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 indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zegerid (Omeprazole)

FDA Announces New Warning On Plavix: Avoid Use With Prilosec/Prilosec OTC
Source: Health News from Medical News Today [2009.11.19]
Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17. New data suggest that when patients take both Prilosec and Plavix, Plavix's ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.

AHA: FDA Drops Clopidogrel Bomb at AHA
Source: MedPage Today Gastroenterology [2009.11.17]
ORLANDO (MedPage Today) -- The FDA has issued a public health advisory warning patients and physicians that concommitant use of clopidogrel (Plavix) and omeprazole (Prilosec and Prilosec OTC) blunts the antiplatelet effect of clopidogrel, so the combination should be avoided.

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Published Studies Related to Zegerid (Omeprazole)

Comparison of omeprazole and pantoprazole influence on a high 150-mg clopidogrel maintenance dose the PACA (Proton Pump Inhibitors And Clopidogrel Association) prospective randomized study. [2009.09.22]
OBJECTIVES: This study sought to compare the effect of 2 proton pump inhibitors (PPIs) on platelet response to clopidogrel after coronary stenting for non-ST-segment elevation acute coronary syndrome (NSTE ACS). BACKGROUND: Use of omeprazole has been reported to significantly decrease the clopidogrel antiplatelet effect because of cytochrome P450 interaction. Because all PPIs are metabolized by CYP2C19, but to a varying degree, we hypothesized that the reported negative omeprazole-clopidogrel drug interaction may not be caused by a class effect... CONCLUSIONS: The present findings suggest the preferential use of pantoprazole compared with omeprazole in patients receiving clopidogrel to avoid any potential negative interaction with CYP2C19.

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.

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.

Clopidogrel inhibits CYP2C19-dependent hydroxylation of omeprazole related to CYP2C19 genetic polymorphisms. [2009.05]
This study explores the impact of clopidogrel on the pharmacokinetics of omeprazole related to CYP2C19 genetic polymorphisms. Twelve healthy volunteers (6 CYP2C19*1/*1, 5 CYP2C19*2/*2, and 1 CYP2C19*2/*3) are enrolled in a 2-phase randomized crossover trial...

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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)

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PATIENT REVIEWS / RATINGS / COMMENTS

Zegerid review by 22 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Laryngopharyngeal Reflux
Dosage & duration:		40 mg taken twice a day for the period of 9 months
Other conditions:		Eustachian Tube Dysfunction
Other drugs taken:		none
		Reported Results
Benefits:		fewer Reflux episodes, less inflammation of the Eustachian Tube, lower cancer risk
Side effects:		digestive problems: a few days per month
Comments:		Laryngopharyngeal Reflux has caused a Eustachian Tube (ET) dysfunction. A reduction of reflux episodes was a necessary condition for the regeneration of the ET. Progress has already been achieved: inflammations of the ET have been reduced, the tissue surrounding the ET is regenerating.

Zegerid review by 50 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Gerd
Dosage & duration:		20 MG taken bid for the period of Ongoing
Other conditions:		allergies
Other drugs taken:		singulair
		Reported Results
Benefits:		Reduced symptoms of acid reflux
Side effects:		diarrhea
Comments:		The insurance company no longer covered Protonix, but substituted Omeprazole. It is not as effective at reducing episodes of acid reflux as Protonix, and the dose had to be doubled to approach the same level of efficacy.

Zegerid review by 50 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		acid reflux
Dosage & duration:		4mg taken twice daily for the period of one month
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The drug reduced the frequency of acid reflux events and the associated pain
Side effects:		After a few days I experienced severe muscle ache in legs such that I had difficulty climbing stairs. I also had overwhelming fatigue and even indigestion
Comments:		This drug was fairly effective after one week's use week but did not cure the reflux completely and the side effects were very debilitating. I experienced a rebound effect after stopping which lasted for approximately four weeks. After having an endoscopy I was diagnosed with gastritis.