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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). Small scientist mac os.
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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
The poem mac os. 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 Dins legacy mac os.
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.
Some side effects may not be reported. You may report them to the FDA.
Use Time Machine, the built-in backup feature of your Mac, to automatically back up your personal data, including apps, music, photos, email, and documents. Having a backup allows you to recover files that were deleted, or that were lost because the hard disk (or SSD) in your Mac needed to be erased or replaced. Learn how to restore your Mac from a backup.
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Create a Time Machine backup
To create backups with Time Machine, all you need is an external storage device. After you connect the storage device and select it as your backup disk, Time Machine automatically makes hourly backups for the past 24 hours, daily backups for the past month, and weekly backups for all previous months. The oldest backups are deleted when your backup disk is full.
Connect an external storage device
Connect one of the following external storage devices, sold separately. Learn more about backup disks that you can use with Time Machine.
- External drive connected to your Mac, such as a USB or Thunderbolt drive
- Network-attached storage (NAS) device that supports Time Machine over SMB
- Mac shared as a Time Machine backup destination
- AirPort Time Capsule, or external drive connected to an AirPort Time capsule or AirPort Extreme Base Station (802.11ac)
Select your storage device as the backup disk
- Open Time Machine preferences from the Time Machine menu in the menu bar. Or choose Apple menu > System Preferences, then click Time Machine.
- Click Select Backup Disk.
Enjoy the convenience of automatic backups
After you select a backup disk, Time Machine immediately begins making periodic backups—automatically and without further action by you. The first backup may take a long time, but you can continue using your Mac while a backup is underway. Time Machine backs up only the files that changed since the previous backup, so future backups will be faster.
To start a backup manually, choose Back Up Now from the Time Machine menu in the menu bar. Use the same menu to check the status of a backup or skip a backup in progress.
Learn more
- Learn about other ways to back up and restore files.
- If you back up to multiple disks, you can press and hold the Option key, then choose Browse Other Backup Disks from the Time Machine menu.
- To exclude items from your backup, open Time Machine preferences, click Options, then click the add (+) button to add an item to be excluded. To stop excluding an item, such as an external hard drive, select the item and click the remove (–) button.
- If using Time Machine to back up to a network disk, you can verify those backups to make sure they're in good condition. Press and hold Option, then choose Verify Backups from the Time Machine menu.
