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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

    Adults: General Anesthesia: <55 Yrs: Induction: 40mg IV every 10 sec until onset (2-2.5mg/kg). Maint: 100-200mcg/kg/min IV or may be given in increments of 25-50mg IV intermittent bolus PRN. Elderly/Debilitated/ASA-PS III/IV: Induction: 20mg IV every 10 sec until onset (1-1.5mg/kg). Maint: 50-100mcg/kg/min IV. Refer to PI for Cardiac and Neurosurgical Anesthesia dosing. MAC Sedation: <55 Yrs: Initial: 100-150mcg/kg/min IV or 0.5mg/kg IV slowly over 3-5 min. Maint: 25-75mcg/kg/min IV for 10-15 min, then decreased to 25-50 mcg/kg/min IV and adjusted to clinical response, or may be given in increments of 10 or 20mg IV intermittent bolus and titrated to desired clinical effect. Elderly/Debilitated/ASA-PS III/IV: Reduce to 80% of usual adult dose. ICU Sedation: Initial: 5mcg/kg/min IV for at least 5 min, then increased by increments of 5-10mcg/kg/min IV over 5-10 min until desired clinical effect is achieved. Maint: 5-50mcg/kg/min IV or higher may be required. Max: 4mg/kg/hr.

    PEDIATRIC DOSAGE

    Pediatrics: General Anesthesia: 3-16 Yrs: Induction: 2.5-3.5mg/kg IV over 20-30 sec. Maint: 2 Months-16 Yrs: 200-300mcg/kg/min IV for 30 min, then decreased to 125-150mcg/kg/min adjusted to clinical response.

    ADMINISTRATION

    IV route. Do not coadminister through the same IV catheter with blood or plasma. Refer to PI for preparation and administration instructions and compatibility information.

    HOW SUPPLIED

    Inj: 10mg/mL [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 resuscitation and airway management when used for sedation of intubated, mechanically ventilated patients in ICU. Lower induction doses and slower rate of administration needed in elderly, debilitated or ASA-PS III/IV patients; monitor for early signs of hypotension, bradycardia, apnea, airway obstruction, and/or oxygen desaturation. May cause propofol infusion syndrome in ICU sedation, characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes, and/or cardiac failure. Consider alternative means of sedation in the 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 with associated anxiety, agitation, and resistance to mechanical ventilation. Adjust infusion to maintain a light level of sedation through the weaning process or evaluation of sedation level. Very rarely, use may be associated with the development of a period of postoperative unconsciousness which may be accompanied by an increase in muscle tone. There is a 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. Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension, occur rarely following administration. Rare cases of pulmonary edema and unexplained postoperative pancreatitis reported. Reports of bradycardia, asystole, and rarely, cardiac arrest reported; consider IV administration of anticholinergics to modify potential increases in vagal tone. Should be initiated as a continuous infusion and changes in the rate of administration made slowly to minimize hypotension and avoid acute overdosage. ICU Sedation: 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. 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 without providing a drug holiday to replace urine zinc losses; consider supplemental zinc with chronic use in those predisposed to zinc deficiency. Neurosurgical Anesthesia: Avoid significant decreases in mean arterial pressure in patients with increased intracranial pressure (ICP) or impaired cerebral circulation. If ICP is suspected, accompany administration with hyperventilation and hypocarbia. Cardiac Anesthesia: Utilize slower rates of administration in premedicated or hemodynamically unstable patients, elderly, and patients with 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

    Apnea, hypotension, inj-site burning/stinging/pain, CNS movement, HTN, rash, hyperlipemia, respiratory acidosis during weaning.

    DRUG INTERACTIONS

    Increased effects with narcotics (eg, morphine, meperidine, fentanyl), combinations of opioids and sedatives (eg, benzodiazepines, barbiturates, chloral hydrate, droperidol); may need to reduce induction dose requirements. May increase effects with concomitant potent inhalational agents (eg, isoflurane, enflurane, halothane); may require reduction of maintenance rate of administration. Concomitant fentanyl may cause serious bradycardia in pediatric patients. Increased risk of propofol infusion syndrome with 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 gamma-aminobutyric acid (GABA) through the ligand-gated GABAA receptors.

    PHARMACOKINETICS

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

    ASSESSMENT

    Assess for hypersensitivity to drug, eggs, or soy products, lipid metabolism disorders, epilepsy, debilitated/elderly, ASA-PS III or IV patients, increased ICP or impaired cerebral circulation, hemodynamically unstable/premedicated patients, patients with recent fluid shifts, renal impairment, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for anaphylactic/anaphylactoid reactions, hypotension and/or cardiovascular depression, apnea, airway obstruction and/or oxygen desaturation, decrease in cerebral perfusion pressure, signs/symptoms of propofol infusion syndrome, postoperative unconsciousness with increased muscle tone, pulmonary edema, increased vagal tone, pancreatitis, and other adverse reactions. For renally impaired, perform baseline urinalysis/urine sediment, then monitor on alternate days during sedation.

    PATIENT COUNSELING

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

    STORAGE

    4-25°C (40-77°F). Do not freeze. Shake well before use.