Index of drugs

5 mg / ml: introduction to general anesthesia in adults and children> 1 months; introduction of anesthesia in diagnostic and surgical procedures in adults and children> 1 months; short-term sedation during diagnostic or surgical procedures (alone or in combination with local or regional anesthesia) in adults.10 mg / ml: introduction and maintenance of general anesthesia in adults and children> 1 months; sedation in patients> 16 years in intensive care units during controlled respiration; sedation during diagnostic or surgical procedures (alone or in combination with local or regional anesthesia) in adults and children> 1 month20 mg / ml: introduction and maintenance of general anesthesia in adults and children> 3 yr; sedation in patients> 16 years in intensive care units during controlled respiration; sedation during diagnostic or surgical procedures (alone or in combination with local or regional anesthesia) in adults and children> 3 years

1 ml of emulsion for injection or infusion contains 5 mg, 10 mg or 20 mg propofol; drug contains sodium (0.03 mg / ml) and soybean oil.

A short-acting intravenous anesthetic. Depending on the rate of injection, the induction time of anesthesia is 30-40 s. The duration of action after a single injection is 4-6 min. Propofol binds 98% of plasma proteins. It is characterized by a three-stage pharmacokinetics (rapid distribution of T_1/2 - 2-4 min, quick elimination of T_1/2β - 30-60 min and slow release phase from poorly supplied blood vessels). It is metabolized in the liver and excreted in the urine as inactive metabolites (88%), less than 0.3% of the dose is excreted in the urine in unchanged form.

Hypersensitivity to propofol or other ingredients of the preparation (including soy or peanut). The drug with a concentration of 5 mg / ml should not be used to maintain general anesthesia, to maintain sedation during diagnostic and surgical procedures in children, for sedation in intensive care. The drug at a concentration of 10 mg / ml and 20 mg / ml should not be used in children ≤16 years for sedation during intensive care.

Propofol is not recommended in newborn infants (up to 1 year of age), due to the risk of overdose, which may result in cardiovascular depression. The use of 20 mg / ml is not recommended in children <3 years due to difficulties in gradually increasing the dose at low volumes of the drug. If the preparation is used for sedation while maintaining awareness during diagnostic and surgical procedures, continuous monitoring of the patient should be ensured to detect early signs of hypotension, airway obstruction or desaturation. Carefully use in procedures requiring complete immobilization of the patient, due to the possibility of involuntary movements during anesthesia. Until awakening, the patient must be monitored with particular care. Considering the action of propofol, the treatment, the drugs used simultaneously, the age and condition of the patient, the patient should be informed about the use of other agents that may have a sedative effect (eg benzodiazepines, opiates, alcohol). Caution should be exercised in patients with heart failure, respiratory, renal or hepatic failure, hypovolaemia, debilitated, as well as in patients with epilepsy. The clearance of propofol depends on the rate of blood flow, therefore the simultaneous administration of drugs that reduce the cardiac output decreases the clearance of propofol. Because propofol has no virolytic effect, intravenous administration of an anticholinergic drug should be considered prior to the introduction of anesthesia, especially in situations where vagus nerve tension is likely to prevail or when propofol is used together with drugs that can cause bradycardia. Special care should be taken in patients with fat metabolism disturbances or with other diseases that require special attention when using fat emulsions. It is recommended to monitor the level of fat in the blood in patients at risk of fat overload.The amount of propofol administered should be corrected if monitoring indicates inadequate excretion of fat from the body. If the patient is currently receiving intravenous fats, the amount should be reduced taking into account the amount of fat infused as a preparation component (1.0 ml of the preparation contains 0.1 g fat). If multiple boluses are used to introduce general anesthesia, the maximum amount of fats can not exceed 150 mg fat / kg / h. Consideration should be given to reducing the dose of propofol or switching to an alternative anesthetic with the first symptoms of the propolophil syndrome; it seems that the main risk factors for these events are: reducing the amount of oxygen delivered to the tissues, serious neurological injury and / or sepsis, using high doses of one or more of the following pharmacological agents - vasoconstrictors, steroids, inotropic drugs and (or) propofol (usually after doses exceeding 4 mg / kg / h). When changing the treatment in patients with increased intracranial pressure, adequate cerebral flow should be ensured. It should be remembered that if possible, do not use doses higher than 4 mg / kg / h.

Propofol should not be used during pregnancy unless clearly necessary. Propofol penetrates the placental barrier and may have a depressive effect on the vital functions of newborns. Propofol can, however, be used during abortions. Propofol is excreted in small amounts in breast milk, therefore mothers should not breastfeed within 24 hours after administration of propofol.

Very common: local pain during induction. Common: headache in the recovery phase, bradycardia, hypotension, transient apnea during induction, nausea and vomiting in the recovery phase. Uncommon: clots and phlebitis. Rare: epileptiform movements including convulsions and opistotonus during induction of anesthesia, during anesthesia and during recovery. Very rare: anaphylaxis (including: angioneurotic edema, bronchospasm, erythema and hypotension), post-operative unconsciousness, pulmonary edema, pancreatitis, changes in the color of the urine after long-term administration, lack of sexual inhibition, and postoperative fever. Not known: metabolic acidosis, hyperkalemia, hyperlipidemia, euphoria, drug abuse, involuntary movements, arrhythmia, heart failure, hepatomegaly, rhabdomyolysis, renal failure, Brugada syndrome ECG (ST elevation and T-wave inversion). Propofol syndrome has been observed: metabolic acidosis, rhabdomyolysis, hyperkalemia, hepatomegaly, renal failure, hyperlipidemia, arrhythmia, ECG-specific changes characteristic of Brugada syndrome and rapidly increasing heart failure, usually not responding to inotropic maintenance treatment (in some cases leading to death of the patient ), mainly in patients with serious medical conditions who often have a number of risk factors.

The preparation may only be used by a physician trained in anaesthesiology or intensive care, only in wards where there is a continuous patient monitoring system, equipment for airway patency, controlled breathing, oxygen supply and resuscitation. Administration of propofol for sedation during surgical or diagnostic procedures should not be performed by the same person who performs surgical or diagnostic procedures.
Intravenously.Introduction to general anesthesia. Adults (a drug with a concentration of 5 mg / ml, 10 mg / ml or 20 mg / ml) can be used: 20-40 mg every 10 s. For most patients aged <55 years, a sufficient dose of propofol is 1.5-2.5 mg / kg In older patients and in patients with risk groups III or IV according to ASA, and especially in patients with heart failure, it may be necessary to reduce the dose to 1 mg / kg. or less; in these patients, the drug should be administered more slowly (approx. 20 mg propofol every 10 seconds). Children> 1 month (you can use the drug at a concentration of 5 mg / ml or 10 mg / ml, and in children> 3 years, also a drug with a concentration of 20 mg / ml): 2.5-4 mg / kg, in children> 8 years usually sufficient there is a dose of 2.5 mg / kg. In children from groups III and IV of the ASA group, the dose should be reduced.Maintaining general anesthesia. Adults (10 mg / ml continuous infusion or injections or 20 mg / ml continuous infusion may be used): the bolus dose may be increased from 25 mg to 50 mg; In infusion 4-12 mg / kg / h. In elderly patients with poor overall condition, patients with stage III or IV risk groups as well as hypovolaemic patients may need to reduce their dose further. Children> 1 month (10 mg / ml drug may be used, and in children> 3 years also 20 mg / ml): 9-15 mg / kg / h in continuous infusion; younger children, especially up to 3 years of age, may require a higher dose. In children from groups III and IV of the ASA group, the dose should be reduced. A 5 mg / ml drug is contraindicated to maintain anesthesia.Sedation during diagnostic and surgical procedures. Adults (5 mg / ml, 10 mg / ml or 20 mg / ml may be used): 0.5-1 mg / kg at the beginning of sedation, in 1-5 min .; maintaining the desired level of sedation: 1.5-4.5 mg / kg / h. Additional boluses of 10-20 mg propofol can be administered when it is necessary to quickly deepen sedation. In patients> 55 years of age and in patients with ASA III or IV risk groups, it may be necessary to reduce the dose and the speed of administration. Children (a drug with a concentration of 5 mg / ml, 10 mg / ml can be used, and in children> 3 years, also a drug with a concentration of 20 mg / ml): 1-2 mg / kg at the beginning of sedation; maintaining sedation: 1.5-9 mg / kg / h. If a rapid deepening of the level of anesthesia is required, the infusion can be supplemented with a bolus delivery of up to 1 mg / kg. Lower doses may be required in children with grade III or IV ASA risk groups. A 5 mg / ml medicine is contraindicated in children for sedation.ICU sedation during ventilator ventilation. Adults and children> 16 years (10 mg / ml or 20 mg / ml may be used): 0.3-4 mg / kg / h infusion. Propofol is not recommended using the TCI system (Target Controlled Infusion) for sedation in ICU patients. A 5 mg / ml drug is contraindicated for sedation in the ICU.
The drug should not be administered via microbiological filters. The drug at a concentration of 5 mg / ml and 10 mg / ml is administered as undiluted or after previous dilution (maximum dilution is 1: 4); at a concentration of 20 mg / ml - in undiluted form. For continuous administration, always monitor the rate of administration using appropriate devices. The continuous infusion time from one infusion system must not exceed 12 hours (10 mg / ml and 20 mg / ml). The 5 mg / ml drug can be administered for a maximum of 1 hour. Lidocaine may be used to reduce pain at the beginning of propofol (inject lidocaine immediately before the injection of the 20 mg / ml formulation or mix the 5 mg / ml formulation or 10 mg / ml with a 1% solution of lidocaine free of preservatives, in a ratio of 40: 1 - for Propofol-Lipuro 5 mg / ml or 20: 1 - for Propofol-Lipuro 10 mg / ml). Before administering muscle relaxants, such as atracurium or mivacurium, the infusion system should be flushed if administered via the same infusion system through which propofol was previously administered.