NEXIUM I.V. SUMMARY
NEXIUM® I.V.
(esomeprazole sodium)
FOR INJECTION
The active ingredient in NEXIUM® I.V. (esomeprazole sodium) for Injection is (S)-5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H -benzimidazole sodium a compound that inhibits gastric acid secretion. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers.
NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of GERD patients with a history of erosive esophagitis as an alternative to oral therapy in patients when therapy with NEXIUM Delayed-Release Capsules is not possible or appropriate.
When oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.
|
NEWS HIGHLIGHTS
Published Studies Related to Nexium I.V. (Esomeprazole)
Evaluation of the pharmacokinetic interaction between esomeprazole (40 mg) and acetylsalicylic acid (325 mg) in healthy volunteers. [2009.09]
OBJECTIVE: To evaluate the effect of esomeprazole on the pharmacokinetics of low-dose acetylsalicylic acid (ASA) during repeated co-administration... CONCLUSIONS: There was no pharmacokinetic interaction between esomeprazole (40 mg) and ASA (325 mg) during repeated co-administration in healthy volunteers.
H. pylori eradication prevents the progression of gastric intestinal metaplasia in reflux esophagitis patients using long-term esomeprazole. [2009.07]
OBJECTIVES: This study aimed to determine whether Helicobacter pylori eradication limits the progression of precancerous changes, manifested as intestinal metaplasia (IM), in patients with reflux esophagitis using long-term esomeprazole... CONCLUSIONS: In patients using long-term esomeprazole for reflux esophagitis, screening for and eradicating H. pylori infection are necessary in order to limit the progression or cause the regression of gastric precancerous changes.
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis. [2009.06.18]
BACKGROUND: Both gastroesophageal reflux disease and allergy/atopy have been implicated in the pathogenesis of eosinophilic esophagitis (EoE). There are no prospective studies comparing treatment of EoE with acid suppression versus topical corticosteroids. OBJECTIVE: To determine the outcome of adult eosinophilic esophagitis patients treated with esomeprazole versus topical fluticasone... CONCLUSIONS: Gastroesophageal reflux disease is common in adult eosinophilic esophagitis patients. Dysphagia improves and esophageal eosinophilic infiltration decreases with either treatment. There was no difference in degree of improvement in dysphagia or eosinophil infiltration in patients treated with either topical fluticasone or oral esomeprazole. GERD may be important in the pathogenesis of adult EoE.
Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care--prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg. [2009.05.01]
BACKGROUND: A trial of empirical PPI therapy is usual practice for most patients with symptoms of gastro-oesophageal reflux disease (GERD) in primary care. AIM: To determine if the 4-week efficacy of rabeprazole 20 mg for resolving heartburn and regurgitation symptoms is non-inferior to esomeprazole 40 mg or 20 mg... CONCLUSIONS: In uninvestigated GERD patients, rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete and satisfactory relief of regurgitation and satisfactory relief of heartburn, and not different for complete resolution of heartburn.
Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. [2009.04.07]
BACKGROUND: Use of proton-pump inhibitors in the management of peptic ulcer bleeding is controversial because discrepant results have been reported in different ethnic groups. OBJECTIVE: To determine whether intravenous esomeprazole prevents recurrent peptic ulcer bleeding better than placebo in a multiethnic patient sample... CONCLUSION: High-dose intravenous esomeprazole given after successful endoscopic therapy to patients with high-risk peptic ulcer bleeding reduced recurrent bleeding at 72 hours and had sustained clinical benefits for up to 30 days. PRIMARY FUNDING SOURCE: AstraZeneca Research and Development.
Clinical Trials Related to Nexium I.V. (Esomeprazole)
Prevention of Gastric Ulcers [Completed]
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This
study looks at the prevention of these gastric ulcers with one of the three following
treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once
daily; versus placebo; in patients at risk.
Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) [Completed]
The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered
orally compared to intravenously on the maximum acid output in subjects with symptoms of
Gastroesophageal reflux disease (GERD).
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® [Active, not recruiting]
Open-label randomized crossover design studies. 60 subjects will be evaluated on Day 1 to
compare effects on stomach acid; 30 subjects will continue treatment for 7 days and will have
repeat evaluations at Day 7.
Ulcer Prevention II [Completed]
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This
study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with
either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued [Completed]
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This
study looks at the treatment of these gastric ulcers with one of the three following
treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine
150 mg twice daily.
|
