PROPOFOL

PROPOFOL- propofol injection, emulsion
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:

  • Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
  • Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
  • Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
  • Sedation for Adult Patients in Combination with Regional Anesthesia
  • Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients

Limitations of Use

Propofol is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use ( 8.4)] .

Safety, effectiveness and dosing guidelines for propofol have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use ( 8.4)].

Propofol is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use ( 8.4)].

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Shake well before use. Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised. Slight creaming, which should disappear after shaking, may be visible upon prolonged standing. Do not use if there is evidence of separation of the phases of the emulsion.

Propofol injectable emulsion with EDTA inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms. Product is packaged under nitrogen.

For general anesthesia or monitored anesthesia care (MAC) sedation, propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and equipment for maintaining a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients.

For sedation of intubated, mechanically ventilated adult patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.

Guidelines for Aseptic Technique for General Anesthesia/MAC Sedation

Propofol must be prepared for use just prior to initiation of each individual anesthetic/sedative procedure. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. Propofol should be drawn into a sterile syringe immediately after a vial is opened. When withdrawing propofol from vials, a sterile vent spike should be used. The syringe should be labelled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened.

Propofol must be prepared for single dose only. Any unused propofol drug product, reservoirs, dedicated administration tubing and/or solutions containing propofol must be discarded at the end of the anesthetic procedure or at 12 hours, whichever occurs sooner. The intravenous line should be flushed every 12 hours and at the end of the anesthetic procedure to remove residual propofol. [see Warnings and Precautions ( 5.2)] .

Guidelines for Aseptic Technique for ICU Sedation

Propofol must be prepared for single dose only. Strict aseptic techniques must be followed. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. A sterile vent spike and sterile tubing must be used for administration of propofol. As with other lipid emulsions, the number of intravenous line manipulations should be minimized. Administration should commence promptly and must be completed within 12 hours after the vial has been spiked. The tubing and any unused propofol drug product must be discarded after 12 hours.

If propofol is transferred to a syringe prior to administration, it should be drawn into a sterile syringe immediately after a vial is opened. When withdrawing propofol from a vial, a sterile vent spike should be used. The syringe should be labelled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened. Propofol injectable emulsion should be discarded and administration lines changed after 12 hours. [see Warnings and Precautions ( 5.2)]

Administration with Lidocaine

If lidocaine is to be administered to minimize pain on injection of propofol injectable emulsion, it is recommended that it be administered prior to propofol injectable emulsion administration or that it be added to propofol injectable emulsion immediately before administration and in quantities not exceeding 20 mg lidocaine/200 mg propofol injectable emulsion. [see Warnings and Precautions ( 5.13)]

Compatibility and Stability

Propofol injectable emulsion should not be mixed with other therapeutic agents prior to administration.

Dilution Prior to Administration

Propofol injectable emulsion is provided as a ready-to-use formulation. However, should dilution be necessary, it should only be diluted with 5% Dextrose Injection, USP, and it should not be diluted to a concentration less than 2 mg/mL because it is an emulsion. In diluted form it has been shown to be more stable when in contact with glass than with plastic (95% potency after 2 hours of running infusion in plastic).

Administration with Other Fluids

Compatibility of propofol injectable emulsion with the coadministration of blood/serum/plasma has not been established [see Warnings and Precautions ( 5.15)] .

When administered using a y-type infusion set, propofol injectable emulsion has been shown to be compatible with the following intravenous fluids:

  • 5% Dextrose Injection, USP
  • Lactated Ringers Injection, USP
  • Lactated Ringers and 5% Dextrose Injection
  • 5% Dextrose and 0.45% Sodium Chloride Injection, USP
  • 5% Dextrose and 0.2% Sodium Chloride Injection, USP.

Administration with Pumps

When administering propofol by infusion, syringe or volumetric pumps are recommended to provide controlled infusion rates. When infusing propofol to patients undergoing magnetic resonance imaging, metered control devices may be utilized if mechanical pumps are impractical.

Administration with Filters

Clinical experience with the use of in-line filters and propofol during anesthesia or ICU/MAC sedation is limited. Propofol should only be administered through a filter with a pore size of 5 micron or greater unless it has been demonstrated that the filter does not restrict the flow of propofol and/or cause the breakdown of the emulsion. Filters should be used with caution and where clinically appropriate. Continuous monitoring is necessary due to the potential for restricted flow and/or breakdown of the emulsion.

2.2 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age

Adult Patients

Most adult patients under 65 years of age and classified as ASA-PS I or II require 2 mg/kg to 2.5 mg/kg of propofol. For induction, whether administered by infusion or intravenous injection the dose of propofol to the patient should be titrated against the response of the patient and until there are clinical signs consistent with the onset of anesthesia. As with other sedative-hypnotic agents, the amount of intravenous opioid and/or benzodiazepine premedication may impact the dose of propofol required for induction of general anesthesia.

Elderly, Debilitated, or ASA-PS III or IV Patients

Due to the reduced clearance and higher blood concentrations, most elderly, debilitated, or ASA-PS III or IV patients require approximately 1 mg/kg to 1.5 mg/kg of propofol for induction of anesthesia. For induction, whether administered by infusion or intravenous injection the dose administration of propofol to the patient should be titrated against the response of the patient and until there are clinical signs consistent with the onset of anesthesia. A rapid bolus may increase the likelihood of undesirable cardiorespiratory depression. [See Warnings and Precautions ( 5.12)]

Pediatric Patients

Most patients aged 3 years through 16 years and classified ASA-PS I or II require 2.5 mg/kg to 3.5 mg/kg of propofol for induction. Within this dosage range, younger pediatric patients may require higher induction doses than older pediatric patients. As with other sedative-hypnotic agents, the amount of intravenous opioid and/or benzodiazepine premedication may impact the dose of propofol required for induction of general anesthesia. A lower dosage is recommended for pediatric patients classified as ASA-PS III or IV. Boluses of propofol may be administered via small veins if pretreated with lidocaine or via antecubital or larger veins [see Dosage and Administration ( 2.7)] .

Neurosurgical Patients

Most adult neurosurgical patients require 1 mg/kg to 2 mg/kg of propofol. Slower induction is recommended to allow for titration to achieve an adequate clinical response. [see Warnings and Precautions ( 5.6)] . Whether administered by infusion or an intravenous injection, the dose of propofol to the patient should be titrated against the response of the patient and until there are clinical signs consistent with the onset of anesthesia.

Cardiac Anesthesia

Most adult cardiac patients require 0.5 mg/kg to 1.5 mg/kg of propofol. Slower induction is recommended to allow for titration to clinical response and to prevent hemodynamic instability. Whether administered by infusion or intravenous injection, the dose of propofol to the patient should be titrated against the response of the patient until the clinical signs show the onset of anesthesia. Other agents used in addition to propofol for induction and maintenance of anesthesia may require propofol doses to be titrated to ensure adequate sedation level.

Propofol has been well-studied in patients with coronary artery disease and in patients with hemodynamically significant valvular or congenital heart disease. No significant safety issues or changes to the induction of anesthesia is generally required for these patient groups. Dosing should be titrated based on depth of anesthesia.

As with other anesthetic and sedative-hypnotic agents, propofol in healthy patients causes a decrease in blood pressure that is secondary to decreases in preload (ventricular filling volume at the end of the diastole) and afterload (arterial resistance at the beginning of the systole). The magnitude of these changes is proportional to the blood and effect site concentrations achieved. These concentrations depend upon the dose and speed of the induction and maintenance infusion rates.

In addition, lower heart rates are observed during maintenance with propofol, possibly due to reduction of the sympathetic activity and/or resetting of the baroreceptor reflexes. Therefore, anticholinergic agents should be administered when increases in vagal tone are anticipated.

As with other anesthetic agents, propofol reduces myocardial oxygen consumption.

Further studies are needed to confirm and delineate the extent of these effects on the myocardium and the coronary vascular system.

Morphine premedication (0.15 mg/kg) with nitrous oxide 67% in oxygen has been shown to decrease the necessary propofol maintenance infusion rates and therapeutic blood concentrations when compared to non-narcotic (lorazepam) premedication. The rate of propofol administration should be determined based on the patient’s premedication and adjusted according to clinical responses.

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