Propofol

Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation Adults only Combined sedation and regional anesthesia Adults only (see PRECAUTIONS) Induction of General Anesthesia Patients greater than or equal to 3 years of age Maintenance of General Anesthesia Patients greater than or equal to 2 months of age Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients Adults only

General (Intravenous) anesthetics

Propofol is a sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol produces hypnosis rapidly with minimal excitation, usually within 45 seconds from the start of an injection (the time for one arm-brain circulation). The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors. Propofol is a highly lipid soluble, short-acting intravenous general anesthetic. Onset of general anesthesia occurs in most patients within 15-45 seconds. Most patients return to consciousness rapidly and recover without confusion or nausea. They are usually completely orientated within only a few minutes from recovery, and fit for discharge after only a few hours. Contrary to many other anesthetic agents, Propofol is not clinically significantly accumulated during maintenance dosage. It is therefore most suitable for sedation during intensive care. Propofol sets standards that inspire imitators. The clinical benefits of MCT/LCT are Superior to conventional LCT or MCT emulsions. Through Propofol- Technology, there is 30% less free, lipophilic and low-water soluble drug substance that can cause pain on injection compared to products dissolved in water, e.g., for Propofol। Remains the only formulation proven to reduce pain on injection site.

Propofol clearance ranges from 23 mL/kg/min to 50 mL/kg/min (1.6 L/min to 3.4 L/min in 70 kg adults). It is chiefly eliminated by hepatic conjugation to inactive metabolites which are excreted by the kidney. A glucuronide conjugate accounts for about 50% of the administered dose. Propofol has a steady-state volume of distribution (10-day infusion) approaching 60 L/kg in healthy adults. A difference in pharmacokinetics due to sex has not been observed. The terminal half-life of propofol after a 10-day infusion is 1 day to 3 days.

Propofol has been used in association with spinal and epidural anaesthesia as well as with various types of premedicants, muscle relaxants, inhalation anaesthetics and analgetics. No pharmacological incompatibility has been observed. Lower doses of Propofol may be sufficient in case Propofol is used as an adjunct to local anaesthetic techniques. In doses applied clinically, propofol will not inhibit the synthesis of adrenocortical hormones. Simultaneous administration of opiates may potentiate respiratory depression caused by Propofol.

It is contraindicated in patients with a known hypersensitivity to propofol or any of this components. this is contraindicated in patients with allergies to eggs,egg products, soybeans or soy products.

Propofol is normally well tolerated. Its most common undesirable effect is pain at the site of injection that can be reduced by mixing the preparation with lidocaine or by injecting it into one of the larger veins of the forearm or the intercubital fossa. Thrombosis and phlebitis are rare. General: Hypotension and transient apnea may occur at the induction of anaesthesia,and may be severe especially in patients who are in a poor general condition. Epileptic movement,convulsions and dystonic reactions have been seen in rare cases. Pulmonary oedema has also been reported. Headache,nausea and,more rarely,vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases,connected with anaphylactic symptoms such as marked hypotension,bronchospasm,oedema and facial erythema

Due to insufficient experience,propofol shall not be used during pregnancy. Propofol is rapidly distributed to the foetus and shall therefore not be used for obstetric anaesthesia. Safety to the neonate has not been established in cases,where propofol has been administered to lactating women.

Overdosage may cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen, and cardiovascular depression by lowering of the patient's head and elevating of his/her legs. Pressor agents and plasma expanders or Ringer-type electrolyte solutions may be used, if necessary.

Propofol should be stored at a temperature not exceeding 25º C. It must not be frozen. Any unused solution shall be discarded.

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