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• Procedural Bp Mac Os Catalina

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Medically reviewed by Drugs.com. Last updated on Aug 24, 2020.

For the Consumer

Applies to propofol: parenteral injectable emulsion

Warning

Special Alerts:

Emergency Use Authorization (EUA) for Propoven:⁷⁵⁸ On May 8, 2020, FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of the unapproved product, Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL, 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. Because Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion has a concentration twice that of the FDA-approved propofol product, there is a risk of unintentional overdose. There are also important differences in the formulation and labeling between the two products. Healthcare providers should review the EUA and the differences between the two products prior to administering Propoven. Documents related to the EUA can be found on the FDA website at [Web], including the most recent letter of authorization ([Web]), a fact sheet on the EUA for healthcare providers ([Web]), and a wall chart outlining the key differences between the two products ([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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-repackaging-or-combining-propofol-drug-products-during-covid-19-public-health.

Side effects include:

General anesthesia or MAC sedation: Bradycardia, arrhythmia, tachycardia, hypotension, hypertension, movement, burning/stinging, pain at injection site, apnea, rash, pruritus.

ICU sedation: Bradycardia, decreased cardiac output, hypotension, hyperlipidemia, respiratory acidosis (during weaning).

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]

References

1. 'Product Information. Propofol (propofol).' Hospira Inc, Lake Forest, IL.

2. 'Product Information. Diprivan (propofol).' Zeneca Pharmaceuticals, Wilmington, DE.

More about propofol

• During Pregnancy or Breastfeeding

Consumer resources

Other brands

Diprivan, Propoven

Professional resources

Related treatment guides

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Procedural Bp Mac Os Catalina

Some side effects may not be reported. You may report them to the FDA.