Dosage of PROFOL 1% must be individualized for each patient, with the dose titrated to achieve the desired clinical effect. Lower doses are usually required for elderly, debilitated or higher risk surgical patient, or those with circulation disorders. The dosage of intravenously administered Propofol should be adjusted according to the type and amount of premedication used.
GENERAL ANAESTHESIA: Induction: Adults up to 55 years of age and/or ASAI OR II patients: Intravenous 2.0 to 2.5 mg per kg of body weight (approximately 40 mg every ten seconds until onset of induction).
Elderly, debilitated, hypovolaemic, and/or ASAIII or IV patients: Intravenous 1.0 to 1.5 mg per kg of body weight (approximately 20 mg every ten seconds until onset of induction).
Maintenance: Adults up to 55 years of age and/or ASAI or II patients: 100 to 200 mcg (0.1 to 0.2 mg) per kg of body weight per minute (6 to 12 mg per kg of body weight per hour).
Elderly, debilitated, hypovolaemic, and/or ASAIII or IV patients: 50 to 100 mcg (0.05 to 0.1 mg) per kg of body weight per minute (3 to 6 mg per kg of body weight per hour).
Intravenous (intermittent): 25 to 50 mg increments, administered as needed. Alternatively some clinicians recommend increments of 500 mcg (0.5 mg) per kg of body weight.
Monitored Anaesthesia Care (MAC) Sedation: Initiation: Adults up to 55 years of age and/or ASA I/or II patients: 100 - 150 mcg/kg/min (6 to 9 mg/kg/hr).
Elderly, ASA III or IV patients: Slow injection similar to adults.
Maintenance: Adults up to 55 years of age and/or ASA I or II patients: 1.5 to 4.5 mg/kg/hr.
Elderly, ASA III or IV patients: Approximately 20% reduction in adult dose.
Intensive Care Unit (ICU) Sedation: Initiation: 5 mcg/kg/min (0.3 mg/kg/hr) for at least 5 min with increments of 5 to 10 mcg/kg/min (0.3 to 0.6 mg/kg/hr) over 5-10 minutes until the desired level of sedation is achieved.
10 mcg/kg/min (0.3 to 0.6 mg/kg/hr) over 5-10 minutes until the desired level of sedation is achieved.
Maintenance: 5 to 50 mcg/kg/min (0.3 to 3 mg/kg/hr) or higher may be required.
CHILDREN: PROFOL 1% is not recommended for use in children less than 3 years of age.
Induction of general anaesthesia: When used to induce anaesthesia in children above 3 years of age, it is recommended that PROFOL 1% be given slowly until the clinical signs show the onset of anaesthesia. The dose should be adjusted for age and/or weight. Most patients over 8 years of age are likely to require approximately 2.5 to 3.5 mg per kg of body weight PROFOL 1% for induction of anaesthesia. Under this age the requirement may be more. Lower dosage is recommended for children of ASA grades III and IV.
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering PROFOL 1% by infusion or repeat bolus injection to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients but rates in the region of 7.5 to 18 mg/kg/hr usually achieve satisfactory anaesthesia.
Administration: PROFOL 1% can be used for infusion undiluted form syringes or glass containers. When PROFOL 1% is used undiluted to maintain anaesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps should always be used to control infusion rates.
PROFOL 1% may also be used diluted with 5% Dextrose Intravenous Injection only and the final concentration should not be less than 2 mg per ml to preserve the emulsion base. Dilutions should be prepared aseptically immediately before administration. The mixture is stable up to 6 hours.
The dilution may be used with a variety of infusion control techniques but a giving set used alone will not avoid the risk of accidental, uncontrolled infusion of large volumes of diluted PROFOL 1%. A suitable controlled infusion device such as volumetric pump must be included in the infusion line.
PROFOL 1% may be administered via a Y-piece close to the injection site, into infusions of 5% Dextrose Injection, 0.45%, Sodium chloride & 5% Dextrose injection and 0.2% Sodium Chloride & 5% Dextrose Injection.
Pain associated with PROFOL 1% can be reduced by concomitant use of local anaesthetic agents most commonly lignocaine. For effective use lignocaine 1%, 2 mL or 2%, 1 mL needs to be given immediately before administration of PROFOL 1% or mixing it with PROFOL 1% just prior to use of propofol. Propofol has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to propofol. PROFOL 1% 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 reported. Lower doses of PROFOL 1% may be required where general anaesthesia is used as an adjunct to regional anaesthesia techniques.