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PROPOFOL is a brand name for Propofol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Propofol 1% (10 mg/ml) is a short-acting intravenous general anaesthetic for ● induction and maintenance of general anaesthesia in adults and children > 1 month ● sedation of ventilated patients > 16 years of age in the intensive care unit ● sedation for diagnostic and surgical procedures, alone or in combination with…
Verbatim from this product's MHRA label. Tap a section to expand.
General instructions Propofol must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. g. ECG, pulse oximeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times.
For sedation during surgical or diagnostic procedures Propofol should not be given by the same person that carries out the surgical or diagnostic procedure. Supplementary analgesic medicinal products are generally required in addition to Propofol.
Posology Propofol is given intravenously. The dosage is adjusted individually according to the patient’s response. ● General anaesthesia in adults Induction of anaesthesia: For induction of anaesthesia Propofol should be titrated (20-40 mg of propofol every 10 seconds) against the patient’s response until the clinical signs show the onset of anaesthesia.
5 mg/kg body weight. In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of Propofol 1% (10 mg/ml) may be reduced to a minimum of 1 mg/kg body weight.
In these patients lower rates of administration should be applied (approximately 2 ml, corresponding to 20 mg every 10 seconds).
Maintenance of anaesthesia:
Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections. 0 ml Propofol 1 % (10 mg/ml)) may be given according to clinical requirements. For maintenance of anaesthesia by continuous infusion the dosage requirements usually are in the range of 4-12 mg/kg body weight/h.
In elderly patients, in patients of poor general condition, in patients of ASA grades III and IV, in hypovolaemic patients and patients with hypoproteinemia the dosage may have to be reduced further depending on the severity of the patient’s condition and on the performed anaesthetic technique.
Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression. ● General anaesthesia in children over 1 month of age Induction of anaesthesia: For induction of anaesthesia Propofol should be slowly titrated against the patient’s response until the clinical signs show the onset of anaesthesia.
Induction and maintenance of anaesthesia or sedation with propofol is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side effects of an anaesthetic/sedative agent, such as hypotension.
The nature, severity and incidence of adverse events observed in patients receiving propofol may be related to the condition of the recipients and the operative or therapeutic procedures being undertaken. Table of Adverse Drug Reactions System Organ Class Frequency Undesirable Effects Immune system disorders: Very rare (< 1/10 000) Anaphylaxis up to anaphylactic shock– may include angioedema, bronchospasm, erythema and hypotension Metabolism and nutritional disorders: Frequency not known (9) Metabolic acidosis (5), hyperkalaemia (5), hyperlipidaemia (5) Psychiatric disorders: Very rare (< 1/10 000) Sexual disinhibition Frequency not known (9) Euphoric mood, drug abuse and drug dependence (8) Nervous system disorders: Common (≥ 1/100, < 1/10) Headache during recovery phase Rare (≥ 1/10 000, < 1/1000) Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recovery Very rare (< 1/10 000) Postoperative unconsciousness Frequency not known (9) Involuntary movements Cardiac disorders: Common (≥ 1/100, < 1/10) Bradycardia (1) Very rare (< 1/10 000) Pulmonary oedema Frequency not known (9) Cardiac arrhythmia (5), cardiac arrest, cardiac failure (5), (7) Vascular disorders: Common (≥ 1/100, < 1/10) Hypotension (2) Common (≥ 1/100, < 1/10) Transient apnoea during induction Respiratory, thoracic and mediastinal disorders: Frequency not known (9) Respiratory depression (dose-dependent) Gastrointestinal disorders: Common (≥ 1/100, < 1/10) Nausea and vomiting during recovery phase Very rare (< 1/10 000) Pancreatitis Hepatobiliary disorders: Frequency not known (9) Hepatomegaly (5), hepatitis (12), acute hepatic failure (12) Musculoskeletal and connective tissue disorders: Frequency not known (9) Rhabdomyolysis (3), (5) Reproductive system and breast disorders: Frequency not known (9) Priapism Very rare (< 1/10 000) Discolouration of urine following prolonged administration Renal and urinary disorders: Frequency not known (9) Renal failure (5) Very common (≥ 1/10) Local pain on induction (4) Uncommon (≥ 1/1000, < 1/100) Injection site thrombosis and injection site phlebitis Very rare (< 1/10 000) Tissue necrosis (10) following accidental extravascular administration (11) General disorders and administration site conditions: Frequency not known (9) Local pain, swelling and inflammation following accidental extravascular administration (11) Investigations: Frequency not known (9) Brugada type ECG (5), (6) Injury, poisoning and procedural complications: Very rare (< 1/10 000) Postoperative fever (1) Serious bradycardias are rare.
Propofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care). Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times.
Propofol should not be administered by the person conducting the diagnostic or surgical procedure. The abuse of and dependence on propofol, predominantly by health care professionals, have been reported. As with other general anaesthetics, the administration of propofol without airway care may result in fatal respiratory complications.
When propofol is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation. As with other sedative agents, when propofol is used for sedation during operative procedures, involuntary patient movements may occur.
During procedures requiring immobility these movements may be hazardous to the operative site. An adequate period is needed prior to discharge of the patient to ensure full recovery after use of propofol. Very rarely the use of propofol may be associated with the development of a period of post-operative unconsciousness, which may be accompanied by an increase in muscle tone.
This may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered. Propofol induced impairment is not generally detectable beyond 12 hours.
g. benzodiazepines, opiates, alcohol). 2). Propofol clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce propofol clearance. Propofol lacks vagolytic activity and has been associated with reports of bradycardia (occasionally profound) and also asystole.
1. Propofol must not be used in patients of 16 years of age or younger for sedation for intensive care. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The dosage should be adjusted according to age and/or body weight. 5 mg/kg body weight of propofol for induction of anaesthesia. 5-4 mg/kg body weight).
Maintenance of general anaesthesia:
Anaesthesia can be maintained by administering Propofol by infusion or repeated bolus injection to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients but rates in the region of 9-15 mg/kg/h usually achieve satisfactory anaesthesia.
In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher. 4) ● Sedation of ventilated patients in the Intensive Care Unit For sedation during intensive care it is advised that propofol should be administered by continuous infusion.
The infusion rate should be determined by the desired depth of sedation. 4). 3). Administration of propofol by Target Controlled Infusion (TCI) system is not advised for sedation in the intensive care unit. ● Sedation for diagnostic and surgical procedures in adults To provide sedation during surgical and diagnostic procedures, doses and administration rates should be adjusted according to the clinical response.
5-1 mg/kg body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol infusion to the desired level of sedation. 5 mg/kg body weight/h. The infusion may be supplemented by bolus administration of 10-20 mg (1-2 ml Propofol 1% (10 mg/ml)) if a rapid increase of the depth of sedation is required.
In patients older than 55 years and in patients of ASA grades III and IV lower doses of Propofol may be required and the rate of administration may need to be reduced. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.
● Sedation for diagnostic and surgical procedures in children over 1 month of age Doses and administration rate should be adjusted according to the required depth of sedation and the clinical response. Most paediatric patients require 1-2 mg/kg body weight of propofol for onset of sedation.
Maintenance of sedation may be accomplished by titrating Propofol as infusion to the desired level of sedation. 5-9 mg/kg/h of propofol. The infusion may be supplemented by bolus administration of up to 1 mg/kg body weight if a rapid increase of depth of sedation is required.
In ASA III and IV patients lower doses may be required. 18% w/v) […]
There have been isolated reports of progression to asystole. (2) Occasionally, hypotension may require use of intravenous fluids and reduction of the administration rate of propofol. (3) Very rare reports of rhabdomyolysis have been received where propofol has been given at doses greater than 4 mg/kg/hr for ICU sedation.
(4) May be minimised by using the larger veins of the forearm and antecubital fossa. With Propofol local pain can also be minimised by the co-administration of lidocaine. 4. (6) Brugada-type ECG – elevated ST-segment and coved T-wave in ECG.
(7) Rapidly progressive cardiac failure (in some cases with fatal outcome) in adults. The cardiac failure in such cases was usually unresponsive to inotropic supportive treatment. (8) Abuse of and drug dependence on propofol, predominantly by health care professionals.
(9) Not known as it cannot be estimated from the available clinical trial data. (10) Necrosis has been reported where tissue viability has been impaired. (11) Treatment is symptomatic and may include immobilisation and, if possible, elevation of affected limb, cooling, close observation, consultation of surgeon if necessary.
(12) After both long- and short-term treatment and in patients without underlying risk factors.
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.
When propofol is administered to an epileptic patient, there may be a risk of convulsion. Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.
Patients with hypoproteinaemia might have a higher risk to obtain adverse events based on a higher fraction of unbound propofol. 2). Paediatric population The use of propofol is not recommended in newborn infants as this patient population has not been fully investigated.
2) indicate that clearance is considerably reduced in neonates and has a very high inter-individual variability. Relative overdose could occur on administering doses recommended for older children and result in severe cardiovascular depression.
3). Advisory statements concerning Intensive Care Unit management Use of propofol for ICU sedation has been associated with a constellation of metabolic disturbances and organ system failures that may result in death.
Reports have been received of combinations of the following:
Metabolic acidosis, Rhabdomyolysis, Hyperkalaemia, Hepatomegaly, Renal failure, Hyperlipidaemia, Cardiac arrhythmia, Brugada-type ECG (elevated ST-segment and coved T-wave) and rapidly progressive Cardiac failure usually unresponsive to inotropic supportive treatment.
Combinations of these events have been referred to as the Propofol infusion syndrome. These events were mostly seen in patients with serious head injuries and children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in the intensive care unit.
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 dosages of one or more of the following pharmacological agents – vasoconstrictors, steroids, inotropes and/or propofol (usually at dose rates greater than 4 mg/kg/h for more than 48 hours).
Prescribers should be alert to these events in patients with the above risk factors and immediately discontinue propofol when the above signs develop. All sedative and therapeutic agents used in the intensive care unit (ICU), should be titrated to maintain optimal oxygen delivery and haemodynamic parameters.
Patients with raised intra- cranial pressure (ICP) should be given appropriate treatment to support the cerebral perfusion pressure during these treatment modifications. Treating physicians are reminded if possible not to exceed the dosage of 4 mg/kg/h.
Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously. It is recommended that blood lipid levels should be monitored if propofol is administered to patients thought to be at particular risk of fat overload.
Administration of propofol should […]