A prescription drug for the treatment of pediatric GERD

(Gastroesophageal Reflux Disease)

U.S. Patent No. 6,930,119














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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.