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Zegerid (Omeprazole) - Summary

 
 



ZEGERID SUMMARY

The active ingredient in ZEGERID™ (omeprazole) powder for oral suspension, is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl]sulfinyl]-1 H -benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion.

ZEGERID™ is indicated for the following:

ZEGERID™ is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Symptomatic GERD

ZEGERID™, is indicated for the treatment of heartburn and other symptoms associated with GERD.

Erosive Esophagitis

ZEGERID™, is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

The efficacy of ZEGERID™ used for longer than 8 weeks in these patients has not been established. In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g. heartburn), additional 4-8 week courses of omeprazole may be considered.

MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS

ZEGERID™ Powder for Oral Suspension is indicated to maintain healing of erosive esophagitis.

Controlled studies do not extend beyond 12 months.


See all Zegerid indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zegerid (Omeprazole)

A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus. [2012]
CONCLUSIONS: In combination with esomeprazole, short-term administration of

A Randomized Study Comparing Levofloxacin, Omeprazole, Nitazoxanide, and Doxycycline versus Triple Therapy for the Eradication of Helicobacter pylori. [2011.11]
OBJECTIVES: Resistance to standard Helicobacter pylori (HP) treatment regimens has led to unsatisfactory cure rates in HP-infected patients. This study was designed to evaluate a novel four-drug regimen (three antibiotics and a proton pump inhibitor (PPI)) for eradication of HP infection in treatment-naive patients... CONCLUSIONS: This open-label, prospective trial demonstrates that LOAD is a highly active regimen for the treatment of HP in treatment-naive patients. A large randomized controlled trial is warranted to further evaluate the efficacy of this regimen.

Improvement in health-related quality of life after therapy with omeprazole in patients with coronary artery disease and recurrent angina-like chest pain. A double-blind, placebo-controlled trial of the SF-36 survey. [2011.09.22]
CONCLUSIONS: A double dose of omeprazole improved the general HRQL in patients with CAD without severe gastrointestinal symptoms more effectively than the placebo.

Prospective, randomized, placebo-controlled evaluation of esomeprazole in coronary artery disease patients. EPAC: esomeprazole prevention of atypical chest pains. [2011.06]
BACKGROUND: Coronary artery disease (CAD) patients experience chest pain (CP) from cardiac and non-cardiac etiologies. OBJECTIVE: Proton pump inhibitor (PPI) treatment of CAD patients with atypical CP would result in less CP, as well as fewer emergency room (ER) visits for CP, medical evaluations, and hospitalizations... CONCLUSIONS: Concomitant esomeprazole therapy in CAD patients without active ischemia but with a history of atypical CP reduces number of patients with further CP symptoms and medical office visits for CP. Larger studies are needed to further evaluate PPI treatment on ER CP visits and hospitalizations in this patient population.

Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. [2011.06]
CONCLUSIONS: Naproxen/esomeprazole magnesium has comparable efficacy to celecoxib for the management of pain associated with osteoarthritis of the knee over 12 weeks.

more studies >>

Clinical Trials Related to Zegerid (Omeprazole)

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.

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.

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.

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).

An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) [Completed]
This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)

more trials >>

Reports of Suspected Zegerid (Omeprazole) Side Effects

Pain (7)Drug Ineffective (5)Abdominal Discomfort (3)Muscle Spasms (3)Hypoaesthesia (3)Hypertension (3)Confusional State (2)Product Substitution Issue (2)Hunger (2)Skin Discolouration (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 11 ratings/reviews, Zegerid has an overall score of 6. The effectiveness score is 7.64 and the side effect score is 7.27. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Zegerid review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   gastritis
Dosage & duration:   20mg taken daily for the period of two weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The symptoms of the gastritis resolved completely within 12 hours after the first dose and were not experienced at all while on the treatment. There were no troublesome side effects compromising compliance. The once daily dose was also ameanable to comlpeting the course of treatment with ease.
Side effects:   None were encountered thus ensuring compliance as stated above.
Comments:   The once daily dose was extremely effective in controlling the debilitating symptoms of gastritis and maintaining the symptom-free period while the treament was taken. There were no side-effects encountered which would have otherwise compromised compliance. The treatment is highly recommended!

 

Zegerid review by 60 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Reflux
Dosage & duration:   10mg taken once daily for the period of periodically over 8 years
Other conditions:   Poor digestive assimilation
Other drugs taken:   None
  
Reported Results
Benefits:   Acid in the stomach was reduced so that the reflux was kept under control. Therefore there was little of no chance of irritation of the esophagus.
Side effects:   Constipation and even less chance of digesting food properly.
Comments:   Even though the reflux was kept under control I felt that constipation and poor digestion was a bad trade-off. As there is bowel cancer in the family clearing of the large intestine is important to me. I have now stopped taking the drug and prefer to treat the reflux by taking care of what I eat, how and when I eat, and being careful not to bend over too much after food. I also use ginger tea which helps to regulate the stomach acid.

 

Zegerid review by 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   acid reflux, GERD
Dosage & duration:   20 mg taken 1 a day for the period of 2-3 months
Other conditions:   n/a
Other drugs taken:   n/a
  
Reported Results
Benefits:   acid reflux was reduced
Side effects:   unfortunately thought the acid reflux went to a minimum, my blood pressure spiked over 50 points on top and 40 points on the bottom number. too much sodium bicarbonate for most people...Please be careful when taking this drug long term
Comments:   I had to get off completely.

See all Zegerid reviews / ratings >>

Page last updated: 2013-02-10

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