Cipepofol (intravenous route)


    Brand Name

    US Brand Name

    Cypsedo


    Description

    Cipepofol 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.

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


    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

    Because of cipepofol's toxicity (eg, brain or nerve problems), use in children is not recommended. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cipepofol injection in the elderly.

    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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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.
    • Heart disease or
    • Lung or breathing problems—Use with caution. May make these conditions worse.
    • Kidney disease, severe or
    • Liver disease, severe—Use is not recommended in patients with these conditions.

    Proper Use

    A doctor or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins.


    Precautions

    It is very important that your doctor check your progress closely while you are receiving this medicine to make sure this medicine is working properly and to check for unwanted effects.

    This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

    Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness or fainting, no blood pressure or pulse, slow or irregular heartbeat, stopping of the heart, trouble breathing, unconsciousness, or unusual tiredness. These may be symptoms of heart problems.

    This medicine may increase the risk for lung or breathing problems. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, or trouble breathing.

    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
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • headache
    • nervousness
    • pounding in the ears
    • slow or fast heartbeat
    • sweating
    • unusual tiredness or weakness

    Less common

    • Chest pain or discomfort
    • muscle contractions
    • pale skin
    • sudden jerky movements of body
    • trouble breathing
    • unusual bleeding or bruising

    Incidence not known

    • Bluish color
    • changes in skin color
    • chest tightness
    • cough
    • difficulty swallowing
    • hives, itching, skin rash
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • swelling of the foot or leg

    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

    • Lack or loss of strength
    • nausea
    • vomiting

    Less 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
    • constipation

    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.






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