REFERENCES

BRIEF SUMMARY

CURRENT
PACKAGE INSERT

REFERENCES

  1. Graham-Lomax K, Graham DY. Contemporary Diagnosis and Management of H. pylori-Associated Gastrointestinal Diseases. 3rd ed. Newtown, PA: Handbooks in Health Care Co; 2005.
  2. H. pylori infection. Mayo Clinic Web site. http://www.mayoclinic.com/health/h-pylori/DS00958/DSECTION=symptoms. Accessed August 30, 2013.
  3. Meurer LN, Bower DJ. Management of Helicobacter pylori infection. Am Fam Physician. 2002;65(7):1327-1336.
  4. Ables AZ, Simin I, Melton ER. Update on Helicobacter pylori treatment. Am Fam Physician. 2007;75(3):351-358.
  5. Helicobacter pylori. Centers for Disease Control and Prevention website. http://www.cdc.gov/ulcer/files/hpfacts.pdf. Accessed August 7, 2013.
  6. World Gastroenterology Organisation Global Guidelines. Helicobacter pylori in developing countries. August 2010.
  7. Chey WD, Wong BCY; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007;102(8):1808-1825.
  8. Cardenas VM, Mulla ZD, Ortiz M, Graham DY. Iron deficiency and Helicobacter pylori infection in the United States. Am J Epidemiol. 2006;163(2):127-134.
  9. Houghton J, Wang TC. Helicobacter pylori and gastric cancer: a new paradigm for inflammation-associated epithelial cancers. Gastroenterology. 2005;128(6):1567-1578.
  10. Vakil N, Megraud F. Eradication therapy for Helicobacter pylori. Gastroenterology. 2007;133(3):985-1001.
  11. Vakil N, Fendrick AM. How to test for Helicobacter pylori in 2005. Cleve Clin J Med. 2005;72(suppl 2):S8-S13.
  12. Chu Y-T, Wang Y-H, Wu J-J, Lei H-Y. Invasion and multiplication of Helicobacter pylori in gastric epithelial cells and implications for antibiotic resistance. Infect Immun. 2010;78(10):4157-4165.
  13. Laine L, Suchower L, Frantz J, Connors A, Neil G. Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials. Am J Gastroenterol. 1998;93(11):2106-2112.
  14. Fennerty MB, Kovacs TO, Krause R, et al. A comparison of 10 and 14 days of lansoprazole triple therapy for eradication of Helicobacter pylori. Arch Intern Med. 1998;158(15):1651-1656.
  15. Laine L, Fennerty MB, Osato M, et al. Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials. Am J Gastroenterol. 2000;95(12):3393-3398.
  16. Laine L, Hunt R, El-Zimaity H, Nguyen B, Osato M, Spénard J. Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, North American trial. Am J Gastroenterol. 2003;98(3):562-567.
  17. Bochenek WJ, Peters S, Fraga PD, et al; Helicobacter pylori Pantoprazole Eradication (HELPPE) Study Group. Eradication of Helicobacter pylori by 7-day triple-therapy regimens combining pantoprazole with clarithromycin, metronidazole, or amoxicillin in patients with peptic ulcer disease: results of two double-blind, randomized studies. Helicobacter. 2003;8(6):626-642.
  18. Vakil N, Lanza F, Schwartz H, Barth J. Seven-day therapy for Helicobacter pylori in the United States. Aliment Pharmacol Ther. 2004;20(1):99-107.
  19. Chiba N, Veldhuyzen Van Zanten SJ. 13C-Urea breath tests are the noninvasive method of choice for Helicobacter pylori detection. Can J Gastroenterol. 1999;13(8):681-683.
  20. Ore L, Hagoel L, Lavi I, Rennert G. Screening with faecal occult blood test (FOBT) for colorectal cancer: assessment of two methods that attempt to improve compliance. Eur J Cancer Prev. 2001;10(3):251-256.
  21. Fee C, Nemer JA. Acute infectious gastrointestinal disorders. Hosp Physician Emerg Med Board Rev Manual. 2004;8(pt 1):2-11.
  22. White N. Asian community at greater risk from stomach cancer; H. pylori blamed. City of Hope: Breakthroughs website. January 22, 2014. http://breakthroughs.cityofhope.org/stomach-cancer-asians.
  23. Malfertheiner P, Megraud F, O’Morain CA, et al; European Helicobacter Study Group. Management of Helicobacter pylori infection—the Maastricht IV/Florence Consensus Report. Gut. 2012;61(5):646-664.
  24. Fock KM, Katelaris P, Sugano K, et al. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009;24(10):1587-1600.
  25. BreathTek UBT [prescribing information]. Otsuka America Pharmaceutical, Inc; 2013.
  26. American Gastroenterological Association. American Gastroenterological Association medical position statement: evaluation of dyspepsia. Gastroenterology. 2005;129(5):1753-1755.

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Brief Summary About BreathTek UBT

Intended Use

The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adult patients and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories or point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.

The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.

Warnings and Precautions

  • For in vitro diagnostic use only. The Pranactin®-Citric solution is taken orally as part of the diagnostic procedure and contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit, and should be used with caution in diabetic patients. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.)
  • A negative result does not rule out the possibility of H. pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternate method.
  • False negative test results may be caused by:
  • Ingestion of proton pump inhibitors (PPIs) within 2 weeks prior to performing the BreathTek UBT. If a negative result is obtained from a patient ingesting a PPI within 2 weeks prior to the BreathTek UBT, it may be a false-negative result and the test should be repeated 2 weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI could be considered positive and be acted upon.
  • Ingestion of antimicrobials, or bismuth preparations within 2 weeks prior to performing the BreathTek UBT
  • Premature POST-DOSE breath collection time for a patient with a marginally positive BreathTek UBT result
  • Post-treatment assessment with the BreathTek UBT less than 4 weeks after completion of treatment for the eradication of H. pylori.
  • False positive test results may be caused by urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii or achlorhydria
  • If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used.
  • Patients who are hypersensitive to mannitol, citric acid or Aspartame should avoid taking the drug solution as this drug solution contains these ingredients. Use with caution in patients with difficulty swallowing or who may be at high risk of aspiration due to medical or physical conditions.
  • No information is available on use of the Pranactin-Citric solution during pregnancy.
  • For pediatric test results, the Urea Hydrolysis Rate (UHR) results must be calculated. The Delta over Baseline (DOB) results are only used to calculate the UHR metrics to determine H. pylori infection in pediatric patients. DOB results cannot be used to determine the infection status of pediatric patients.
  • Use the web-based pUHR-CA (http://BreathTekKids.com) to calculate the UHR.
  • Safety and effectiveness has not been established in children below the age of 3 years

Adverse Events

During post-approval use of the BreathTek UBT in adults, the following adverse events have been identified: anaphylactic reaction, hypersensitivity, rash, burning sensation in the stomach, tingling in the skin, vomiting and diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.

In two clinical studies conducted in 176 (analyzed) pediatric patients ages 3 to 17 years to determine the initial diagnosis and post treatment monitoring of H. pylori, the following adverse events experienced by >1% of these patients were: vomiting (5.1%), oropharyngeal pain (4.5% to include throat irritation, sore throat, throat burning), nausea (2.3%), restlessness (2.3%), stomach ache/belly pain (1.1%), and diarrhea (1.1%). Most of the adverse events were experienced by patients within minutes to hours of ingestion of the Pranactin-Citric solution.

In another clinical study comparing the UBiT®-IR300 and POCone® in pediatric patients ages 3 to 17 years, the following adverse events were observed among the 99 subjects enrolled: 2 incidences of headache, and 1 incidence each of cough, dry mouth and acute upper respiratory infection.

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FOR THE LONG-TERM CONTROL OF THE SIDE EFFECTS ASSOCIATED WITH DYSPEPSIA:

ERADICATE THE SOURCE

COMBINE FORCES WITH THE ACG/AGA GUIDELINES AND THE RELIABILITY OF THE BREATHTEK® UBT TO ERADICATE H. pylori.

START ERADICATION

Upon completion, you’ll have an opportunity to receive additional literature about H. pylori testing and treatment.

THE H. pylori INFECTION CAN BE FOUND WORLDWIDE

H. pylori

A common, chronic, worldwide infection1

Know the symptoms—the 3 Bs:

Burning, Bloating, and Belching2-4

Acute infection is often asymptomatic3

VIEW OUTBREAK

50% OF THE WORLD’S ADULT POPULATION ARE INFECTED WITH H. pylori5

Central/South America: 70%-90%

Africa: 70%-90%

India: 88%

Asia: 50%-80%

Eastern Europe: 70%

Western Europe: 30%-50%

United States: 30%-40%

Found in nearly 6 of 10 Americans born outside the US6

CONTINUE

50% OF THE WORLD’S ADULT POPULATION ARE INFECTED WITH H. pylori5

Capable of following a clear
and predictable progression1,7

Capable of following a clear and predictable progression1,7

CONTINUE

H. pylori RESISTANCE IS ON THE RISE8

Resistance to eradication therapy and antibiotics is increasing8-10

Trials demonstrate that the resistance of H. pylori to antibiotics in triple therapy may be as high as 35%8

VIEW CLINICAL TRIALS

CONTINUE

H. pylori RESISTANCE IS ON THE RISE8

25% of patients may fail their H. pylori eradication therapy9,10

CONTINUE

H. pylori RESISTANCE IS ON THE RISE8

Serology testing may provide false positives in 33% of positive results9,17,18

  • Serologic tests cannot distinguish active H. pylori infection from past infection17

CONTINUE

H. pylori RESISTANCE IS ON THE RISE8

Stool testing may lead to lower patient compliance19

In a mail-in study of fecal occult blood testing, overall compliance rate was 17.9% (N=1940)19

CONTINUE

Now that the need to act is clear, tell us about your patients

Discover how H. pylori may be infecting your patient population

CONTINUE

WHAT PERCENTAGE OF YOUR PATIENTS ARE >50 YEARS OF AGE?

0%

100%

0%

SUBMIT

APPROXIMATELY 50% OF ALL AMERICANS OVER THE AGE OF 50 HAVE THE H. pylori INFECTION.20

20%

CONTINUE

HOW MANY PATIENTS WITH DYSPEPSIA DO YOU SEE IN A WEEK?

0

50

0

PATIENTS

SUBMIT

ONE-THIRD OF ALL PATIENTS EXAMINED FOR DYSPEPSIA HAVE THE H. pylori INFECTION.4

10

CONTINUE

WHAT PERCENTAGE OF YOUR PATIENT POPULATION ARE ASIAN?

0%

100%

0%

ASIAN

SUBMIT

THE H. pylori INFECTION DISPROPORTIONATELY AFFECTS THE ASIAN COMMUNITY.21

25%

CONTINUE

H. pylori PREVALENCE IN YOUR PRACTICE MAY BE HIGHER THAN YOU REALIZE...

Risk profile is based on answers to previous questions.

CONTINUE

TEST WITH BREATHTEK UBT TO ERADICATE H. pylori

TEST WITH BREATHTEK UBT TO ERADICATE H. pylori

JOIN FORCES WITH THE ACG/AGA

TEST WITH BREATHTEK UBT TO ERADICATE H. pylori

UBT methods are guideline recommended4,17,22,23

ACG calls UBT “the most reliable nonendoscopic test…” to confirm eradication17

The flexible testing of the BreathTek UBT takes approximately 20 minutes

Easy to administer, with minimal staff time required and no dedicated room needed

Simple detection for your patients— with no special training required

Breathtek UBT has excellent 96% sensitivity and 96% specificity for confirmation of eradication in adults24

Indicated for diagnosis and monitoring in patients as young as 3 years of age24

BreathTek UBT is readily available through laboratories and in your practice.

CONFIRM ERADICATION

POPULATION DOMINATION BY THE H. pylori INFECTION AVERTED

H. pylori INFECTION

TESTED1

TREATED8,17

CONFIRMED9

H. pylori status:

ERADICATED

CONTINUE

THANK YOU FOR YOUR TIME. WE HOPE YOU HAVE FOUND THIS EXPERIENCE HELPFUL.

Learn more about detecting and exposing the H. pylori infection

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© 2014 Otsuka America Pharmaceutical, Inc. August 2014  05US14EBP1256