Description
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.
This product is available in the following dosage forms:
- Emulsion
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
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
- Azithromycin
- Barbital
- Benzhydrocodone
- Bromazepam
- Bromopride
- Bupivacaine
- Bupivacaine Liposome
- Buprenorphine
- Bupropion
- Butabarbital
- Butalbital
- Butorphanol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbidopa
- Carbinoxamine
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
- Clobazam
- Clonazepam
- Clorazepate
- Codeine
- Cyclobenzaprine
- Cyproheptadine
- Daridorexant
- Dexmedetomidine
- Diazepam
- Dichloralphenazone
- Dihydrocodeine
- Doxylamine
- Esketamine
- Estazolam
- Eszopiclone
- Fentanyl
- Flibanserin
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
- Tizanidine
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
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
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
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.
DRG-20488192
