AXID SUMMARY
Axid®(nizatidine) Capsules, USP
Nizatidine (USP) is a histamine H2-receptor antagonist.
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 with nizatidine 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 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
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NEWS HIGHLIGHTS
Published Studies Related to Axid (Nizatidine)
Weight gain management in patients with schizophrenia during treatment with olanzapine in association with nizatidine. [2006.12]
CONCLUSIONS: The concomitant use of olanzapine with nizatidine was not effective in controlling weight gain in patients who had previously gained weight during treatment with olanzapine when compared to placebo.
Pharmacokinetics of ranitidine and nizatidine in very elderly patients. [2005.05]
This study was undertaken to examine whether the pharmacokinetic profiles of ranitidine and nizatidine, the H2 antagonists, differed with repeated doses in very elderly patients (>80 years old). Ranitidine (150 mg) or nizatidine (150 mg) was given twice daily in 10 very elderly female patients for 14 days...
Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: an open-label, multiple-dose, randomized, multicenter clinical trial in 210 children. [2005.04]
BACKGROUND: Gastroesophageal reflux disease (GERD), which is reflux that produces damage or troubling symptoms, afflicts approximately 7% of infants and children to the extent that administration of physician-directed pharmacotherapy is warranted. OBJECTIVE: This study was designed in conjunction with the US Food and Drug Administration (FDA) to assess the tolerability and effectiveness of nizatidine, in different doses and formulations, including a newly formulated premade oral solution, for pediatric GERD... CONCLUSIONS: This large study, although limited by its open-label design and post hoc analyses, supports the tolerability and effectiveness of 8 weeks of treatment with nizatidine in children aged 5 days through 18 years. AE incidence and severity were as expected for children during the winter season. There was an overall improvement in symptoms and a decrease in antacid use. Formulation did not appear to alter tolerability or effectiveness assessments: the premade solution, extemporaneous solution, and capsule provided comparable symptomatic relief with no disproportionate adverse reactions.
Bioequivalence of two oral formulations of nizatidine capsules in healthy male volunteers. [2005.04]
PURPOSE: The purpose of this randomized, crossover study was to compare the bioavailability of a generic and an innovator formulation of nizatidine 300 mg capsules under fasting conditions... CONCLUSION: The results indicate that these two formulations are equivalent in the rate and extent of absorption. Copyright 2005 John Wiley & Sons, Ltd.
Comparative study of nizatidine and famotidine for maintenance therapy of erosive esophagitis. [2005.02]
BACKGROUND: The therapeutic effect of combined administration of prokinetics and histamine H2 receptor antagonists (H2RA) in gastroesophageal reflux disease is reported to be superior to that of monotherapy with H2RA alone. In addition to its acid-suppressing effect, the H2RA nizatidine also has a prokinetic action by suppressing acetylcholine esterase. The present multicenter, randomized controlled study was performed to investigate whether nizatidine is superior to famotidine, which does not suppress acetylcholine esterase activity, in maintenance therapy for erosive esophagitis. In addition, the question as to whether the grade of erosive esophagitis affects the non-recurrence rate during the maintenance therapy with H2RA was also investigated... CONCLUSION: Nizatidine is a more effective H2RA than famotidine in the maintenance therapy of patients with reflux esophagitis. (c) 2004 Blackwell Publishing Asia Pty Ltd.
Clinical Trials Related to Axid (Nizatidine)
Safety and Efficacy Study of Axid Use in Infants Suffering From GERD [Active, not recruiting]
Weight Gain Management in Patients With Schizophrenia [Completed]
Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with
schizophrenia who have been under treatment with olanzapine for at least two months and
evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent
adverse events, changes in vital signs, laboratory results and extrapyramidal effects.
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Page last updated: 2007-02-12
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