Propofol

Source: UK SPC (eMC) for Propofol 1% (10 mg/ml) emulsion for injection or infusion, §4.2 (https://www.medicines.org.uk/emc/product/15152/smpc). GENERAL: propofol must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of intensive care patients; circulatory and respiratory function must be constantly monitored (e.g. ECG, pulse oximeter) with airway, ventilation and resuscitation facilities immediately available; it should not be given by the person carrying out the surgical or diagnostic procedure; supplementary analgesics are generally required. Dosage is adjusted individually according to the patient's response. OLDER / ASA III–IV PATIENTS: in patients over 55 years and in ASA grades III and IV, especially with impaired cardiac function, requirements are less and the total induction dose may be reduced to a minimum of 1 mg/kg, given at a lower rate (approximately 2 ml, i.e. 20 mg, every 10 seconds). In elderly patients, patients of poor general condition, ASA III–IV, hypovolaemic and hypoproteinaemic patients the maintenance dose may have to be reduced further. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression. SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE: administer by continuous infusion; infusion rate determined by the desired depth of sedation; in most patients sufficient sedation is obtained with 0.3–4 mg/kg/h. Propofol is NOT indicated for intensive care sedation of patients aged 16 years or younger (see §4.3), and TCI is not advised for ICU sedation. SEDATION FOR DIAGNOSTIC AND SURGICAL PROCEDURES IN ADULTS: most patients require 0.5–1 mg/kg over 1 to 5 minutes for onset of sedation; maintenance by titrated infusion, most patients requiring 1.5–4.5 mg/kg/h; the infusion may be supplemented by a bolus of 10–20 mg (1–2 ml of 1%) if a rapid increase in depth of sedation is required. In patients older than 55 years and ASA III–IV lower doses and a reduced rate may be required. TARGET CONTROLLED INFUSION: 'Propofol may also be used by Target Controlled Infusion. Due to the different algorithms available on the market for dosage recommendations please refer to the instructions for use leaflet of the device manufacturer.' — the SPC states no TCI target concentrations. DURATION: propofol can be administered for a maximum period of 7 days; continuous infusion from one infusion system must not exceed 12 hours, after which the line and reservoir must be discarded and replaced. DILUTION/COMPATIBILITY: dilute only with glucose 5%, sodium chloride 0.9%, or sodium chloride 0.18% with glucose 4%; maximum dilution 1 part propofol to 4 parts diluent (minimum concentration 2 mg/ml); prepared aseptically immediately before use and used within 6 hours. To reduce pain on injection propofol may be mixed with preservative-free lidocaine injection 1% (20 parts propofol to up to 1 part lidocaine 1%). Rinse the line before giving atracurium or mivacurium through it. Contains no antimicrobial preservative and supports microbial growth — draw up aseptically and start administration without delay; single use in one patient. NOTE ON SOURCES: §4.5 was not retrieved in this bundle — the interactions below come from §7 of the US label (Heritage/Avet propofol injectable emulsion, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e7991b6c-43de-45f6-9105-bb03c7eaddf4). §4.4 and §4.8 were truncated at the fetch limit.

SPC §4.2 'General anaesthesia in children over 1 month of age': for induction, propofol should be slowly titrated against the patient's response until clinical signs of anaesthesia, with the dose adjusted for age and/or body weight — most patients over 8 years of age require approximately 2.5 mg/kg (the value given here); in younger children, especially between 1 month and 3 years, requirements may be higher (2.5–4 mg/kg). Maintenance: rates in the region of 9–15 mg/kg/h usually achieve satisfactory anaesthesia, and requirements may be higher in children aged 1 month to 3 years. SEDATION for diagnostic and surgical procedures in children over 1 month: most paediatric patients require 1–2 mg/kg for onset of sedation, maintenance by titrated infusion at 1.5–9 mg/kg/h, supplemented if needed by a bolus of up to 1 mg/kg. CONTRAINDICATED for intensive care sedation in patients aged 16 years or younger (§4.3). Verify all under-18 dosing against a children's formulary before use.