1. DURLAZA [package insert]. New Haven, CT: New Haven Pharmaceuticals; 2015.
  2. Data on file, New Haven Pharmaceuticals.
  3. Cavender M et al. Abstract presented at: American College of Cardiology 63rd Annual Scientific Session & Expo; March 29, 2014; Washington, DC.
  4. Lee EY, Kim SJ, Song YJ, Choi SJ, Song J. Immature platelet fraction in diabetes mellitus and metabolic syndrome. Thromb Res. 2013;132(6):692-695.
  5. Samad F, Ruf W. Inflammation, obesity, and thrombosis. Blood. 2013;122(20):3415-3422.
  6. Dotevall A, Kutti J, Teger-Nilsson AC, Wadenvik H, Wilhelmsen L. Platelet reactivity, fibrinogen and smoking. Eur J Haematol. 1987;38(1):55-59.
  7. Willoughby S, Holmes A, Loscalzo J. Platelets and cardiovascular disease. Eur J Cardiovasc Nurs. 2002;1(4):273-288.
  8. Slavka G, Perkmann T, Haslacher H, et al. Mean platelet volume may represent a predictive parameter for overall vascular mortality and ischemic heart disease. Arterioscler Thromb Vasc Biol. 2011;31(5):1215-1218.
  9. Saving KL, Mankin PE, Gorman MJ. Differences in adhesion receptor expression between immature and older platelets and red blood cells of neonates and adults. Pediatr Hematol Oncol. 2002;24(2):120-124.
  10. Cesari F, Marcucci R, Gori AM, et al. Reticulated platelets predict cardiovascular death in acute coronary syndrome patients. Insights from the AMI-Florence 2 Study. Thromb Haemost. 2013;109(5):846-853.
  11. Grove EL, Hvas AM, Mortensen SB, Larsen SB, Kristensen SD. Effect of platelet turnover on whole blood platelet aggregation in patients with coronary artery disease. J Thromb Haemost. 2011;9(1):185-191.
  12. Perneby C, Wallén NH, Rooney C, Fitzgerald D, Hjemdahl P. Dose- and time-dependent antiplatelet effects of aspirin. Thromb Haemost. 2006;95(4):652-658.
  13. Kaushansky K. Historical review: megakaryopoiesis and thrombopoiesis. Blood. 2008;111(3):981-986.
  14. Bliden K, Patrick J, et al. Drug Delivery and Therapeutic Impact of Extended-release Acetylsalicylic Acid.Bliden K, Patrick J, et al. Drug Delivery and Therapeutic Impact of Extended-release Acetylsalicylic Acid. Future Cardiology. 2016; 12(1):45-58.
  15. Gurbel PA, Bliden KP, Patrict J, Saadin K, Tantry U. Durability of Antiplatelet Effect of a Novel Extended- Release Formulation of Acetylsalicylic Acid, DURLAZA in Patient with Diabetes. Circulation. 2015; 132: A19503.
  16. Krasopoulos G. et al. Aspirin "resistance" and risk of cardiovascular morbidity: systematic review and meta-analysis BMJ 2008;336:195

Important Safety Information

Indications and Usage

DURLAZA® (aspirin) Extended-Release Capsules 162.5 mg is indicated:

  • to reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina;
  • to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.

Limitation of Use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).

Important Safety Information

Contraindications: DURLAZA is contraindicated in patients with a hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) and in patients with the syndrome of asthma, rhinitis, and nasal polyps. DURLAZA may cause severe urticaria, angioedema, or bronchospasm.

Warnings and precautions:

  • DURLAZA increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk for bleeding.
  • DURLAZA may cause gastric ulceration and bleeding. Avoid DURLAZA in patients with active peptic ulcer disease.
  • DURLAZA can cause fetal harm when administered to a pregnant woman, including low birth weight, increased incidence for intracranial hemorrhage in premature infants, stillbirths and neonatal death. Avoid DURLAZA in the third trimester of pregnancy.

Adverse reactions: The following adverse reactions have been reported for products containing low dose aspirin:

  • Central Nervous System: Agitation, cerebral edema, coma, confusion, dizziness, headache, lethargy, seizures;
  • Fluid and Electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis;
  • Gastrointestinal: Dyspepsia, hepatic enzyme elevation, hepatitis, Reye's Syndrome;
  • Renal: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure.

Drug interactions:

  • Alcohol: Do not take DURLAZA 2 hours before or 1 hour after consuming alcohol.
  • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia.
  • Anticoagulant and antiplatelets: Increased risk of bleeding.
  • Anticonvulsants: Decreased phenytoin concentration and increased serum valproic acid levels.
  • Methotrexate: Increased risk of bone marrow toxicity.
  • NSAIDs: Increased risk of bleeding. Nonselective NSAIDs may interfere with the antiplatelet effect of DURLAZA.

Use in specific populations:

  • Pregnancy: Avoid use during the third trimester.
  • Hepatic Impairment: Avoid use in patients with severe impairment.
  • Renal Impairment: Avoid use in patients with GFR <10mL/min.

Please see full Prescribing Information for DURLAZA.