Drugs List

Therapeutic Indications

Uses

Cholera - prophylaxis

Active immunisation against disease caused by Vibrio cholerae serogroup O1 in individuals who will be visiting endemic/epidemic areas.

Administration

Adults and children over 6 years

The effervescent granules should be dissolved in approximately 150 ml of cool water to give a solution of sodium hydrogen carbonate. The vaccine suspension is mixed with the solution.

Children aged 2 to 6 years

Half of the sodium hydrogen carbonate solution prepared from the effervescent granules should be discarded. The remaining half (approximately 75 ml) is mixed with all of the vaccine suspension.

Contraindications

Children under 2 years
Febrile disorder
Acute gastrointestinal disorder

Precautions and Warnings

Immunosuppression
Patients over 65 years
Breastfeeding
Immunodeficiency syndromes
Positive HIV status
Pregnancy

No protection against other strains of vibrio
Postpone immunisation if there is active or suspected infection
Sodium content of formulation may be significant
Adhere to standard protective measures to avoid infection
Vaccine may not be effective in 100% of patients
May contain trace amounts of formaldehyde
No food or drink for 1 hour before/after use
No other medicines for 1 hour before/after use
Reconstitute only in accordance with manufacturer's instructions
Follow national immunisation guidelines
No clinical data on protective efficacy after booster doses
Advise on measures to take if diarrhoea occurs

Immunisation protects against Vibrio cholerae serogroup O1 only, and not against Vibrio cholerae serogroup O139 or other species of vibrio.

In HIV infected individuals, limited data is available on the immunogenicity and safety of the vaccine. The protective efficacy of the vaccine has not been studied. Immunisation of those with HIV could result in transient increases of viral load. The vaccine may fail to induce protective antibody levels in those with advanced HIV disease, although an effectiveness study in a population with high HIV prevalence showed similar levels of protection as in other populations.

Pregnancy and Lactation

Pregnancy

Use cholera vaccine with caution in pregnancy.

The vaccine may be administered during pregnancy after careful benefit/risk assessment.

Schaefer (2007) suggests that because the vaccine protection is short term and incomplete, antibiotic treatment of cholera infection is the preferred choice during pregnancy. However, Schaefer (2007) also suggests that if travel to an endemic area cannot be postponed, vaccination should be performed during pregnancy.

No specific clinical studies have been performed and there is no available data on reproduction toxicity in animals.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use cholera vaccine with caution in breastfeeding.

The vaccine may be administered to breastfeeding women after careful benefit/risk assessment.

Maternal vaccination significantly increases the levels of cholera antibodies excreted in their milk (IgA, IgG) and breastfed infants are generally protected from cholera (Hale, 2014).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal cramps
Abdominal discomfort
Abdominal pain
Angioedema
Arthralgia
Asthenia
Chills
Cough
Dehydration
Diarrhoea/loose stools
Disturbances of appetite
Dizziness
Drowsiness
Dyspepsia
Dyspnoea
Fainting
Fatigue
Fever
Flatulence
Gastro-enteritis
Gastro-intestinal symptoms
Headache
Hypertension
Increased sputum
Influenza-like syndrome
Insomnia
Joint pain
Lymphadenitis
Malaise
Nausea
Pain
Paraesthesia
Pruritus
Rash
Respiratory symptoms
Rhinitis
Shivering
Sore throat
Stomach/abdominal gurgling
Sweating
Taste disturbances
Urticaria
Vomiting

Presentation

Oral suspension and effervescent granules of inactivated cholera vaccine

Drugs List

Therapeutic Indications

Uses

Cholera - prophylaxis

Active immunisation against disease caused by Vibrio cholerae serogroup O1 in individuals who will be visiting endemic/epidemic areas.

Dosage

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Adults

Children

Administration

Adults and children over 6 years

The effervescent granules should be dissolved in approximately 150 ml of cool water to give a solution of sodium hydrogen carbonate. The vaccine suspension is mixed with the solution.

Children aged 2 to 6 years

Half of the sodium hydrogen carbonate solution prepared from the effervescent granules should be discarded. The remaining half (approximately 75 ml) is mixed with all of the vaccine suspension.

Contraindications

Children under 2 years
Febrile disorder
Acute gastrointestinal disorder

Precautions and Warnings

Immunosuppression
Patients over 65 years
Breastfeeding
Immunodeficiency syndromes
Positive HIV status
Pregnancy

No protection against other strains of vibrio
Postpone immunisation if there is active or suspected infection
Sodium content of formulation may be significant
Adhere to standard protective measures to avoid infection
Vaccine may not be effective in 100% of patients
May contain trace amounts of formaldehyde
No food or drink for 1 hour before/after use
No other medicines for 1 hour before/after use
Reconstitute only in accordance with manufacturer's instructions
Follow national immunisation guidelines
No clinical data on protective efficacy after booster doses
Advise on measures to take if diarrhoea occurs

Immunisation protects against Vibrio cholerae serogroup O1 only, and not against Vibrio cholerae serogroup O139 or other species of vibrio.

In HIV infected individuals, limited data is available on the immunogenicity and safety of the vaccine. The protective efficacy of the vaccine has not been studied. Immunisation of those with HIV could result in transient increases of viral load. The vaccine may fail to induce protective antibody levels in those with advanced HIV disease, although an effectiveness study in a population with high HIV prevalence showed similar levels of protection as in other populations.

Pregnancy and Lactation

Pregnancy

Use cholera vaccine with caution in pregnancy.

The vaccine may be administered during pregnancy after careful benefit/risk assessment.

Schaefer (2007) suggests that because the vaccine protection is short term and incomplete, antibiotic treatment of cholera infection is the preferred choice during pregnancy. However, Schaefer (2007) also suggests that if travel to an endemic area cannot be postponed, vaccination should be performed during pregnancy.

No specific clinical studies have been performed and there is no available data on reproduction toxicity in animals.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use cholera vaccine with caution in breastfeeding.

The vaccine may be administered to breastfeeding women after careful benefit/risk assessment.

Maternal vaccination significantly increases the levels of cholera antibodies excreted in their milk (IgA, IgG) and breastfed infants are generally protected from cholera (Hale, 2014).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal cramps
Abdominal discomfort
Abdominal pain
Angioedema
Arthralgia
Asthenia
Chills
Cough
Dehydration
Diarrhoea/loose stools
Disturbances of appetite
Dizziness
Drowsiness
Dyspepsia
Dyspnoea
Fainting
Fatigue
Fever
Flatulence
Gastro-enteritis
Gastro-intestinal symptoms
Headache
Hypertension
Increased sputum
Influenza-like syndrome
Insomnia
Joint pain
Lymphadenitis
Malaise
Nausea
Pain
Paraesthesia
Pruritus
Rash
Respiratory symptoms
Rhinitis
Shivering
Sore throat
Stomach/abdominal gurgling
Sweating
Taste disturbances
Urticaria
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last full review: September 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 24 August 2016.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Dukoral suspension and effervescent granules for oral suspension, Cholera vaccine (inactivated, oral). Valneva UK Ltd. Revised March 2015