propofol injectable emulsion (contains edetate disodium) Highlights

(propofol injectable emulsion (contains edetate disodium))

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
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients

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, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Opioids, Sedatives or Other Analgesic Agents: May increase the anesthetic/sedative and cardiorespiratory effects (7)

Valproate: May lead to increased blood levels of propofol (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023

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Highlights

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
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients

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, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Opioids, Sedatives or Other Analgesic Agents: May increase the anesthetic/sedative and cardiorespiratory effects (7)

Valproate: May lead to increased blood levels of propofol (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023

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