DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Zegerid (Omeprazole) - Summary



ZEGERID® (omeprazole/sodium bicarbonate) is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole 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.

Duodenal Ulcer

ZEGERID (omeprazole/sodium bicarbonate) 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. [See Clinical Studies ]

Gastric Ulcer

ZEGERID is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies]

Treatment of Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD

ZEGERID is indicated for the treatment of heartburn and other symptoms associated with GERD. [See Clinical Studies ]

Erosive Esophagitis

ZEGERID is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.

The efficacy of ZEGERID used for longer than 8 weeks in these patients has not been established. If a patient does not respond 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 ZEGERID may be considered. [See Clinical Studies]

Maintenance of Healing of Erosive Esophagitis

ZEGERID is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. [See Clinical Studies ]

Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (40mg oral suspension only)

ZEGERID Powder for Oral Suspension 40 mg/1680 mg is indicated for the reduction of risk of upper GI bleeding in critically ill patients. [See CLINICAL STUDIES , Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients]

See all Zegerid indications & dosage >>


Published Studies Related to Zegerid (Omeprazole)

Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole 40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms. [2014]
AIM: To compare the efficacy of pantoprazole-Mg and esomeprazole in GERD... CONCLUSIONS: Pantoprazole-Mg 40 mg was at least as effective as esomeprazole

Randomised clinical trial: sodium alginate oral suspension is non-inferior to omeprazole in the treatment of patients with non-erosive gastroesophageal disease. [2013]
to omeprazole in adult subjects with NERD... CONCLUSION: The study showed that sodium alginate was as effective as omeprazole

[Efficacy and safety of esomeprazole, compared with omeprazole, in maintenance therapy for reflux esophagitis -a phase III, multicenter, randomized, double-blind trial-]. [Article in Japanese] [2013]
A multicenter, randomized, double-blind study comparing the efficacy and safety of esomeprazole 20mg/day (E20) and 10mg/day (E10) with omeprazole 10mg/day (O10) for maintenance of remission in patients with healed reflux esophagitis (RE). For RE, at week 24, the estimated Kaplan-Meier recurrence-free rates were 92.0%, 87.5%, and 82.7% in the E20, E10, and O10 groups, respectively...

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.

more studies >>

Clinical Trials Related to Zegerid (Omeprazole)

Prilosec Bioequivalence Study in Healthy Volunteers [Completed]
This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck

A Study to Compare Omeprazole Administered as Zegerid� Powder and as Prilosec� Capsule in Healthy Participants (P08050)(CL2010-12) [Completed]
This study compares the bioequivalence of omeprazole administered as either Zegerid powder for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.

Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study [Completed]
The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.

Optimal Dosing of Omeprazole in Neonates [Completed]
"The principal aim of this trial is to determine the minimum effective dose of omeprazole in neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry), to obtain a short-term efficacy in the pHmetry of control performed 72 hrs 24 after initiation of omeprazole. The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon other pHmetry parameters, (2) to characterize the population pharmacokinetics and pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates."

A Pharmacodynamic Study Comparing Zegerid and Prilosec OTC (Study CL2008-02)(P07814)(COMPLETED) [Completed]
Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.

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 >>


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

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

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

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: 2014-12-01

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015