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Prilosec (Omeprazole) - Summary

 


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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

PRILOSEC Delayed-Release Capsules are 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.

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

PRILOSEC Delayed-Release Capsules, in combination with clarithromycin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori.

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see CLINICAL PHARMACOLOGY, Clinical Studies and DOSAGE AND ADMINISTRATION).

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, and the clarithromycin package insert, MICROBIOLOGY section.)

Gastric Ulcer

PRILOSEC Delayed-Release Capsules are indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. (See CLINICAL PHARMACOLOGY, Clinical Studies, Gastric Ulcer.)

Treatment of Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD
PRILOSEC Delayed-Release Capsules are indicated for the treatment of heartburn and other symptoms associated with GERD.
Erosive Esophagitis

PRILOSEC Delayed-Release Capsules are 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 PRILOSEC 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 (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

Maintenance of Healing of Erosive Esophagitis

PRILOSEC Delayed-Release Capsules are indicated to maintain healing of erosive esophagitis.

Controlled studies do not extend beyond 12 months.

Pathological Hypersecretory Conditions

PRILOSEC Delayed-Release Capsules are indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis).


See all Prilosec indications & dosage >>

PRILOSEC NEWS HIGHLIGHTS

Media Articles Related to Prilosec (Omeprazole)

FDA: Nexium, Prilosec OK for Heart
Source: MedicineNet esomeprazole Specialty [2007.12.11]

Nexium, Prilosec: No Heart Risks Seen
Source: MedicineNet esomeprazole Specialty [2007.08.13]

Prilosec and Dyspepsia
Source: MedicineNet omeprazole Specialty [2006.12.21]

esomeprazole, Nexium
Source: MedicineNet Nonsteroidal Anti-inflammatory Drugs and Ulcers Specialty [2008.02.28]

more >>

Published Studies Related to Prilosec (Omeprazole)

Efficacy of esomeprazole (20 mg once daily) for reducing the risk of gastroduodenal ulcers associated with continuous use of low-dose aspirin. [2008.10]

Double-blind, placebo-controlled trial with esomeprazole for symptoms and signs associated with laryngopharyngeal reflux. [2008.09]

Comparing laparoscopic antireflux surgery with esomeprazole in the management of patients with chronic gastro-oesophageal reflux disease: a 3-year interim analysis of the LOTUS trial. [2008.09]

Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study. [2008.08]

The effect of double dose of omeprazole on the course of angina pectoris and treadmill stress test in patients with coronary artery disease--a randomised, double-blind, placebo controlled, crossover trial. [2008.07.04]

more >>

Clinical Trials Related to Prilosec (Omeprazole)

A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® [Active, not recruiting]

Prevention of Gastric Ulcers [Completed]

Ulcer Prevention II [Completed]

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]

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]

more >>

PRILOSEC PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 5 ratings/reviews, Prilosec has an overall score of 7.40. The effectiveness score is 8 and the side effect score is 8.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   heart burn
Dosage & duration:   20 mg taken 1 per day for the period of 14 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   My heart burn was relieved within forty eight hours and continued for the length of the treatment. I was very satisfied with the results.
Side effects:   There were no side effects from taking this medicine.
Comments:   I took the medicine once a day in the morning for 14 days. Whenever heart burn reoccurs I repeat the treatment.

 

Prilosec review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   GERD
Dosage & duration:   20 mg taken once daily for the period of 2 weeks
Other conditions:   rheumatoid arthritis
Other drugs taken:   prednisone, arava, methotrexate
  
Reported Results
Benefits:   It somewhat relieved my heartburn for a few days.
Side effects:   No side effects.
Comments:   Because of the high cost of my prescription Previcid, I tried Prilosec OTC. It seemed to calm my heartburn for about 3-4 days. Then the heartburn returned along with nasaus. I continued Prilosec for about 10 days, but my heartburn became too intense and I reverted back to Previcid. Previcid seems to be the only drug that completely stops the heartburn.

See all Prilosec reviews / ratings >>

Page last updated: 2008-11-03

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