Propofol Injectable Emulsion 10 mg/mL
Propofol Injectable Emulsion · INJECTION, EMULSION · Dr. Reddy's Laboratories, Inc.
Propofol Injectable Emulsion is a general anesthetic medication given by intravenous injection that is used to induce and maintain anesthesia during medical procedures and surgery. This medication works by depressing the central nervous system to produce sedation and unconsciousness.
Key Facts
- Brand Name
- Propofol Injectable Emulsion
- Generic Name
- Propofol Injectable Emulsion
- NDC Code (Product)
43598-548- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA205067
- Drug Class
- General Anesthetic [EPC]
- Marketing Start
- 11/15/2018
Recall History
Hospira Inc.
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Hospira Inc.
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Hospira Inc.
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Hospira Inc.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Pfizer Inc.
Presence of particulate matter
Hospira Inc.
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Hospira Inc.
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Hospira, Inc.
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Pfizer Inc.
Presence of particulate matter: particulate identified as a beetle.
Hospira Inc.
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use ( 8.4 )]. Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use ( 8.4 )] . Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been establ…
Dosage & 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 continuou…
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 )
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 …
Adverse Reactions
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity reaction [see Warnings and Precautions ( 5.1 )] • Hypotension and/or bradycardia [see Warnings and Precautions ( 5.4 )] • Propofol Infusion Syndrome [see Warnings and Precautions ( 5.9 )] In the description below, rates of the more common events represent U.S/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. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Anesthesia and MAC Sedation in Adults The following estimates of adverse e…
Frequently Asked Questions
What is Propofol Injectable Emulsion used for?
Propofol Injectable Emulsion is a general anesthetic medication given by intravenous injection that is used to induce and maintain anesthesia during medical procedures and surgery. This medication works by depressing the central nervous system to produce sedation and unconsciousness.
Is Propofol Injectable Emulsion a controlled substance?
Propofol Injectable Emulsion is not classified as a controlled substance by the DEA.
What is the generic name for Propofol Injectable Emulsion?
The generic name for Propofol Injectable Emulsion is Propofol Injectable Emulsion. There are no other listed brand versions of Propofol Injectable Emulsion.
What is the NDC code for Propofol Injectable Emulsion 10 mg/mL?
The NDC (National Drug Code) for Propofol Injectable Emulsion 10 mg/mL is 43598-548, listed by Dr. Reddy's Laboratories, Inc..
Other Propofol Injectable Emulsion Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)