Propofol

DIPRIVAN 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 DIPRIVAN 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.

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.

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. DIPRIVAN with EDTA inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms. Product is packaged under nitrogen.

DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components. DIPRIVAN is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products. Known hypersensitivity to propofol, egg or soybean.

Hypersensitivity Reactions: Serious and sometimes fatal reactions. Microbial Contamination: Strict aseptic technique must be maintained during handling. DIPRIVAN 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. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly.

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity reaction • Hypotension and/or bradycardia • Propofol Infusion Syndrome In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients, there are insufficient data to support an accurate estimate of their incidence rates. These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient.

Opioids and Sedatives The induction dose requirements of DIPRIVAN may be reduced in patients with intramuscular or intravenous premedication, particularly with opioids (e.g., morphine, meperidine, and fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates, chloral hydrate, droperidol, etc.). These agents may increase the anesthetic or sedative effects of DIPRIVAN and may also result in more pronounced decreases in systolic, diastolic, and mean arterial pressures and cardiac output. In pediatric patients, administration of fentanyl concomitantly with DIPRIVAN may result in serious bradycardia.

Store between 4°C to 25°C (40°F to 77°F). Do not freeze.