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Yosprala Generic Name & Formulations
Legal Class
Rx
General Description
Aspirin delayed-rel, omeprazole immediate-rel; 81mg/40mg, 325mg/40mg; delayed-rel tabs.
Pharmacological Class
Antiplatelet + proton pump inhibitor.
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
NO
Yosprala Indications
Indications
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 MI, or before PCI. Not shown to reduce risk of GI bleeding due to aspirin. Not interchangeable with individual aspirin and omeprazole.
Yosprala Dosage and Administration
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.
Yosprala Contraindications
Contraindications
NSAID allergy and syndrome of asthma, rhinitis, nasal polyps. Viral infections in pediatric patients. Concomitant rilpivirine-containing drugs (due to omeprazole component).
Yosprala Boxed Warnings
Not Applicable
Yosprala Warnings/Precautions
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 tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus develops. Gastric malignancy. Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Long-term therapy (>3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor for hypomagnesemia during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). 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.
Yosprala Pharmacokinetics
See Literature
Yosprala Interactions
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.
Yosprala Adverse Reactions
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); possible C. diff-associated diarrhea, reversible infertility; rare: hypomagnesemia and mineral metabolism.
Yosprala Clinical Trials
See Literature
Yosprala Note
Not Applicable
Yosprala Patient Counseling
See Literature
