Pronunciation:

PROE-poe-fol

Brand Names:

• Diprivan
• Fresenious Propoven

Dosage Forms:

• Emulsion

Warnings:

Emergency Use Authorization of Fresenius Propoven 2% Emulsion: Note important differences in formulation and labeling between the current US marketed FDA-approved Diprivan(R) injectable emulsion, USP 10 mg/mL products and Fresenius Propoven 2% emulsion. See details in the Fact Sheet for Health Care Providers before administering Fresenius Propoven 2% emulsion .

Classifications:

Therapeutic—

Sedative-Hypnotic

Uses of This Medicine:

Propofol injection is used to help you relax or sleep before and during surgery or other medical procedures. This medicine is an anesthetic and a sedative. Propofol may also be used to sedate coronavirus (COVID-19) patients who need mechanical ventilation in the intensive care unit (ICU).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Propofol-Lipuro 1% injection to sedate children older than 16 years of age with coronavirus disease (COVID-19) in the ICU.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Diprivan® injection to induce anesthesia in children 3 years of age and older, and to maintain anesthesia in children 2 months of age and older. Use of this medicine to induce anesthesia in children younger than 3 years of age and to maintain anesthesia in children younger than 2 months of age is not recommended. Safety and efficacy have not been established in children for other approved conditions.

Serious unwanted effects on early brain development of children younger than 3 years of age may occur with repeated or prolonged use of this medicine. Talk to your doctor if you have concerns about this.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of propofol injection in the elderly. However, elderly patients are more likely to have age-related heart or lung disease (eg, low blood pressure, breathing problems), which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Amobarbital
• Barbital
• Benzhydrocodone
• Bromazepam
• Bromopride
• Bupivacaine
• Bupivacaine Liposome
• Buprenorphine
• Bupropion
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Daridorexant
• Dexmedetomidine
• Diazepam
• Dichloralphenazone
• Dihydrocodeine
• Doxylamine
• Esketamine
• Estazolam
• Eszopiclone
• Fentanyl
• Flibanserin
• Gabapentin
• Gabapentin Enacarbil
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Ketamine
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lidocaine
• Lofexidine
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Meperidine
• Mephobarbital
• Meprobamate
• Methadone
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Oxazepam
• Oxycodone
• Oxymorphone
• Paraldehyde
• Pentazocine
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Ramelteon
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Tapentadol
• Temazepam
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Valproic Acid
• Zaleplon
• Zolpidem
• Zopiclone
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Succinylcholine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to eggs, egg products, soybeans, or soy products, history of—Should not be used in patients with this condition.

• Brain or nerve problems (eg, head injury, stroke, or seizures), history of or
• Diabetes or
• High fat or cholesterol in the blood or
• Infection (eg, sepsis), severe or
• Pancreatitis (swelling of the pancreas)—Use with caution. May increase risk for more serious side effects.

• Heart disease or
• Kidney disease or
• Lung or breathing problems or
• Mitochondrial disorder (genetic disorder) or
• Seizures—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to make sure this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat after receiving this medicine.

This medicine may cause propofol infusion syndrome, which can lead to more serious problems (eg, high potassium in the blood, high fat or cholesterol in the blood, rhabdomyolysis, enlarged liver, kidney failure, heart failure). Tell your doctor right away if you have chest pain or discomfort, confusion, dark-colored urine, dizziness, drowsiness, lightheadedness, fainting, fever, muscle cramps, spasms, pain, or stiffness, nausea, right upper abdominal or stomach pain and fullness, slow or irregular heartbeat, trouble breathing, stomach cramps, unusual tiredness or weakness after receiving this medicine.

Check with you doctor right away if you have bluish lips or skin, blurred vision, choking, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, drowsiness, pale skin, sweating, trouble breathing or speaking, unusual tiredness or weakness after receiving this medicine. These could be symptoms of a serious heart or lung problem.

This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, slow, irregular, or pounding heartbeat or pulse

headache

nervousness

pounding in the ears

problems with movement

sweating

unusual tiredness or weakness

Less common

Bluish lips or skin

chest pain or discomfort

difficulty breathing

lightheadedness, dizziness, or fainting

Rare

Anxiety

bleeding gums

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in vision

chills

cloudy urine

cough

coughing up blood

delirium or hallucinations

difficult urination

difficulty swallowing

dry eyes, mouth, nose, or throat

excessive muscle tone

eye pain

fever

flushing or redness of the face

general feeling of illness

hives, itching, skin rash

inability to move the eyes

increased blinking or spasms of the eyelid

increased menstrual flow or vaginal bleeding

increased watering of the mouth

irritability

joint pain or swelling

loss of appetite

mood or mental changes

muscle aches, cramps, or pains

muscle spasms or twitching

muscle stiffness, tension, or tightness

nausea or vomiting

nosebleeds

pain in the arms or legs

prolonged bleeding from cuts

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red or dark brown urine

red or black, tarry stools

restlessness

shaking

sleepiness or unusual drowsiness

sore throat

sticking out of tongue

tightness in the chest

trembling

trouble sleeping

trouble speaking

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual facial expressions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.