Diprofol 2%

/ Taro

Induction of General Anaesthesia: Propofol must be used only in well equipped hospitals or medical centers by doctors trained in anaesthesia or the treatment of intensive care patients. Continual monitoring of the circulation and the respiration (for example, ECG pulse oxymeter) is necessary. Provisions for prevention of airway obstruction, artificial respiration and other resuscitation provisions must be immediately available at all times. As regards sedation during surgical or diagnostic operations propofol must not be administered by the same person who performs the surgical or diagnostic operation. Additional analgesics are generally necessary in combination with propofol. Propofol may be used to induce anaesthesia by infusion. Administration of Propofol by bolus injection is not recommended. Propofol may be used to induce anaesthesia by infusion but only in those patients who will receive Propofol for maintenance of anaesthesia.
In unpremedicated and premedicated patients, it is recommended that Propofol should be titrated (approximately 2 ml [40 mg] every 10 seconds in an average healthy adult by infusion) against the response of the patient until the clinical signs show the onset of anaesthesia. Most adult patients aged less than 55 years are likely to require 1.5–2.5 mg/kg of Propofol. The total dose required can be reduced by lower rates of administration (1–2.5 ml/min [20–50 mg/min]).
In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of Propofol may be reduced to a minimum of 1 mg/kg body weight. In these patients lower rates of administration should be applied (approximately 1 ml, corresponding to 20 mg every 10 seconds).
Older people: In older people the dose requirement for induction of anaesthesia with Propofol is reduced. The reduction should take into account of the physical status and age of the patient. The reduced dose should be given at a slower rate and titrated against the response.
Paediatric population: Propofol is not indicated for induction of anaesthesia in children less than 3 years of age. For induction of anaesthesia in children over 3 years of age, Propofol should be titrated slowly until clinical signs show the onset of anaesthesia. The dose should be adjusted according to age and/or body weight. Most patients over 8 years of age require approximately 2.5 mg/kg body weight of Propofol for induction of anaesthesia. In younger children, dose requirements may be higher (2.5–4 mg/kg body weight). For ASA 3 and 4 patients lower doses are recommended.
For Maintenance of General Anaesthesia, method of administration, special populations –   See prescribing information for full details.

Induction and maintenance of general anaesthesia in adults and children > 3 years. Sedation of ventilated patients > 16 years of age in the intensive care unit. Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 3 years.

Hypersensitivity to the active substance or to any of the excipients. The drug contains soybean oil and should not be used in patients who are hypersensitive to peanut or soya. Must not be used in patients of 16 years of age or younger for sedation in intensive care.

Propofol 2% should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care). Patients should be constantly monitored and facilities for maintenance of a patient airway, artificial ventilation and oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol 2% should not be administered by the person conducting the diagnostic or surgical procedure. Abuse of, and dependence on Propofol 2%, predominantly by health care professionals, have been reported. As with other general anaesthetics, the administration of Propofol 2% without airway care may result in fatal respiratory complications. When Propofol 2% is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation. During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedicants and other agents. Occasionally, hypotension may require use of intravenous fluids and reduction of the rate of administration of Propofol 2% during the period of anaesthetic maintenance. As with other sedative agents, when Propofol 2% is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility these movements maybe hazardous to the operative site.
Paediatric population: The use of Propofol is not indicated in newborn infants as this patient population has not been fully investigated. Pharmacokinetic data indicate that clearance is considerably reduced in neonates and has a very high inter-individual variability. Relative overdose could occur on administering doses recommended for older children and result in severe cardiovascular depression. Propofol 2% is not indicated for use in children < 3 years of age due to difficulty in titrating small volumes. Propofol must not be used in patients of 16 years of age or younger for sedation for intensive care as the safety and efficacy of propofol for sedation in this age group have not been demonstrated.
See prescribing information for full details.

Headache during recovery phase, hypotension, Transient apnoea during induction, Nausea and vomiting during recovery phase.
See prescribing information for full details.

Method of administration: Propofol 20 mg/ml should be administered undiluted intravenously.  Propofol 20 mg/ml must not be mixed with injection or infusion fluids. However, simultaneous administration of propofol 20 mg/ml together with an infusion of glucose 5% or sodium chloride 0.9% via a Y-connector close to the injection site is possible. Ampoules and vials should be shaken before use. Before use the neck of the ampoule and the rubber stopper of the infusion vial must be disinfected with medicinal alcohol (spray or tissues). After use, any remaining medicine must be destroyed. Propofol does not contain any preservatives and promotes the growth of micro-organisms. After opening of an ampoule or piercing of a vial, the contents must therefore immediately be put aseptically into a sterile syringe or infusion system and then administered directly. During the infusion period the sterility of both propofol and the infusion system should be maintained.
See prescribing information for full details.

Pregnancy: The drug  should not be given to pregnant women except when absolutely necessary,  can however, be used during an induced abortion.
Obstetrics: Propofol crosses the placenta and can cause neonatal depression. It should not be used for obstetric anaesthesia
Lactation: Studies of breastfeeding mothers showed that small quantities of Propofol are excreted in human milk.

Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression would require lowering of the patient’s head and, if severe, use of plasma expanders and pressor agents.

Storage: Protect from light. Store below 25°C. Do not freeze. Vials that their contents have been frozen can no longer be used.