PROPOFOL injection, emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF)

Available from:

General Injectables and Vaccines, Inc

INN (International Name):

PROPOFOL

Composition:

PROPOFOL 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propofol injectable emulsion is an IV general anesthetic and sedation drug that can be used as described in the table below. Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see PRECAUTIONS, Pediatric Use ). Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years 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 injectable emulsion 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 injectable emulsion is not indicated for use in Pediatric ICU sedation sin

Product summary:

Propofol Injectable Emulsion, USP is supplied as follows: Propofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Do not freeze. Shake well before use. 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 the stability of the product has been compromised. Slight creaming, which should disappear after shaking, may be visible upon prolonged standing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPOFOL- PROPOFOL INJECTION, EMULSION
GENERAL INJECTABLES AND VACCINES, INC
----------
PROPOFOL INJECTABLE EMULSION
PAA 109887
PROPOFOL Injectable Emulsion
10 MG/ML
CONTAINS BENZYL ALCOHOL (SEE PRECAUTIONS)
Rx only
Fliptop Vial
FOR INTRAVENOUS ADMINISTRATION
SHAKE WELL BEFORE USE
PAA 109887
_Strict aseptic technique must always be maintained during handling.
Propofol injectable emulsion is a single_
_access parenteral product (single patient infusion vial) which
contains benzyl alcohol 1.5 mg/mL and sodium_
_benzoate 0.7 mg/mL to inhibit the rate of growth of microorganisms,
for up to 12 hours, in the event of_
_accidental extrinsic contamination. However, propofol injectable
emulsion can still support the growth of_
_microorganisms, as it is not an antimicrobially preserved product
under USP standards. Accordingly, strict_
_aseptic technique must still be adhered to. Do not use if
contamination is suspected. Discard unused drug_
_product as directed within the required time limits. 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/or death._
_There have been reports, in the literature and other public sources,
of the transmission of bloodborne_
_pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe
injection practices, and use of propofol_
_vials intended for single use on multiple persons. Propofol
injectable emulsion vials are never to be accessed_
_more than once or used on more than one person._
_(see _WARNINGS AND DOSAGE AND ADMINISTRATION, _HANDLING PROCEDURES_).
DESCRIPTION
Propofol injection emulsion is a sterile, nonpyrogenic emulsion
containing 10 mg/mL of propofol
suitable for intravenous administration. Propofol is chemically
described as 2,6-diisopropylphenol.
The structural formula is:
Propofol is slightly soluble in water and, thus, is formulated in a
white, oil-in-water emulsion. The pKa
is 11.