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Drug Notebook

FDA Alerts

Special Alerts:

[Posted 06/15/2007] FDA informed healthcare professionals about several clusters of patients who experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia. Multiple vials and several lots of propofol used in patients who experienced these symptoms were tested and there was no evidence that the propofol vials or prefilled syringes used were contaminated with bacteria or endotoxins. Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. To minimize the potential for bacterial contamination, propofol vials and prefilled syringes should be used within six hours of opening and one vial should be used for one patient only. Patients who develop fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol should be evaluated for bacterial sepsis. Healthcare professionals who administer propofol for sedation or general anesthesia should carefully follow the recommendations for handling and use in the product's full prescribing information. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Diprivan and http://www.fda.gov/cder/drug/infopage/propofol/default.htm.

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propofol

What is this medicine?

PROPOFOL is an anesthetic. It is used to produce relaxation and sleep before or during surgery. It is also used in patients on a ventilator.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 months old for selected conditions, precautions do apply.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

This medicine may also interact with the following medications:

  • alcohol
  • barbiturates for sleep or seizures
  • levodopa
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for sleep
  • narcotic medicines for pain
  • other medicines for sleep during surgery

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in vision
  • dark urine
  • fast, irregular heartbeat
  • feeling faint or lightheaded, falls
  • fever
  • low blood pressure
  • muscle pain or weakness
  • numbness or tingling in the hands or feet
  • seizures
  • stomach pain
  • trouble passing urine or change in the amount of urine
  • uncontrollable muscle spasm
  • unusual weakness

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • dizziness
  • nausea
  • pain at site where injected

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: May 19, 2008
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