Diprofol 1%

/ Taro

In unpremedicated and premedicated patients, it is recommended that Propofol1% should be titrated (approximately 4 ml [40 mg] every 10 seconds in an average healthy adult by bolus injection or 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 (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 Propofol1% may be reduced to a minimum of 1 mg/kg body weight. In these patients lower rates of administration should be applied (approximately 2 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 aged less than 1 month. For induction of anaesthesia in children over 1 month 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, especially between the age of 1 month and 3 years, dose requirements may be higher (2.5–4 mg/kg body weight).
For ASA 3 and 4 patients lower doses are recommended.
Maintenance of general anaesthesia adults: Anaesthesia can be maintained by administering Propofol  either by continuous infusion or by repeat bolus injections to prevent the clinical signs of light anaesthesia. Recovery from anaesthesia is typically rapid and it is therefore important to maintain Propofol  administration until the end of the procedure.
Continuous Infusion: The required rate of administration varies considerably between patients, but rates in the region of 4–12 mg/kg/h usually maintain satisfactory anaesthesia.
Repeat Bolus Injections: If a technique involving repeat bolus injections is used, increments of 25 mg (2.5 ml) to 50 mg (5.0 ml) may be given according to clinical need.
Older people: When Propofol  is used for maintenance of anaesthesia the rate of infusion or ‘target concentration’ should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.
Paediatric population: Propofol  is not indicated for maintenance of anaesthesia in children aged less than 1 month. Anaesthesia can be maintained in children over 1 month of age by administering Propofol  by infusion or repeated bolus injection to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients, but rates in the region of 9–15 mg/kg/h usually achieve satisfactory anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher. For ASA 3 and 4 patients lower doses are recommended.
For sedation during intensive care: See prescribing information for full details.

Propofol  is a short-acting intravenous general anaesthetic for: Induction and maintenance of general anaesthesia in adults and children > 1 month. 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 > 1 month.

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

The drug 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, oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol should not be administered by the person conducting the diagnostic or surgical procedure. Abuse of, and dependence on propofol  predominantly by health care professionals, have been reported. As with other general anaesthetics, the administration of Diprofol 1% without airway care may result in fatal respiratory complications. When propofol  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.
See prescribing information for full details.

Headache during recovery phase, hypotension, nausea and vomiting during recovery phase.
See prescribing information for full details.

This drug  has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking drugs, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered. Lower doses of Propofol  may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques. Profound hypertension has been reported following anaesthetic with propofol in patients treated with rifampicin. The concurrent administration of other CNS depressants such as pre-medication drugs, inhalation agents, analgesic agents may add to the sedative, anaesthetic and cardiorespiratory depressant effects of Propofol.

Pregnancy: The safety of this drug during pregnancy hasnot been established.
Lactation: Studies of breastfeeding mothers showed that small quantities of the drug are excreted in human milk.
See prescribing information for full details.

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. Ampoules and vials that their contents have been frozen can no longer be used.
Compatibility: The neuromuscular blocking agent, atracurium, should not be given through the same intravenous line as propofol without prior flushing.