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How to Take Typhoid Vaccine Capsules

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How to Take Typhoid Vaccine Capsules Your travel medicine provider has given you How to take the oral typhoid fever vaccine, Vivotif ®. Unlike other vaccines that are given as a shot, this Typhoid Vaccine Capsules vaccine is contained in four capsules and is taken orally. This easy-to-understand guide provides answers to Frequently Asked Questions. Vaccine Please read this handout carefully. As with any drug, it is important that you follow the in a instructions carefully. DO’s DON’T’s Do I have to take all 4 doses? DO complete at least Don’T take the Capsule vaccine if you are Yes. You must take all 4 capsules to get the full 1 week before traveling taking antibiotics long term effect of the vaccine. (Consult your doctor) DO take each capsule Just as important, you need to skip a day on an empty stomach Don’T take with between capsules. Remember to take a capsule (1 hour before eating alcohol (wait at least EVERY OTHER DAY. or 2 hours after eating) 2 hours before drinking alcohol) DO take each capsule DON’T open or with a full glass of cool chew capsules or lukewarm water Don’T forget to DO keep capsules in skip a day between refrigerator capsules Don’T forget to take all 4 capsules DAY 1 DAY 3 DAY 5 DAY 7 TAKE TAKE TAKE TAKE DAY 2 DAY 4 DAY 6 KEEP SKIP SKIP SKIP REFRIGERATED Telephone 800-533-5899 IMPORtaNT www.bernaproducts.com The last dose must be taken at least 1 week before you enter a high-risk area User’s Guide for Travelers COT-V23-VIC (1/06) Quick Reference for Do’s and Don’t’s on Back Panel RV (1/07) How does the oral typhoid Do I have to take the capsule fever vaccine work? with water? Yes. It is best to swallow each capsule with a full This oral vaccine is contained in a glass of cool or room temperature WATER. Don’t special type of capsule. This capsule open or chew the capsule — remember that the is designed to dissolve only when vaccine capsule needs to reach the small intestine it reaches the small intestine. Once before it dissolves. there, the vaccine is absorbed into the body to begin providing protection. Can I take each capsule with food? Can I drink alcohol? No. The oral vaccine must be taken on an empty stomach. That means you should take the capsule After taking a capsule, wait at least TWO either 1 hour before eating a meal or 2 hours after hours before taking a drink of an alcoholic eating a meal. beverage. The alcohol can cause the capsule to dissolve before reaching the small intestines. Why is it important to take on Also, alcohol itself can destroy the vaccine. an empty stomach? If there is any food in the stomach, the capsule Does each dose have to be taken will remain in the stomach for a at the same time of day? much longer time where the stomach Taking the vaccine at approximately the same acids can dissolve the capsule. Once time will make it easier for you to remember. the capsule is destroyed, the vaccine Many patients find it easiest to take the capsule will also be destroyed before it can be as soon as they wake up in the morning. Precautions absorbed into the intestine. One hour after taking the capsule, you Do not take the oral vaccine if you: can eat some food. Is there an easy way to help • Are taking antibiotics remind me of when to take • Have had any bad reactions to this oral typhoid each dose? vaccine or enteric coated capsules in the past Side Effects A sticker is available to help you • Have a fever In clinical trials, the most frequently reported side remember when to take each of the • Have continued vomiting effects were abdominal pain, nausea, headache, 4 capsules. Write the day you are • Have diarrhea or a stomach illness. fever, diarrhea, vomiting and skin rash. Although supposed to take each of them in the Be sure to tell your travel medicine provider if you are infrequent and mild, nausea was the most mentioned space provided and put it somewhere pregnant, nursing or immunodeficient. side effect. You should report any serious side effect you will see it each day. Your travel to your doctor or directly to the Vaccine Adverse You should still avoid potentially contaminated food or medicine provider may also have Event Reporting System (1-800-822-7967). other helpful materials for you. water, as not all people will be fully protected against typhoid fever. Can a child take the vaccine? If you have any additional questions, please discuss them Yes, children 6 years and older can take the oral with your travel medicine provider. typhoid vaccine. Vivotif® is a registered trademark of Keep the vaccine Typhoid Vaccine Live Oral Ty21a capsules in the refrigerator Please refer to full product information on reverse side. Vivotif ® Typhoid Vaccine Live Oral Ty21a Description Vivotif® Typhoid Vaccine Live Oral Ty21a is a live attenuated vaccine lipopolysaccharide is synthesized to evoke a protective immune response. Despite low Indications and Usage for oral administration only. The vaccine contains the attenuated strain Salmonella typhi levels of lipopolysaccharide synthesis, the cells lyse before regaining a virulent phenotype Vivotif® (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults Ty21a (1,2). due to the intracellular build-up of intermediates during lipopolysaccharide synthesis and children greater than 6 years of age against disease caused by Salmonella typhi. Vivotif® is manufactured by the Berna Biotech Ltd. The vaccine strain is grown (1,2). Routine typhoid vaccination is not recommended in the United States of America. in fermentors under controlled conditions in medium containing a digest of yeast Results from clinical studies indicate that adults and children greater than 6 years Selective immunization against typhoid fever is recommended for the following groups: extract, an acid digest of casein, dextrose and galactose. The bacteria are collected by of age may be protected against typhoid fever following the oral ingestion of 4 doses of 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons centrifugation, mixed with a stabilizer containing sucrose, ascorbic acid and amino acids, Vivotif® (Typhoid Vaccine Live Oral Ty21a). The efficacy of theS. typhi Ty21a strain has with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology and lyophilized. The lyophilized bacteria are mixed with lactose and magnesium stearate been evaluated in a series of randomized, double-blind, controlled field trials. Suspected laboratorians who work frequently with S. typhi (7). There is no evidence to support the and filled into gelatin capsules which are coated with an organic solution to render them typhoid cases, detected by passive surveillance, were confirmed bacteriologically either use of typhoid vaccine to control common source outbreaks, disease following natural resistant to dissolution in stomach acid. The enteric-coated, salmon/white capsules are by blood or bone marrow culture. The first trial was performed in Alexandria, Egypt disasters or in persons attending rural summer camps. then packaged in 4-capsule blisters for distribution. The contents of each enteric-coated with a study population of 32,388 children aged 6 to 7 years. Three doses of vaccine, Not all recipients of Vivotif® will be fully protected against typhoid fever. Vaccinated capsule are shown in Table 1. in the form of a freshly reconstituted suspension administered after ingestion of 1 g of individuals should continue to take personal precautions against exposure to typhoid bicarbonate, were given on alternate days. Immunization resulted in a 95% decrease organisms. The vaccine will not afford protection against species of Salmonella other Table 1: Contents of one enteric-coated capsule [95% confidence interval (CI) = 77%–99%] in the incidence of typhoid fever over a than Salmonella typhi or other bacteria that cause enteric disease. The vaccine is not of Vivotif® (Typhoid Vaccine Live Oral Ty21a) 3-year period of surveillance (9). A series of field trials were subsequently performed in suitable for treatment of acute infections with S. typhi. Santiago, Chile to evaluate efficacy when the vaccine strain was administered in the form Contraindications 9 of an acid-resistant enteric-coated capsule. The initial trial involved 82,543 school-aged Viable S. typhi Ty21a .......................................2–6.8 x 10 colony-forming units* Hypersensitivity to any component of the vaccine or the enteric-coated capsule. The 9 children, and compared 1 or 2 doses of vaccine given one week apart. After 24 months Non-viable S. typhi Ty21a ..............................................5–50 x 10 bacterial cells vaccine should not be administered to persons during an acute febrile illness. Safety of of surveillance vaccine efficacy was 29% (95% CI = 4%–47%) for the single dose Sucrose ................................................................................................26-130 mg the vaccine has not been demonstrated in persons deficient in their ability to mount schedule and 59% (95% CI = 41%–71%) for the 2-dose schedule (10). A further field Ascorbic acid ............................................................................................1–5 mg a humoral or cell-mediated immune response, due to either a congenital or acquired trial was performed in Santiago, Chile involving 109,594 school-aged children (11). Amino acid mixture ..............................................................................1.4–7 mg immunodeficient state including treatment with immunosuppressive or antimitotic Three doses of enteric-coated capsules were administered
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