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Basic Drug Info
Drug Name:Propofol
Manufacturer:Bedford Laboratories
Other Info:

Propofol should be prepared for single-patient use only.

When propofol is administered directly from the vial/pre-filled syringe, strict aseptic techniques must be followed.

The vial/pre-filled syringe 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 IV 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 portions of propofol must be discarded after 12 hours.If propofol is transferred to a syringe or other container prior to administration, the handling procedures for general anesthesia/MAC sedation should be followed, and the product should be discarded and administration lines changed after 6 hours.



Clinical Trials:


Indications and Usage

Propofol injectable emulsion is an IV sedative-hypnotic agent that can be used as described in the table below. TABLE 3.

INDICATIONS FOR PROPOFOL INJECTABLE EMULSION IndicationApproved Patient Population Initiation and maintenance of Monitored AnesthesiaAdults only Care (MAC) sedation Combined sedation and regional anesthesiaAdults only (See PRECAUTIONS) Induction of General AnesthesiaPatients ? 3 years of age Maintenance of General AnesthesiaPatients ? 2 months of age Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patientsAdults only  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 PRECAUTIONS - Pediatric 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.In the Intensive Care Unit (ICU), propofol can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses, only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.Propofol is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established.

(See PRECAUTIONS - Pediatric use.)Propofol is not recommended for obstetrics, including Cesarean section deliveries.

Propofol crosses the placenta, and as with other general anesthetic agents, the administration of propofol may be associated with neonatal depression.

(See PRECAUTIONS.)Propofol is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known.

(See PRECAUTIONS.)
Sedation --

Absence of sensation --

Contraindications
Propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of its components.Propofol injectable emulsion is contraindicated in patients with allergies to eggs, egg products, soybeans or soy products.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Use of propofol has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions.For general anesthesia or monitored anesthesia care (MAC) sedation, propofol 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 facilities for maintenance of 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 patients in the Intensive Care Unit (ICU), propofol should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.Use of propofol infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death.

The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, cardiac and renal failure.

The syndrome is most often associated with prolonged, high-dose infusions (>5 mg/kg/h for >48h) but has also been reported following large-dose,short-term infusions during surgical anesthesia.

In the setting of prolonged need for sedation, increasing propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a propofol infusion, consideration should be given to using alternative means of sedation.Abrupt discontinuation of propofol 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 maintain a light level of sedation through the weaning process or evaluation of sedation level.

(See PRECAUTIONS.)Propofol injectable emulsion should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established.

In vitro tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals.

The clinical significance of these findings is not known.There have been reports in which failure to use aseptic technique when handling propofol injectable emulsion was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death.

Do not use if contamination is suspected.

Discard unused portions as directed within the required time limits (See DOSAGE AND ADMINISTRATION - Handling Procedures.)
Branded Drugs
The following US Branded drugs contain Propofol


DIPRIVAN -- ABRAXIS BIOSCIENCE INC


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