Propofol

What it is and how it works

Mechanism of Action The mechanism of action, like all general anesthetics, is poorly understood. However, propofol is thought to produce its sedative/anesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABA A receptors.

Indications

• 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 Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug indicated for: 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 Propofol Injectable Emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia be…

Dosage and administration (summary)

See Full Prescribing Information for detailed dosing instructions. Important Dosage and Administration Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. 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. Do not use if there is evidence of separation of the phases of the emulsion.

Contraindications

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 eggs, egg products, soybeans or soy products. Known hypersensitivity to propofol, egg or soybean

Warnings and precautions

Hypersensitivity Reactions : Serious and sometimes fatal reactions 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 Cardiovascular depression : Cases of bradycardia, asystole, and cardiac arrest have been reported.

Pregnancy

Pregnancy Risk Summary Data from randomized controlled trials, cohort studies and case series over several decades with propofol use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Storage and supply

Propofol Injectable Emulsion, USP is a white or almost white homogeneous emulsion and is supplied as follows: NDC Propofol Injectable Emulsion, USP Package Factor 71288- 729 -21 200 mg per 20 mL Single-Dose Vial (10 mg per mL) 20 mL ready-to-use single-dose infusion vial in packages of ten.

Source: Propofol (Propofol) — US FDA prescribing information, 2025-12-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.