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A prescription drug for the treatment of pediatric GERD(Gastroesophageal Reflux Disease)

 

 

 


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What is Axid Oral Solution?                                                                                           Axid Oral Solution is an alcohol-free, clear, yellow, oral solution with a bubble gum flavor. Each 1 mL of Axid Oral Solution contains 15 mg of the active ingredient nizatidine. It is available by prescription.

How does it work?

Axid Oral Solution is in a class of drugs called histamine (H2) receptor antagonists. It works by decreasing the amount of acid the stomach produces.  It is used to treat conditions in which acid comes up into the esophagus and causes heartburn, such as gastroesophageal reflux disease (GERD). 

When should my child take AXID Oral Solution?                                                                  It is usually taken twice a day. But every child is different. Your doctor will tell you what time of day is best. AXID Oral Solution contains no alcohol. The tasty, bubble-gum flavor makes it easy to take.

At what age can my child take it?                                                                                    AXID Oral Solution is generally safe for children. AXID Oral Solution is proven effective in children 12-18 years. The effectiveness in pediatric patients <12 years has not been established.

For how long?                                                                                                                  AXID Oral Solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Your doctor will tell you how long to use it. 

Are there any side effects?                                                                                                Like all medicines, AXID Oral Solution can cause some side effects. The most common in children include fever, stuffy nose, and sore throat. They may also include cough, diarrhea, vomiting, and feeling cranky. Tell your doctor if any side effect becomes severe or lasts too long.

Who should not take AXID Oral Solution?                                                                            It should not be taken by anyone who reacts poorly to nizatidine. That is the main part of the drug. Anyone who has reacted poorly to other drugs like this one should not take it. If a patient has kidney problems, the doctor may reduce the amount of drug to take.

 

 

 

 

 

 

 

 

 

 


Click here for full prescribing information

 

In pediatric patients AXID Oral Solution is indicated for ages 12 years and older. AXID Oral Solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.

The most common adverse events (>5%) in controlled clinical trials with pediatric patients were pyrexia, nasopharyngitis, diarrhea, vomiting, irritability, nasal congestion, and cough. In controlled clinical trials with adults, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the nizatidine group than with placebo. The following treatment-emergent AEs occurred in controlled clinical trials with nizatidine vs placebo in adults: headache (16.6% vs 15.6%), diarrhea (7.2% vs 6.9%), dizziness (4.6% vs 3.8%), and rhinitis (9.8% vs 9.6%).

Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy. Pharmacokinetic studies in patients with hepatorenal syndrome have not been done. Part of the dose of nizatidine is metabolized in the liver. AXID Oral Solution is contraindicated in patients with known hypersensitivity to the drug. Because cross sensitivity in this class of components has been observed, H2RAs, including nizatidine, should not be administered to patients with a history of hypersensitivity to other H2RAs. Dosage should be reduced in patients with moderate to severe renal insufficiency including some elderly patients with decreased creatinine clearance.

References: 1. Zantac Syrup full prescribing information. 2. AXID Oral Solution full prescribing information. 3. Pediatric Gastroesophageal Reflux. Clinical Practice Guideline Summary. Available at: http://www.cdhnf.org/pdf/GERD_8_pg_brochure_031103.pdf.  Accessed September 3, 2004.

Zantac is a registered trademark of GlaxoSmithKline.