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Prilosec

Generic Name: Omeprazole
Drug Category: PPI
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 1 month old for a maximum duration of 1 year.

Approved Uses

Indicated for:

Treatment of Active Duodenal Ulcer:

• 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.

Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:

Triple 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.

Dual Therapy

• 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.

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 and the clarithromycin prescribing information.

Treatment of Active Benign Gastric Ulcer:

• Short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.

Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD):

• Treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 1 year of age and older.

Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD:

Pediatric Patients 1 Year of Age to Adults:

• The short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 1 year of age and older.

The efficacy of PRILOSEC used for longer than 8 weeks in patients with EE 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 EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of PRILOSEC may be considered.

Pediatric Patients 1 Month to Less than 1 Year of Age:

• The short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.

Maintenance of Healing of EE Due to Acid-Mediated GERD:

• The maintenance healing of EE due to acid-mediated GERD in patients 1 year of age and older. Controlled studies do not extend beyond 12 months.

Pathological Hypersecretory Conditions:

• The long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

Dosage reduction of PRILOSEC to 10 mg once daily is recommended for patients with hepatic impairment for maintenance of healing of EE.

The safety and effectiveness of PRILOSEC have not been established patients less than 1 month of age for any indication.

Proton pump inhibitors (PPIs), including PRILOSEC, are contraindicated in patients receiving rilpivirine-containing products.

Avoid concomitant use of PRILOSEC with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using PRILOSEC, consider alternative anti-platelet therapy.

Acute interstitial nephritis has been observed in patients taking PPIs including PRILOSEC.

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy.

PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year.

Published observational studies suggest that PPI therapy like PRILOSEC may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients.

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole.

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.

Asians had approximately a four-fold higher exposure than Caucasians. Dosage reduction of PRILOSEC to 10 mg once daily is recommended for Asian patients for maintenance of healing of EE.

Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria.

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.

The safety and effectiveness of PRILOSEC have not been established in patients less than 1 year of age for:

  • Treatment of symptomatic GERD
  • Maintenance of healing of EE due to acid-mediated GERD

The safety and effectiveness of PRILOSEC have not been established in pediatric patients for:

  • Treatment of active duodenal ulcer
  • H. pylori eradication to reduce the risk of duodenal ulcer recurrence
  • Treatment of active benign gastric ulcer
  • Pathological hypersecretory conditions

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.

Avoid concomitant administration of PRILOSEC with clopidogrel, St. John’s Wort or rifampin.

Avoid concomitant use with atazanavir or nelfinavir.

PRILOSEC is contraindicated in patients receiving rilpivirine-containing products.

Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance.

Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity.

Use with citalopram increases exposure of citalopram leading to an increased risk of QT prolongation. Limit the dose of citalopram to a maximum of 20 mg per day.

Increased exposure of one of the active metabolites of cilostazol (3,4-dihydro-cilostazol). Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol. 

PRILOSEC use with phenytoin potentially increases exposure of phenytoin.

PRILOSEC use with diazepam increases exposure of diazepam.

Potential for increased exposure of digoxin.

Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.

Use PRILOSEC with caution in transplant patients receiving mycophenolate mofetil (MMF). Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving PRILOSEC and MMF. Use PRILOSEC with caution in transplant patients receiving MMF.

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.

Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition.

Potential for increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (e.g., cyclosporine, disulfiram).

There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.

Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma. Temporarily stop PRILOSEC treatment at least 14 days before assessing to allow gastrin levels to return to baseline.

Decreased exposure of omeprazole when used concomitantly with strong inducers.

CYP2C19 or CYP3A4 inhibitors increases exposure of omeprazole.

The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population.

Limited data suggest omeprazole may be present in human milk.

GoToSource

Off-label Uses

• Esophageal stricture and barrett’s esophagus. GoToSource

• Nonsteroidal anti-inflammatory drug (NSAID) gastric ulcer. GoToSource

• Improve pancreatic enzyme absorption in cystic fibrosis patients with intestinal malabsorption. GoToSource

• Stress ulcer prophylaxis in critically ill patients. GoToSource

• Use in patients under 1 month of age. GoToSource

Adverse Events

⚠️ Higher drug concentrations in patients with CYP2C19 gene variation.

Hip, wrist and spine fractures. GoToSource

Increased risk of myocardial infarction. GoToSource

Hypomagnesaemia (abnormally low levels of magnesium) causing hypoparathyroidism (low levels of parathyroid hormone), hypocalcemia (low level of calcium in blood) and hypokalemia (low potassium levels). GoToSource

Pneumonia, enteric bacterial infections, nosocomial clostridium difficile-associated diarrhea, hypergastrinemia (excess gastrin in blood) and parietal cell hyperplasia leading to rebound acid hypersecretion. GoToSource

Bilateral blurred vision. GoToSource

New dyspeptic or reflux symptoms may develop in asymptomatic patients after withdrawal of a short course of PPI (Prilosec). GoToSource

Microscopic colitis (inflammation of the large intestine). GoToSource

Acute generalized exanthematous pustulosis (skin eruption). GoToSource

Acute interstitial nephritis (kidney disorder). GoToSource

Gynaecomastia (male breast enlargement). GoToSource 

Subacute cutaneous lupus erythematosus (skin lesions). GoToSource

Fundic gland polyps. GoToSource

Vitamin B12 deficiency. GoToSource

Litigation

Lawsuits filed for hip, wrist and spine fractures, low magnesium levels and cardiovascular death.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024