Diprivan (Propofol) Injectable Emulsion, USP is the #1 prescribed propofol in the U.S.¹
Diprivan Product Features
Contains EDTA (Disodium Edetate)
Container closures not made with natural rubber latex
Sulfite free
Spike-and-hang vial (50 mL and 100 mL)
Indications and Dosing
Summary of Dosage Guidelines: Dosages and rates of administration in the following table should be individualized and titrated to clinical response. Safety and dosing requirements for induction of anesthesia in pediatric patients have only been established for children 3 years of age or older. Safety and dosing requirements for the maintenance of anesthesia have only been established for children 2 months of age and older. (See DOSAGE AND ADMINISTRATION in Full Prescribing Information)
Healthy Adults Less Than 55 Years of Age: 40 mg every 10 seconds until induction onset (2 mg/kg to 2.5 mg/kg).
Elderly, Debilitated, or ASA-PS III or IV Patients: 20 mg every 10 seconds until induction onset (1 mg/kg to 1.5 mg/kg).
Cardiac Anesthesia: 20 mg every 10 seconds until induction onset (0.5 mg/kg to 1.5 mg/kg).
Neurosurgical Patients: 20 mg every 10 seconds until induction onset (1 mg/kg to 2 mg/kg).
Pediatric Patients—healthy, from 3 years to 16 years of age: 2.5 mg/kg to 3.5 mg/kg administered over 20 to 30 seconds.
(see PRECAUTIONS, Pediatric Use and CLINICAL PHARMACOLOGY, Pediatrics in Full Prescribing Information)
Healthy Adults Less Than 55 Years of Age: 100 mcg/kg/min to 200 mcg/kg/min (6 mg/kg/h to 12 mg/kg/h).
Elderly, Debilitated, or ASA-PS III or IV Patients: 50 mcg/kg/min to 100 mcg/kg/min (3 mg/kg/h to 6 mg/kg/h).
Cardiac Anesthesia: Most patients require: Primary Diprivan Injectable Emulsion with Secondary Opioid—
100 mcg/kg/min to 150 mcg/kg/min
Low-Dose Diprivan Injectable Emulsion with Primary Opioid—
50 mcg/kg/min to 100 mcg/kg/min
(see DOSAGE AND ADMINISTRATION, Table 4 in Full Prescribing Information)
Neurosurgical Patients: 100 mcg/kg/min to 200 mcg/kg/min (6 mg/kg/h to 12 mg/kg/h).
Pediatric Patients—healthy, from 2 months of age to 16 years of age: 125 mcg/kg/min to 300 mcg/kg/min (7.5 mg/kg/h to 18 mg/kg/h).
Following the first half hour of maintenance, if clinical signs of light anesthesia are not present, the infusion rate should be decreased.
(see PRECAUTIONS, Pediatric Use and CLINICAL PHARMACOLOGY, Pediatrics in Full Prescribing Information)
Healthy Adults Less Than 55 Years of Age: Slow infusion or slow injection techniques are recommended to avoid apnea or hypotension. Most patients require an infusion of 100 mcg/kg/min to 150 mcg/kg/min (6 mg/kg/h to 9 mg/kg/h) for 3 minutes to 5 minutes or a slow injection of 0.5 mg/kg over 3 minutes to 5 minutes followed immediately by a maintenance infusion.
Elderly, Debilitated, Neurosurgical, or ASA-PS III or IV Patients: Most patients require dosages similar to healthy adults. Rapid boluses are to be avoided (see WARNINGS in Full Prescribing Information)
Healthy Adults Less Than 55 Years of Age: A variable rate infusion technique is preferable over an intermittent bolus technique. Most patients require an infusion of 25 mcg/kg/min to 75 mcg/kg/min (1.5 mg/kg/h to 4.5 mg/kg/h) or incremental bolus doses of 10 mg or 20 mg.
Elderly, Debilitated, Neurosurgical, or ASA-PS III or IV Patients: Most patients require 80% of the usual adult dose. A rapid (single or repeated) bolus dose should not be used (see WARNINGS in Full Prescribing Information)
Because of the residual effects of previous anesthetic or sedative agents, in most patients the initial infusion should be 5 mcg/kg/min (0.3 mg/kg/h) for at least 5 minutes. Subsequent increments of 5 mcg/kg/min to 10 mcg/kg/min (0.3 mg/kg/h to 0.6 mg/kg/h) over 5 to 10 minutes may be used until desired clinical effect is achieved. Maintenance rates of 5 mcg/kg/min to 50 mcg/kg/min (0.3 mg/kg/h to 3 mg/kg/h) or higher may be required. Administration should not exceed 4 mg/kg/hour unless the benefits outweigh the risks (see WARNINGS in Full Prescribing Information)
Evaluation of clinical effect and assessment of CNS function should be carried out daily throughout maintenance to determine the minimum dose of Diprivan Injectable Emulsion required for sedation.
The tubing and any unused portions of Diprivan Injectable Emulsion should be discarded after 12 hours because Diprivan Injectable Emulsion contains no preservatives and is capable of supporting growth of microorganisms (see WARNINGS and DOSAGE AND ADMINISTRATION in Full Prescribing Information).
Adults only
See PRECAUTIONS in Full Prescribing Information
REFERENCE
1. Data on file.
Important Safety Information
CONTRAINDICATIONS
DIPRIVAN is contraindicated in patients with Known hypersensitivity to propofol, egg or soybean.
WARNING AND PRECAUTIONS
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.
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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.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA at 1-800-551-7176 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.
Valproate: May lead to increased blood levels of propofol.
INDICATIONS AND USAGE
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.
- MAC sedation in the pediatric population is not recommended. DIPRIVAN is not indicated for use in Pediatric ICU sedation.
This Important Safety Information does not include all the information needed to use DIPRIVAN® (Propofol), Injectable Emulsion, USP safely and effectively. Please see full prescribing information for DIPRIVAN® (Propofol), Injectable Emulsion, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.