PROPOFOL injection, emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF)

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 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 is not indicate

Product summary:

Propofol Injectable Emulsion, USP Vials containing 10 mg/mL of propofol, is available as follows: 20 mL single dose vial in cartons of 10. NDC 0641-6194-10. 50 mL single-patient infusion vial in cartons of 20. NDC 0641-6195-20. 100 mL single-patient infusion vial in cartons of 10. NDC 0641-6196-10. Store between 4° to 25°C (40° to 77°F). DO NOT FREEZE. Shake well before use.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPOFOL- PROPOFOL INJECTION, EMULSION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROPOFOL INJECTABLE
EMULSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PROPOFOL
INJECTABLE EMULSION.
PROPOFOL INJECTABLE EMULSION, USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Propofol injectable emulsion is an intravenous general anesthetic and
sedation drug indicated for: (1)
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: (1)
Propofol is not recommended for induction of anesthesia below the age
of 3 years or for maintenance of
anesthesia below the age of 2 months (1)
MAC sedation in the pediatric population is not recommended (1)
Propofol is not indicated for use in Pediatric ICU sedation (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for detailed dosing instructions. (2)
DOSAGE FORMS AND STRENGTHS
Injectable emulsion: 200 mg per 20 mL (10 mg/mL), 500 mg per 50 mL (10
mg/mL), and 1,000 mg per
100 mL (10 mg/mL) single-dose vials (3)
CONTRAINDICATIONS
Known hypersensitivity to propofol, egg or soybean (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Serious and sometimes fatal reactions
(5.1)
Microbial Contamination: Strict aseptic technique must be maintained
during handling. Propofol injectable
emulsion 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 (5.2)
Cardiovascular d