Prilosec (Omeprazole) - Summary

PRILOSEC SUMMARY

The active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1Hbenzimidazole, a compound that inhibits gastric acid secretion.

PRILOSEC is indicated for the following:

Duodenal Ulcer (adults)

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

PRILOSEC in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.

PRILOSEC, in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [ see Clinical Studies (14.1) and Dosage and Administration (2) ].

Among patients who fail therapy, PRILOSEC with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. 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 Microbiology section (12.4) ], and the clarithromycin package insert, Microbiology section.)

Gastric Ulcer (adults)

PRILOSEC is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults. [ See Clinical Studies (14.2) ]

Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)

Symptomatic GERD

PRILOSEC is indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.

Erosive Esophagitis

PRILOSEC is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [ See Clinical Studies (14.4) ]

The efficacy of PRILOSEC used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)

PRILOSEC is indicated to maintain healing of erosive esophagitis in pediatric patients and adults.

Controlled studies do not extend beyond 12 months. [ See Clinical Studies (14.4) ]

Pathological Hypersecretory Conditions (adults)

PRILOSEC is indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Prilosec (Omeprazole)

Results Of Phase I Study Show Novel, Investigational PA65020 Compound Significantly Decreased Risk Of Upper Gastrointestinal Damage In Healthy Adults
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2009.10.28]
POZEN Inc. (NASDAQ: POZN) announced the results of a Phase I study that showed a novel, investigational combination of enteric-coated aspirin (EC-ASA) and immediate-release omeprazole known as PA65020, is associated with a significantly decreased risk of GI mucosal damage compared to analgesic doses (650 mg twice daily) of over-the-counter enteric-coated aspirin (EC-ASA) in healthy adults treated for one month.

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Published Studies Related to Prilosec (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 Prilosec (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

Prilosec review by 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		GERD
Dosage & duration:		40 mg taken daily for the period of Continuous
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Acid reflux ceased to exist when taking Prilosec.
Side effects:		I have had no side effects from Prilosec.
Comments:		It's pill you take 20 minutes before eating breakfast. It stops the acid from the stomach backing up into the esopogus.

Prilosec review by 31 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Heartburn
Dosage & duration:		40 mg taken twice daily for the period of 4 Years
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		It reduced the amount of acid that my stomach produced and therefore allowed my stomach and esophagus to heal to some degree. I also took it for years to control my regular acid reflux problems.
Side effects:		I developed joint pains and arthritis as well as constipation, stomach aches, and overall reduced health.
Comments:		Eventually my body was so used to the Prilosec that it was almost impossible to get off. My body was working very hard to produce enough acid for protein digestion that whenever I stopped taking Prilosec there would be a huge backlash of extreme acid production.

Prilosec review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Acid Reflux
Dosage & duration:		20mg taken once per day for the period of 2 years
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Reduction of acid.
Side effects:		Side effects from 20mg per day after one year of use were those listed in over-dose of prilosec side effects; along with other side effects not listed. Anxiety, heart racing, saliva depletion (resulting in excessive cavities), facial bumps (going away after two weeks off), constant extreme thirst, aggitation, saliva gland malfunction/swelling, lack of hair growth.
Comments:		Very difficult to get off of this drug. Took apple cidar vinegar.