Delex Pharma


Full Prescribing Info
Each mL of emulsion contains Propofol BP 10 mg.
Excipients/Inactive Ingredients: The vehicle contains Glycerol, Purified egg lecithin, Sodium hydroxide, Disodium edetate, Soybean oil and water.
Pharmacology: Pharmacokinetics: The pharmacokinetics of propofol are best described by a 3-compartment model. After a single bolus dose, two distribution phases are seen. The first phase has a half-life of 2 to 4 minutes. This is followed by a slow distribution phase with a half-life of 30 to 60 minutes. Significant metabolism of propofol occurs during the second phase. The termination of anaesthetic effect after a single intravenous bolus or maintenance infusion is due to extensive redistribution from the brain to other tissues and to metabolic clearance. Propofol is over 95% bound to plasma proteins. It undergoes extensive hepatic metabolism to conjugates which are eliminated in the urine. The terminal half-life ranges from 3-12 hours; with prolonged use, the terminal half-life may be longer. The pharmacokinetics of propofol do not appear to be altered by gender, chronic hepatic cirrhosis, or chronic renal impairment. Propofol crosses the placental barrier and is distributed into breast milk.
Propofol is a short-acting anaesthetic given intravenously for the induction and maintenance of general anaesthesia. It is also used for sedation in adult patients undergoing diagnostic procedures, in those undergoing surgery in conjunction with local or regional anaesthesia, and in ventilated adult patients under intensive care. When used for anaesthesia, induction is rapid, as is recovery. Propofol has no analgesic activity and supplementary analgesia may be required.
Dosage/Direction for Use
Propofol is available as 1 or 2% emulsion. The 1% emulsion may be given by intravenous injection or infusion, but the 2% emulsion is for infusion only. Infusions and injections should be prepared using aseptic techniques, see Administration as follows.
Induction of anaesthesia is generally carried out by giving propofol by injection or infusion at a rate of 40 mg every 10 seconds; a rate of 20 mg every 10 seconds may be used in high-risk patients including elderly, neurosurgical, and debilitated patients. Most adults under 55 years of age can be anaesthetised by a dose of 1.5 to 2.5 mg/kg; high-risk patients usually require a dose of 1 to 1.5 mg/kg.
When used for maintenance propofol is infused at a rate of between 4 to 12 mg/kg per hour (or 3 to 6 mg/kg per hour for elderly and debilitated patients); alternatively intermittent bolus injections of 20 to 50 mg may be given; rapid bolus doses should be avoided in high risk patients.
A novel delivery system is also available for the induction and maintenance of anaesthesia in adults. The Diprifusor target-controlled infusion system allows the speed of induction and depth of anaesthesia to be controlled by specifying target blood concentrations of propofol. Initial target concentrations for induction range from 4 to 8 micrograms/mL for patients under 55 years of age; lower initial target concentrations should be used in older and debilitated patients and should be increased gradually thereafter in steps of 0.5 to 1 microgram/mL at intervals of 1 minute to achieve a gradual induction of anaesthesia. Target concentrations for maintenance are 3 to 6 micrograms/mL.
In the UK, children aged 1 month and over may be given propofol for the induction and maintenance of anaesthesia. The dose should be adjusted for weight and age and administered slowly until the onset of anaesthesis. Most children over 8 years require an induction dose of 2.5 mg/kg; younger children may require a higher dose within the range of 2.5 to 4 mg/kg. Doses of 9 to 15 mg/kg per hour by intravenous infusion or intermittent bolus injections are suitable for maintenance.
For sedation in diagnostic and surgical procedures in adults an initial infusion of 6 to 9 mg/kg per hour may be given for 3 to 5 minutes; alternatively 0.5 to 1 mg/kg may be injected over 1 to 5 minutes. An infusion of 1.5 to 4.5 mg/kg per hour may be used for maintenance of sedation. High-risk patients usually require a 20% reduction in the maintenance dose.
For the sedation of ventilated adults propofol can be given by intravenous infusion in a dose of 0.3 to 4 mg/kg per hour. If the duration of sedation is in excess of 3 days, lipid concentrations should be monitored. Propofol is contraindicated for sedation in children aged 16 years or less.
Administration: IV Administration: Administer by IV infusion or IV injection. For IV infusion, use a controlled-infusion device (pump), preferably a volumetric pump. In patients undergoing magnetic resonance imaging (MRI), use metered controlled devices when mechanical pumps are not suitable.
Use the larger veins of the forearm or antecubital fossa (rather than hand veins) in adults and children to minimize pain at the injection site; may also administer IV lidocaine prior to administration of propofol to minimize pain.
Transfer contents of the vial into a sterile, single-use syringe immediately after cleaning the rubber stopper with 70% isopropyl alcohol; use a sterile venting spike when withdrawing propofol from vials.
Shake well just prior to administration.
Manufacturers state that propofol should not be admixed with other therapeutic agents prior to administration. Do not administer through the same catheter as blood, serum, or plasma.
Sedation in critical care settings: Minimize manipulations of IV lines; start administration promptly and complete within 12 hours after spiking the vial. Discard any unused portion and the IV tubing at the end of the procedure or after 12 hours (within 6 hours if the drug has been transferred prior to administration).
Dilution: See table.

Click on icon to see table/diagram/image
Special Precautions
Propofol should not be given to patients known to be allergic to it. Propofol should be used with caution in patients with hypovolemia, epilepsy, or lipid metabolism disorders, and in the elderly. Since there have been reports of delayed convulsions associated with the use of propofol it is recommended that special care should be taken when propofol is used for day-case surgery. When used in patients with increased intracranial pressure it should be given slowly to avoid a substantial increase in mean arterial pressure and a resultant decrease in cerebral perfusion pressure. It is also recommended that propofol should not be used in ECT. Premedication with an antimuscarinic may be advisable since propofol does not cause vagal inhibition.
Propofol is used to provide continuous sedation for ventilated adult patients under intensive care. Account should be taken of increasing the patient's lipid load. If the duration of sedation is in excess of 3 days, lipid concentrations should be monitored. Children aged 16 years or less should not be sedated in this manner with propofol. Propofol is not recommended for use in obstetrics including caesarian section.
Adverse Reactions
Early studies with propofol used a preparation formulated with polyethoxylated castor oil. Because of anaphylactoid reactions the preparation was reformulated with a vehicle of soya oil and purified egg phosphatide. Adverse effects with this preparation include pain on injection especially if the injection is into a small vein.
Local pain may be reduced by injection into a large vein or by injection of intravenous lidocaine. Apnoea may be frequent; apnoea lasting longer than 60 seconds has been reported to occur in 12% of patients. There are isolated reports of pulmonary oedema. Cardiovascular effects include a reduction in blood pressure and bradycardia. There have been reports of convulsions sometimes delayed in onset and involuntary movements. Fever and pancreatitis have occurred very rarely. Discoloration of urine has been reported following prolonged use. Anaphylactoid reactions have been reported. Nausea, vomiting and headache may occur during recovery.
Children given propofol for prolonged sedation have suffered severe reactions and there have been fatalities.
Drug Interactions
The use of propofol with other CNS depressants, including those used in premedication, may increase the sedative, anaesthetic, and cardiorespiratory depressant effects of propofol. It is recommended that propofol is given after opioids so that the dose of propofol can be carefully titrated in against the response. The dosage of propofol should be reduced if used with nitrous oxide or halogenated anaesthetics. Although propofol does not potentiate the effects of neuromuscular blockers, bradycardia and asystole have occurred after use of propofol with atracurium or suxamethonium.
Store at temperatures not exceeding 25°C. Protect from light.
ATC Classification
N01AX10 - propofol ; Belongs to the class of other general anesthetics.
Emulsion for inj (vial) 10 mg/mL (white, oil in water isotonic emulsion) x 20 mL x 1's.
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