Cholera vaccine (oral route)


    Brand Name

    US Brand Name

    Vaxchora


    Description

    Cholera vaccine is used in adults to help prevent cholera. Cholera is a serious disease that can cause death. It is caused by a germ called Vibrio cholerae, and is spread most often through infected food or water. If you are traveling to cholera-infected areas, avoid eating uncooked food, especially fish and shellfish, and peel fruit yourself. Avoid water that may be infected, carbonated bottled water and carbonated soft drinks are safe.

    Cholera is rare in the U.S. and other areas of the world that have good water and sewage (waste) systems. However, it is a problem in parts of the world that do not have such systems. If you are traveling to cholera-infected areas (eg, developing countries of Africa, Asia, and Latin America) cholera vaccine may help protect you from cholera. It is very important to avoid infected persons and food and water that may be infected, even if you have received the vaccine.

    This vaccine is to be given only by or under the supervision of a doctor.

    This product is available in the following dosage forms:

    • Powder for Suspension

    Before Using

    In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, 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 cholera vaccine in children younger than 2 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies have not been performed on the relationship of age to the effects of cholera vaccine in the geriatric population. Safety and efficacy have not been established.

    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 vaccine, 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.

    Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

    • Deflazacort
    • Thiotepa

    Receiving this vaccine 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.

    • Adalimumab
    • Alemtuzumab
    • Amikacin
    • Amoxicillin
    • Ampicillin
    • Anifrolumab-fnia
    • Antithymocyte Globulin Rabbit
    • Atidarsagene Autotemcel
    • Axicabtagene Ciloleucel
    • Azanidazole
    • Azithromycin
    • Aztreonam
    • Bacampicillin
    • Balofloxacin
    • Baricitinib
    • Belatacept
    • Bendamustine
    • Benznidazole
    • Besifloxacin
    • Betibeglogene Autotemcel
    • Bimekizumab-bkzx
    • Bortezomib
    • Bosutinib
    • Brexucabtagene Autoleucel
    • Brodalumab
    • Cabazitaxel
    • Canakinumab
    • Capecitabine
    • Capreomycin
    • Carboplatin
    • Carfilzomib
    • Carmustine
    • Cefaclor
    • Cefadroxil
    • Cefamandole
    • Cefatrizine
    • Cefazolin
    • Cefdinir
    • Cefditoren
    • Cefepime

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

    • Weak immune system—Use with caution. Safety and efficacy have not been established in patients with this condition.

    Proper Use

    A nurse or other trained health professional will give you this vaccine. It is given by mouth as a single dose a minimum of 10 days before potential exposure to cholera.

    Drink the full contents of the cup within 15 minutes of mixing the vaccine.

    Do not eat or drink for 60 minutes before or after receiving this vaccine.

    If you are using antibiotics, tell your doctor before receiving this vaccine. You should not receive antibiotics given by mouth or by injection within 14 days of getting this vaccine.

    If you are using chloroquine, take this vaccine at least 10 days before using it.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this vaccine is working properly and to check for unwanted effects.

    Tell your doctor if you have any type of cancer or are receiving medicine or a procedure that may weaken the immune system, including steroids, cancer medicines, or radiation.

    Tell your doctor if you spend time with a person who has an immune system problem or is getting cancer medicines. Your doctor may recommend ways (eg, proper hand washing after using the bathroom or before preparing or handling food) to help prevent the spread of vaccine virus to other people.

    Tell your doctor if you are pregnant before receiving this vaccine.

    Tell your doctor if you have a headache, nausea or vomiting, stomach pain, tiredness, and diarrhea after 7 days of receiving this vaccine.

    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 immediately if any of the following side effects occur:

    Rare

    • Fever

    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

    • Headache
    • lack of appetite
    • nausea or vomiting
    • stomach pain
    • tiredness

    Less common

    • Diarrhea

    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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