Generic Name and Formulations:
Aspirin 162.5mg; ext-rel caps.
Indications for DURLAZA:
To reduce risk of death and MI in patients with chronic coronary artery disease (eg, history of MI, unstable angina, or chronic stable angina). To reduce risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack (TIA).
Limitations Of use:
Use immediate-release aspirin if rapid onset of action is required (eg, acute MI or before PCI).
Swallow whole. Take with full glass of water at same time each day. 1 capsule once daily.
NSAID allergy. Asthma. Rhinitis. Nasal polyps.
Active peptic ulcer disease, severe hepatic or renal impairment (GFR <10mL/min); avoid. Pregnancy: avoid during 3rd trimester, 1 week prior to and during labor & delivery. Nursing mothers: not recommended.
Increased bleeding risk with anticoagulants, antiplatelets, or chronic NSAID use. Do not take 2hrs before or 1hr after consuming alcohol. Dual inhibition of the renin-angiotensin system (RAS) may increase risk of hypotension, hyperkalemia, renal impairment; monitor renal function esp. if elderly, volume depleted or compromised renal function. NSAIDs may attenuate antihypertensive effects of RAS inhibitors. May affect anticonvulsants (eg, phenytoin, valproic acid). May potentiate methotrexate; possible bone marrow toxicity esp. in elderly or renally impaired. Concomitant other NSAIDs may increase renal impairment. Ibuprofen or nonselective NSAIDs may interfere with antiplatelet effect of low-dose aspirin. Give ibuprofen 400mg at least 2–4hrs after Durlaza; wait 8hrs after ibuprofen dose before giving aspirin.
GI effects (eg, bleeding, dyspepsia, hepatic enzyme elevation, hepatitis, Reye's Syndrome), CNS effects, fluid and electrolyte imbalance, renal insufficiency and failure; fetal toxicity, salicylate toxicity.
Ext-rel caps—30, 90