Propofol Injection

WHY is this medicine prescribed?

Propofol is used to begin and maintain general anesthesia (you are unconscious and unaware of what is happening) during surgery in adults and children.It is also used to provide sedation (you are relaxed, sleepy or in some cases asleep) in adults during surgical or other medical procedures.Propofol is also used to provide sedation for adults in intensive care units that are receiving mechanical ventilation (a machine that takes over the work of breathing). Propofol is in a class of medications called anesthetic agents. It works by changing the activity of certain substances in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Propofol comes as a emulsion (liquid) to give intravenously (into a vein) by a specially trained healthcare provider. It is usually given by infusion or injections as frequently and in amounts required to maintain anesthesia or sedation depending on age, health, and other factors. Your dose will be adjusted based on your response. You will be monitored carefully by your healthcare provider while you are receiving propofol and for a period of time afterwards.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving propofol,

• tell your doctor and pharmacist if you are allergic to propofol, any other medications, or any of the ingredients in propofol emulsion. Also tell your doctor and pharmacist if you have a serious allergic reaction to eggs, egg products, soybeans, or soy products. Your doctor will probably not give you propofol. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving propofol. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had seizures, pancreatitis, diabetes, increased triglyceride levels, or low levels in zinc in your body.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.

• you should know that propofol may make you drowsy and reduce mental alertness. Do not drive a car, operate machinery, or sign legal documents until your doctor recommends you to do so.

What SIDE EFFECTS can this medicine cause?

Propofol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• burning, stinging, or pain at injection site

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• itching, rash, hives; difficulty breathing; dizziness; swelling of the lips, tongue, throat or eyes
• difficulty breathing or swallowing
• irregular heartbeat
• sudden, twitching, jerking, or spasm of muscles that you cannot control
• nausea, vomiting, pain in the upper abdomen that spread to the back

Propofol may may have negative effects on their developing brain cause in children younger than 3 years of age. Talk to your doctor about the risks of giving this medication to young children.

Propofol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.