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 Prilosec indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Prilosec (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 Prilosec (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.

Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed Conditions [Completed]
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR capsules of Dr. Reddy's Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets)of Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fed conditions.

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."

Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition [Completed]

more trials >>

Reports of Suspected Prilosec (Omeprazole) Side Effects

Drug Ineffective (837),  Drug Dose Omission (478),  Gastrooesophageal Reflux Disease (450),  Malaise (235),  Dyspepsia (225),  Vomiting (155),  Pain (147),  OFF Label USE (133),  Intentional Drug Misuse (132),  Abdominal Pain Upper (117), more >>

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 65 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		nausea after eating
Dosage & duration:		20 mg taken 2ce/day for the period of 6 months
Other conditions:		high blood pressure
Other drugs taken:		HCTZ
		Reported Results
Benefits:		I was able to eat without nausea and vomiting after meals. I was able to regain lost weight. I was able to eat normal sized meals again.
Side effects:		I had no side effect with the treatment. The only drawback was the need to eat within 30 minutes of taking the medication. There were times when an unavoidable delay in the mealtime made it necessary to eat something else in the interim.
Comments:		I didn't have usual GERD symptoms of heart burn. I was skeptical that my stomach was producing too much acid. I tried other home remedies like drinking diluted apple cider after a meal that seemed to work at times but didn't always. After my doctor prescribed prilosec, it took several weeks before relief was complete. I am still taking the medication but have scaled back to 20 mg just once a day.

Prilosec review by 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		heartburn
Dosage & duration:		40 mg taken 1 x day for the period of 10 years
Other conditions:		arthritis, colostomy
Other drugs taken:		levothyroxine, allopurinol. zolpidem
		Reported Results
Benefits:		stopped the heartburn
Side effects:		impossible to get off of them after a period of time....if you stop after years (I started on them when they first came out) your throat will feel like it is being ripped with a knife and you will eventually take them again (trust me...I stopped opiates cold turkey...but not these)
Comments:		I think the drug should be removed from the market, accept for severe cases of GERD , and, patients should only be on them for a couple weeks..otherwise, they should be told they will be on them the rest of their lives--they should never be allowed OTC...why do you think Prilosec has that new commercial out, "let your doctor do his job"? Because everyone is complaining that they cannot get off of it now...