PROPOFOL

Posology Induction of General Anaesthesia Adults Propofol 2% may be used to induce anaesthesia by infusion. Administration of Propofol 2% by bolus injection is not recommended. Propofol 2% may be used to induce anaesthesia by infusion but only in those patients who will receive Propofol 2% for maintenance of anaesthesia.

In unpremedicated and premedicated patients, it is recommended that Propofol 2% should be titrated (approximately 2 ml [40 mg] every 10 seconds in an average healthy adult by infusion) against the response of the patient until the clinical signs show the onset of anaesthesia.

5 mg/kg of Propofol 2%. 5 ml/min [20-50 mg/min]). Over this age, the requirement will generally be less. In patients of ASA Grades 3 and 4, lower rates of administration should be used (approximately 1 ml [20 mg] every 10 seconds). Elderly In older people the dose requirement for induction of anaesthesia with Propofol 2% is reduced.

The reduction should take into 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. Paediatric population Propofol 2% is not recommended for induction of anaesthesia in children less than 3 years of age.

For induction of anaesthesia in children over 3 years of age, Propofol 2% should be titrated slowly until clinical signs show the onset of anaesthesia. The dose should be adjusted according to age and/or body weight. 5 mg/kg body weight of Propofol 2% for induction of anaesthesia.

5–4 mg/kg body weight). 4) Maintenance of General Anaesthesia Anaesthesia can be maintained by administering Propofol 2% by continuous infusion to prevent the clinical signs of light anaesthesia. Administration of Propofol 2% by bolus injection is not recommended.

Recovery from anaesthesia is typically rapid and it is therefore important to maintain Propofol 2% administration until the end of the procedure. Adults The required rate of administration varies considerably between patients, but rates in the region of 4-12 mg/kg/h usually maintain satisfactory anaesthesia.

Elderly When Propofol 2% is used for maintenance of anaesthesia the rate of infusion should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

Paediatric population Propofol 2% is not recommended for maintenance of anaesthesia in children less than 3 years of age. Anaesthesia can be maintained in children over 3 years of age by administering Propofol 2% by infusion 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, dose requirements may be higher. 4). Sedation During Intensive Care Adults For sedation during intensive care it is advised that Propofol 2% should be administered by continuous infusion.

The infusion rate should be determined by the desired depth of sedation. 3–4 mg/kg/h of Propofol 2% (See

General Induction and maintenance of anaesthesia or sedation is generally smooth with minimal evidence of excitation. Side effects during induction, maintenance and recovery occur uncommonly. 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 2% may be related to the condition of the recipients and the operative or therapeutic procedures being undertaken.

The following definitions of frequencies are used:

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) and not known (cannot be estimated from the available data). Table of Adverse Drug Reactions System Organ Class Frequency Undesirable Effects Very rare Anaphylaxis – may include angioedema, bronchospasm, erythema and hypotension Immune system disorders Not known Anaphylactic shock Metabolism and nutrition disorders Not known (9) Metabolic acidosis (5), hyperkalaemia (5), hyperlipidaemia (5) Psychiatric disorders Not known (9) Euphoric mood.

Drug abuse and drug dependence (8) Nervous system disorders Common Headache during recovery phase Rare Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recovery Very rare Postoperative unconsciousness Not known (9) Involuntary movements Cardiac disorders Common Bradycardia (1) Very rare Pulmonary oedema Not known (9) Cardiac arrhythmia (5), cardiac failure (5), (7) Vascular disorders Common Hypotension (2) Uncommon Thrombosis and phlebitis Common Transient apnoea during inductionRespiratory, thoracic and mediastinal disorders Not known (9) Respiratory depression (dose dependent) Gastrointestinal disorders Common Nausea and vomiting during recovery phase Very rare Pancreatitis Hepatobiliary disorders Not known (9) Hepatomegaly (5) Musculoskeletal and connective tissue disorders Not known (9) Rhabdomyolysis (3), (5) Very rare Discolouration of urine following prolonged administration Renal and urinary disorders Not known (9) Renal failure(5) Reproductive system and breast disorders Very rare Not Known Sexual disinhibition Priapism General disorders and administration site conditions Very common Local pain on induction (4) Very rare Tissue necrosis (10) following accidental extravascular administration Not known (9) Local pain, swelling, following accidental extravascular administration Investigations Not known (9) Brugada type ECG (5), (6) Injury, poisoning and procedural complications Very rare Postoperative fever 1.

Serious bradycardias are rare. There have been isolated reports of progression to asystole. 2. Occasionally, hypotension may require use of intravenous fluids and reduction of the administration rate of Propofol. 3. Very rare reports of rhabdomyolysis have been received where Propofol has been given at doses greater than 4 mg/kg/hr for ICU sedation.

4. May be minimised by using the larger veins of the forearm and antecubital fossa. With Propofol 1% local pain can also be minimised by the co-administration of lidocaine.

). 3 Contraindications). It is recommended that blood lipid levels be monitored should Propofol 2% be administered to patients thought to be at particular risk of fat overload. Administration of Propofol 2% should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body.

1 g of fat. If the duration of sedation is in excess of 3 days, lipids should be monitored in all patients. Elderly When Propofol 2% is used for sedation of anaesthesia the rate of infusion should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate.

Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression. Paediatric population Propofol 2% is contra-indicated for the sedation of ventilated children aged 16 years or younger receiving intensive care.

Sedation for Surgical and Diagnostic Procedures Adults To provide sedation for surgical and diagnostic procedures, rates of administration should be individualised and titrated to clinical response. 5-1 mg/kg over 1-5 minutes for onset of sedation.

5 mg/kg/h. In addition to the infusion, bolus administration of 10-20 mg may be used if a rapid increase in the depth of sedation is required. In patients of ASA Grades 3 and 4 the rate of administration and dosage may need to be reduced.

Elderly When Propofol 2% is used for sedation the rate of infusion or ‘target concentration’ should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

Paediatric population Propofol 2% is not recommended for surgical and diagnostic procedures in children aged less than 3 years. In children over 3 years of age, doses and adminisration rates 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 2% for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol 2% infusion to the desired level of sedation. 5–9 mg/kg/h Propofol 2%. In ASA 3 and 4 patients lower doses may be required.

Method of administration Propofol 2% has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol 2%. Propofol has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking drugs, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered.

Lower doses of Propofol 2% may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques. Profound hypotension has been reported following anaesthetic induction with propofol in patients treated with rifampicin.

Propofol 2% should not be diluted. When Propofol 2% is used to maintain anaesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps should always be used to control infusion rates. Propofol 2% should not be mixed prior to administration with injections or infusion fluids.

P. P. P. 1. Propofol 2% contains soya oil and should not be used in patients who are hypersensitive to peanut or soya. 4). 4 Special warnings and precautions for use Propofol 2% 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 patient airway, artificial ventilation and oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol 2% should not be administered by the person conducting the diagnostic or surgical procedure.

Abuse of, and dependence on Propofol 2%, predominantly by health care professionals, have been reported. As with other general anaesthetics, the administration of Propofol 2% without airway care may result in fatal respiratory complications.

When Propofol 2% 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. During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedicants and other agents.

Occasionally, hypotension may require use of intravenous fluids and reduction of the rate of administration of Propofol 2% during the period of anaesthetic maintenance. As with other sedative agents, when Propofol 2% 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 […]

). It is recommended that blood lipid levels be monitored should Propofol 2% be administered to patients thought to be at particular risk of fat overload. Administration of Propofol 2% should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body.

1 g of fat. If the duration of sedation is in excess of 3 days, lipids should be monitored in all patients. Elderly When Propofol 2% is used for sedation of anaesthesia the rate of infusion should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate.

Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression. Paediatric population Propofol 2% is contra-indicated for the sedation of ventilated children aged 16 years or younger receiving intensive care.

Sedation for Surgical and Diagnostic Procedures Adults To provide sedation for surgical and diagnostic procedures, rates of administration should be individualised and titrated to clinical response. 5-1 mg/kg over 1-5 minutes for onset of sedation.

5 mg/kg/h. In addition to the infusion, bolus administration of 10-20 mg may be used if a rapid increase in the depth of sedation is required. In patients of ASA Grades 3 and 4 the rate of administration and dosage may need to be reduced.

Elderly When Propofol 2% is used for sedation the rate of infusion or ‘target concentration’ should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

Paediatric population Propofol 2% is not recommended for surgical and diagnostic procedures in children aged less than 3 years. In children over 3 years of age, doses and adminisration rates 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 2% for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol 2% infusion to the desired level of sedation. 5–9 mg/kg/h Propofol 2%. In ASA 3 and 4 patients lower doses may be required.

Method of administration Propofol 2% has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol 2%. Propofol has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking drugs, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered.

Lower doses of Propofol 2% may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques. Profound hypotension has been reported following anaesthetic induction with propofol in patients treated with rifampicin.

Propofol 2% should not be diluted. When Propofol 2% is used to maintain anaesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps should always be used to control infusion rates. Propofol 2% should not be mixed prior to administration with injections or infusion fluids.

P. P. P. 1. Propofol 2% contains soya oil and should not be used in patients who are hypersensitive to peanut or soya. 4).