NEXIUM SUMMARY
The active ingredient in NEXIUM® (esomeprazolemagnesium) Delayed-Release Capsules is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1
H
-benzimidazole-1-yl) magnesium trihydrate, 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 is indicated for the following:
TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Healing of Erosive Esophagitis
NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 week course of NEXIUM may be considered. Maintenance of Healing of Erosive Esophagitis
NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease
NEXIUM is indicated for treatment of heartburn and other symptoms associated with GERD.
H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
Triple Therapy (NEXIUM plus amoxicillin and clarithromycin): NEXIUM, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See Clinical Studies and DOSAGE AND ADMINISTRATION.)
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. (See CLINICAL PHARMACOLOGY, Microbiology and the clarithromycin package insert, CLINICAL PHARMACOLOGY, Microbiology.)
|
NEXIUM NEWS HIGHLIGHTS Media Articles Related to Nexium (Esomeprazole)
FDA OKs Nexium for Kids 1-11
Source: MedicineNet esomeprazole Specialty [2008.02.29]
Title: FDA OKs Nexium for Kids 1-11
Category: Health News
Created: 2/29/2008
Last Editorial Review: 2/29/2008
Nexium GERD Treatment for Infants and Children
Source: MedicineNet esomeprazole Specialty [2008.02.28]
Title: Nexium GERD Treatment for Infants and Children
Category: Health Facts
Created: 2/28/2008
Last Editorial Review: 2/28/2008
POZEN Submits New Drug Application For VIMOVO™ (PN 400)
Source: Arthritis / Rheumatology News From Medical News Today [2009.07.02]
POZEN Inc. (NASDAQ:POZN), announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVO™ (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca entered into a global co-development agreement for VIMOVO in August 2006.
Published Studies Related to Nexium (Esomeprazole)
Moxifloxacine plus amoxicillin and ranitidine bismuth citrate or esomeprazole triple therapies for Helicobacter pylori infection. [2008.12]
Up to 20% of patients, or even more, will fail to obtain eradication after a standard triple therapy... pylori in developing regions of the world.
Efficacy of esomeprazole (20 mg once daily) for reducing the risk of gastroduodenal ulcers associated with continuous use of low-dose aspirin. [2008.10]
OBJECTIVES: Low-dose aspirin is standard treatment for prevention of cardiovascular events in at-risk patients. However, long-term administration of low-dose aspirin is associated with a greater risk of adverse events, including gastroduodenal ulcers. This study determined the efficacy of esomeprazole [generic for Nexium] for reducing the risk of gastric and/or duodenal ulcers and dyspeptic symptoms in patients receiving continuous, low-dose aspirin therapy... CONCLUSIONS: Esomeprazole 20 mg once daily reduces the risk of developing gastric and/or duodenal ulcers and symptoms associated with the continuous use of low-dose aspirin in patients aged > or =60 yr without preexisting gastroduodenal ulcers.
Double-blind, placebo-controlled trial with esomeprazole for symptoms and signs associated with laryngopharyngeal reflux. [2008.09]
OBJECTIVE: To determine the efficacy of proton pump inhibitor (PPI) therapy with esomeprazole [generic for Nexium] on symptoms and signs associated with laryngopharyngeal reflux (LPR)... CONCLUSION: In the treatment of LPR-related symptoms a high placebo effect can be observed. However, compared to control, twice-daily PPI treatment for three months demonstrated a significantly greater improvement in laryngeal appearance and LPR symptoms.
Comparing laparoscopic antireflux surgery with esomeprazole in the management of patients with chronic gastro-oesophageal reflux disease: a 3-year interim analysis of the LOTUS trial. [2008.09]
BACKGROUND: With the introduction of laparoscopic antireflux surgery (LARS) for gastro-oesophageal reflux disease (GORD) along with the increasing efficacy of modern medical treatment, a direct comparison is warranted. The 3-year interim results of a randomised study comparing both the efficacy and safety of LARS and esomeprazole [generic for Nexium] (ESO) are reported... CONCLUSIONS: Over the first 3 years of this long-term study, both laparoscopic total fundoplication and continuous ESO treatment were similarly effective and well-tolerated therapeutic strategies for providing effective control of GORD.
The effect of famotidine, esomeprazole, and ezetimibe on levothyroxine absorption. [2008.05]
Background: Recent literature describing the effect of gastric acid suppression on levothyroxine absorption has been inconsistent. Also, ezetimibe, a lipid-lowering compound that inhibits intestinal absorption of cholesterol, may interfere with levothyroxine absorption...
Clinical Trials Related to Nexium (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.
|
NEXIUM PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 23 ratings/reviews, Nexium has an overall score of 7.83. The effectiveness score is 8.61 and the side effect score is 9.13. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Nexium review by 35 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | heartburn |
| Dosage & duration: | | 20mg taken once a day for the period of life long |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | no more heartburn, was able to eat without experiencing any further heartburn or reflux. will take the product as a long term solution to acid reflux |
| Side effects: | | none, experienced no noticable side effects or discomfort, no more reflux or heartburn was very happy with the ddrug will keep oj using it |
| Comments: | | nexium 20mg before meals, at least 20 min before each meal. can be taken before all meals with no bad effects. has long lasting effects |
|
| | Nexium review by 38 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Indigestion and check pain |
| Dosage & duration: | | 1 pill per day taken once a day for the period of once a day |
| Other conditions: | | heartburn |
| Other drugs taken: | | none (only ibuprofen for pain) | | |
Reported Results |
| Benefits: | | The chest pain went away almost immediately. I rarely had heartburn even when I ate spicey foods. Even though I still may have heartburn occasionally, the tightness of my chest and the frequent indigestion has almost completely disappeared. Before I had indigestion at random times during the day, which would cause unexpected chest pains. |
| Side effects: | | I did not experience any side effects. Possibly because I did not the pills on an empty stomache. |
| Comments: | | My doctor asked me to take Nexium once a day until they were gone to see if the tightness in my check, the indigestion, and the heartburn could be cured by the pills. The tightness in the check and indigestion were not signs of heart problems as the doctor discovered. To date, the pills seemed to have worked. |
|
| | Nexium review by 32 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | acic reflux |
| Dosage & duration: | | one pill taken once a day for the period of 1 year |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The treatment benefits are that it has stopped the acid from coming up into my esphogus. I also has benefited from further damage to my esphogus from the acid reflux. I do not have bad breath from the acid and i am no longer horse in my throat when i talk alot. The nexxium has stopped my stomach from producing acid. |
| Side effects: | | After about a couple of months i began to experience severe stomach cramping, bloating, and diareaha. My body is now completely depended on the drug and my understanding is that the pill is telling my body not to produce acid which in turn works harder to produce more, which makes since when i have tried to go off of it my acid reflux was 20 times worse. My body has become completely dependent on the drug. |
| Comments: | | The treatment details were that i did not need to change my diet, but to just take one pill every day and that would take care of my issue with my body producing to much acid. |
|
|
|
Page last updated: 2009-07-02
|
