PROPOFOL injection, emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pfizer Laboratories Div Pfizer 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: Unit of Sale Concentration NDC 0069-0209-05 Carton of 5 Single-Patient Use Vials 200 mg/20 mL (10 mg/mL) NDC 0069-0209-10 Carton of 10 Single-Patient Use Vials 200 mg/20 mL (10 mg/mL) NDC 0069-0209-25 Carton of 25 Single-Patient Use Vials 200 mg/20 mL (10 mg/mL) NDC 0069-0234-01 Carton of 1 Single-Patient Use Vials 500 mg/50 mL (10 mg/mL) NDC 0069-0234-05 Carton of 5 Single-Patient Use Vials 500 mg/50 mL (10 mg/mL) NDC 0069-0234-20 Carton of 20 Single-Patient Use Vials 500 mg/50 mL (10 mg/mL) NDC 0069-0248-01 Carton of 1 Single-Patient Use Vials 1,000 mg/100 mL (10 mg/mL) NDC 0069-0248-10 Carton of 10 Single-Patient Use Vials 1,000 mg/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 between 4°C to 25°C (40°F to 77°F). 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
PFIZER LABORATORIES DIV PFIZER 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)
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•
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•
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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: 200 mg per 20 mL (10 mg/mL), 500 mg per 50 mL (10
mg/mL), and 1,000 mg per
100 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 not use if contamination is
suspected (5.2)
Cardiovascular Depression: Cases of bradycardia, asystole, and cardiac
arrest have been reported.
Pediatric patients are susceptible to this effect, particularly when
fentanyl is given concomitantly (5.4)
ADVERSE REACTIONS
The most common adverse reactions >1% were bradycardia, arrhythmia,
tachycardia, hypotension,
hypertension, decreased cardiac output, movement, ap