Is it just a bellyache, or could it be an. infection? Please see accompanying BRIEF SUMMARY and enclosed Current Package Insert.

Size: px

Start display at page:

Download "Is it just a bellyache, or could it be an. infection? Please see accompanying BRIEF SUMMARY and enclosed Current Package Insert."

Sherilyn Reed
5 years ago
Views:

1 Is it just a bellyache, or could it be an infection? Please see accompanying BRIEF SUMMARY and enclosed Current Package Insert.

2 I have a bellyache. As a parent or caregiver, anytime you hear your child complain their tummy hurts, you naturally want to know why. Often, it s just something they ate, and it passes quickly. But, if your child has stomach pain, is vomiting or has less of an appetite than usual, it could be caused by an infection called Helicobacter pylori, or H. pylori. 1,2 (Pronounced: H. Pie-lore-ee) What is H. pylori? H. pylori is a common, chronic infection in the stomach. If your child has it, they re not alone. H. pylori is a common chronic infection affecting 1 in 4 children, ages 6 to 17, in the United States. 3 H. pylori is a common chronic infection affecting 1 in 4 children in the United States 3 2 Please see accompanying BRIEF SUMMARY a

3 What are the symptoms? If your child is infected with H. pylori, they may or may not have symptoms. 4 However, symptoms of H. pylori infection can include pain and burning feelings in the stomach. 1 In fact, H. pylori is linked to gastritis (stomach distress) and certain ulcers (sores in the lining of the digestive tract) in children. 1,5 How are children infected? While no one knows for sure how children get infected, H. pylori is known to pass between mother and child. It is also passed between brothers and sisters. Once a child has been treated for H. pylori, they can still be reinfected by untreated family members. When someone in your family has H. pylori, your whole family may be at risk for infection and reinfection. 6,7 and enclosed Current Package Insert. 3

Ask your doctor to test with BreathTek UBT for H. pylori BreathTek UBT is FDA approved to aid in the diagnosis of H. pylori infection in adults and children 3 to 17 years of age.

4 Ask your doctor to test with BreathTek UBT for H. pylori BreathTek UBT is FDA approved to aid in the diagnosis of H. pylori infection in adults and children 3 to 17 years of age. 8 BreathTek UBT is a noninvasive, convenient way to test your child for H. pylori infection. BreathTek UBT can be taken at your doctor s office or at a local lab, as prescribed by your child s doctor. Administering BreathTek UBT takes about 20 minutes. Your child s doctor will provide test results to you. What to expect when your doctor uses BreathTek UBT 1 Your child will inhale, hold their breath momentarily, then exhale into a blue collection bag. 2 3 After the HCP prepares the Pranactin -Citric drug solution* using water, your child will drink the solution through a straw from the plastic cup provided. Wait 15 minutes. 4 Your child will once again inhale, hold their breath momentarily, then exhale into a pink collection bag. * Phenylketonurics: The drug solution contains Phenylalanine (a protein in Aspartame ), 84 mg per dosage unit. (12 ounces of a typical diet cola soft drink contains approximately 80 mg of Phenylalanine.) 4 Please see accompanying BRIEF SUMMARY

6 Consumer Brief Summary About BreathTek UBT Intended Use The BreathTek UBT for H. pylori Kit is a breath test that detects a common infection of the stomach called Helicobacter pylori (H. pylori). A licensed health care practitioner may prescribe BreathTek UBT to test for H. pylori infection in patients aged 3 years and older. A patient may need to take the test again 4 weeks after completing antibiotic therapy to monitor whether H. pylori has been wiped out. BreathTek UBT is always administered by a health care practitioner, as ordered by a licensed health care practitioner. Warnings and Precautions BreathTek UBT is an in vitro diagnostic test requiring you to provide breath samples and drink a drug solution called Pranactin -Citric If you are sensitive to mannitol, citric acid, or Aspartame, avoid drinking the drug solution (Pranactin-Citric) Confirm treatment outcome 4 weeks later (date): Last day of antibiotic treatment (date): First day of antibiotic treatment (date): Schedule your follow-up test Tell your health care practitioner if you are Phenylketonuric (PKU), as this drug contains Phenylalanine (a component of Aspartame). For reference, 12 ounces of a typical diet cola drink contains approximately the same amount of Phenylalanine False negative and false positive results may occur with this test Tell your health care practitioner if you continue to have symptoms. You may need to be retested with a new sample or a different method Inaccurate results may be caused by drugs you are taking within 2 weeks prior to this test. These may include: Proton pump inhibitors (PPIs) such as Aciphex (rabeprazole), Nexium (esomeprazole), Prevacid (lansoprazole), Prilosec (omeprazole), Prilosec OTC (omeprazole), Protonix (pantoprazole), Zegerid (omeprazole/sodium bicarbonate), and Dexilant (dexlansoprazole) Antibiotics Bismuth-based drugs (Pepto-Bismol ) 6 Please see accompanying BRIEF SUMMARY

7 Consumer Brief Summary About BreathTek UBT (cont.) Inaccurate test results can also occur if: The second breath sample is collected too soon You were treated for H. pylori with antibiotics, but take your confirmation test with BreathTek UBT less than 4 weeks after completing your therapy Tell your health care practitioner if you have trouble swallowing because of a medical or physical condition The safety of using the BreathTek UBT Kit during pregnancy and lactation is not established BreathTek UBT is not to be used with children under the age of 3 Adverse Events The following adverse events in adults have been identified: anaphylactic (allergic) reaction, oversensitivity and rash, burning sensation in the stomach, tingling in the skin, vomiting, and diarrhea. In one study, the following adverse events in children 3 to 17 years old have been identified: throwing up, mouth and throat pain (including irritation, soreness, and burning), unsettled stomach, restlessness, stomach ache/belly pain, and diarrhea. Most of these adverse events were experienced within minutes to hours of ingestion of the drug solution (Pranactin-Citric). In another study, some patients also experienced headache, cough, dry mouth, and acute upper respiratory tract infection. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA January US16IBR0002 and enclosed Current Package Insert. 7

Is it just a bellyache, or could it be an infection? References: 1. Helicobacter pylori. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/ulcer/files/hpfacts.pdf.

8 Is it just a bellyache, or could it be an infection? References: 1. Helicobacter pylori. Centers for Disease Control and Prevention Web site. Accessed August 7, Uc A, Chong SK. Treatment of Helicobacter pylori gastritis improves dyspeptic symptoms in children. J Pediatr Gastroenterol Nutr. 2002;34(3): Staat MA, Kruszon-Moran D, McQuillan GM, Kaslow RA. A population-based serologic survey of Helicobacter pylori infection in children and adolescents in the United States. J Infect Dis. 1996;174(5): Gold BD, Colletti RB, Abbott M, et al. Helicobacter pylori infection in children: recommendations for diagnosis and treatment. J Pediatr Gastroenterol Nutr. 2000;31: Pacifico L, Anania C, Osborn JF, Ferraro F, Chiesa C. Consequences of Helicobacter pylori infection in children. World J Gastroenterol. 2010;16(41): Kivi M, Tindberg Y. Helicobacter pylori occurrence and transmission: a family affair? Scand J Infect Dis. 2006;38(6-7): Rowland M, Kumar D, Daly L, et al. Low rates of Helicobacter pylori reinfection in children. Gastroenterology. 1999;116: Package Insert for BreathTek UBT. Otsuka America Pharmaceutical, Inc; Koletzko S, Jones NL, Goodman K, et al; H. pylori working groups of ESPGHAN, NASPGHAN. Evidence-based guidelines from ESPGHAN and NASPGHAN for Helicobacter pylori infection in children. J Pediatr Gastroenterol Nutr. 2011;53(2): Learn more at BreathTek.com or call Please see enclosed Current Package Insert Otsuka America Pharmaceutical, Inc. September US16EBP0076

Heartburn, also referred to acid reflux, happens when stomach acid flows back (refluxes) into your esophagus.

Heartburn, also referred to acid reflux, happens when stomach acid flows back (refluxes) into your esophagus. WHILE almost everyone experiences mild heartburn from time to time and many individuals have some antacids or another medication on hand for its relief, talk to your doctor, if you have heartburn more