Fresenious Propoven (Intravenous)

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.

It is very important that your doctor checks your or your child's progress closely while you are receiving this medicine to ensure it 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 (e.g., 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 your 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.

In deciding to use a medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Current studies have not shown any specific problems that would limit the use of Propofol-Lipuro 1% injection for sedating children older than 16 years of age with coronavirus disease (COVID-19) in the ICU.

Current studies have not shown any specific problems that would limit the use 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. It is not recommended to use this medicine to induce anesthesia in children younger than 3 years of age or to maintain anesthesia in children younger than 2 months of age. Safety and effectiveness have not been established in children for other approved conditions.

Repeated or prolonged use of this medicine may seriously affect early brain development in children younger than 3 years of age. Discuss any concerns with your doctor.

Geriatric

Current studies have not shown any specific problems that would limit the use of propofol injection in elderly patients. However, older adults are more likely to have heart or lung issues related to aging (e.g., low blood pressure, breathing problems), which may require caution and a dose adjustment for patients taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may need to change the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions have been selected based on their potential significance and are not all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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 increase the risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Alfentanil
• Succinylcholine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food since interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Make sure to inform your doctor if you have any other medical issues, 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 (e.g., head injury, stroke, or seizures), history of or
• Diabetes or
• High fat or cholesterol in the blood or
• Severe infection (e.g., sepsis) or
• Pancreatitis (swelling of the pancreas)—Use with caution. May increase the 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 worsen these conditions.

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

In the U.S.

• Diprivan
• Fresenious Propoven

Available Dosage Forms:

• Emulsion

Therapeutic Class: Sedative-Hypnotic

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.