesia with propofol. Dependence, Tolerance and/or Abuse Liability There are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries.
Instances of self -administration of propofol by health care professionals have also been reported, which have resulted in fatalities and other injuries. Driving and Operating Machinery Patients receiving PROPOFOL INJECTION on an outpatient basis should not engage in hazardous activities requiring complete mental alertness such as driving a motor vehicle or operating machinery until the effects of PROPOFOL INJECTION have completely subsided.
Endocrine and Metabolism PROPOFOL INJECTION should not be used for ICU sedation in patients who have severe lipidemia or severely disordered fat metabolism because the vehicle of PROPOFOL INJECTION is a lipid emulsion. Therefore, the restrictions that apply to lipid emulsions should also be considered when using PROPOFOL PROPOFOL INJECTION propofol Page 15 of 37 Unclassified / Non classifié INJECTION in the ICU.
PROPOFOL INJECTION should be given with caution in conditions of impaired lipid metabolism as in renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (if hypertri-glyceridemic) and sepsis.
If givento patients with these conditions, close monitoring of the serum triglyceride concentration is obligatory: fat elimination should be checked daily and the dosage adjusted to the patient's capacity for fat elimination. In cases of verified or suspected liver insufficiency, liver function must be closely followed.
005% w/v as a microbial inhibitor. EDTA is a chelator of metal ions, including zinc. The need for supplemental zinc should be consideredduring prolonged administration of PROPOFOL INJECTION particularly in patients who are predisposed to zinc deficiency, such as those with burns, diarrhoea and/or major sepsis.
Hepatic/Biliary/Pancreatic The long-term administration of propofol to patients with hepatic insufficiency has not been evaluated. Immune Use of propofol has been associated with both fatal and life threatening anaphylactic and anaphylactoid reactions.
Neurologic Neurosurgical Anaesthesia:
When using PROPOFOL INJECTION in patients with increased intracranial pressure (ICP) or impaired cerebral circulation, significant decreases in mean arterial pressure should be avoided because of the resultant decreases in cerebral perfusion pressure.
When increased ICP is suspected, hyperventilation and hypocarbia should accompany the administration of PROPOFOL INJECTION (see 4 DOSAGE AND ADMINISTRATION). Epilepsy Since various manifestations of seizures have been reported during propofol anaesthesia, special care should be taken when giving the drug to epileptic patients.
Ophthalmologic Preliminary findings in patients with normal intraocular pressure […]
, General). PROPOFOL INJECTION should only be administered to intubated, mechanically ventilated, adult patients in the Intensive Care Unit (ICU) to provide continuous sedation and control of stress responses. In this setting, PROPOFOL INJECTION should be administered only by or under the supervision of persons trained in general anaesthesia or critical care medicine.
1 Pediatrics Pediatrics (3 to ≤ 18 years of age): PROPOFOL INJECTION is only indicated for anaesthesia in children 3 years of age and older. PROPOFOL INJECTION is not indicated for sedation or during surgical/diagnostic procedures in children under the age of 18, as safety and efficacy have not been established in this patient population.
3. WARNINGS AND PRECAUTIONS, Pediatrics and 4 DOSAGE AND ADMINISTRATION). (See 2 CONTRAINDICATIONS). AND PRECAUTIONS, Geriatrics and 4 DOSAGE AND ADMINISTRATION). 2. Contraindications PROPOFOL INJECTION (propofol) is contraindicated: • in patients who are hypersensitive or allergic to this drug, lipid emulsions or to any other ingredient in the formulation, including any non-medicinal ingredient, (including eggs or egg products, and soybeans or soy products), or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • for the sedation of children 18 years or younger receiving intensive care (see 4 DOSAGE AND ADMINISTRATION) • when sedation or general anaesthesia are contraindicated PROPOFOL INJECTION propofol Page 5 of 37 Unclassified / Non classifié 4.
1 Dosing Considerations For general anaesthesia or sedation for surgical/diagnostic procedures, PROPOFOL INJECTION (propofol injectable emulsion) should be administered only by persons trained in the administration of general anaesthesia and not involved in the conduct of surgical/diagnostic procedures.
Patients should be continuously monitored and facilities for maintenance of a patent airway, artificial ventilation, and oxygen enrichment and circulatory resuscitation must be immediately available. For sedation of intubated, mechanically ventilated, adult patients in the ICU, PROPOFOL INJECTION (propofol injectable emulsion) should be administered only by persons trained in general anaesthesia or critical care medicine.
As with other general anaesthetics, the administration of PROPOFOL INJECTION (propofol injectable emulsion) without airway care may result in fatal respiratory complications. Strict aseptic techniques must always be maintained during handling as PROPOFOL INJECTION (propofol injectable emulsion) is a single-use parenteral product, for use in an individual patient, and contains noantimicrobial preservatives.
The vehicle is capable of supporting rapid growth of microorganisms. Failure to follow aseptic handling procedures may result in microbial contamination causing fever/infection/sepsis which could lead to life-threatening illness. PROPOFOL INJECTION should be visually inspected for particulate matter, emulsion separation and/or discolouration prior to use.
Do not use if any of these things are seen. If no signs of particulatematter, emulsion separation and/or discolouration are seen, shake gently before use. Dosage and rate of administration should be individualized and titrated to the desired effect according to clinically relevant factors including preinduction and concomitant medications, age,ASA status and level of debilitation of the patient.
In heavily premedicated patients, both the induction and maintenance doses should be reduced. v. catheter with blood or plasma because compatibility has not been established. In vitro tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals.
The clinical significance is not known. v. line as PROPOFOL INJECTION without prior flushing. The administration of PROPOFOL INJECTION should be initiated as a continuous infusion and changes in the rate of administration made slowly (>5 min) in order to minimize hypotension and avoid acute overdosage.
Since PROPOFOL INJECTION is formulated in an oil-water emulsion, patients should be monitored for lipemia. Administration of PROPOFOL INJECTION should be adjusted if fat is being inadequately cleared from the body. 1 kcal). PROPOFOL INJECTION propofol Page 6 of 37 Unclassified / Non classifié In adults and children, attention should be paid to minimize pain on administration of propofol.
v. v. 0 mL of a 1% solution). Concomitant use of midazolam has been reported to prolong the anaesthesia and to reduce the respiratory rate. 4 DRUG INTERACTIONS, drug-drug interactions). v. sedative or narcotic premedications shortly prior to induction.
5 mg/kg of propofol injectable emulsion for induction when unpremedicated or when premedicated with oral benzodiazepines or intramuscular narcotics. For induction, PROPOFOL INJECTION should be titrated (approximately 40 mg every 10 seconds by bolus […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
). AND PRECAUTIONS, Geriatrics and
This is not medical advice. Consult a qualified healthcare professional.
Brands in Canada (1)
USUnited States· FDA
1 product
Uses
4 )] . 4 )]. 4 )]. Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients Sedation for Adult Patients in Combination with Regional Anesthesia Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use : Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months MAC sedation in the pediatric population is not recommended Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation
How to take
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for detailed dosing instructions. 1 Important Dosage and Administration Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Shake well before use. Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised.
Slight creaming, which should disappear after shaking, may be visible upon prolonged standing. Do not use if there is evidence of separation of the phases of the emulsion. Propofol injectable emulsion with EDTA inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms.
Product is packaged under nitrogen. For general anesthesia or monitored anesthesia care (MAC) sedation, propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.
Sedated patients should be continuously monitored, and equipment for maintaining a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available.
Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients.
For sedation of intubated, mechanically ventilated adult patients in the Intensive Care Unit, propofol injectable emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Guidelines for Aseptic Technique for General Anesthesia/MAC Sedation Propofol injectable emulsion must be prepared for use just prior to initiation of each individual anesthetic/sedative procedure. The vial rubber stopper should be disinfected using 70% isopropyl alcohol.
Propofol injectable emulsion should be drawn into a sterile syringe immediately after a vial is opened. When withdrawing propofol injectable emulsion from vials, a sterile vent spike should be used. The syringe should be labelled with appropriate information including the date and time the vial was opened.
Administration should commence promptly and be completed within 12 hours after the vial has been opened. Propofol injectable emulsion must be prepared for single dose only. Any unused propofol injectable emulsion drug product, reservoirs, dedicated administration tubing and/or solutions containing propofol injectable emulsion must be discarded at the end of the anesthetic procedure or at 12 hours, whichever occurs sooner.
The intravenous line should be flushed every 12 hours and at the end of the anesthetic procedure to remove residual propofol injectable emulsion. 2 )] . Guidelines for Aseptic Technique for ICU Sedation Propofol injectable emulsion must be prepared for single dose only.
Strict aseptic techniques must be followed. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. A sterile vent spike and sterile tubing must be used for administration of propofol injectable emulsion. As with other lipid emulsions, the number of intravenous line manipulations should be minimized.
Administration should commence promptly and must be completed within 12 hours after the vial has been spiked. The tubing and any unused propofol injectable emulsion drug product must be discarded after 12 hours. If propofol injectable emulsion is transferred to a syringe prior to administration, it should be drawn into a sterile syringe immediately after a vial is opened.
When withdrawing propofol injectable emulsion from a vial, a sterile vent spike should be used. The syringe should be labelled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened.
Propofol injectable emulsion should be discarded and administration lines changed after 12 hours. 2 )] Administration with Lidocaine If lidocaine is to be administered to minimize pain on injection of propofol injectable emulsion, it is recommended that it be administered prior to propofol injectable emulsion administration or that it be added to propofol injectable emulsion immediately before administration and in quantities not exceeding 20 mg lidocaine/200 mg propofol injectable emulsion.
13 )] Compatibility and Stability Propofol injectable emulsion should not be mixed with other therapeutic agents prior to administration. Dilution Prior to Administration Propofol injectable emulsion is provided as a ready-to-use formulation.
However, should dilution be necessary, it should only be diluted with 5% Dextrose Injection, USP, and it should not be diluted to a concentration less than 2 mg/mL because it is an emulsion. In diluted form it has been shown to be more stable when in contact with glass than with plastic (95% potency after 2 hours of running infusion in plastic).
15 )] . 2% Sodium Chloride Injection, USP. Administration with Pumps When administering propofol injectable emulsion by infusion, syringe or volumetric pumps are recommended to provide controlled infusion rates. When infusing propofol injectable emulsion to patients undergoing magnetic resonance imaging, metered control devices may be utilized if mechanical pumps are impractical.
Administration with Filters Clinical experience with the use of in-line filters and propofol injectable emulsion during anesthesia or ICU/MAC sedation is limited. Propofol injectable emulsion should only be administered through a filter with a pore size of 5 micron or greater unless it has been demonstrated that the filter does not restrict the flow of propofol injectable emulsion and/or cause the breakdown of the emulsion.
Filters should be used with caution and where clinically appropriate. Continuous monitoring is necessary due to the potential for restricted flow and/or breakdown of the emulsion. 5 mg/kg of propofol injectable emulsion. For induction, whether administered by infusion or intravenous injection the dose of propofol injectable emulsion to the patient should be titrated against the response of the patient and until there are clinical signs consistent with the onset of anesthesia.
As with other sedative-hypnotic agents, the amount of intravenous opioid and/or benzodiazepine premedication may impact the dose of propofol injectable emulsion required for induction of general anesthesia. 5 mg/kg of propofol injectable emulsion for induction of anesthesia.
For induction, whether administered by infusion or intravenous injection the dose administration of propofol injectable emulsion to the patient should be titrated against the response of the patient and until there are clinical signs consistent with the onset of anesthesia.
A rapid bolus may increase the likelihood of undesirable cardiorespiratory depression. 5 mg/kg of propofol injectable emulsion for induction. Within this dosage range, younger pediatric patients may require higher induction doses than older pediatric patients.
As with other sedative-hypnotic agents, the amount of intravenous opioid and/or benzodiazepine premedication may impact the dose of propofol injectable emulsion required for induction of general anesthesia. A lower dosage is recommended for pediatric patients classified as ASA-PS III or IV.
7 )] . Neurosurgical Patients Most adult neurosurgical patients require 1 mg/kg to 2 mg/kg of propofol injectable emulsion. Slower induction is recommended to allow for titration to achieve an adequate clinical response. 6 )] . Whether administered by infusion or an intravenous injection, the dose of propofol injectable emulsion to the patient should be titrated against the response of the patient and until there are clinical signs consistent with the onset of anesthesia.
5 mg/kg of propofol injectable emulsion. Slower induction is recommended to allow for titration to clinical response and to prevent hemodynamic instability. Whether administered by infusion or intravenous injection, the dose of propofol injectable emulsion to the patient should be titrated against the response of the patient until the clinical signs show the onset of anesthesia.
Other agents used in addition to propofol injectable emulsion for induction and maintenance of anesthesia may require propofol injectable emulsion doses to be titrated to ensure adequate sedation level. Propofol injectable emulsion has been well-studied in patients with coronary artery disease and in patients with hemodynamically significant valvular or congenital heart disease.
No significant safety issues or changes to the induction of anesthesia is generally required for these patient groups. Dosing should be titrated based on depth of anesthesia. As with other anesthetic and sedative-hypnotic agents, propofol injectable emulsion in healthy patients causes a decrease in blood pressure that is secondary to decreases in preload (ventricular filling volume at the end of the diastole) and afterload (arterial resistance at the beginning of the systole).
The magnitude of these changes is proportional to the blood and effect site concentrations achieved. These concentrations depend upon the dose and speed of the induction and maintenance infusion rates. In addition, lower heart rates are observed during maintenance with propofol injectable emulsion, possibly due to reduction of the sympathetic activity and/or resetting of the baroreceptor reflexes.
Therefore, anticholinergic agents should be administered when increases in vagal tone are anticipated. As with other anesthetic agents, propofol injectable emulsion reduces myocardial oxygen consumption. Further studies are needed to confirm and delineate the extent of these effects on the myocardium and the coronary vascular system.
15 mg/kg) with nitrous oxide 67% in oxygen has been shown to decrease the necessary propofol injectable emulsion maintenance infusion rates and therapeutic blood concentrations when compared to non-narcotic (lorazepam) premedication.
The rate of propofol injectable emulsion administration should be determined based on the patient's premedication and adjusted according to clinical responses. 3 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age Propofol injectable emulsion has been used with a variety of agents commonly used in anesthesia such as atropine, scopolamine, glycopyrrolate, diazepam, depolarizing and nondepolarizing muscle relaxants, and opioid analgesics, as well as with inhalational and regional anesthetic agents.
In the elderly, debilitated, or ASA-PS III or IV patients, rapid bolus doses should not be used, as this will increase the likelihood of undesirable cardiorespiratory depression. Adult Patients In adults, anesthesia can be maintained by administering propofol injectable emulsion by infusion or intermittent intravenous bolus injection.
The patient's clinical response will determine the infusion rate or the amount and frequency of incremental injections Continuous Infusion Propofol injectable emulsion 100 mcg/kg/min to 200 mcg/kg/min administered in a variable rate infusion with 60% to 70% nitrous oxide and oxygen provides anesthesia for patients undergoing general surgery.
Maintenance by infusion of propofol injectable emulsion should immediately follow the induction dose in order to provide satisfactory or continuous anesthesia during the induction phase. During this initial period following the induction dose, higher rates of infusion are generally required (150 mcg/kg/min to 200 mcg/kg/min) for the first 10 minutes to 15 minutes.
Infusion rates should subsequently be decreased 30% to 50% during the first half-hour of maintenance. Generally, rates of 50 mcg/kg/min to 100 mcg/kg/min in adults should be achieved during maintenance in order to optimize recovery times.
Other drugs that cause CNS depression (hypnotics/sedatives, inhalational anesthetics, and opioids) can increase the CNS depression induced by propofol. 5 mL) to 50 mg (5 mL) may be administered in adult patients undergoing general surgery.
The incremental boluses should be administered when changes in vital signs indicate a response to surgical stimulation or light anesthesia. Cardiac Anesthesia The maintenance dose of propofol in adult cardiac patients should be administered as 25 to 100 mcg/kg/min, and should be adjusted according to the patient's sedation level and clinical response.
Pediatric Patients In children greater than or equal to 2 months of age, anesthesia can be maintained by administering propofol injectable emulsion by infusion or intermittent intravenous bolus injection. 5 to 2 mg/kg). The patient's clinical response will determine the infusion rate or the amount and frequency of incremental injections.
Continuous Infusion Propofol injectable emulsion administered as a variable rate infusion provides satisfactory anesthesia for most children 2 months of age or older, ASA-PS I or II, undergoing general anesthesia. In general, for the pediatric population, maintenance by infusion of propofol injectable emulsion at a rate of 200 mcg/kg/min to 300 mcg/kg/min should immediately follow the induction dose.
Following the first half-hour of maintenance, infusion rates of 125 mcg/kg/min to 150 mcg/kg/min are typically needed. Propofol injectable emulsion should be titrated to achieve the desired clinical effect. 1 )] . 5 to 2 mg/kg doses as needed.
The incremental boluses should be administered when changes in vital signs indicate a response to surgical stimulation or light anesthesia. 4 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients When propofol injectable emulsion is administered for MAC sedation, rates of administration should be individualized and titrated to clinical response.
In most patients, the rates of propofol injectable emulsion administration will be in the range of 25 mcg/kg/min to 75 mcg/kg/min. During initiation of MAC sedation, slow infusion or slow injection techniques are preferable over rapid bolus administration.
During maintenance of MAC sedation, a variable rate infusion is preferable over intermittent bolus dose administration. 12 )] . A rapid bolus injection may result in undesirable cardiorespiratory depression. Initiation of MAC Sedation in Adult Patients For initiation of MAC sedation, either an infusion or a slow injection method may be utilized while closely monitoring cardiorespiratory function.
With the infusion method, sedation may be initiated by infusing propofol injectable emulsion at 100 mcg/kg/min to 150 mcg/kg/min (6 mg/kg/hour to 9 mg/kg/hour) for a period of 3 minutes to 5 minutes and titrating to the desired clinical effect while closely monitoring respiratory function.
5 mg/kg administered over 3 minutes to 5 minutes and titrated to clinical responses. When propofol injectable emulsion is administered slowly over 3 minutes to 5 minutes, most patients will be adequately sedated, and the peak drug effect can be achieved while minimizing undesirable cardiorespiratory effects occurring at high plasma levels.
12 )]. The rate of administration should be over 3 minutes to 5 minutes and the dosage of propofol injectable emulsion should be reduced to approximately 80% of the usual adult dosage in these patients according to their condition, responses, and changes in vital signs.
Maintenance of MAC Sedation in Adult Patients For maintenance of sedation, a variable rate infusion method is preferable over an intermittent bolus dose method. 5 mg/kg/hour) during the first 10 minutes to 15 minutes of sedation maintenance.
Infusion rates should subsequently be decreased over time to 25 mcg/kg/min to 50 mcg/kg/min and adjusted to clinical responses. In titrating to clinical effect, allow approximately 2 minutes for onset of peak drug effect. Infusion rates should always be titrated downward in the absence of clinical signs of light sedation until mild responses to stimulation are obtained in order to avoid sedative administration of propofol injectable emulsion at rates higher than are clinically necessary.
If the intermittent bolus dose method is used, increments of propofol injectable emulsion 10 mg (1 mL) or 20 mg (2 mL) can be administered and titrated to desired clinical effect. With the intermittent bolus method of sedation maintenance, there is increased potential for respiratory depression, transient increases in sedation depth, and prolongation of recovery.
12 )] . The rate of administration and the dosage of propofol injectable emulsion should be reduced to approximately 80% of the usual adult dosage in these patients according to their condition, responses, and changes in vital signs.
Propofol injectable emulsion can be administered as the sole agent for maintenance of MAC sedation during surgical/diagnostic procedures. When propofol injectable emulsion sedation is supplemented with opioid and/or benzodiazepine medications, these agents increase the sedative and respiratory effects of propofol injectable emulsion and may also result in a slower recovery profile [see Drug Interactions ( 7 )].
5 mL) to 50 mg (5 mL) incremental boluses and/or by increasing the infusion rate of propofol injectable emulsion. , body surface) nitrous oxide (60% to 70%) can be combined with a variable rate propofol injectable emulsion infusion to provide satisfactory anesthesia.
, intra- abdominal), or if supplementation with nitrous oxide is not provided, administration rate(s) of propofol injectable emulsion and/or opioids should be increased in order to provide adequate anesthesia. Infusion rates should always be titrated downward in the absence of clinical signs of light anesthesia in order to avoid administration of propofol injectable emulsion at rates higher than are clinically necessary.
Generally, rates of 50 mcg/kg/min to 100 mcg/kg/min in adults should be achieved during maintenance in order to optimize recovery times. Other drugs that cause CNS depression (hypnotics/sedatives, inhalational anesthetics, and opioids) can increase CNS depression induced by propofol.
15 mg/kg) with nitrous oxide 67% in oxygen has been shown to decrease the necessary propofol injection maintenance infusion rate and therapeutic blood concentrations when compared to non-narcotic (lorazepam) premedication. Propofol blood concentrations at steady state are generally proportional to infusion rates, especially in individual patients.
Undesirable effects such as cardiorespiratory depression are likely to occur at higher blood concentrations which result from bolus dosing or rapid increases in the infusion rate. An adequate interval (3 minutes to 5 minutes) must be allowed between dose adjustments to allow for and assess the clinical effects.
6 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients In the Intensive Care Unit (ICU), propofol injectable emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.
10 ) ]. For intubated, mechanically ventilated adult patients, Intensive Care Unit (ICU) sedation should be initiated slowly with a continuous infusion in order to titrate to desired clinical effect and minimize hypotension. 3 mg/kg/hour).
6 mg/kg/hour) until the desired level of sedation is achieved. A minimum period of 5 minutes between adjustments should be allowed for onset of peak drug effect. 3 mg/kg/hour to 3 mg/kg/hour) titrated to desired level of clinical response.
With medical ICU patients or patients who have recovered from the effects of general anesthesia or deep sedation, the rate of administration of 50 mcg/kg/min or higher may be required to achieve adequate sedation. These higher rates of administration may increase the likelihood of patients developing hypotension.
8 )] . Dosage and rate of administration should be individualized and titrated to the desired effect, according to clinically relevant factors including the patient's underlying medical problems, preinduction and concomitant medications, age, ASA-PS classification, and level of debilitation of the patient.
12 )] . Dosages of propofol injectable emulsion should be reduced in patients who have received large dosages of opioids. The propofol injectable emulsion dosage requirement may also be reduced by adequate management of pain with analgesic agents.
6 )] . 4 )] . Bolus administration of 10 mg or 20 mg should only be used to rapidly increase depth of sedation in patients where hypotension is not likely to occur. 4 )] . 8 )] . 7 Summary of Dosage Guidelines Dosages and rates of administration in the following table should be individualized and titrated to clinical response.
Safety and dosing requirements for induction of anesthesia in pediatric patients have only been established for children 3 years of age or older. Safety and dosing requirements for the maintenance of anesthesia have only been established for children 2 months of age and older.
Table 1. 5 mg/kg until induction onset, as determined by clinical response of the patient. 5 mg/kg until induction onset, as determined by clinical response to the onset of anesthesia. 5 mg/kg until induction onset, as determined by clinical response of the patient.
Neurosurgical Patients: 1 mg/kg to 2 mg/kg until induction onset, as determined by clinical response of the patient. 2 )] .
Maintenance of General Anesthesia:
Infusion Healthy Adults Less Than 65 Years of Age: Infusion of 100 mcg/kg/min to 200 mcg/kg/min (6 mg/kg/hour to 12 mg/kg/hour).
Elderly, Debilitated, ASA-PS III or IV Patients:
Infusion of 50 mcg/kg/min to 100 mcg/kg/min (3 mg/kg/hour to 6 mg/kg/hour).
Cardiac Anesthesia:
Infusion of 25 mcg/kg/min to 100 mcg/kg/min Neurosurgical Patients: Infusion of 100 mcg/kg/min to 200 mcg/kg/min (6 mg/kg/hour to 12 mg/kg/hour). 5 mg/kg/hour to 18 mg/kg/hour). 2 )] Intermittent Bolus Healthy Adults Less Than 65 Years of Age: Increments of 20 mg to 50 mg as needed.
Initiation of MAC Sedation:
Healthy Adults Less Than 65 Years of Age: Slow infusion or slow injection techniques are recommended to avoid apnea or hypotension. 5 mg/kg over 3 minutes to 5 minutes followed immediately by a maintenance infusion.
Elderly, Debilitated, Neurosurgical, or ASA-PS III or IV Patients:
Most patients require dosages similar to healthy adults. 12 )] .
Maintenance of MAC Sedation:
Healthy Adults Less Than 65 Years of Age: A variable rate infusion technique is preferable over an intermittent bolus technique. 5 mg/kg/hour) or incremental bolus doses of 10 mg or 20 mg.
In Elderly, Debilitated, Neurosurgical, or ASA-PS III or IV Patients:
Most patients require 80% of the usual adult dose. 12 )] . 3 mg/kg/hour) for at least 5 minutes. 6 mg/kg/hour) over 5 minutes to 10 minutes may be used until desired clinical effect is achieved. 3 mg/kg/hour to 3 mg/kg/hour) or higher may be required.
8 )] . Evaluation of clinical effect and assessment of CNS function should be carried out daily throughout maintenance to determine the minimum dose of propofol injectable emulsion required for sedation. 2 )] .
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 2,332 reports total. [4]
- Drug Ineffective 243
- Hypotension 181
- Acute Kidney Injury 172
- Anaphylactic Shock 169
- Off Label Use 152
- Drug Interaction 137
- Anaphylactic Reaction 118
- Cardiac Arrest 116
- Serotonin Syndrome 78
- Tachycardia 72
- Rhabdomyolysis 71
- Toxicity To Various Agents 57
Side effects & warnings
9 )] In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates.
These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Anesthesia and MAC Sedation in Adults The following estimates of adverse events for propofol injectable emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2,889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with propofol injectable emulsion was greater than the comparator incidence rate in these trials.
Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship. The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with propofol injectable emulsion during anesthesia (see Table 3 below).
During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea. Anesthesia in Pediatric Patients Generally, the adverse experience profile from reports of 506 propofol injectable emulsion pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with propofol injectable emulsion during anesthesia in adults.
Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients. ICU Sedation in Adults The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients).
Probably related incidence rates for ICU sedation were determined by individual case report form review. Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge. In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown.
Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship. Table 2. 14 )]. , phlebitis or thrombosis, have been reported rarely (<1%).
The most common adverse reactions >1% were bradycardia, arrhythmia, tachycardia, hypotension, hypertension, decreased cardiac output, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc.
gov/medwatch
1 ) Microbial Contamination : Strict aseptic technique must be maintained during handling. Propofol injectable emulsion vials are never to be accessed more than once or used on more than one person. Administration should commence promptly and be completed within 12 hours after the vial has been opened.
Discard unused drug product. 2 ) Cardiovascular depression : Cases of bradycardia, asystole, and cardiac arrest have been reported. 1 Anaphylactic and Anaphylactoid Reactions Use of propofol injectable emulsion has been associated with both fatal and life threatening anaphylactic and anaphylactoid reactions.
Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension, occur rarely following propofol injectable emulsion administration. 2 Risks of Microbial Contamination Strict aseptic technique must always be maintained during handling.
005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, propofol injectable emulsion can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards.
Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports in which failure to use aseptic technique when handling propofol injectable emulsion was associated with microbial contamination of the product and with fever, infection/sepsis, other life-threatening illness, and/or death.
Propofol injectable emulsion vials are never to be accessed more than once or used on more than one person. There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and of the use of propofol vials intended for single use on multiple persons.
3 Risks of Pediatric Neurotoxicity Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours.
The clinical significance of these findings is not clear. 2 )]. Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects.
These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness. Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other.
Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks. 4 Risks of Bradycardia, Asystole, and Cardiac Arrest Propofol injectable emulsion has no vagolytic activity.
Reports of bradycardia, asystole, and rarely, cardiac arrest have been associated with propofol injectable emulsion. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly. , succinylcholine) or surgical stimuli.
5 Risk of Seizures When propofol injectable emulsion is administered to an epileptic patient, there is a risk of seizure during the recovery phase. 6 Neurosurgical Anesthesia When propofol injectable emulsion is used in patients with increased intracranial pressure or impaired cerebral circulation, significant decreases in mean arterial pressure should be avoided because of the resultant decreases in cerebral perfusion pressure.
To avoid significant hypotension and decreases in cerebral perfusion pressure, an infusion or slow bolus should be utilized instead of rapid, more frequent, and/or larger boluses of propofol injectable emulsion. Slower induction, titrated to clinical responses, will generally result in reduced induction dosage requirements (1 mg/kg to 2 mg/kg).
1 )] . 7 Cardiac Anesthesia Slower rates of administration should be utilized in premedicated patients, geriatric patients, patients with recent fluid shifts, and patients who are hemodynamically unstable. Fluid deficits should be corrected prior to administration of propofol injectable emulsion.
, elevation of lower extremities, or use of pressor agents, may be useful to offset the hypotension which is associated with the induction of anesthesia with propofol injectable emulsion. 5 )] . Patients should be monitored for early signs of significant hypotension and/or cardiovascular depression, which may be profound.
These effects are responsive to discontinuation of propofol injectable emulsion, intravenous fluid administration, and/or vasopressor therapy. In the elderly, debilitated, or ASA-PS III or IV patients, rapid (single or repeated) bolus administration should not be used during sedation in order to minimize undesirable cardiorespiratory depression.
As with other sedative medications, there is wide interpatient variability in propofol injectable emulsion dosage requirements, and these requirements may change with time. Failure to reduce the infusion rate in patients receiving propofol injectable emulsion for extended periods may result in excessively high blood concentrations of the drug.
Thus, titration to clinical response and daily evaluation of sedation levels are important during use of propofol injectable emulsion infusion for ICU sedation, especially when it is used for long durations. Opioids and paralytic agents should be discontinued and respiratory function optimized prior to weaning patients from mechanical ventilation.
Infusions of propofol injectable emulsion should be adjusted to maintain a light level of sedation prior to weaning patients from mechanical ventilatory support. Throughout the weaning process, this level of sedation may be maintained in the absence of respiratory depression.
Abrupt discontinuation of propofol injectable emulsion prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation.
It is therefore recommended that administration of propofol injectable emulsion be continued in order to maintain a light level of sedation throughout the weaning process until 10 to 15 minutes prior to extubation, at which time the infusion can be discontinued.
9 Risks of Propofol Infusion Syndrome in Patients with ICU Sedation Use of propofol injectable emulsion infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death.
The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes (Coved ST segment elevation -similar to ECG changes of the Brugada syndrome) and/or cardiac failure.
The following appear to be 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 prolonged, high-dose infusions of propofol (> 5 mg/kg/hour for > 48 hours).
The syndrome has also been reported following large-dose, short-term infusions during surgical anesthesia. In the setting of prolonged need for sedation, increasing propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a propofol infusion, consideration should be given to using alternative means of sedation.
Prescribers should be alert to these events in patients with the above risk factors and immediately discontinue propofol when the above signs develop. 10 Risk of Elevations in Serum Triglycerides Propofol injectable emulsion use requires caution when administered to patients with disorders of lipid metabolism such as primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.
Since propofol injectable emulsion is formulated in an oil-in-water emulsion, elevations in serum triglycerides may occur when propofol injectable emulsion is administered for extended periods of time. Patients at risk of hyperlipidemia should be monitored for increases in serum triglycerides or serum turbidity.
Administration of propofol injectable emulsion should be adjusted if fat is being inadequately cleared from the body. 1 kcal). 11 Risks of Zinc Losses EDTA is a strong chelator of trace metals – including zinc. Although with propofol injectable emulsion there are no reports of decreased zinc levels or zinc deficiency-related adverse events, propofol injectable emulsion should not be infused for longer than 5 days without providing a drug holiday to safely replace estimated or measured urine zinc losses.
5 mg/day to 2 mg/day in pediatric patients. In patients who are predisposed to zinc deficiency, such as those with burns, diarrhea, and/or major sepsis, the need for supplemental zinc should be considered during prolonged therapy with propofol injectable emulsion.
12 Use in the Elderly, Debilitated, or ASA-PS III or IV Patients A lower induction dose and a slower maintenance rate of administration should be used in elderly, debilitated, or ASA-PS III or IV patients [see Dosage and Administration ( 2 )].
Patients should be continuously monitored for early signs of hypotension and/or bradycardia. Apnea requiring ventilatory support often occurs during induction and may persist for more than 60 seconds. 13 Risk of Transient Local Pain Attention should be paid to minimize pain on administration of propofol injectable emulsion.
Transient local pain can be minimized if the larger veins of the forearm or antecubital fossa are used. Pain during intravenous injection may also be reduced by prior injection of intravenous lidocaine (1 mL of a 1% solution). Pain on injection occurred frequently in pediatric patients (45%) when a small vein of the hand was utilized without lidocaine pretreatment.
With lidocaine pretreatment or when antecubital veins were utilized, pain was minimal (incidence less than 10%) and well-tolerated. There have been reports in the literature indicating that the addition of lidocaine to propofol injectable emulsion in quantities greater than 20 mg lidocaine/200 mg propofol injectable emulsion results in instability of the emulsion which is associated with increases in globule sizes over time and (in rat studies) a reduction in anesthetic potency.
Therefore, it is recommended that lidocaine be administered prior to propofol injectable emulsion administration or that it be added to propofol injectable emulsion immediately before administration and in quantities not exceeding 20 mg lidocaine/200 mg propofol injectable emulsion.
14 Risk of Local Reactions Phlebitis or venous thrombosis has been reported. In two clinical studies using dedicated intravenous catheters, no instances of venous sequelae were observed up to 14 days following induction. Accidental intra-arterial injection has been reported in patients, and, other than pain, there were no major sequelae.
15 Risk of Aggregation if Administered through the Same Intravenous Catheter with Blood or Plasma Propofol injectable emulsion should not be coadministered through the same intravenous catheter with blood or plasma because compatibility has not been established.
In vitro tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals. The clinical significance of these findings is not known. 16 Risk of Postoperative Unconsciousness Very rarely the use of propofol injectable emulsion may be associated with the development of a period of postoperative unconsciousness which may be accompanied by an increase in muscle tone.
This may or may not be preceded by a brief period of wakefulness. Recovery is spontaneous. 17 Risks of Perioperative Myoclonia Perioperative myoclonia, rarely including convulsions and opisthotonos, has occurred in association with propofol injectable emulsion administration.
18 Risks of Pulmonary Edema There have been rare reports of pulmonary edema in temporal relationship to the administration of propofol injectable emulsion, although a causal relationship is unknown. 19 Risks of Unexplained Postoperative Pancreatitis Rarely, cases of unexplained postoperative pancreatitis (requiring hospital admission) have been reported after anesthesia in which propofol injectable emulsion was one of the induction agents used.
Due to a variety of confounding factors in these cases, including concomitant medications, a causal relationship to propofol injectable emulsion is unclear.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
4 CONTRAINDICATIONS Propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. Propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products.
Known hypersensitivity to propofol, egg or soybean ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
Drug interactions
Known interactions involving Propofol. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 513. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL001160675 · revised May 15, 2026
- [2]Health Canada (DPD) · 02525879 · revised January 26, 2026
- [3]FDA DailyMed · 10272dc1-657d-47… · revised May 26, 2025 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.