Heartburn/GERD Health Center
This article is from the WebMD News Archive
FDA OKs Prilosec for Kids as Young as 1
March 21, 2008 -- The FDA today announced its approval of the use of Prilosec in children as young as 1 year old.
The FDA yesterday approved Prilosec delayed-release oral suspension (liquid) for the short-term treatment of gastroesophageal reflux disease (GERD) and the healing of erosive esophagitis (erosions in the lining of the esophagus) in children aged 1-2.
Prilosec, made by AstraZeneca, was previously approved for use in children aged 2 to 16.
Last month, the FDA approved another GERD drug, Nexium, for use in children aged 1-11. Nexium, which is also made by AstraZeneca, was already approved for use in kids aged 12-17.
Neither pill is approved for use in children younger than 1 year old.
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Important Safety Information
- KAPIDEX may not be right for everyone. You should not take KAPIDEX if you are allergic to KAPIDEX or any of its ingredients. Severe allergic reactions have been reported.
- Symptom relief does not rule out other serious stomach conditions.
- The most common side effects of KAPIDEX were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%). KAPIDEX and certain other medicines can affect each other. Before taking KAPIDEX, tell your doctor if you are taking ampicillin, atazanavir, digoxin, iron, ketoconazole, or tacrolimus. If you are taking KAPIDEX with warfarin, you may need to be monitored because serious risks could occur.
Uses of KAPIDEX
- Persistent heartburn two or more days a week, despite treatment and diet changes, could be acid reflux disease (ARD). Prescription KAPIDEX capsules are used in adults to treat heartburn related to ARD, to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE), and to stop EE from coming back. Individual results may vary. Most damage (erosions) heals in 4–8 weeks.
Talk to your doctor or healthcare professional. Please see full Prescribing Information for KAPIDEX.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
KAPIDEX™ is a trademark of Takeda Pharmaceuticals North America, Inc., and is used under license by Takeda Pharmaceuticals America, Inc.
LPD-00767
It’s not just what you eat that can cause your stomach to churn. It’s also how much you eat and what you do after meals.
