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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 a histamine H2-receptor antagonist. It is formulated as a clear, yellow, oral solution with a bubble gum flavor and each 1 mL contains 15 mg of the active ingredient nizatidine. Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-receptors, particularly those in the gastric parietal cells.

What is Axid Oral Solution indicated for?

  • Axid Oral Solution is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.
  • Axid Oral Solution is indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy for longer than 1 year are not known.  
  • Axid Oral Solution is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
  • Axid Oral Solution is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.
  • 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.

 

Is Axid Oral Solution safe for children?

In randomized pediatric trials, nizatidine was administered to patients for up to 8 weeks. A total of 230 pediatric patients 2 to 18 years of age were administered nizatidine at a dose of either 2.5mg/kg b.i.d., or 5.0 mg/kg b.i.d. (patients 12 and under) or 150 mg b.i.d. (12 to 18 years). In patients 2 to 18 years of age, nizatidine was found generally safe and well tolerated. In these studies in patients 12 years and older, nizatidine was found to reduce the severity and frequency of GERD symptoms, improve physical well being, and reduce the frequency of supplemental antacid consumption. No efficacy in pediatric patients <12 years of age has been established. Clinical studies in patients 2 to 12 years of age with GERD demonstrated no difference in either symptom improvements or healing rates between nizatidine and placebo or between different doses of nizatidine.

 

What are the contraindications?

Axid Oral Solution is contraindicated in patients with known hypersensitivity to the drug. Because cross-sensitivity in this class of compounds has been observed, H2-receptor antagonists, including nizatidine, should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.

 

What is the recommended dose for Axid Oral Solution?

  • Adults:
    • Active Duodenal Ulcer – the recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.  
    • Maintenance of Healed Duodenal Ulcer – the recommended oral dosage for adults is 150 mg once daily at bedtime.  
    • Gastroesophageal Reflux Disease - the recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.
    • Active Benign Ulcer - the recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime.  
  • Pediatric patients - Axid Oral Solution is indicated for patients 12 years of age and older.
    • Erosive esophagitis – the dosage is 150 mg b.i.d. (300mg/d). The maximum daily dosage for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.
    • Gastroesophageal Reflux Disease - the dosage is 150 mg b.i.d. (300mg/d). The maximum daily dosage for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.

 

 

 

 

 

 

 

 


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.