Propofol
Generic: PROPOFOL
Basic Information
Manufacturer
Avenacy, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
de351d5f-581d-4768-a4af-fbd8e5bce264
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 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 2 months.
MAC sedation in the pediatric population is not recommended.
Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation.
( 1 )
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 2 months.
MAC sedation in the pediatric population is not recommended.
Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation.
( 1 )
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 US/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.
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 ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 events for propofol injectable emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2,889 adult patients).
The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with propofol injectable emulsion was greater than the comparator incidence rate in these trials.
Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship.
The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with propofol injectable emulsion during anesthesia (see Table 3 below).
During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea.
Anesthesia in Pediatric Patients Generally, the adverse experience profile from reports of 506 propofol injectable emulsion pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with propofol injectable emulsion during anesthesia in adults.
Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients.
ICU Sedation in Adults The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients).
Probably related incidence rates for ICU sedation were determined by individual case report form review.
Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge.
In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown.
Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship.
Table 2: Treatment Emergent Adverse Events Observed from Clinical Trials Anesthesia/MAC Sedation ICU Sedation Body as a Whole: Anaphylaxis/Anaphylactoid reaction perinatal disorder, tachycardia, bigeminy, bradycardia, premature ventricular contractions, hemorrhage, ECG abnormal arrhythmia atrial, fever, extremities pain, anticholinergic syndrome, asthenia, awareness, chest pain, extremities pain, fever, increased drug effect, neck rigidity/stiffness, trunk pain Fever, sepsis, trunk pain, whole body weakness Cardiovascular: Premature atrial contractions Syncope, hypotension [see also Clinical Pharmacology ( 12 )], tachycardia Nodal, arrhythmia Bradycardia, arrhythmia, atrial fibrillation, atrioventricular heart block, bigeminy, bleeding, bundle branch block, cardiac arrest, ECG abnormal, edema, extrasystole, heart block, hypertension, myocardial infarction, myocardial ischemia, premature ventricular contractions, ST segment depression, supraventricular tachycardia, tachycardia, ventricular fibrillation Bradycardia, decreased cardiac output, arrhythmia, atrial fibrillation, bigeminy, cardiac arrest, extrasystole, right heart failure, ventricular tachycardia Central Nervous System: Hypertonia/Dystonia, paresthesia, movement, abnormal dreams, agitation, amorous behavior, anxiety, bucking/jerking/thrashing, chills/shivering/clonic/myoclonic movement, combativeness, confusion, delirium, depression, dizziness, emotional lability, euphoria, fatigue, hallucinations, headache, hypotonia, hysteria, insomnia, moaning, neuropathy, opisthotonos, rigidity, seizures, somnolence, tremor, twitching Agitation, hypotension, hills/shivering, intracranial hypertension, seizures, somnolence, thinking abnormal Digestive: Hypersalivation, nausea, cramping, diarrhea, dry mouth, enlarged parotid, nausea, swallowing, vomiting Ileus, liver function abnormal Hemic/Lymphatic: Leukocytosis, coagulation disorder, leukocytosis Injection Site: Phlebitis, pruritus, burning/Stinging or pain, hives/itching, phlebitis, redness/discoloration Metabolic/Nutritional: Hypomagnesemia, hyperkalemia, hyperlipemia BUN increased, creatinine increased, dehydration, hyperglycemia, metabolic acidosis, osmolality increased, hyperlipemia Musculoskeletal: Myalgia Nervous: Dizziness, agitation, chills, somnolence Delirium Respiratory: Wheezing, cough, laryngospasm, hypoxia, apnea, bronchospasm, burning in throat, dyspnea, hiccough, hyperventilation, hypoventilation, pharyngitis, sneezing, tachypnea, upper airway obstruction Decreased lung function, respiratory acidosis during weaning, hypoxia Skin and Appendages: Flushing, Pruritus, rash, conjunctival hyperemia, diaphoresis, urticaria Rash Special Senses: Amblyopia, vision abnormal, diplopia, ear pain, eye pain, nystagmus, taste perversion, tinnitus Urogenital: Cloudy urine, oliguria, urine retention Green urine, kidney failure Postmarketing Experience During the post-marketing period, there have been rare reports of local pain, swelling, blisters, and/or tissue necrosis following accidental extravasation of propofol injectable emulsion [see Warnings and Precautions ( 5.14 )].
Venous sequelae, i.e., phlebitis or thrombosis, have been reported rarely (<1%).
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.
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 ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 events for propofol injectable emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2,889 adult patients).
The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with propofol injectable emulsion was greater than the comparator incidence rate in these trials.
Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship.
The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with propofol injectable emulsion during anesthesia (see Table 3 below).
During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea.
Anesthesia in Pediatric Patients Generally, the adverse experience profile from reports of 506 propofol injectable emulsion pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with propofol injectable emulsion during anesthesia in adults.
Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients.
ICU Sedation in Adults The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients).
Probably related incidence rates for ICU sedation were determined by individual case report form review.
Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge.
In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown.
Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship.
Table 2: Treatment Emergent Adverse Events Observed from Clinical Trials Anesthesia/MAC Sedation ICU Sedation Body as a Whole: Anaphylaxis/Anaphylactoid reaction perinatal disorder, tachycardia, bigeminy, bradycardia, premature ventricular contractions, hemorrhage, ECG abnormal arrhythmia atrial, fever, extremities pain, anticholinergic syndrome, asthenia, awareness, chest pain, extremities pain, fever, increased drug effect, neck rigidity/stiffness, trunk pain Fever, sepsis, trunk pain, whole body weakness Cardiovascular: Premature atrial contractions Syncope, hypotension [see also Clinical Pharmacology ( 12 )], tachycardia Nodal, arrhythmia Bradycardia, arrhythmia, atrial fibrillation, atrioventricular heart block, bigeminy, bleeding, bundle branch block, cardiac arrest, ECG abnormal, edema, extrasystole, heart block, hypertension, myocardial infarction, myocardial ischemia, premature ventricular contractions, ST segment depression, supraventricular tachycardia, tachycardia, ventricular fibrillation Bradycardia, decreased cardiac output, arrhythmia, atrial fibrillation, bigeminy, cardiac arrest, extrasystole, right heart failure, ventricular tachycardia Central Nervous System: Hypertonia/Dystonia, paresthesia, movement, abnormal dreams, agitation, amorous behavior, anxiety, bucking/jerking/thrashing, chills/shivering/clonic/myoclonic movement, combativeness, confusion, delirium, depression, dizziness, emotional lability, euphoria, fatigue, hallucinations, headache, hypotonia, hysteria, insomnia, moaning, neuropathy, opisthotonos, rigidity, seizures, somnolence, tremor, twitching Agitation, hypotension, hills/shivering, intracranial hypertension, seizures, somnolence, thinking abnormal Digestive: Hypersalivation, nausea, cramping, diarrhea, dry mouth, enlarged parotid, nausea, swallowing, vomiting Ileus, liver function abnormal Hemic/Lymphatic: Leukocytosis, coagulation disorder, leukocytosis Injection Site: Phlebitis, pruritus, burning/Stinging or pain, hives/itching, phlebitis, redness/discoloration Metabolic/Nutritional: Hypomagnesemia, hyperkalemia, hyperlipemia BUN increased, creatinine increased, dehydration, hyperglycemia, metabolic acidosis, osmolality increased, hyperlipemia Musculoskeletal: Myalgia Nervous: Dizziness, agitation, chills, somnolence Delirium Respiratory: Wheezing, cough, laryngospasm, hypoxia, apnea, bronchospasm, burning in throat, dyspnea, hiccough, hyperventilation, hypoventilation, pharyngitis, sneezing, tachypnea, upper airway obstruction Decreased lung function, respiratory acidosis during weaning, hypoxia Skin and Appendages: Flushing, Pruritus, rash, conjunctival hyperemia, diaphoresis, urticaria Rash Special Senses: Amblyopia, vision abnormal, diplopia, ear pain, eye pain, nystagmus, taste perversion, tinnitus Urogenital: Cloudy urine, oliguria, urine retention Green urine, kidney failure Postmarketing Experience During the post-marketing period, there have been rare reports of local pain, swelling, blisters, and/or tissue necrosis following accidental extravasation of propofol injectable emulsion [see Warnings and Precautions ( 5.14 )].
Venous sequelae, i.e., phlebitis or thrombosis, have been reported rarely (<1%).