Propofol Injectable Emulsion
FDA Drug Information • Also known as: Propofol Injectable Emulsion
- Brand Names
- Propofol Injectable Emulsion
- Drug Class
- General Anesthetic [EPC]
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, EMULSION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is: Chemical name: 2,6 diisopropylphenol Molecular formula: C 12 H 18 O Molecular weight:178.27 Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 4.5 to 7.4. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), and benzyl alcohol (0.15%); with sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion is isotonic and has a pH of 5.5 to 7.4.
What Is Propofol Injectable Emulsion Used For?
1 INDICATIONS AND USAGE Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:
Dosage and Administration
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for detailed dosing instructions. 2.1 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. Propofol injectable emulsion with EDTA inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms. Product is packaged under nitrogen. For general anesthesia or monitored anesthesia care (MAC) sedation, propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and equipment for maintaining a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients. For sedation of intubated, mechanically ventilated adult patients in the Intensive Care Unit, propofol injectable emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. Guidelines for Aseptic Technique for General Anesthesia/MAC Sedation Propofol injectable emulsion must be prepared for use just prior to initiation of each individual anesthetic/sedative procedure. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. Propofol injectable emulsion should be drawn into a sterile syringe immediately after a vial is opened. When withdrawing propofol injectable emulsion from vials, a sterile vent spike should be used. The syringe should be labelled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened. Propofol injectable emulsion must be prepared for single dose only. Any unused propofol injectable emulsion drug product, reservoirs, dedicated administration tubing and/or solutions containing propofol injectable emulsion must be discarded at the end of the anesthetic procedure or at 12 hours, whichever occurs sooner. The...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:
Drug Interactions
7 DRUG INTERACTIONS Opioids and Sedatives The induction dose requirements of propofol injectable emulsion 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 propofol injectable emulsion 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 propofol injectable emulsion may result in serious bradycardia. Analgesic Agents During maintenance of anesthesia or sedation, the rate of propofol injectable emulsion administration should be adjusted according to the desired level of anesthesia or sedation and may be reduced in the presence of supplemental analgesic agents (e.g., nitrous oxide or opioids). The concurrent administration of potent inhalational agents (e.g., isoflurane, sevoflurane, desflurane, enflurane, and halothane) during maintenance with propofol injectable emulsion are routinely used. These inhalational agents can also be expected to increase the anesthetic or sedative and cardiorespiratory effects of propofol injectable emulsion. Valproate The concomitant use of valproate and propofol may lead to increased blood levels of propofol. Reduce the dose of propofol when co-administering with valproate. Monitor patients closely for signs of increased sedation or cardiorespiratory depression. Common Neuromuscular Blocking Agents Propofol injectable emulsion does not cause a clinically significant change in onset, intensity or duration of action of the commonly used neuromuscular blocking agents (e.g., succinylcholine and nondepolarizing muscle relaxants). Common Drugs Used as Premedication or Drugs Used During Anesthesia or Sedation No significant adverse interactions with commonly used premedications or drugs used during anesthesia or sedation (including a range of muscle relaxants, inhalational agents, analgesic agents, and local anesthetic agents) have been observed in adults. 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 )
Contraindications
4 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 ( 4 )
Pregnancy and Breastfeeding
8.1 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. Most of the reported exposures to propofol describe propofol exposure at the time of cesarean delivery. There are reports of neonatal depression in infants exposed to propofol during delivery (see Clinical Considerations). In animal reproduction studies, decreased pup survival concurrent with increased maternal mortality was observed with intravenous administration of propofol to pregnant rats either prior to mating and during early gestation or during late gestation and early lactation at exposures less than the human induction dose of 2.5 mg/kg. In pregnant rats administered 15 mg/kg/day intravenous propofol (equivalent to the human induction dose) from two weeks prior to mating to early in gestation (Gestation Day 7), offspring that were allowed to mate had increased postimplantation losses. The pharmacological activity (anesthesia) of the drug on the mother is probably responsible for the adverse effects seen in the offspring. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [see Data, Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.4 )]). The clinical significance of these nonclinical findings is not known, and the benefits of appropriate anesthesia in pregnant women who require procedures should be balanced with the potential risks suggested by the nonclinical data. The estimated background risk...
Overdosage
10 OVERDOSAGE Overdosage is likely to cause cardiorespiratory depression. 10.1 Symptoms Overdosage is likely to cause cardiorespiratory depression. 10.2 Treatment If overdosage occurs, propofol injectable emulsion administration should be discontinued immediately. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require respositioning of the patient by raising the patient's legs, increasing the flow rate of intravenous fluids, and administering pressor agents and/or anticholinergic agents.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Propofol injectable emulsion, USP is available as follows: NDC Code Strength NDC 43598-265-25 200 mg in a 20 mL vial (10 mg per mL) 20 mL ready-to-use single-dose infusion vial in packages of twenty five NDC 43598-265-58 200 mg in a 20 mL vial (10 mg per mL) 20 mL ready-to-use single-dose infusion vial in packages of ten. NDC 43598-548-21 500 mg in a 50 mL vial (10 mg per mL) 50 mL ready-to-use single-dose infusion vial in packages of twenty. NDC 43598-549-10 1,000mg in a 100 mL vial (10 mg per mL) 100 mL ready-to-use single-dose infusion vial in packages of ten. Store between 4 to 25°C (40°F to 77°F). Do not freeze. Shake well before use.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.