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  • Diprivan
    (Propofol) - Fresenius

    THERAPEUTIC CLASS

    General anesthetic

    DEA CLASS

    RX

    INDICATIONS

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

    ADULT DOSAGE

    Adults: General Anesthesia: <55 yrs: Induction: 40mg IV q10 seconds 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 q10 seconds 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 adjusted to clinical response or may be given in increments of 10 or 20mg IV intermittent bolus PRN. Elderly/Debilitated/ASA-PS III/IV: Avoid rapid bolus administration. Maint: 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. Maint: 5-50mcg/kg/min IV or higher may be required. Max: 4mg/kg/hr.

    PEDIATRIC DOSAGE

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

    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 reactions reported. Proper use of aseptic technique required to prevent microbial contamination. 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, lipidemia, rhabdomyolysis, hepatomegaly, and cardiac/renal failure. Consider alternative means of sedation if increased dose is required or metabolic acidosis occurs. Avoid abrupt d/c prior to weaning or for daily evaluation of sedation level; may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. Local pain, swelling, blisters, tissue necrosis reported following accidental extravasation. Failure to reduce infusion rate in ICU sedation for extended periods may result in excessively high blood concentrations. May elevate serum TG when administered in extended periods; caution with disorders of lipid metabolism. Do not infuse for >5 days without drug holiday to replace zinc losses; consider supplemental zinc with chronic use in those predisposed to zinc deficiency. In renal impairment, perform baseline urinalysis/urine sediment, then monitor on alternate days during sedation. Correct fluid deficits prior to use.

    ADVERSE REACTIONS

    Bradycardia, arrhythmia, hypotension, HTN, tachycardia nodal, decreased cardiac output, CNS movement, injection-site burning/stinging/pain, hyperlipemia, apnea, rash, pruritus, 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) and potent inhalational agents (eg, isoflurane, enflurane, halothane). Concomitant fentanyl may cause bradycardia in pediatrics. Increased risk of propofol infusion syndrome with vasoconstrictors, steroids, and inotropes.

    PREGNANCY

    Category B, not for use in nursing.

    MECHANISM OF ACTION

    Sedative-hypnotic agent. Suspected to produce effects by the positive mondulation of the inhibitory function of the neurotransmitter gamma-aminobutyric acid (GABA) through the ligand-gated GABAA receptors.

    PHARMACOKINETICS

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

    ASSESSMENT

    Assess for hypersensitivity to drug, eggs, or soy products, lipid metabolism disorders (eg, hyperlipidemia, pancreatitis), convulsive disorders, debilitated/elderly, ASA-PS III or IV patients, increased intracranial pressure or impaired cerebral circulation, hemodynamically unstable patients, 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 events.

    PATIENT COUNSELING

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

    ADMINISTRATION/STORAGE

    Administration: IV infusion or intermittent IV bolus injection. Refer to PI for compatibility, dilution, and administration with other fluids. Storage: 4-25°C (40-77°F). Do not freeze. Shake well before use.