Applies to propofol: parenteral injectable emulsion.
Warning
Special Alerts:
Emergency Use Authorization (EUA) for Propofol-Lipuro:759 760 On March 12, 2021, FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of the unapproved product, Propofol-Lipuro 1% injectable emulsion for infusion, to maintain sedation via continuous infusion in patients older than 16 years of age who require mechanical ventilation in an intensive care unit (ICU) setting during the COVID-19 pandemic. The product should be used only in accordance with the conditions described in the authorization and with dosage regimens recommended in the fact sheet for healthcare providers. For additional information, consult the EUA at [Web] and the fact sheet for healthcare providers at [Web].
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency:756 During the COVID-19 public health emergency, FDA has received several inquiries from healthcare professionals concerning the unavailability of propofol drug products used in the treatment and management of patients with complications related to COVID-19. FDA is issuing this guidance to communicate its temporary policy regarding the repackaging or combining of propofol drug products by a licensed pharmacist in a State licensed pharmacy, a Federal facility, or an outsourcing facility registered pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b) as outlined in this guidance for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, or for such shorter time as FDA may announce through updated guidance. This policy is intended to remain in effect for no longer than the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). FDA is continually assessing the needs and circumstances that make issuance of this guidance appropriate. As relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw policies in this guidance as appropriate. For additional information, please see the full guidance at [Web]/regulatory-information/search-fda-guidance-documents/temporary-policy-repackaging-or-combining-propofol-drug-products-during-covid-19-public-health.
Side effects include:
Common adverse reactions (>1%): bradycardia, arrhythmia, tachycardia, hypotension, hypertension, decreased cardiac output, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, hyperlipemia.
For Healthcare Professionals
Applies to propofol: intravenous emulsion.
Cardiovascular
Very common (10% or more): Hypotension (75%)
Common (1% to 10%): Hypertension, bradycardia
Uncommon (0.1% to 1%): Arrhythmias, atrial fibrillation, atrioventricular heart block, bigeminy, bundle branch block, cardiac arrest, ECG abnormal, edema, extrasystole, heart block, myocardial infarction, myocardial ischemia, premature ventricular contractions, ST segment depression, supraventricular tachycardia, tachycardia, ventricular fibrillation, extrasystole, syncope, chest pain, right heart failure
Rare (0.01% to 0.1%): Pulmonary edema, asystole, syncope, perioperative arrhythmias, cardiac arrest
Very rare (less than 0.01%): Cardiac failure
Frequency not reported: Cardiac arrhythmia[Ref]
Dermatologic
Very common (10% or more): Pruritus (28%)
Common (1% to 10%): Transient flush, rash
Uncommon (0.1% to 1%): Conjunctival hyperemia, diaphoresis, urticaria[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, vomiting
Uncommon (0.1% to 1%): Hypersalivation, cramping, diarrhea, dry mouth, enlarged parotid, nausea, impaired swallowing, vomiting, ileus
Very rare (less than 0.01%): Pancreatitis, abdominal cramps[Ref]
Genitourinary
Uncommon (0.1% to 1%): Urinary retention oliguria
Rare (Less than 0.1%): Discoloration of the urine following prolonged use[Ref]
Hepatic
Frequency not reported: Hepatomegaly[Ref]
Hypersensitivity
Rare (0.01% to 0.1%): Anaphylaxis, in some cases with angioedema, bronchospasm, erythema, and hypotension (these reactions have been reported to respond to adrenaline)[Ref]
Local
Common (1% to 10%): Pain during injection (e.g., burning, tingling/slinging)
Very rare (less than 0.01%): Tissue necrosis following accidental extravascular administration
Uncommon (0.1% to 1%): Hives/itching, phlebitis, redness/discoloration[Ref]
Metabolic
Uncommon (0.1% to 1%): BUN Increased, creatinine increased, dehydration, hyperglycemia, metabolic acidosis, osmolality increased
Very rare (less than 0.01%): Metabolic acidosis, hyperkalemia, hyperlipidemia[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Pain in extremities, trunk pain, whole body weakness, pain in extremities, neck rigidity/stiffness
Very rare (less than 0.01%): Rhabdomyolysis (when administered at doses greater than 4 mg/kg/hour for ICU sedation)[Ref]
Nervous system
Paresthesias (including burning, tingling, stinging) and/or pruritus, usually manifested in the perineal region, were the most frequently recorded adverse reactions in clinical trials. Paresthesias and pruritus generally occurred within 5 minutes after administration of the initial dose and were generally transient and mild to moderate in intensity. The pharmacologic basis of these sensory phenomena is unknown. No pretreatments, including the use of nonsteroidal anti-inflammatory drugs, opioids, or lidocaine, are known to have an effect on or to reduce the incidence of these sensations.[Ref]
Very common (10% or more): Paresthesia (74%), excitation phenomena such as involuntary movements, twitches, tremors, hypertonus, hiccup
Common (1% to 10%): Headache, shivering
Rare (0.01% to 0.1%): Convulsions and seizures of the epileptic type
Very rare (less than 0.01%): Postoperative unconsciousness
Frequency not reported: Involuntary movements[Ref]
Respiratory
Very common (10% or more): Hypoxemia (11%)
Common (1% to 10%): Procedural pain (bronchoscopy), transient apnea, cough, respiratory acidosis during weaning
Uncommon (0.1% to 1%): Bronchospasm, burning in throat, cough, dyspnea, hiccough, hyperventilation, hypoventilation, hypoxia, laryngospasm, pharyngitis, sneezing, tachypnea, upper airway obstruction, apnea
Very rare (less than 0.01%): Pulmonary edema[Ref]
Renal
Very rare (less than 0.01%): Renal failure[Ref]
Hematologic
Common (1% to 10%): Thrombosis, phlebitis
Uncommon (0.1% to 1%): Hemorrhage, coagulation disorder, leukocytosis[Ref]
Immunologic
Uncommon (0.1% to 1%): Sepsis[Ref]
Ocular
Uncommon (0.1% to 1%): Diplopia, eye pain, nystagmus[Ref]
Psychiatric
Common (1% to 10%): Elation/euphoria
Frequency not reported: Drug abuse and dependence[Ref]
Other
Uncommon (0.1% to 1%): Fever, anticholinergic syndrome, ear pain, taste perversion, tinnitus[Ref]
