Brand Name

    US Brand Name

    Kinevac


    Description

    Sincalide injection is a diagnostic aid used to help diagnose certain problems of the gallbladder and pancreas. It is also used to speed up barium digestion to decrease radiation exposure during bowel examination (eg, fluoroscopy, x-ray examination).

    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:

    • Powder for Solution

    Before Using

    In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, 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 sincalide injection in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Although appropriate studies on the relationship of age to the effects of sincalide injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

    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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

    • Allergy to sulfites, history of or
    • Bowel blockage—Should not be used in patients with these conditions.
    • Gallstones (gallbladder stones)—Use with caution. May increase risk for more side effects.

    Proper Use

    A nurse or other trained health professional will give you this medicine before you have your medical test done. It is given through an IV placed into one of your veins.


    Precautions

    It is very important that your doctor check your progress closely while receiving the medicine to make sure that 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. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

    Tell your doctor if you are pregnant before receiving this medicine. Sincalide may cause pre-term labor and early pregnancy loss in pregnant women. Talk to your doctor if you have concerns about this.

    This medicine stimulates the gallbladder to contract. If you have small gallstones, they may get stuck in the cystic duct or in the common bile duct and cause blockage. Talk to your doctor if you have concerns about this.

    This medicine may cause stomach or bowel problems. Tell your doctor right away if you have dizziness, flushing, nausea, stomach pain or cramping, or vomiting.

    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:

    Less common

    • Blurred vision
    • chest tightness
    • confusion
    • cough
    • difficulty swallowing
    • dizziness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fainting
    • headache
    • hives, itching, skin rash
    • loss of consciousness
    • nervousness
    • numbness of the face, lips, and eyes
    • pounding in the ears
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • seizures
    • slow or fast heartbeat
    • stomach cramping
    • sweating
    • unusual tiredness or weakness

    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

    • Nausea
    • stomach discomfort or pain

    Less common

    • Diarrhea
    • feeling of warmth
    • increased sweating
    • redness of the face, neck, arms, and occasionally, upper chest
    • sneezing
    • urge to defecate
    • vomiting

    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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