YOSPRALA™ (aspirin And Omeprazole) Delayed

Clinical pharmacology

Mechanism of Action
Aspirin (acetylsalicylic acid) is an inhibitor of both prostaglandin synthesis and platelet aggregation. The differences in activity between aspirin and salicylic acid are thought to be due to the acetyl group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase via acetylation.

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the [H+/K+]-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

Indications and usage

Drug UPDATES: YOSPRALA™ (aspirin and omeprazole) delayed-release tablets,
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Initial U.S. Approval: 2016

INDICATIONS AND USAGE:

YOSPRALA is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.

The aspirin component of YOSPRALA is indicated for:

reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli,
reducing the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris,
reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris,
use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated.

The omeprazole component of YOSPRALA is indicated for decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (= 55) or documented history of gastric ulcers. (1)

Limitations of Use:

Not for use as the initial dose of aspirin therapy during onset of acute coronary syndrome, acute myocardial infarction or before percutaneous coronary intervention. (1)
Has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin. (1)
YOSPRALA is not interchangeable with the individual components of aspirin and omeprazole. (1)

Dosage and administration

DOSAGE AND ADMINISTRATION: PDF
Recommended dosage: One tablet daily at least 60 minutes before a meal.
Do not split, chew, crush or dissolve the tablet.

How supplied

HOW SUPPLIED:
Delayed-Release Tablets:

81 mg delayed-release aspirin/40 mg immediate-release omeprazole
325 mg delayed-release aspirin/40 mg immediate-release omeprazole

Reference

Package insert data

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.