Fresofol 1% MCT/LCT

Propofol

Induction & maintenance of general anaesth, & sedation for diagnostic & surgical procedures (alone or in combination w/ local or regional anaesth) in adults, adolescents & childn >1 mth. Sedation of ventilated patients >16 yr in the ICU.

IV Max duration of administration: 7 days. Induction of anaesth Adult <55 yr 1.5-2.5 mg/kg. Adult >55 yr & patient w/ ASA grades III & IV, especially w/ cardiac impairment 1 mg/kg. Childn >8 yr 2.5 mg/kg, 1 mth to 3 yr 2.5-4 mg/kg. Maintenance of anaesth Adult 4-12 mg/kg/hr by continuous infusion. If to be administered as repeat bolus inj, administer in increments of 25-50 mg according to clinical requirements. Elderly, unstable general conditions, cardiac impairment or hypovolaemia & ASA grades III & IV 4 mg/kg/hr. Childn >1 mth 9-15 mg/kg/hr by continuous infusion. Sedation for diagnostic & surgical procedures Adult Onset: 0.5-1 mg/kg over 1-5 min. Maintenance: 1.5-4.5 mg/kg/hr, may be supplemented by bolus administration of 10-20 mg if rapid increase in depth of sedation is required. Childn >1 mth Onset: 1-2 mg/kg. Maintenance: 1.5-9 mg/kg/hr, may be supplemented by bolus administration of up to 1 mg/kg if rapid increase in depth of sedation is required. Sedation in ICU Patient >16 yr 0.3-4 mg/kg/hr by continuous infusion.

Hypersensitivity to propofol, peanut or soya. Sedation of patients ≤16 yr in intensive care.

Single infusion must not exceed 12 hr. Administration by target-controlled infusion (TCI) system is not advised for sedation in ICU. Reports of abuse & dependence. Administration w/o airway care may result in fatal resp complications. Monitor for early signs of hypotension, airway obstruction & O₂ desaturation when administered for conscious sedation, for surgical & diagnostic procedures. Involuntary patient movements may occur. Very rarely associated w/ development of post-op unconsciousness period, which may be accompanied by increased muscle tone. Risk of convulsion/seizure in epileptic patients. Delayed epileptiform attacks may occur even in non-epileptic patients, period ranging from a few hr to several days. Lacks vagolytic activity. Associated w/ reports of bradycardia (occasionally profound) & asystole. Risk of propofol infusion syndrome in the ICU setting. Inj lidocaine prior to propofol emulsion to reduce inj site pain during anaesth induction; do not use IV lidocaine in patients w/ hereditary acute porphyria. Reduced clearance w/ drugs known to reduce cardiac output. Not recommended w/ electroconvulsive therapy. May impair ability to drive or operate machinery. Propofol-induced impairment is not generally detectable beyond 12 hr. Patients w/ cardiac, resp, renal or hepatic impairment. Hypovolaemic or debilitated patients. Patients w/ disorders of fat metabolism & in other conditions where lipid emulsions must be used cautiously. Patients w/ high ICP & low mean arterial pressure. Patients w/ mitochondrial disease. Pregnancy; avoid high doses (>2.5 mg/kg for induction or 6 mg/kg/hr for maintenance). Women should not breastfeed for 24 hr after administration. Not recommended in newborn infants. Not advised for general anaesth in childn aged <1 mth. Not recommended to use TCI in paed patients <2 yr. Do not use rapid bolus administration (single or repeated) in the elderly as this may lead to cardiopulmonary depression.

Local pain during induction. Headache during recovery; bradycardia & tachycardia during induction; hypotension; transient apnoea, coughing & singultus during induction; nausea & vomiting during recovery.

Lower doses when used as adjunct to regional anaesth techniques; when used concomitantly w/ valproate. Profound hypotension w/ rifampicin. Prolonged anaesth & reduced resp rate w/ benzodiazepines, parasympatholytic agents or inhalational anaesth. Intensified & prolonged sedative effects w/ opioids. Potentiated anaesth & CV side effects w/ premedication, inhalation agents or analgesic agents. Intensified sedative effects of CNS depressants (eg, alcohol, general anaesth, narcotic analgesics). Severe resp & CV depression w/ parenterally administered centrally depressant drugs. Temporarily increased blood level w/ fentanyl. Bradycardia & cardiac arrest w/ suxamethonium or neostigmine. Leucoencephalopathy w/ cyclosporine.

Anaesthetics - Local & General

N01AX10 - propofol ; Belongs to the class of other general anesthetics.

P₁S₁S₃