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Dukoral (Cholera Vaccine)

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  • Product Details

    Description

    Dukoral® is an oral, inactivated vaccine indicated for the prevention of diarrhea caused by Vibrio cholerae (cholera) and enterotoxigenic Escherichia coli (ETEC)-associated diarrhea in adults and children. It is especially useful for travelers visiting areas where cholera or ETEC-related diarrhea is endemic. Dukoral contains killed whole-cell V. cholerae (O1 strain) and recombinant cholera toxin B subunit, which helps stimulate mucosal immunity in the gut. It is the only licensed oral vaccine that offers dual protection against cholera and ETEC diarrhea through induction of secretory IgA responses in the intestine.

    Fact Table

    Formula

    Killed *V. cholerae* O1 (classical and El Tor) + recombinant cholera toxin B subunit (rCTB)

    License

    EMA, Health Canada, WHO prequalified

    Bioavailability

    Local (gastrointestinal mucosal immunity)

    Legal status

    OTC (in some countries); Rx in others

    Chemical Name

    Oral cholera vaccine (inactivated + rCTB)

    Elimination half-life

    Not applicable (vaccine-induced immunity)

    Dosage (Strength)

    2 oral doses (=6 years); 3 doses (2–6 years), 1 dose booster within 2 years

    Pregnancy

    Use only if clearly needed; limited data

    Brands

    Dukoral

    Protein binding

    Not applicable

    PubChem CID

    Not assigned

    MedlinePlus

    a607026

    ChEBI

    Not listed

    ATC code

    J07AE01

    DrugBank

    DB11607

    KEGG

    D10845

    Routes of administration

    Oral (buffered solution)

    Directions

    Dukoral is taken orally in conjunction with a bicarbonate buffer solution to protect the vaccine from gastric acid degradation. Dosing is as follows:

    • Adults and children =6 years: 2 doses, taken 1–6 weeks apart.
    • Children aged 2 to 6 years: 3 doses, taken 1–6 weeks apart.

    Each dose should be administered at least 1 hour before or after food, drink, or other oral medications, and ingestion of the buffer solution is required prior to drinking the vaccine. Full protection begins about 1 week after the last dose and lasts approximately 3 months for ETEC and up to 2 years for cholera. A booster dose is recommended after 2 years for continued cholera protection, or after 3 months for ETEC in travelers.

    Ingredients

    Each dose of Dukoral contains:

    • Inactivated Vibrio cholerae O1 strains (classical and El Tor biotypes, Inaba and Ogawa serotypes)
    • Recombinant cholera toxin B subunit (rCTB)
    • Sodium dihydrogen phosphate
    • Sodium hydrogen carbonate
    • Sodium carbonate
    • Citric acid
    • Sodium chloride
    • Raspberry flavoring
    • Water for oral administration (buffer sachet)

    The vaccine is supplied as a vial of liquid suspension with an accompanying sachet of effervescent buffer granules.

    Contraindications

    Dukoral is contraindicated in individuals with:

    • Known hypersensitivity to any component of the vaccine or buffer
    • Acute gastrointestinal illness at the time of vaccination
    • Children under 2 years of age (safety and efficacy not established)

    Cautions

    • Dukoral does not replace standard food and water precautions in travelers; hygiene measures must still be followed.
    • Immunosuppressed individuals may have a reduced immune response.
    • The vaccine is not indicated for treatment of cholera or ETEC-related diarrhea.
    • Care must be taken to administer the vaccine correctly with the buffer; improper use may lead to vaccine degradation in the stomach.

    Side Effects

    Common side effects include:

    • Abdominal pain
    • Nausea
    • Diarrhea
    • Headache
    • Fever
    • Vomiting

    These effects are typically mild and transient.

    Rare or serious adverse effects may include:

    • Hypersensitivity reactions (e.g., rash, pruritus, urticaria)
    • Anaphylaxis (extremely rare)

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 11640

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