PROPOFOL injection, emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Limitations of Use Propofol injectable emulsion 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 [see Pediatric Use (8.4)] . 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 Pediatric Use (8.4)] . Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)] . Propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. Propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to

Product summary:

Propofol Injectable Emulsion, USP is supplied as follows: NDC 0409-4699-30 Carton of 5 Single-Patient Use Fliptop vials 200 mg/20 mL (10 mg/mL) NDC 0409-6010-25 Tray of 25 Single-Patient Use Fliptop vials 200 mg/20 mL (10 mg/mL) NDC 0409-4699-33 Tray of 20 Single-Patient Use Fliptop vials 500 mg/50 mL (10 mg/mL) NDC 0409-4699-24 Tray of 10 Single-Patient Use Fliptop vials 1 g/100 mL (10 mg/mL) Propofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path. Store at 20°C to 25°C (68°F 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
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROPOFOL INJECTABLE
EMULSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PROPOFOL INJECTABLE
EMULSION.
PROPOFOL INJECTABLE EMULSION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Propofol injectable emulsion is an intravenous general anesthetic and
sedation drug indicated for: (1)
• Induction of General Anesthesia for Patients Greater than or Equal
to 3 Years of Age (1)
• Maintenance of General Anesthesia for Patients Greater than or
Equal to 2 Months of Age (1)
• Initiation and Maintenance of Monitored Anesthesia Care (MAC)
Sedation in Adult Patients (1)
• Sedation for Adult Patients in Combination with Regional
Anesthesia (1)
• Intensive Care Unit (ICU) Sedation of Intubated, Mechanically
Ventilated Adult Patients (1)
Limitations of Use: (1)
Propofol injectable emulsion is not recommended for induction of
anesthesia below the age of 3 years or
for maintenance of anesthesia below the age of 2 months (1)
MAC sedation in the pediatric population is not recommended (1)
Propofol Injectable Emulsion is not indicated for use in Pediatric ICU
sedation (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for detailed dosing instructions. (2)
DOSAGE FORMS AND STRENGTHS
Injectable emulsion: 1 g per 100 mL (10 mg/mL), 200 mg per 20 mL (10
mg/mL), and 500 mg per 50 mL
(10 mg/mL) Single-Patient Use Vials (3)
CONTRAINDICATIONS
Known hypersensitivity to propofol, egg or soybean (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Serious and sometimes fatal reactions
(5.1)
Microbial Contamination: Strict aseptic technique must be maintained
during handling. Propofol Injectable
Emulsion vials are never to be accessed more than once or used on more
than one person.
Administration should commence promptly and be completed within 12
hours after the vial has been
opened. Discard unused drug product. Do