Cholera Vaccine Live Oral

Name: Cholera Vaccine Live Oral

Uses for Cholera Vaccine Live Oral

Prevention of Cholera Infection

Prevention of disease caused by V. cholerae serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas.1

Cholera is an acute, intestinal infection caused by toxigenic V. cholerae and may be associated with sudden onset of profuse watery diarrhea and rapid progression to volume depletion, severe dehydration, hypovolemic shock, and death.3 5 7 8 11 115 Many individuals with V. cholerae infection are asymptomatic or have only mild to moderate disease;7 8 11 10–20% of infected individuals develop severe disease and potentially fatal dehydration.7 Transmitted principally by ingestion of water and/or food contaminated with feces from individuals with V. cholera infection and generally occurs in countries that lack clean drinking water or proper sanitation.5 7 8 11 115 Although more than 200 V. cholerae serogroups identified,11 only toxigenic strains of V. cholerae serogroups O1 and O139 have been associated with cholera epidemics; serogroup O1 is the leading cause of cholera worldwide.3 8 11 115

Cholera is uncommon in US, but endemic in approximately 50–60 countries, principally in less well-developed areas of the world that have poor sanitation and primitive water systems (e.g., areas of Africa, South and Southeast Asia, the Caribbean).3 5 7 9 11 115 In 2015, 172,454 cases (including 1304 fatalities) were reported in 42 different countries.8 9 However, many cases unreported and it has been estimated that up to 3–4 million cholera cases (up to 95,000–143,000 fatalities) may occur annually worldwide.3 8 9 11 Large cholera epidemic began in Haiti in 2010 following a devastating earthquake;9 115 CDC states cholera likely to persist at endemic levels in Haiti for the foreseeable future and sporadic cases may continue be associated with travel to and from Caribbean countries, including Haiti, the Dominican Republic, and Cuba.5 115

During 2001–2013, there were 123 confirmed cases of cholera in the US in individuals who had been traveling abroad.115 Risk of acquiring cholera is highest in those traveling to countries where cholera is endemic or epidemic, and is especially high in travelers who drink untreated water, eat raw or poorly cooked food (especially seafood), or do not follow proper hygiene recommendations while in cholera endemic or outbreak settings.115 Individuals at increased risk for poor clinical outcome if infected with toxigenic V. cholerae include those without rapid access to medical care and rehydration therapy; those with certain chronic medical conditions (e.g., immunosuppression, cardiovascular disease, renal disease); those with low gastric acidity related to antacid therapy, partial gastrectomy, or other causes; those with blood type O; and pregnant women.3 11

For US travelers, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) recommends cholera vaccine live oral for adults 18 through 64 years of age who will be at increased risk of exposure to toxigenic V. cholerae O1 because they will be traveling to areas with active cholera transmission.3 4 These areas are defined as a province, state, or other administrative subdivision within a country with endemic or epidemic cholera caused by toxigenic V. cholerae O1.3 4 This includes areas that have had cholera activity within the past year and are prone to recurrence of cholera epidemics;3 does not include areas with only rare imported or sporadic cholera cases.3

ACIP states that routine use of cholera vaccine is not recommended for most travelers from the US since the majority do not visit areas with active cholera transmission and, therefore, are at low risk of exposure to toxigenic V. cholerae.3 4

Efficacy for prevention of cholera not established in individuals living in cholera-affected areas or in individuals who have preexisting immunity because of previous exposure to V. cholerae or previous vaccination with a cholera vaccine.1

Has not been shown to provide protection against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.1

All travelers to cholera-affected areas should follow safe food and water precautions and proper sanitation and personal hygiene measures, regardless of vaccination status.3 7 8 9 115 If severe diarrhea develops, traveler should seek prompt medical attention, particularly fluid replacement therapy.3

The most recent information regarding geographic areas where cholera is actively being transmitted and additional information on vaccination and other precautions for prevention of cholera are available from CDC at and .4 115

Stability

Storage

Oral

For Oral Suspension

Single-dose carton containing foil packet of lyophilized live, attenuated V. cholerae CVD 103-HgR (active component) and foil packet of dry powder buffer (buffer component): Store in a freezer at −25 to −15°C;1 protect from light and moisture.1

After removal from frozen storage, complete reconstitution and mixing (see Reconstitution under Dosage and Administration) within 15 minutes;1 do not expose to temperatures >27°C.1

Uses

This vaccine is used to prevent cholera infection caused by a certain bacteria (V. cholerae). People can get infected by eating food or drinking water that has been contaminated. This vaccine is recommended for adults who are traveling to areas where this infection is common. Cholera vaccine contains live bacteria that have been weakened. It works by causing the body to produce its own protection (antibodies) against the bacteria.

Vaccines may not fully protect everyone who receives them. While traveling, you should still avoid contaminated food or water (such as by drinking only bottled or boiled water, eating only fully cooked food). Ask your health care professional for more details.

How to use Cholera Vaccine, Live Suspension For Reconstitution

Read all vaccine information available from your health care professional before taking the vaccine. If you have any questions, ask your health care professional.

Take this vaccine by mouth as directed by the health care professional. You should get this vaccine at least 10 days before traveling to at-risk areas. Do not eat or drink 1 hour before and 1 hour after taking this vaccine.

This vaccine should not be taken at the same time as a certain medication used to prevent malaria (chloroquine) or antibiotics taken by mouth or given by injection. Ask the health care professional for more details. See also Drug Interactions section.

Side Effects

Diarrhea may occur. If this effect lasts or gets worse, tell your health care professional promptly.

Remember that your health care professional has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.

Contact the health care professional for medical advice aboutside effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

List Cholera Vaccine, Live Suspension For Reconstitution side effects by likelihood and severity.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Avoid using certain medications to treat bacterial infections (antibiotics) by mouth or injection when receiving this vaccine. If you are currently using an antibiotic by mouth or injection, do not take this vaccine until at least 14 days after stopping the antibiotic.

Avoid taking a certain medication (chloroquine) used to prevent malaria when receiving this vaccine. Take this vaccine at least 10 days before you start treatment with chloroquine.

Overdose

Not applicable.

Notes

Keep all regular medical and lab appointments.

Missed Dose

Not applicable.

Storage

Store in the freezer. Protect from light. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised March 2017. Copyright(c) 2017 First Databank, Inc.

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