Healthcare institutions and laboratories are encouraged to exercise and continue to practice appropriate clinical precautions when handling breath samples from patients. These groups should refer to their own policies on how to handle its COVID-19 response and should respond appropriately as the COVID-19 situation applies to and impacts its breath testing in its facilities.

Judgement on whether or not to test a patient using the BreathTek® UBT for H. pylori Kit should continue to be made by the patient’s prescribing physician and in collaboration with local testing laboratories on an individual patient basis.

While the COVID-19 situation continues to be dynamic, Otsuka sources the components of the BreathTek® UBT in the United States and currently does not foresee disruptions to its supply.

April 202005US20EBP0007

Healthcare institutions and laboratories are encouraged to exercise and continue to practice appropriate clinical precautions when handling breath samples from patients. These groups should refer to their own policies on how to handle its COVID-19 response and should respond appropriately as the COVID-19 situation applies to and impacts its breath testing in its facilities.

Judgement on whether or not to test a patient using the BreathTek® UBT for H. pylori Kit should continue to be made by the patient’s prescribing physician and in collaboration with local testing laboratories on an individual patient basis.

While the COVID-19 situation continues to be dynamic, Otsuka sources the components of the BreathTek® UBT in the United States and currently does not foresee disruptions to its supply.

April 202005US20EBP0007

For Patients Taking PPIs

It is recommended that antibiotics, PPIs, or bismuth preparations not be taken within 2 weeks prior to administering BreathTek UBT.

  • If patients currently taking PPIs test positive for H. pylori infection, it is considered positive and eradication therapy can be started immediately; if the test is negative, it may be a false negative and results should be confirmed with a second breath test administered 2 weeks after discontinuing PPIs
  • Histamine 2-receptor antagonists (H2RAs) may be substituted for PPIs. These medications include Zantac® (ranitidine), Tagamet® (cimetidine), Pepcid® (famotidine), and Axid® (nizatidine). The effect of H2RAs may reduce urease activity on urea breath tests. H2RAs may be discontinued for 24-48 hours before the BreathTek UBT1
PPIs

Test for H. pylori infection before starting PPI therapy.

Approximately 60% of adult patients are already taking a PPI when they initially present with GI symptoms.2

  • Commonly used PPIs include Nexium® (esomeprazole magnesium), Prevacid® (lansoprazole), Prilosec® (omeprazole), Zegerid® (omeprazole/sodium bicarbonate), AcipHex® (rabeprazole sodium), Dexilant® (dexlansoprazole), and Protonix® (pantoprazole sodium)
  • Many patients resist discontinuing PPIs before testing because of concerns about symptom aggravation2

PPIs are commonly indicated for short-term therapy.

  • Patients typically stay on prescription PPI therapy for an average of 180 days3
  • Guidelines recommend a test-and-treat strategy for cases of uninvestigated dyspepsia1

Manufacturer-Recommended Duration of PPI Therapy

  Nexium®4 (esomeprazole magnesium) Prevacid®5,6* (lansoprazole)

Short-Term
Therapy

10 days to 8 weeksd,e 10 days to 12 weeksa,d,e

Long-Term
Therapy

Up to 6 monthsg,h Up to 12 monthsh,i
  Prilosec®7,8† (omeprazole) Zegerid®9,10‡ (omeprazole/sodium bicarbonate)

Short-Term
Therapy

10 days to 8 weeksa,b,d,e 2 weeks to 8 weeksa,b,c,e,f

Long-Term
Therapy

More than 5 yearsh,j Up to 12 monthsh
  Aciphex®11(rabeprazole sodium) Dexilant®12 (dexlanso-prazole)

Short-Term
Therapy

7 days to 16 weeksa,d,e Up to 8 weeksc

Long-Term
Therapy

Up to 12 monthsj Up to 6 monthsh

Indications

a -Duodenal ulcers

b -Gastric ulcers

c -Erosive esophagitis

d -Eradication of H. pylori infection to reduce the risk of duodenal ulcer recurrence

e -Gastroesophageal reflux disease (GERD)

f -Risk of upper gastrointestinal bleeding in critically ill

g -Risk reduction of NSAID-associated gastric ulcers

h -Healing of erosive esophagitis

i -Maintenance of healed duodenal ulcers

j -Pathological hypersecretory conditions

Long-term PPI use may mask H. pylori infection and cause many side effects.13-16

*Includes Prevacid® 24 HR. Includes Prilosec OTC®. Includes Zegerid OTC®.

All registered marks are the property of their respective owners.

Abbreviations: NSAID, nonsteroidal anti-inflammatory drug; PPI, proton pump inhibitor.

References
  • 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.
  • Data on file. Otsuka America Pharmaceutical, Inc.
  • US Food and Drug Administration. FDA drug safety communication: low magnesium levels can be associated with long-term use of proton pump inhibitor drugs (PPIs). http://www.fda.gov/drugs/drugsafety/ucm245011.htm. Updated August 4, 2017. Accessed March 12, 2019.
  • Package Insert for Nexium. AstraZeneca Pharmaceuticals LP; 2014.
  • Package Insert for Prevacid. Takeda Pharmaceuticals America, Inc; 2016.
  • Package Label for Prevacid 24HR. http://general.takedapharm.com/content/file.aspx?filetypecode=PREVACIDPI&cacheRandomizer=8a59d3dd-883a-4a12-990d-936c608a6a70. Accessed March 12, 2019.
  • Package Insert for Prilosec. AstraZeneca Pharmaceuticals LP; 2016.
  • About Prilosec OTC: warnings and directions. Prilosec OTC website. https://www.prilosecotc.com/en-us/about-prilosec-otc/side-effects. Accessed March 12, 2019.
  • Package Insert for Zegerid. Santarus, Inc; 2014.
  • Package Label for Zegerid OTC. http://www.zegeridotc.com/download/zegeridotc_product_labeling.pdf. Accessed March 12, 2019.
  • Package Insert for AcipHex. Eisai Inc; 2014.
  • Prescribing Information for Dexilant. Takeda Pharmaceuticals America, Inc; 2016.
  • Spiegel BMR, Farid M, Van Oljen MGH, et al. Adherence to best practice guidelines in dyspepsia: a survey comparing dyspepsia experts, community gastroenterologists and primary-care providers. Aliment Pharmacol Ther. 2009;29(8)871-881.
  • Chubineh S, Birk J. Proton pump inhibitors: the good, the bad, and the unwanted. South Med J. 2012;105(11):613-618.
  • Helicobacter pylori and peptic ulcer disease: the key to cure. Centers for Disease Control and Prevention website. http://www.cdc.gov/ulcer/keytocure.htm. Updated September 28, 2006. Accessed March 12, 2019.
  • Nasser SC, Slim M, Nassif JG, et al. Influence of proton pump inhibitors on gastritis diagnosis and pathologic gastric changes. World J Gastroenterol. 2015;21(15):4599-4606.