Propofol Injectable Emulsion
Drug Details
- Generic Name
- Propofol Injectable Emulsion
- Brand Names
- Propofol Injectable Emulsion
- Application Number
- ANDA205067
- Sponsor
- Dr. Reddy's Laboratories, Inc.
- NDC Codes
- 3
- Dosage Forms
- INJECTION, EMULSION
- Routes
- INTRAVENOUS
- Active Ingredients
- PROPOFOL
Indications and 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 established [see Pediatric Use ( 8.4 )]. 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 2months. MAC sedation in the pediatric population is not recommended propofol injectable emulsion is not indicated for use in Pediatric ICU sedation.