SEQUENTIAL DELIVERY FOR ADDED PROTECTION
Yosprala is not interchangeable with the individual components of aspirin and omeprazole1
For illustration purposes only. Not a visual representation of the tablet.
Adverse reactions occurring in ≥2% of YOSPRALA-treated patients and more common than in the control arm: gastritis (18% vs 16%), nausea (3% vs 2%), diarrhea (3% vs 2%), gastric polyps (2% vs 1%), noncardiac chest pain (2% vs 1%)1 AE, adverse event, EC, enteric-coated.
*Study design: Efficacy of the omeprazole component in Yosprala was evaluated in 2 randomized, multicenter, double-blind, 6-month, Phase 3 trials in patients who had a cerebrovascular or CV diagnosis and were taking 325 mg of aspirin for ≥3 months, expected to continue treatment for ≥6 months, and at risk for aspirin-associated gastric ulcers based on being ≥55 years-of-age or 18 to 54 years old with a documented history of gastric or duodenal ulcer within the 5 years before study enrollment. Patients received Yosprala 325-mg delayed-release aspirin/40-mg immediate-release omeprazole or 325-mg of enteric-coated aspirin. Gastric and duodenal ulcer formation was assessed by gastroduodenal endoscopy at screening and after 1, 3, and 6 months of treatment.1,3-5
81-mg delayed-release aspirin/ 40-mg immediate-release omeprazole
325-mg delayed-release aspirin/ 40-mg immediate-release omeprazole
*The tablets are to be swallowed whole with liquid. Do not split, chew, crush, or dissolve the tablet.1
For illustration purposes only. Not a visual representation of the tablets.
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References: 1. Yosprala Prescribing Information. Charleston, WV: Innovida Pharmaceutique Corporation 2018. 2. Miner PB, Fort JG, Zhang Y. Intragastric acidity and omeprazole exposure during dosing with either PA32540 (enteric-coated aspirin 325 mg + immediate-release omeprazole 40 mg) or enteric-coated aspirin 325 mg + enteric-coated omeprazole 40 mg–a randomised, phase 1, crossover study. Aliment Pharmacol Ther. 2013;38(1):62-71. 3. Whellan DJ, Goldstein JL, Cryer BL, et al. PA32540 (a coordinated-delivery tablet of enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) versus enteric-coated aspirin 325 mg alone in subjects at risk for aspirin-associated gastric ulcers: results of two 6-month, phase 3 studies. Am Heart J. 2014;168(4):495-502. 4. Data on file. #0266. Innovida Pharmaceutique Corporation 5. Data on file. #0267. Innovida Pharmaceutique Corporation