Generic Name and Formulations:
Aspirin delayed-rel, omeprazole immediate-rel; 81mg/40mg, 325mg/40mg; delayed-rel tabs.
Company:
Aralez Pharmaceuticals

Select therapeutic use: Thromboembolic disorders
RECENT UPDATES Monograph added.

Indications for YOSPRALA:
Patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. For separate components: see full labeling.

Limitations Of use:
Not for use as initial dose of aspirin therapy during onset of acute coronary syndrome, acute myocardial infarction, or before PCI. Not shown to reduce risk of GI bleeding due to aspirin. Not interchangeable with individual aspirin and omeprazole.

Adult:
Swallow whole. Take 1 tab daily at least 1hr before a meal. Use lowest effective dose for shortest duration. Usually aspirin 81mg is acceptable; can consider the need for 325mg and refer to current guidelines.

Children:
Not established.

Contraindications:
NSAID allergy and syndrome of asthma, rhinitis, nasal polyps. Viral infections in pediatric patients. Concomitant rilpivirine-containing drugs (due to omeprazole component).

Warnings/Precautions:
Coagulation abnormalities; monitor for increased bleeding. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). Discontinue if significant bleeding from any source, acute interstitial nephritis, or cutaneous/systemic lupus erythematosus develops. Gastric malignancy. Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Long-term therapy may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels with long-term therapy. Avoid abrupt cessation. Pre-existing renal disease. Hepatic impairment or severe renal impairment (GFR <10mL/min): not recommended. Asians with unknown CYP2C19 genotype or known to be poor metabolizers: not recommended. Elderly. Labor & delivery. Pregnancy (≥30 weeks gestation: avoid). Nursing mothers: not recommended.

Interactions:
See Contraindications. Concomitant St. John's wort, rifampin, atazanavir, nelfinavir, voriconazole: not recommended. Concomitant heparin, warfarin: monitor and adjust dose as needed. Avoid concomitant clopidogrel; consider alternative antiplatelet therapy. Potentiates saquinavir, hypoglycemics, acetazolamide, valproic acid, citalopram (limit to max 20mg daily), cilostazol (reduce to 50mg twice daily). May potentiate phenytoin, diazepam, tacrolimus, digoxin, methotrexate (consider temporary withdrawal if on high-doses); monitor and adjust dose as needed. May antagonize ACE inhibitors, β-blockers, diuretics, uricosurics; monitor. Increased bleeding risk with NSAIDs or chronic, heavy alcohol use. NSAIDs increase risk of renal dysfunction. Caution with drugs that may cause hypomagnesemia (eg, digoxin, diuretics); monitor. May alter absorption of pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, ketoconazole, itraconazole, mycophenolate mofetil). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). May interfere with lab tests; discontinue ≥14 days prior to CgA level assessment and secretin stimulation test. May cause false (+) THC urine test; use alternative confirmatory method. For the 325mg/40mg tab strength: avoid concomitant ticagrelor.

Pharmacological Class:
Antiplatelet + proton pump inhibitor.

Adverse Reactions:
Gastritis, nausea, diarrhea, gastric polyps, non-cardiac chest pain; ulcers (monitor), abnormal lab tests (eg, increased liver enzymes, BUN, creatinine, hyperkalemia, proteinuria, prolonged bleeding time); C. diff-associated diarrhea, cutaneous/systemic lupus erythematosus, infertility.

Generic Availability:
NO

How Supplied:
Tabs—30, 90