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YOSPRALA™ (aspirin and omeprazole) delayed-release tablets

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back      |  ---- led    ]
CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION HOW SUPPLIED

CLINICAL PHARMACOLOGY: top of page

 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  top of page



Drug UPDATES:  YOSPRALA™ (aspirin and omeprazole) delayed-release tablets,
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
BOXED WARNING

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  top of page


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 top of page



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
Medical Calculators - A thru Z
Lab Values - A thru Z