FDA approved Nexium for kids
AstraZeneca Plc’s Nexium drug has been approved in the United States for treating excess stomach acid in children aged 1 to 11, the Food and Drug Administration (FDA) said on Thursday.
The FDA approved Nexium, Astra’s top seller and the world’s second-biggest prescription medicine, in two forms — a delayed response capsule and a liquid — it said in a statement.
It was approved in a dose of 10 milligrams, or 20mg daily, for children aged between 1 and 11, half the dosage for patients aged 12 to 17.
Nexium approved for kids
The Food and Drug Administration has approved use of the drug Nexium in children aged 1 to 11 who have acid reflux disease.
FDA said Thursday it approved liquid and delayed-release capsules of Nexium in doses of 10 milligrams or 20 milligrams for these youngsters. It is already approved in doses of 20 milligrams or 40 milligrams for those aged 12 to 17.
Nexium, manufactured by AstraZeneca of Wilmington, Del., is a type of drug known as a proton pump inhibitor, which reduces the amount of acid produced in the stomach and helps heal damage to the esophagus caused by excess acid.
The approval was for short-term use in these children, FDA said. The most common side effects in children were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness, the agency said.
Nexium information:
Nexium decreases the amount of acid produced in the stomach.
Nexium is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Nexium is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid),
Nexium may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).
Nexium may also be used for purposes other than those listed in this medication guide.
Important information about Nexium
Do not use Nexium if you are allergic to esomeprazole or to any other benzimidazole medication such as albendazole (Albenza), or mebendazole (Vermox). Before taking Nexium, tell your doctor if you have ever had liver disease or any type of heart disease. You may need a dose adjustment or special tests during treatment.
Some conditions are treated with a combination of Nexium and antibiotics. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.
Take Nexium for the entire length of time prescribed by your doctor. Your symptoms may get better before your treatment is completed. Do not crush, break, or open a delayed-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.
Nexium side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Other less serious side effects are more likely to occur, such as:
- headache;
- diarrhea;
- nausea, stomach pain, gas, constipation; or
- dry mouth.
Before taking Nexium, tell your doctor if you are using any of the following drugs:
- atazanavir (Reyataz);
- digoxin (Lanoxin, Lanoxicaps);
- diazepam (Valium);
- ketoconazole (Nizoral);
- iron (Feosol, Mol-Iron, Fergon, Femiron, others); or
- a blood thinner such as warfarin (Coumadin).
If you are using any of these drugs, you may not be able to use Nexium, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect Nexium. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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