PROPOFOL-LIPURO

What it is

PROPOFOL-LIPURO is a sterile, milky white, isotonic, oil in water emulsion for intravenous infusion or injection containing 10 mg propofol per 1 mL (PROPOFOL-LIPURO 1%) or 20 mg propofol per 1 mL (PROPOFOL-LIPURO 2%). Propofol is a short-acting general anaesthetic agent with a rapid onset of action of approximately 30 seconds. Propofol produces its sedative/anaesthetic effects principally by the positive modulation of the inhibitory function of the neurotransmitter GABA through GABAA receptors.

Approved indications

— Induction of general anaesthesia in adults and children aged one month and older. — Maintenance of general anaesthesia in adults and children aged 3 years and older. — Maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided. — Sedation of ventilated patients receiving intensive care in patients over 16 years. — Monitored conscious sedation for surgical and diagnostic procedures in adults.

Dosing overview

In elderly patients the dose requirement for induction of anaesthesia with PROPOFOL-LIPURO is reduced, taking account of the physical status and age of the patient, and the reduced dose should be given at a slower rate and titrated against the response.

Key safety warnings

The most commonly observed adverse effects of propofol are hypotension and respiratory depression, which depend on the propofol dose administered but also on the type of premedication and other concomitant medication. During induction in clinical trials, hypotension and transient apnoea occurred in up to 75% of patients. When propofol is used for sedation during intensive care, life-threatening adverse events known as Propofol Infusion Syndrome (PRIS) can occur, including cardiac failure, arrhythmias, metabolic acidosis, rhabdomyolysis, ECG changes and/or rapidly progressive cardiac failure (in some cases with a fatal outcome), hyperkalaemia, hepatomegaly, hyperlipidaemia and renal failure. Very rare reports of occurrence of PRIS in adults (in some cases with a fatal outcome) have been recorded in patients treated for more than 48 hours with propofol infusions in excess of 5 mg/kg/hour. The maximum dose of propofol for adult sedation during intensive care should not exceed 4.0 mg/kg/hour. PROPOFOL-LIPURO is contraindicated for sedation in children as safety and efficacy have not been demonstrated. Although no causal relationship has been established, serious adverse events (including fatalities) have been observed from spontaneous reports of unregistered use, seen more frequently in children with respiratory tract infections (including croup) given doses in excess of those recommended for adults. Because PROPOFOL-LIPURO is formulated in an oil-in-water emulsion, elevations in serum triglycerides may occur when administered for extended periods of time. Patients at risk of hyperlipidaemia should be monitored for increases in serum triglycerides or serum turbidity.

Contraindications

PROPOFOL-LIPURO is contraindicated in patients with a known hypersensitivity to propofol or to any of the other ingredients contained in PROPOFOL-LIPURO, namely soya oil, medium chain triglycerides, glycerol, egg lecithin, and sodium oleate. PROPOFOL-LIPURO is contraindicated in patients who are allergic to soya or peanut. PROPOFOL-LIPURO is contraindicated for induction and maintenance of general anaesthesia in children younger than 1 month. PROPOFOL-LIPURO is contraindicated in patients of 16 years of age or younger for sedation during intensive care and for monitored conscious sedation for surgical and diagnostic procedures.

Regulatory history

PROPOFOL-LIPURO 1% was first approved on 20 November 2009. PROPOFOL-LIPURO 2% was first approved on 10 March 2015. Multiple ARTG entries exist for PROPOFOL-LIPURO 1% and 2% in various container sizes, registered under licence category RE.