This medication belongs to the class of medications called vaccines. Specifically, it is a vaccine to prevent diarrhea caused by the bacteria V. choleraefor people who are travelling to an area where cholera is present.

This vaccine works by introducing very small amounts of weakened cholera bacteria into the body. This allows the body to make antibodies against the bacteria so that if the bacteria gets into the body, they are immediately attacked by the body's own defense system. It generally takes one week after finishing the first course of immunization for the body's defenses to develop protection against the bacteria.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual dose of cholera vaccine is the contents of 1 sachet, prepared as outlined below, at least 10 days before you plan to enter the area with cholera. Always refer to the package insert included in the medication carton.

Do not eat or drink for one hour before or after taking the vaccine.

In the package you receive from your pharmacist, there will be 2 sachets: the buffer component of the vaccine (the black and white sachet) and the active component of the vaccine (the blue and white sachet).

• Pour 100 mL of still or sparkling bottled water into a clean cup. Do not use tap water or other liquids to prepare the medication.
• Using scissors, cut the top off the sachet containing the buffer component, and empty the sachet into the cup. The contents of the cup will fizz or bubble.
• Using a stirrer, stir until the buffer component completely dissolves. If you are giving this medication to a child aged 2 to 5, discard half of the buffer solution after it is mixed. This will reduce the amount of fluid that the child will have to drink.
• Using scissors, cut the top off the sachet containing the active component, and empty the sachet into the cup containing the buffer solution.
• Stir the powder into the buffer solution for at least 30 seconds. It is possible that some of the powder will not dissolve. The solution should become a cloudy suspension, and it may contain some white particles.
• Within 15 minutes of preparing the dose, drink the entire contents of the cup. If there is any residue left in the cup, safely discard the residue.
• Clean any used items (glass, spoon) or spills with paper towel, soap, and hot water.
• Wash your hands with soap and hot water when you are finished. This reduces the risk of contaminating other surfaces with the weakened bacteria.

If the medication is not prepared correctly (i.e. the sachet 2 is added to the water before sachet 1) the vaccine must be discarded. Start over with a new carton.

If desired, 1 teaspoon of table sugar or ¼ teaspoon of stevia may be added to the vaccine, to sweeten the suspension. Do not add any other sweeteners or flavours.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If for some reason, you do not consume the entire dose of medication, contact your doctor for instructions. The entire dose is needed to provide the best protection from cholera infection.

Before preparing the vaccine, store this medication in the refrigerator, protect it from light and moisture, and keep it out of the reach of children. Once the vaccine has been prepared, it should be consumed immediately.

Each carton of vaccine contains 2 sachets.

Each dose of active drug inside sachet 2 (active component) contains 2 grams of powder for oral suspension, containing 4 x 108 to 2 x 109 CFU of recombinant live attenuated V. cholerae vaccine strain CVD 103-HgR, Nonmedicinal ingredients: ascorbic acid, hydrolyzed casein, lactose, and sucrose.

Sachet 1 (buffer sachet) contains ascorbic acid, lactose, sodium bicarbonate, and sodium carbonate.

Do not take this medication if you are allergic to cholera vaccine or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• diarrhea
• fatigue
• headache
• lack of appetite
• nausea
• vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Gastrointestinal problems: People with an inflammation of the digestive tract causing nausea, vomiting, or diarrhea, should not take this medication until symptoms have gone away. The vaccine may not be as effective if you are experiencing diarrhea or vomiting.

Immunocompromised people: This vaccine may not be as effective for people with a compromised immune system (e.g., people with AIDS, people taking anti-rejection medications after an organ transplant, people receiving chemotherapy, people taking any medication that suppresses the immune system). People who have reduced immune function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

It is possible that the weakened bacteria will be shed in the stools for 7 days after taking the dose. Theoretically, the bacteria may be passed on to family members who have not been vaccinated. If you have family members who are immunocompromised, talk to your doctor about ways to protect them.

Protection against cholera: Not all people who take the vaccine will be fully protected against cholera. This vaccine will not protect against diarrhea caused by other organisms. Travellers should take all necessary precautions to avoid contact with, or ingestion of, potentially contaminated sources of food or water (e.g., drink bottled or boiled water, wash hands before eating and after using toilet facilities).

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if cholera vaccine passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 2 years of age.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.