Indications & Uses
Lipuro is used for the induction and maintenance of general anaesthesia, for sedation during intensive care, and for sedation during surgical and diagnostic procedures.
Pharmacology
Propofol is a sedative-hypnotic agent used to start and maintain anesthesia or sedation. After an intravenous injection of a therapeutic dose, hypnosis comes on rapidly with minimal excitation, usually within 45 seconds from the start of the injection (the time for one arm-brain circulation). It works by positively modulating the inhibitory action of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors.
Propofol is highly lipid soluble and short-acting. In most patients general anesthesia begins within 15 to 45 seconds. Most patients wake up quickly and recover without confusion or nausea. They are usually fully orientated within a few minutes of recovery, and fit for discharge after only a few hours. Unlike many other anesthetic agents, propofol does not accumulate to a clinically significant degree during maintenance dosing, so it is well suited to sedation in intensive care.
The original text also says that the MCT/LCT formulation has clinical benefits over conventional LCT or MCT emulsions, and that with this technology there is 30% less free, lipophilic, poorly water-soluble drug substance, which can cause pain on injection, compared with products dissolved in water. It describes this formulation as the only one proven to reduce pain at the injection site. The text does not say which products the 30% comparison was made against.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage for Adults
Induction of general anaesthesia: The dose of Propofol should be adjusted for each patient based on how they respond. The usual starting dose in adults is 40 mg (4 ml) given by slow intravenous bolus injection at intervals of 10 seconds, continued until clinical signs show that anaesthesia has begun. The usual induction dose in a healthy patient under 55 years of age is 2.2 to 2.5 mg/kg. A dose of 1.0 to 1.5 mg/kg is often enough for an older patient. Lower doses, most often 20 mg (2 ml) at intervals of 10 seconds, are recommended for patients of ASA grades 3 and 4.
Maintenance of general anaesthesia: Anaesthesia can be maintained by giving Propofol either as a continuous infusion or as repeated bolus injections to keep the patient sufficiently anaesthetised. For continuous infusion, the rate needed varies considerably from patient to patient. At the start of anaesthesia, roughly during the first 10 to 20 minutes, some patients may need a slightly higher infusion rate of 8 to 10 mg/kg/h. However, sufficient anaesthesia is normally achieved with an infusion of 4 to 6 mg/kg/h, and sometimes up to 12 mg/kg/h. For repeated bolus injections, doses of 25 to 50 mg (2.5 to 5.0 ml) can be given depending on the patient's response.
Sedation during intensive care: A bolus injection of 1.0 to 2.0 mg/kg should be given first, followed by a continuous infusion adjusted to the degree of sedation required. An infusion rate of 0.3 to 4 mg/kg/h is usually enough.
Sedation for surgical and diagnostic procedures: Doses should be adjusted for each patient. Sufficient sedation for surgical and diagnostic procedures can usually be achieved by giving an initial dose of 0.5 to 1 mg/kg over 1 to 5 minutes, then maintaining sedation with a continuous infusion at a rate of 1 to 4.5 mg/kg/h. A bolus dose of 10 to 20 mg can be given in addition if deeper sedation is suddenly needed. Lower doses of Propofol are often enough for patients of ASA grades 3 and 4, and for older patients.
Children: Propofol is not recommended for children under 3 years of age, as its safety has not been demonstrated in this age group.
Induction of general anaesthesia: The dose of Propofol in children should be adjusted for weight and age. The average induction dose in children over 8 years is 2.5 mg/kg, given by slow intravenous injection until clinical signs show that anaesthesia has begun. Younger children may need slightly higher doses of Propofol per kilogram of body weight. Lower doses are recommended for children of ASA grades 3 and 4.
Maintenance of general anaesthesia: Anaesthesia can be maintained by giving Propofol either as a continuous infusion or as repeated bolus injections. The dose should be adjusted for each child, but an infusion rate of 9 to 15 mg/kg/h is usually enough to achieve satisfactory anaesthesia.
Sedation during intensive care and for surgical or diagnostic procedures: Propofol is not recommended for sedation in children, as its effectiveness and safety have not been demonstrated for this use. Although no causal link has been established, serious adverse events, including deaths, have been reported in cases where Propofol was used against these recommendations. Adverse events have most commonly been seen in children with respiratory tract infections who were given doses higher than those recommended for adults.
Side Effects
Local: Lipuro is usually well tolerated. The most common side effect is pain at the injection site, which can be lessened by mixing the preparation with lidocaine or by injecting into one of the larger veins of the forearm or the crook of the elbow. Thrombosis and phlebitis are uncommon. General: Low blood pressure and a brief pause in breathing can occur when anaesthesia is induced, and these effects may be pronounced in patients who are already in poor general health. Epileptic-type movements, convulsions, and dystonic reactions have been seen, though rarely. Fluid in the lungs (pulmonary oedema) has also been reported. Headache, nausea, and, less commonly, vomiting may occur in some patients on recovery, which may also come with a further brief spell of clouded consciousness. Hypersensitivity reactions have been reported in some cases, presenting with anaphylactic-type symptoms such as marked low blood pressure, bronchospasm, swelling, and facial redness. Cardiac arrest has occurred in some cases linked to Lipuro's use. With long-term use, urine may turn green or reddish-brown; this is due to Lipuro's quinol metabolites and is not harmful. As with other anaesthetics, changes in sexual behaviour may occur.
Cautions & Contraindications
Warnings & Precautions
Lipuro should only be given by specialists in anaesthesiology or under their supervision. The physician performing a surgical or diagnostic procedure should not administer Lipuro. Facilities for resuscitation in case of any complication should be available at the treatment unit. During administration of Lipuro, patients shall be monitored continuously so that possible hypotension, obstruction in the respiratory tract, hypoventilation or insufficient oxygen intake can be picked up at a sufficiently early stage. Special attention shall be paid to patients sedated by Lipuro for a surgical or diagnostic procedure who are not artificially ventilated. Caution shall be taken in administering Lipuro to patients with cardiac, respiratory, renal or hepatic insufficiency. Hypovolemic patients and those in poor general condition form another risk group. Since Lipuro lacks vagolytic activity, bradycardia, even asystole, may occur. Intravenous administration of an anticholinergic agent before induction and during maintenance of anaesthesia should be considered, especially if Lipuro is used together with other agents likely to cause bradycardia, and in situations where vagal tone is likely to predominate. Since Lipuro is a lipid emulsion, appropriate care should be applied in patients with severe disorders of fat metabolism such as pathological hyperlipidemia. If Lipuro is given to a patient for whom excessive fat intake may be risky, blood lipid values shall be monitored and the Lipuro dosage decreased if necessary. If the patient is also receiving other parenteral lipid emulsions besides Lipuro, the amount of lipid in Lipuro (0.1 g/ml) shall be taken into account when calculating total fat intake. In epileptic patients, Lipuro may lead to convulsions. The analgesic effect of Lipuro on its own is insufficient, so analgesics shall be used to ensure adequate pain relief. Full recovery from general anaesthesia shall be confirmed before discharge. It should be noted that the aftermath of general anaesthesia may impair the patient's ability to understand instructions given after the procedure.
Contraindications
Do not use propofol if you are allergic to propofol or to any other ingredient in the preparation.
Pregnancy & Breastfeeding
Propofol should not be used during pregnancy, because there is not enough experience with its use in pregnant women. It passes quickly to the foetus, so it should not be used for anaesthesia during childbirth either. Its safety for the newborn has not been established in cases where propofol was given to a woman who is breastfeeding.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Propofol is not recommended for children under 3 years of age, because its safety has not been shown in this age group.
Overdose
An overdose of propofol may cause cardiorespiratory depression. If breathing is depressed, the patient should be given artificial ventilation with oxygen. If the heart and circulation are depressed, the patient's head should be lowered and his or her legs raised. Pressor agents and plasma expanders, or Ringer-type electrolyte solutions, can be used if they are needed.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Propofol at a temperature not above 25º C, and don't let it freeze. If any solution is left unused, throw it away.
Drug Interactions
Common questions about Pofol IV 20 ml 20 mg/ml
What is Pofol IV 20 ml 20 mg/ml IV Injection?
Pofol IV 20 ml 20 mg/ml IV Injection is a medicine that contains Propofol. It is made by Popular Pharmaceuticals PLC. It belongs to the General (Intravenous) anesthetics group of medicines.
What is Pofol IV 20 ml used for?
Lipuro is used for the induction and maintenance of general anaesthesia, for sedation during intensive care, and for sedation during surgical and diagnostic procedures.
What are the side effects of Pofol IV 20 ml?
Local: Lipuro is usually well tolerated. The most common side effect is pain at the injection site, which can be lessened by mixing the preparation with lidocaine or by injecting into one of the larger veins of the forearm or the crook of the elbow.
Can I take Pofol IV 20 ml during pregnancy or while breastfeeding?
Propofol should not be used during pregnancy, because there is not enough experience with its use in pregnant women. It passes quickly to the foetus, so it should not be used for anaesthesia during childbirth either. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Pofol IV 20 ml?
An overdose of propofol may cause cardiorespiratory depression. If breathing is depressed, the patient should be given artificial ventilation with oxygen. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Pofol IV 20 ml?
Keep Propofol at a temperature not above 25º C, and don't let it freeze. If any solution is left unused, throw it away.
Can I take other medicines with Pofol IV 20 ml?
Some medicines can interact with Propofol, for example: Sevoflurane, Terlipressin Acetate, Cisatracurium Besylate. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Pofol IV 20 ml?
Pofol IV 20 ml is a prescription (Rx) medicine. Take it as your doctor advises.