Propofol: Package Insert and Label Information (Page 5 of 6)

Maintenance of General Anesthesia

Propofol Injectable Emulsion has been used with a variety of agents commonly used in anesthesia such as atropine, scopolamine, glycopyrrolate, diazepam, depolarizing and nondepolarizing muscle relaxants, and opioid analgesics, as well as with inhalational and regional anesthetic agents.

In the elderly, debilitated, or ASA-PS III or IV patients, rapid bolus doses should not be used, as this will increase cardiorespiratory effects including hypotension, apnea, airway obstruction, and oxygen desaturation.

Adult Patients

In adults, anesthesia can be maintained by administering Propofol Injectable Emulsion by infusion or intermittent IV bolus injection. The patient’s clinical response will determine the infusion rate or the amount and frequency of incremental injections.

Continuous Infusion

Propofol Injectable Emulsion 100 mcg/kg/min to 200 mcg/kg/min administered in a variable rate infusion with 60% to 70% nitrous oxide and oxygen provides anesthesia for patients undergoing general surgery. Maintenance by infusion of Propofol Injectable Emulsion should immediately follow the induction dose in order to provide satisfactory or continuous anesthesia during the induction phase. During this initial period following the induction dose, higher rates of infusion are generally required (150 mcg/kg/min to 200 mcg/kg/min) for the first 10 minutes to 15 minutes. Infusion rates should subsequently be decreased 30% to 50% during the first half-hour of maintenance. Generally, rates of 50 mcg/kg/min to 100 mcg/kg/min in adults should be achieved during maintenance in order to optimize recovery times.

Other drugs that cause CNS depression (e.g., sedatives, anesthetics, and opioids) can increase the CNS depression induced by propofol.

Intermittent Bolus

Increments of Propofol Injectable Emulsion 25 mg (2.5 mL) to 50 mg (5 mL) may be administered with nitrous oxide in adult patients undergoing general surgery. The incremental boluses should be administered when changes in vital signs indicate a response to surgical stimulation or light anesthesia.

Pediatric Patients

Propofol Injectable Emulsion administered as a variable rate infusion supplemented with nitrous oxide 60% to 70% provides satisfactory anesthesia for most children 2 months of age or older, ASA-PS I or II, undergoing general anesthesia.

In general, for the pediatric population, maintenance by infusion of Propofol Injectable Emulsion at a rate of 200 mcg/kg/min to 300 mcg/kg/min should immediately follow the induction dose. Following the first half-hour of maintenance, infusion rates of 125 mcg/kg/min to 150 mcg/kg/min are typically needed. Propofol Injectable Emulsion should be titrated to achieve the desired clinical effect. Younger pediatric patients may require higher maintenance infusion rates than older pediatric patients. (See Table 2 Clinical Trials.)

Monitored Anesthesia Care (MAC) Sedation

Adult Patients

When Propofol Injectable Emulsion is administered for MAC sedation, rates of administration should be individualized and titrated to clinical response. In most patients, the rates of Propofol Injectable Emulsion administration will be in the range of 25 mcg/kg/min to 75 mcg/kg/min.

During initiation of MAC sedation, slow infusion or slow injection techniques are preferable over rapid bolus administration. During maintenance of MAC sedation, a variable rate infusion is preferable over intermittent bolus dose administration. In the elderly, debilitated, or ASA-PS III or IV patients, rapid (single or repeated) bolus dose administration should not be used for MAC sedation (see WARNINGS). A rapid bolus injection can result in undesirable cardiorespiratory depression including hypotension, apnea, airway obstruction, and oxygen desaturation.

Initiation of MAC Sedation

For initiation of MAC sedation, either an infusion or a slow injection method may be utilized while closely monitoring cardiorespiratory function. With the infusion method, sedation may be initiated by infusing Propofol Injectable Emulsion at 100 mcg/kg/min to 150 mcg/kg/min (6 mg/kg/h to 9 mg/kg/h) for a period of 3 minutes to 5 minutes and titrating to the desired clinical effect while closely monitoring respiratory function. With the slow injection method for initiation, patients will require approximately 0.5 mg/kg administered over 3 minutes to 5 minutes and titrated to clinical responses. When Propofol Injectable Emulsion is administered slowly over 3 minutes to 5 minutes, most patients will be adequately sedated, and the peak drug effect can be achieved while minimizing undesirable cardiorespiratory effects occurring at high plasma levels.

In the elderly, debilitated, or ASA-PS III or IV patients, rapid (single or repeated) bolus dose administration should not be used for MAC sedation (see WARNINGS). The rate of administration should be over 3 minutes to 5 minutes and the dosage of Propofol Injectable Emulsion should be reduced to approximately 80% of the usual adult dosage in these patients according to their condition, responses, and changes in vital signs (see DOSAGE AND ADMINISTRATION).

Maintenance of MAC Sedation

For maintenance of sedation, a variable rate infusion method is preferable over an intermittent bolus dose method. With the variable rate infusion method, patients will generally require maintenance rates of 25 mcg/kg/min to 75 mcg/kg/min (1.5 mg/kg/h to 4.5 mg/kg/h) during the first 10 minutes to 15 minutes of sedation maintenance. Infusion rates should subsequently be decreased over time to 25 mcg/kg/min to 50 mcg/kg/min and adjusted to clinical responses. In titrating to clinical effect, allow approximately 2 minutes for onset of peak drug effect.

Infusion rates should always be titrated downward in the absence of clinical signs of light sedation until mild responses to stimulation are obtained in order to avoid sedative administration of Propofol Injectable Emulsion at rates higher than are clinically necessary.

If the intermittent bolus dose method is used, increments of Propofol Injectable Emulsion 10 mg (1 mL) or 20 mg (2 mL) can be administered and titrated to desired clinical effect. With the intermittent bolus method of sedation maintenance, there is increased potential for respiratory depression, transient increases in sedation depth, and prolongation of recovery.

In the elderly, debilitated, or ASA-PS III or IV patients, rapid (single or repeated) bolus dose administration should not be used for MAC sedation (see WARNINGS). The rate of administration and the dosage of Propofol Injectable Emulsion should be reduced to approximately 80% of the usual adult dosage in these patients according to their condition, responses, and changes in vital signs (see DOSAGE AND ADMINISTRATION).

Propofol Injectable Emulsion can be administered as the sole agent for maintenance of MAC sedation during surgical/diagnostic procedures. When Propofol Injectable Emulsion sedation is supplemented with opioid and/or benzodiazepine medications, these agents increase the sedative and respiratory effects of Propofol Injectable Emulsion and may also result in a slower recovery profile (see PRECAUTIONS, Drug Interactions).

ICU Sedation

(See WARNINGS and DOSAGE AND ADMINISTRATION, Handling Procedures.)

Abrupt discontinuation of Propofol Injectable Emulsion prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. Infusions of Propofol Injectable Emulsion should be adjusted to assure a minimal level of sedation is maintained throughout the weaning process and when assessing the level of sedation (see PRECAUTIONS).

Adult Patients

For intubated, mechanically ventilated adult patients, Intensive Care Unit (ICU) sedation should be initiated slowly with a continuous infusion in order to titrate to desired clinical effect and minimize hypotension (see DOSAGE AND ADMINISTRATION).

Most adult ICU patients recovering from the effects of general anesthesia or deep sedation will require maintenance rates of 5 mcg/kg/min to 50 mcg/kg/min (0.3 mg/kg/h to 3 mg/kg/h) individualized and titrated to clinical response (see DOSAGE AND ADMINISTRATION). With medical ICU patients or patients who have recovered from the effects of general anesthesia or deep sedation, the rate of administration of 50 mcg/kg/min or higher may be required to achieve adequate sedation. These higher rates of administration may increase the likelihood of patients developing hypotension. Administration should not exceed 4 mg/kg/hour unless the benefits outweigh the risks (see WARNINGS).

Dosage and rate of administration should be individualized and titrated to the desired effect, according to clinically relevant factors including the patient’s underlying medical problems, preinduction and concomitant medications, age, ASA-PS classification, and level of debilitation of the patient. The elderly, debilitated, and ASA-PS III or IV patients may have exaggerated hemodynamic and respiratory responses to rapid bolus doses (see WARNINGS).

Propofol Injectable Emulsion should be individualized according to the patient’s condition and response, blood lipid profile, and vital signs (see PRECAUTIONS, Intensive Care Unit Sedation). For intubated, mechanically ventilated adult patients, Intensive Care Unit (ICU) sedation should be initiated slowly with a continuous infusion in order to titrate to desired clinical effect and minimize hypotension. When indicated, initiation of sedation should begin at 5 mcg/kg/min (0.3 mg/kg/h). The infusion rate should be increased by increments of 5 mcg/kg/min to 10 mcg/kg/min (0.3 mg/kg/h to 0.6 mg/kg/h) until the desired level of sedation is achieved. A minimum period of 5 minutes between adjustments should be allowed for onset of peak drug effect. Most adult patients require maintenance rates of 5 mcg/kg/min to 50 mcg/kg/min (0.3 mg/kg/h to 3 mg/kg/h) or higher. Administration should not exceed 4 mg/kg/hour unless the benefits outweigh the risks (see WARNINGS). Dosages of Propofol Injectable Emulsion should be reduced in patients who have received large dosages of narcotics. The Propofol Injectable Emulsion dosage requirement may also be reduced by adequate management of pain with analgesic agents. As with other sedative medications, there is interpatient variability in dosage requirements, and these requirements may change with time (see SUMMARY OF DOSAGE GUIDELINES). Evaluation of level of sedation and assessment of CNS function should be carried out daily throughout maintenance to determine the minimum dose of propofol required for sedation (see Clinical Trials, Intensive Care Unit (ICU) Sedation). Bolus administration of 10 mg or 20 mg should only be used to rapidly increase depth of sedation in patients where hypotension is not likely to occur. Patients with compromised myocardial function, intravascular volume depletion, or abnormally low vascular tone (e.g., sepsis) may be more susceptible to hypotension (see PRECAUTIONS).

SUMMARY OF DOSAGE GUIDELINES

Dosages and rates of administration in the following table should be individualized and titrated to clinical response. Safety and dosing requirements for induction of anesthesia in pediatric patients have only been established for children 3 years of age or older. Safety and dosing requirements for the maintenance of anesthesia have only been established for children 2 months of age and older.

For complete dosage information, see DOSAGE AND ADMINISTRATION.

INDICATION

DOSAGE AND ADMINISTRATION

Induction of General Anesthesia:

Healthy Adults Less Than 55 Years of Age:

40 mg every 10 seconds until induction onset (2 mg/kg to 2.5 mg/kg).

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

20 mg every 10 seconds until induction onset (1 mg/kg to 1.5 mg/kg).

Cardiac Anesthesia:

20 mg every 10 seconds until induction onset (0.5 mg/kg to 1.5 mg/kg).

Neurosurgical Patients:

20 mg every 10 seconds until induction onset (1 mg/kg to 2 mg/kg).

Pediatric Patients — healthy, from 3 years to 16 years of age:

2.5 mg/kg to 3.5 mg/kg administered over 20 seconds to 30 seconds. (see PRECAUTIONS, Pediatric Use and CLINICAL PHARMACOLOGY, Pediatrics)

Maintenance of General Anesthesia:

Infusion

Healthy Adults Less Than 55 Years of Age:

100 mcg/kg/min to 200 mcg/kg/min (6 mg/kg/h to 12 mg/kg/h).

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

50 mcg/kg/min to 100 mcg/kg/min (3 mg/kg/h to 6 mg/kg/h).

Cardiac Anesthesia: Most patients require:

Primary Propofol Injectable Emulsion with Secondary Opioid –

100 mcg/kg/min to 150 mcg/kg/min.

Low-Dose Propofol Injectable Emulsion with Primary Opioid –

50 mcg/kg/min to 100 mcg/kg/min.

(see DOSAGE AND ADMINISTRATION, Table 4)

Neurosurgical Patients:

100 mcg/kg/min to 200 mcg/kg/min (6 mg/kg/h to 12 mg/kg/h).

Pediatric Patients — healthy, from 2 months of age to 16 years of age:

125 mcg/kg/min to 300 mcg/kg/min (7.5 mg/kg/h to 18 mg/kg/h).

Following the first half hour of maintenance, if clinical signs of light anesthesia are not present, the infusion rate should be decreased. (see PRECAUTIONS, Pediatric Use and CLINICAL PHARMACOLOGY, Pediatrics)

Maintenance of General Anesthesia:

Intermittent Bolus

Healthy Adults Less Than 55 Years of Age:

Increments of 20 mg to 50 mg as needed.

  • Initiation of MAC Sedation:

Healthy Adults Less Than 55 Years of Age:

Slow infusion or slow injection techniques are recommended to avoid apnea or hypotension. Most patients require an infusion of 100 mcg/kg/min to 150 mcg/kg/min (6 mg/kg/h to 9 mg/kg/h) for 3 minutes to 5 minutes or a slow in to 5 minutes followed immediately by a maintenance infusion.

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

Most patients require dosages similar to healthy adults.

Rapid boluses are to be avoided (see WARNINGS).

Maintenance of MAC Sedation:

Healthy Adults Less Than 55 Years of Age:

A variable rate infusion technique is preferable over an intermittent bolus technique. Most patients require an infusion of 25 mcg/kg/min to 75 mcg/kg/min (1.5 mg/kg/h to 4.5 mg/kg/h) or incremental bolus doses of 10 mg

In Elderly, Debilitated, Neurosurgical, or ASA-PS III or IV Patients:

Most patients require 80% of the usual adult dose. A rapid (single or

repeated) bolus dose should not be used (see WARNINGS).

Initiation and Maintenance of ICU Sedation in Intubated, Mechanically Ventilated

Adult Patients — Because of the residual effects of previous anesthetic or sedative agents, in most patients the initial infusion should be 5 mcg/kg/min (0.3 mg/kg/h) for at least 5 minutes. Subsequent increments of 5 mcg/kg/min to 10 mcg/kg/min (0.3 mg/kg/k to 0.6 mg/kg/h) over 5 minutes to 10 minutes may be until desired clinical effect is achieved. Maintenance rates of 5 mcg/kg/min to 50 mcg/kg/min (0.3 mg/kg/h to 3 mg/kg/h) or higher may be required. Administration should not exceed 4 mg/kg/hour unless the benefits outweigh the risks (see WARNINGS).

Evaluation of clinical effect and assessment of CNS function should be

carried out daily throughout maintenance to determine the minimum

dose of Propofol Injectable Emulsion required for sedation.

The tubing and any unused Propofol Injectable Emulsion drug product

should be discarded after 12 hours because Propofol Injectable Emulsion

contains no preservatives and is capable of supporting growth

of microorganisms (see WARNINGS and DOSAGE AND ADMINISTRATION).

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.

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). 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

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