1
INDICATIONS AND USAGE
YOSPRALA, a combination of aspirin and omeprazole,isindicated 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 thecombined 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 thecombined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris,
reducing thecombined risk of MI and sudden death in patients with chronic stable angina pectoris,
use in patients who have undergonerevascularization procedures (Coronary Artery Bypass Graft [CABG] orPercutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated.
The omeprazole component ofYOSPRALA 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.
Limitations
of Use
:
YOSPRALA contains a delayed-release formulation of aspirin and it is not for use as the initial dose of aspirin therapy during onset ofacute coronary syndrome, acute myocardial infarction or before percutaneous coronary intervention (PCI), for which immediate-release aspirin therapy is appropriate.
YOSPRALAhas not been shown to reduce the risk of gastrointestinal bleeding due to aspirin.
Do not substitute YOSPRALA with the single-ingredient products of aspirin and omeprazole.
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] orPercutaneous 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)
Do not substitute YOSPRALA with the single-ingredient products of aspirin and omeprazole. (1)