Aspirin/Omeprazole

DEA Class;  Rx

Common Brand Names; Yosprala

Antiplatelet Agents, Cardiovascular, Proton Pump Inhibitors

Combination antiplatelet agent and proton pump inhibitor

Used for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers

Not intended for the initial dose of aspirin therapy during onset of acute coronary syndrome, acute myocardial infarction, or before percutaneous coronary intervention

Indicated for the reduction of cardiovascular mortality and prevention of secondary cardiovascular and cerebrovascular events (e.g., myocardial infarction prophylaxis, stroke prophylaxis) in patients at risk for aspirin associated gastric ulcers and also have a history of stroke, TIA, myocardial infarction, angina (including unstable angina), or are post cardiac surgery (CABG, PTCA). 

Known allergy to aspirin and other NSAIDs

Patients with the syndrome of asthma, rhinitis, and nasal polyps; aspirin may cause severe urticaria, angioedema, or bronchospasm

Known hypersensitivity to aspirin, omeprazole, substituted benzimidazoles, or any of the excipients in the formulation

Proton pump inhibitors (PPIs) are contraindicated with rilpivirine-containing products

Not indicated for pediatric patients (safety and efficacy not established); aspirin is contraindicated in children with suspected viral infections, with or without fever, because of the risk of Reye syndrome with concomitant use of aspirin in certain viral illnesses

>10%

Headache (10-39%)

Dyspepsia (4-18%)

Abdominal pain (4-18%)

Nausea (6-16%)

Diarrhea (13%)

1-10%

Vomiting (3-8%)

Pain (6%)

Fatigue (6%)

Arthralgia (5%)

Back pain (5%)

Hemorrhage, nonspecific (3%)

Accidental injury (3%)

Gastric acid suppression may increase serum chromogranin A (CgA). Increased CgA concentrations may cause false positive results in diagnostic investigations for neuroendocrine tumors. Clinicians should temporarily stop aspirin; omeprazole 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

Pregnancy 

Aspirin

Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal

Omeprazole

Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women not exposed

The number of infants exposed in utero to omeprazole who had any malformation, low birth weight, low Apgar score, or hospitalization was similar to women not exposed in each study

Lactation

Individual components, aspirin and omeprazole, are secreted in human milk

Limited data describe the presence of aspirin in human milk at relative infant doses of 2.5-10.8% of the maternal weight-adjusted dosage

Case reports of breastfeeding infants whose mothers were exposed to aspirin during lactation describe adverse reactions, including metabolic acidosis, thrombocytopenia, and hemolysis

Limited data describe the presence of omeprazole in human milk at a relative infant dose of 0.9% of the maternal weight-adjusted dosage; there are no reports of adverse effects of omeprazole on the breastfed infant

Adults

325 mg aspirin; 40 mg omeprazole.

Geriatric

325 mg aspirin; 40 mg omeprazole.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Tablet

81mg/40mg

325mg/40mg