Conivaptan (intravenous route)


    Brand Name

    US Brand Name

    Vaprisol


    Description

    Conivaptan injection is used to treat euvolemic hyponatremia (a condition where there is not enough sodium in your blood but with a normal blood volume). Sodium is a chemical that the body needs to be able to function well. Even if there is a normal blood volume, but with a low sodium level, it can still be a danger to your health. Conivaptan works by maintaining the right amount of sodium that the body needs.

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

    This product is available in the following dosage forms:

    • Solution

    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 have not been performed on the relationship of age to the effects of conivaptan injection in the pediatric population. 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 conivaptan 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. 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.

    • Alfuzosin
    • Boceprevir
    • Ceritinib
    • Clarithromycin
    • Cobicistat
    • Colchicine
    • Delavirdine
    • Dronedarone
    • Eletriptan
    • Eplerenone
    • Ergotamine
    • Flibanserin
    • Idelalisib
    • Indinavir
    • Itraconazole
    • Ivabradine
    • Ketoconazole
    • Levoketoconazole
    • Lomitapide
    • Lonafarnib
    • Lopinavir
    • Lurasidone
    • Maraviroc
    • Mifepristone
    • Nefazodone
    • Nelfinavir
    • Nimodipine
    • Paritaprevir
    • Posaconazole
    • Ribociclib
    • Ritonavir
    • Saquinavir
    • Telaprevir
    • Telithromycin
    • Troleandomycin
    • Tucatinib
    • Voriconazole

    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.

    • Acalabrutinib
    • Adagrasib
    • Ado-Trastuzumab Emtansine
    • Afatinib
    • Alfentanil
    • Alprazolam
    • Amiodarone
    • Amlodipine
    • Apalutamide
    • Apixaban
    • Aprepitant
    • Aripiprazole
    • Artemether
    • Asciminib
    • Atogepant
    • Atorvastatin
    • Avacopan
    • Avanafil
    • Avapritinib
    • Axitinib
    • Bedaquiline
    • Belzutifan
    • Benzhydrocodone
    • Berotralstat
    • Betrixaban
    • Bosutinib
    • Brexpiprazole
    • Brigatinib
    • Bromocriptine
    • Budesonide
    • Buprenorphine
    • Buspirone
    • Cabazitaxel
    • Cabozantinib
    • Calcifediol
    • Capivasertib
    • Carbamazepine
    • Cariprazine
    • Cilostazol
    • Cisapride

    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.

    • Aripiprazole Lauroxil

    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. 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 is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

    • Grapefruit Juice

    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:

    • Anuria (trouble urinating) or
    • Hypovolemic hyponatremia (low blood sodium with low blood volume)—Should not be used in patients with these conditions.
    • Heart disease (eg, heart failure) or
    • Hypotension (low blood pressure) or
    • Hypovolemia (low blood volume)—Use with caution. May make these conditions worse.
    • Kidney disease, moderate or severe or
    • Liver disease, severe—Use with caution. These conditions may increase the concentration of conivaptan in your blood.

    Proper Use

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


    Precautions

    It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

    If your symptoms do not improve within a few days or if they become worse, check with your doctor.

    You should not use clarithromycin (Biaxin®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), or ritonavir (Norvir®). Using these medicines together may cause serious unwanted effects.

    Tell your doctor right away if you have the following symptoms after receiving this medicine: a slurred speech, trouble speaking, trouble swallowing, seizures, or unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness. These may be symptoms of a nerve problem called osmotic demyelination syndrome.

    This medicine may make you feel dizzy or lightheaded. Do not drive or do anything 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

    • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the site
    • bloating or swelling of the face, arms, hands, lower legs, ankles, or feet
    • blurred vision
    • decreased urine
    • dizziness
    • dry mouth
    • headache
    • increased thirst
    • irregular heartbeat
    • loss of appetite
    • mood changes
    • muscle pain or cramps
    • nausea or vomiting
    • nervousness
    • numbness or tingling in the hands, feet, or lips
    • pounding in the ears
    • rapid weight gain
    • seizures
    • slow or fast heartbeat
    • tingling of hands or feet
    • unusual tiredness or weakness
    • unusual weight gain or loss

    Less common

    • Abdominal or stomach pain
    • bladder pain
    • bloody or cloudy urine
    • bluish color
    • change in consciousness
    • changes in skin color
    • chest pain
    • cold sweats
    • confusion
    • cool pale skin
    • cough
    • decreased urination
    • depression
    • difficult, burning, or painful urination
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • drowsiness
    • fainting
    • fear
    • fever or chills
    • flushed, dry skin
    • frequent urge to urinate
    • fruit-like breath odor
    • increase in amount of urine
    • increase in heart rate
    • increased hunger
    • increased urination
    • loss of consciousness
    • lower back or side pain
    • mental changes
    • muscle spasms [tetany] or twitching
    • nightmares
    • pale skin
    • problems in urination
    • rapid breathing
    • shakiness
    • slurred speech
    • sneezing
    • sore mouth or tongue
    • sore throat
    • sunken eyes
    • sweating
    • swelling of the foot or leg
    • tenderness
    • thirst
    • tightness in the chest
    • trembling
    • trouble sleeping
    • troubled breathing with exertion
    • unusual bleeding or bruising
    • white patches in the mouth or on the tongue
    • wrinkled skin

    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

    • Diarrhea

    Less common

    • Difficulty having a bowel movement (stool)
    • redness of the skin
    • unusually warm skin

    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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