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  • Diprivan
    (propofol)

    THERAPEUTIC CLASS

    General anesthetic

    DEA CLASS

    RX

    INDICATIONS

    Initiation and maintenance of monitored anesthesia care (MAC) sedation, and combined sedation and regional anesthesia in adult patients. Intensive care unit (ICU) sedation of intubated, mechanically ventilated adult patients. Induction of general anesthesia in patients ≥3 yrs of age. Maintenance of general anesthesia in patients ≥2 months of age.

    ADULT DOSAGE

    General Anesthesia

    Induction:
    <55 Years:

    40mg IV every 10 sec until onset (2-2.5mg/kg)

    Cardiac Anesthesia:
    20mg IV every 10 sec until induction onset (0.5-1.5mg/kg)

    Neurosurgical Patients:
    20mg IV every 10 sec until induction onset (1-2mg/kg)

    Maint:
    <55 Years:
    100-200mcg/kg/min (6-12mg/kg/hr)

    Cardiac Anesthesia:
    Primary Propofol Injectable Emulsion w/ Secondary Opioid:
    Usual:
    100-150mcg/kg/min
    Low-Dose Propofol Injectable Emulsion w/ Primary Opioid:
    Usual:
    50-100mcg/kg/min
     
    Neurosurgical Patients:
    100-200mcg/kg/min (6-12mg/kg/hr)

    Intermittent Bolus:
    <55 Years:
    Increments of 20-50mg as needed

    Monitored Anesthesia Care

    Sedation:
    <55 Years:
    Initial:
    100-150mcg/kg/min (6-9mg/kg/hr) infusion for 3-5 min or slow inj of 0.5mg/kg over 3-5 min followed immediately by a maint infusion

    Slow infusion or slow inj techniques are recommended to avoid apnea or hypotension

    Maint: Usual: 25-75mcg/kg/min (1.5-4.5mg/kg/hr) infusion for 10-15 min, then decreased to 25-50mcg/kg/min and adjusted to clinical response, or may be given as intermittent bolus dose method, where increments of 10 or 20mg are administered and titrated to desired clinical effect

    Sedation

    ICU Sedation of Intubated, Mechanically Ventilated Patients:
    Initial:
    5mcg/kg/min (0.3mg/kg/hr) for at least 5 min, then increase by increments of 5-10mcg/kg/min (0.3-0.6mg/kg/hr) over 5-10 min until desired clinical effect is achieved
    Maint:
    5-50mcg/kg/min (0.3-3mg/kg/hr) or higher may be required
    Max:
    4mg/kg/hr

    PEDIATRIC DOSAGE

    General Anesthesia

    Induction:
    3-16 Years:

    2.5-3.5mg/kg IV over 20-30 sec

    Maint:
    2 Months of Age-16 Years:
    Usual: 200-300mcg/kg/min for 30 min immediately follow the induction dose, then a decrease to an infusion rate of 125-150mcg/kg/min adjusted to clinical response is typically needed

    DOSE MODIFICATION

    Elderly
    General Anesthesia:
    Induction: 20mg every 10 sec until onset (1-1.5mg/kg)
    Maint: 50-100mcg/kg/min (3-6mg/kg/hr)

    Monitored Anesthesia Care (MAC) Sedation:
    Maint:
    Reduce to 80% of usual adult dose

    Other Important Modifications
    General Anesthesia:
    Debilitated/ASA-PS III/IV:
    Induction:
    20mg every 10 sec until onset (1-1.5mg/kg)
    Maint: 50-100mcg/kg/min (3-6mg/kg/hr)

    MAC Sedation:
    Neurosurgical, or ASA-PS III or IV Patients:
    Maint:
    Reduce to 80% of usual adult dose

    ADMINISTRATION

    IV route

    Shake well before use
    Do not coadminister through the same IV catheter w/ blood or plasma
    Do not mix w/ other therapeutic agents prior to administration
    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 stability of product has been compromised
    Dilute only w/ D5W; should not be diluted to a concentration <2mg/mL
    Should only be administered through a filter w/ a pore size of ≥5 micron unless it has been demonstrated that filter does not restrict flow of propofol and/or cause breakdown of the emulsion 
    When administering by infusion, syringe or volumetric pumps are recommended to provide controlled infusion rates
    When infusing to patients undergoing MRI, metered control devices may be utilized if mechanical pumps are impractical
    Always titrate infusion rates downward in absence of clinical signs of light anesthesia until a mild response to surgical stimulation is obtained
    Refer to PI for further administration instructions

    HOW SUPPLIED

    Inj: 10mg/mL [10mL, 20mL, 50mL, 100mL]

    CONTRAINDICATIONS

    Allergies to eggs, egg products, soybeans, or soy products.

    WARNINGS/PRECAUTIONS

    Fatal and life-threatening anaphylactic/anaphylactoid reactions reported. Should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure when used for general anesthesia or MAC sedation. Should be administered only by persons skilled in the management of critically ill patients and trained on cardiovascular (CV) resuscitation and airway management when used for sedation of intubated, mechanically ventilated patients in ICU. Lower induction dose and slower rate of administration should be used in elderly, debilitated or ASA-PS III/IV patients. Use for ICU sedation associated w/ propofol infusion syndrome, a syndrome characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes, and/or cardiac failure. Consider alternative means of sedation in setting of prolonged need for sedation, if increased dose is required, or onset of metabolic acidosis. Avoid abrupt discontinuation prior to weaning or for daily evaluation of sedation levels; may result in rapid awakening w/ associated anxiety, agitation, and resistance to mechanical ventilation. Adjust infusion to maintain light level of sedation through the weaning process or evaluation of sedation level. Caution w/ lipid metabolism disorders. Use may be associated w/ development of a period of postoperative unconsciousness, which may be accompanied by an increase in muscle tone. Risk of seizure during recovery phase, when administered to an epileptic patient. Pain on administration can be minimized if larger veins of the forearm or antecubital fossa are used and may be reduced by prior inj of IV lidocaine. Local pain, swelling, blisters, and tissue necrosis reported following accidental extravasation. Perioperative myoclonia, rarely including convulsions and opisthotonos, reported. Pulmonary edema and unexplained postoperative pancreatitis reported. Bradycardia, asystole, and rarely, cardiac arrest reported. Consider IV administration of anticholinergics (eg, atropine, glycopyrrolate) to modify potential increases in vagal tone due to concomitant agents (eg, succinylcholine) or surgical stimuli. ICU Sedation: Should be initiated as a continuous infusion and changes in the rate of administration made slowly to minimize hypotension and avoid acute overdosage. Failure to reduce infusion rate for extended periods may result in excessively high blood concentrations. D/C opioids and paralytic agents and optimize respiratory function prior to weaning patients from mechanical ventilation. Infusion should be adjusted to maintain light level of sedation prior to weaning patients from mechanical ventilatory support. May elevate serum TGs when administered for extended periods; adjust administration if fat is being inadequately cleared from the body. Do not infuse for >5 days w/o providing a drug holiday to replace urine zinc losses; consider supplemental zinc w/ chronic use in those predisposed to zinc deficiency. Neurosurgical Anesthesia: Avoid significant decreases in mean arterial pressure in patients w/ increased intracranial pressure (ICP) or impaired cerebral circulation. If increased ICP is suspected, accompany administration w/ hyperventilation and hypocarbia. Cardiac Anesthesia: Utilize slower rates of administration in premedicated or hemodynamically unstable patients, elderly, and patients w/ recent fluid shifts. Correct fluid deficits prior to therapy. Other measures (eg, elevation of lower extremities, use of pressor agents) may be useful to offset hypotension in patients where additional fluid therapy may be contraindicated.

    ADVERSE REACTIONS

    Hypotension, inj-site burning/stinging/pain, HTN, rash, hyperlipemia, respiratory acidosis during weaning.

    DRUG INTERACTIONS

    Induction dose requirements of propofol may be reduced in patients w/ IM or IV premedication, particularly w/ narcotics (eg, morphine, meperidine, fentanyl) and combinations of opioids and sedatives (eg, benzodiazepines, barbiturates, chloral hydrate, droperidol); these agents may increase anesthetic or sedative effects of propofol and may also result in more pronounced decreases in systolic, diastolic, and mean arterial pressures and cardiac output. May increase effects w/ concomitant potent inhalational agents (eg, isoflurane, enflurane, halothane); may require reduction of maintenance rate of propofol administration. Concomitant use of fentanyl may cause serious bradycardia in pediatric patients. Increased risk of propofol infusion syndrome w/ high doses of vasoconstrictors, steroids, and/or inotropes.

    PREGNANCY AND LACTATION

    Category B, not for use in nursing.

    MECHANISM OF ACTION

    General anesthetic; not established. Suspected to produce sedative/anesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABAA receptors.

    PHARMACOKINETICS

    Distribution: Vd=60L/kg. Crosses placenta; found in breast milk. Elimination: Urine; T1/2=1-3 days.

    ASSESSMENT

    Assess for hypersensitivity to drug, eggs, or soy products; neurological injury; sepsis; epilepsy; lipid metabolism disorders; epilepsy; renal impairment, pregnancy/nursing status; or any other conditions where treatment is contraindicated or cautioned. Assess for possible drug interactions. In patients at risk for renal impairment, check urinalysis and urine sediment before initiation of sedation.

    MONITORING

    Monitor for anaphylactic/anaphylactoid reactions, hypotension, bradycardia, apnea, airway obstruction, oxygen desaturation, propofol infusion syndrome, pulmonary edema, perioperative myoclonia, pancreatitis, and other adverse reactions.  In patients at risk for renal impairment, monitor urinalysis and urine sediment on alternate days during sedation.

    PATIENT COUNSELING

    Advise that performance of activities requiring mental alertness (eg, operating a motor vehicle/hazardous machinery, signing legal documents), may be impaired for some time after general anesthesia or sedation.

    STORAGE

    4-25°C (40-77°F). Do not freeze.