(BPT) – Patients of varying ages, including kids, may be affected by acid-related disorders. In fact, children 1 year or older can experience symptoms associated with gastroesophageal reflux disease (GERD).1 This is important to understand as GERD may be difficult to distinguish from other gastrointestinal health conditions with similar symptoms.2 Additionally, infants 1 month to 1 year old can experience erosive esophagitis (EE) due to acid-mediated GERD.3
“Knowing if your child has GERD can be difficult to spot,” says Mark Gilger, MD, Pediatrician-in-Chief at the Children’s Hospital of San Antonio. “Young children suffering from GERD may not be able to communicate all aspects of their discomfort, so understanding how to spot signs and symptoms is crucial.”
For children, symptoms of GERD can include9-10:
- Spitting up
- Back arching and crying that can’t be calmed
- Feeding difficulties
- Poor weight gain
- Persistent vomiting
- Weight loss
Treatment Options Are Available
If a child under your care is diagnosed with GERD, work with his or her health care provider to choose the best course of treatment. For some children, lifestyle changes are generally recommended, including changes to diet.2 However, if you and your child’s doctor decide that other treatment is needed, options are available that may offer relief.
AstraZeneca’s NEXIUM® (esomeprazole magnesium) Packets for Delayed-Release Oral Suspension can be used for patients who may be unable to swallow a pill, such as children.
NEXIUM Packets is the only proton pump inhibitor (PPI) for oral suspension approved by the US Food and Drug Administration (FDA) for children as young as 1 month old.4-8 For infants 1 month to less than 1 year, NEXIUM is indicated for the short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD. NEXIUM is also indicated for the short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. The safety and effectiveness of NEXIUM for patients younger than 1 month has not been established.4
“NEXIUM Packets is an important alternative for young patients who are unable to swallow a capsule and for patients who need dosing flexibility,” says Anthony Piraino, MD, PhD, Senior Medical Director, AstraZeneca Pharmaceuticals. “It’s essential that these young patients have access to an effective treatment.”
The use of NEXIUM in pediatric and adolescent patients 1 to 17 years of age for short-term treatment (up to 8 weeks) of GERD is supported by extrapolation of results from adequate and well-controlled studies for adults, and safety and pharmacokinetic studies performed in pediatric and adolescent patients.4
Editor’s Note: This content is brought to you by AstraZeneca.
IMPORTANT SAFETY INFORMATION ABOUT NEXIUM® (esomeprazole magnesium) PACKETS
- Symptom relief does not rule out the presence of other serious stomach conditions your child may have
- NEXIUM may increase your child’s risk of getting severe diarrhea. Call your child’s doctor right away if your child has watery stool, stomach pain and fever that does not go away
- Talk to your child’s doctor about your child’s risk for
- Bone fractures if your child takes multiple daily doses of NEXIUM for a long period of time
- Low vitamin B12 if your child has been on NEXIUM for a long time (more than 3 years)
- Low magnesium levels if your child takes NEXIUM for a long period of time
- Tell your child’s doctor about all of the medicines your child takes, prescription and nonprescription drugs, including clopidogrel, vitamins and herbal supplements. NEXIUM may affect how other medicines work and other medicines may affect how NEXIUM works
- In children 1 to 17 years of age, side effects with NEXIUM include headache, diarrhea, abdominal pain, nausea and sleepiness
- In infants aged 1 month to less than 1 year old, side effects with NEXIUM include abdominal pain, regurgitation, rapid breathing, and abnormal liver blood tests
NEXIUM® (esomeprazole magnesium) is prescribed to treat the symptoms of acid reflux disease, which typically include persistent heartburn on 2 or more days per week, despite treatment and change of diet in patients 1 year of age and older.
For patients as young as 1 month of age, NEXIUM is also prescribed to heal damage to the esophagus called erosive esophagitis. This damage may be caused over time from stomach acid wearing away the lining of the esophagus. Only a doctor can diagnose this condition. With NEXIUM, most erosions heal in 4 to 8 weeks. Results with NEXIUM may vary.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
Patients can find out more information about NEXIUM Packets at www.PurplePill.com or by calling the Information Center at AstraZeneca at 1-800-236-9933.
AstraZeneca offers the AZ&MeTM Prescription Savings Program. To determine eligibility, patients can visit www.AZandMe.com or call 1-800-AZandMe (292-6363).
Interested in the NEXIUM Packets Savings Card? Eligible commercially insured patients with a valid prescription for NEXIUM who present the savings card at participating pharmacies will pay $15 for a 30-day supply or $30 for a 60-day supply or 90-day supply, subject to a maximum savings of $125 per 30-day supply. Eligibility and restrictions apply. Visit www.nexiumpackets.com for more information about the NEXIUM Packets Savings Card.
1. Lightdale J, Gremse D. Gastroesophageal Reflux: Management Guidance for the Pediatrician. PEDIATRICS. 2013. Vol. 131. No. 5. May 1, 2013.
2. Vandenplas Y, Rudolph C, DiLorenzo C, et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). Journal of Pediatric Gastroenterology and Nutrition. 2009.
3. Gilger MA, El-Serag HB, Gold BD, Dietrich CL, Tsou VM, McDuffie A, Shub MD. Prevalence of Endoscopic Findings of Erosive Esophagitis in Children: A Population-based Study. Journal of Pediatric Gastroenterology & Nutrition. 2008. Volume 47 – Issue 2.
4. Prescribing Information for NEXIUM Packets. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
5. Prescribing Information for Aciphex. Management Co, Ltd, Eisai Inc, Woodcliff Lake, NJ.
6. Prescribing Information for Protonix. Wyeth Pharmaceuticals, Inc, a subsidiary of Pfizer Inc, Philadelphia, PA.
7. Prescribing Information for Prilosec. AstraZeneca Pharmaceuticals LP, Wilmington DE.
8. Prescribing Information for Prevacid. Novartis Consumer Health, Inc, Parsippany, NJ.
9. Gold B. Gastroesophageal reflux disease in infants, children, and adolescents. Advanced Studies in Medicine. 2003. 3(3A); 117-122.
10. National Institute of Diabetes and Digestive and Kidney Diseases. Gastroesophageal Reflux (GER) and Gastroesophageal Reflux Disease (GERD) in Children and Adolescents. Last updated Sept. 5, 2013. Date accessed Aug. 18, 2015. http://www.niddk.nih.gov/health-information/health-topics/digestive-diseases/ger-and-gerd-in-children-and-adolescents/Pages/facts.aspx
Intended Audience is US Consumers.