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Operol

Operol Special Precautions

propofol

Manufacturer:

Medhaus

Distributor:

Medhaus
Full Prescribing Info
Special Precautions
General: Adult and Pediatric Patients: A lower induction dose and a slower maintenance rate of administration should be used in elderly, debilitated, or ASA-PS III or IV patients. Patients should be continuously monitored for early signs of hypotension and/or bradycardia. Apnea requiring ventilatory support often occurs during induction and may persist for more than 60 seconds. Propofol injectable emulsions use requires caution when administered to patients with disorders of lipid metabolism such as primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.
Very rarely the use of Propofol injectable emulsion may be associated with the development of a period of postoperative unconsciousness which may be accompanied by an increase in muscle tone. This may or may not be preceded by a brief period of wakefulness.
When Propofol injectable emulsion is administered to an epileptic patient, there is a risk of seizure during the recovery phase.
Attention should be paid to minimize pain on administration of Propofol injectable emulsion. Transient local pain can be minimized if the larger veins of the forearm or antecubital fossa are used. Pain during intravenous injection may also be reduced by prior injection of IV lidocaine (1 mL of a 1% solution). Pain on injection occurred frequently in pediatric patients (45%) when a small vein of the hand was utilized without lidocaine pretreatment. With lidocaine pretreatment or when antecubital veins were utilized, pain was minimal (incidence less than 10%) and well tolerated. It is recommended that lidocaine be administered prior to Propofol administration or it can be added to Propofol immediately before administration and in quantities not exceeding 20 mg lidocaine/200 mg Propofol.
Intensive Care Unit Sedation: Adult Patients: The administration of Propofol injectable emulsion should be initiated as continous infusion and changes in the rate of administration made slowly (>5 min) in order to minimize hypotension and avoid acute over dosage. Patients should be monitored for early signs of significant hypotension and/or cardiovascular depression, which may be profound. These effects are responsive to discontinuation of Propofol injectable emulsion, IV fluid administration, and/or vasopressor therapy. In the elderly, debilitated, or ASA-PS III or IV patients, rapid (single or repeated) bolus administration should not be used during sedation in order to minimize undesirable cardio respiratory depression, including hypotension, apnea, airway obstruction, and oxygen desaturation.
As with other sedative meditations, there is wide interpatient variability in Propofol injectable emulsion dosage requirements, and these requirement may change with time. Faiture to reduce the infusion rate in patients receiving Propofol injectable emulsion for extended periods may result in excessively high blood concentrations of the drug. Thus, titration to clinical response and daily evaluation of sedation levels are important during use of Propofol injectable emulsion infusion for ICU sedation, especially when it is used for long durations.
Opioids and paralytic agents should be discontinued and respiratory function optimized prior to weaning patients from mechanical ventilation.
Emulsion should be adjusted to maintain a light level  of sedation prior weaning patients from mechanical ventilatory support. Throughout the weaning process, this level of sedation may be maintained in the absence of respiratory depression. Because of the rapid clearance of Propofol injectable emulsion, abrupt discontinuation of a patient's infusion may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation, making weaning from mechanical ventilation difficult. It is therefore recommended that administration of Propofol injectable emulsion be continued in order to maintain a light level of sedation throughout the weaning process until 10-15 minutes prior to extubation, at which time the infusion can be discontinued.
The long-term administration of Propofol injectable emulsion to patients with renal failure and/or hepatic insufficiency has not been evaluated.
Neurological Anesthesia: When Propofol injectable emulsion is used in patients with increased intracranial pressure or impaired cerebral circulation, significant decreases in mean arterial pressure should be avoided because of the resultant decreases in cerebral perfusion pressure. To avoid significant hypotension and decreases in cerebral perfusion pressure, an infusion or slow bolus of approximately 20 mg every 10 seconds should be utilized instead of rapid, more frequent, and/or larger boluses of Propofol Injectable emulsion.
Cardiac Anesthesia: Slower rates of administration should be utilized in premedicated patients, geriatric patients, patients with recent fluid shifts, and patients who are hemodynamically unstable. Fluid deficits should be corrected prior to administration of Propofol injectable emulsion. In those patients where additional fluid therapy maybe contraindicated, other measures, e.g., elevation of tower extremities, or use of pressor agents, may be useful to offset the hypotension which is associated with the induction of anesthesia with Propofol injectable emulsion.
Carcinogenesis, mutagenesis, impairment of fertility: Long term studies in animals have not been performed to evaluate the carcinogenic, mutagenic, impairment of fertility potential of Propofol.
Use in Elderly: A lower induction dose and a slower maintenance rate of administration of Propofol injectable emulsion should be used in elderly patients.
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