Aspirin (Lexi-Drugs)

Pronunciation

(AS pir in)

Brand Names: US

Ascriptin Maximum Strength [OTC]; Ascriptin Regular Strength [OTC]; Aspercin [OTC]; Aspir-low [OTC]; Aspirin Adult Low Dose [OTC]; Aspirin Adult Low Strength [OTC]; Aspirin EC Low Strength [OTC]; Aspirtab [OTC]; Bayer Aspirin EC Low Dose [OTC]; Bayer Aspirin Extra Strength [OTC]; Bayer Aspirin Regimen Adult Low Strength [OTC]; Bayer Aspirin Regimen Children’s [OTC]; Bayer Aspirin Regimen Regular Strength [OTC]; Bayer Genuine Aspirin [OTC]; Bayer Plus Extra Strength [OTC]; Bayer Women’s Low Dose Aspirin [OTC]; Buffasal [OTC]; Bufferin Extra Strength [OTC]; Bufferin [OTC]; Buffinol [OTC]; Durlaza; Ecotrin Arthritis Strength [OTC]; Ecotrin Low Strength [OTC]; Ecotrin [OTC]; Halfprin [OTC] [DSC]; St Joseph Adult Aspirin [OTC]; Tri-Buffered Aspirin [OTC]

Brand Names: Canada

Asaphen; Asaphen E.C.; Entrophen; Novasen; Praxis ASA EC 81 Mg Daily Dose; Pro-AAS EC-80

Dosing: Adult

Note: For most cardiovascular uses, typical maintenance dosing of aspirin is 81 mg once daily. Manufacturer recommended dosing for some indications have been superseded by more recent guideline recommended doses and therefore manufacturer recommended dosing may not be represented; terminologies may also differ from manufacturer’s prescribing information.

Acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-ST-elevation acute coronary syndromes [NSTE-ACS]): Oral:

Initial: 162 to 325 mg given on presentation (patient should chew nonenteric-coated aspirin especially if not taking before presentation) (ACC/AHA [Amsterdam 2014]; ACCF/AHA [O’Gara 2013]); for patients unable to take oral, may use a rectal suppository dose of 600 mg (Maalouf 2009).

Maintenance (secondary prevention): 81 to 325 mg once daily continued indefinitely; when aspirin is used with ticagrelor, the recommended maintenance dose of aspirin is 81 mg/day (ACC/AHA [Amsterdam 2014]; ACCF/AHA [O’Gara 2013]) According to the STEMI guidelines, 81 mg once daily is preferred (ACCF/AHA [O’Gara 2013]).

Concomitant antiplatelet therapy:

STEMI: Aspirin is recommended in combination with either clopidogrel, prasugrel, or ticagrelor given as early as possible or at time of PCI. In addition to dual antiplatelet therapy, parenteral anticoagulant therapy is indicated. Post-PCI stenting, consult clinical practice guidelines for recommended duration of maintenance antiplatelet therapy depending on type of stenting (ACCF/AHA [O’Gara 2013]).

NSTE-ACS:

If early-invasive strategy chosen: Aspirin is recommended in combination with either clopidogrel or ticagrelor. In addition to dual antiplatelet therapy, parenteral anticoagulant therapy is indicated. In select high-risk patients (ie, troponin positive), an IV GP IIb/IIIa inhibitor may be considered as part of initial antiplatelet therapy (if given before PCI, eptifibatide and tirofiban are preferred agents). In patients post-PCI with stenting (bare metal or drug-eluting stent), aspirin should be given with either clopidogrel, ticagrelor, or prasugrel for at least 12 months (ACC/AHA [Amsterdam 2014]).

If ischemia-guided strategy (ie, noninvasive strategy) chosen: Aspirin is recommended in combination with clopidogrel or ticagrelor for up to 12 months. In addition to dual antiplatelet therapy, parenteral anticoagulant therapy is indicated (ACC/AHA [Amsterdam 2014]).

Analgesic and antipyretic:

Oral: Immediate release: 325 to 650 mg as needed every 4 hours or 975 mg as needed every 6 hours or 500 to 1,000 mg as needed every 4 to 6 hours for no more than 10 days or as directed by health care provider; maximum daily dose: 4 g/day.

Rectal: 300 to 600 mg every 4 hours for no more than 10 days or as directed by health care provider

Anti-inflammatory (off-label dosing): Note: The use of non-aspirin NSAIDs has largely supplanted the use of aspirin for osteoarthritis, rheumatoid arthritis, and other inflammatory arthritides.

Immediate release: Oral: Usual maintenance dose: 2.1 to 7.3 g/day in divided doses (individualize dose); monitor serum salicylate concentrations especially when symptoms of salicylism (eg, tinnitus) appear; adjust dose accordingly (Csuka 1989).

Aortic valve repair (off-label use): Immediate release: Oral: 50 to 100 mg once daily (ACCP [Guyatt 2012])

Atrial fibrillation (to prevent thromboembolism) (off-label use): Immediate release: Oral: Primary prevention: Patients at low risk of ischemic stroke (CHA2DS2-VASc score of 1): 75 to 325 mg once daily may be considered (AHA/ACC/HRS [January 2014]).

Carotid artery stenosis (asymptomatic) (off-label use): Immediate release: Oral: 75 to 100 mg once daily (ACCP [Alonso-Coello 2012]). Note: The addition of statin therapy has also been recommended for asymptomatic carotid stenosis (AHA/ASA [Meschia 2014]). When symptomatic, the use of clopidogrel or aspirin/extended-release dipyridamole has been suggested over aspirin alone (ACCP [Alonso-Coello 2012]).

Carotid endarterectomy (off-label dosing): Immediate release: Oral: 75 to 100 mg once daily (ACCP [Alonso-Coello 2012]; AHA [Biller 1998]). The use of clopidogrel or aspirin/extended-release dipyridamole has been suggested over aspirin alone (ACCP [Alonso-Coello 2012]).

Colorectal cancer risk reduction (off-label use): Note: The optimal dose and duration of therapy for colorectal cancer risk reduction are unknown. Consider risk versus benefit ratio when initiating aspirin for this indication.

Primary/Secondary prevention: Immediate release: Oral: 75 to 325 mg once daily (Rothwell 2010; Sandler 2003; Ye 2013)

Hereditary nonpolyposis colon cancer (HNPCC; Lynch Syndrome) carriers: Immediate release: Oral: 600 mg once daily for at least 2 years (ASCO [Stoffel 2014]; Burn 2011)

Coronary artery disease (CAD), established or chronic:

Immediate release (off-label dosing): Oral: 75 to 100 mg once daily (ACCP [Guyatt 2012])

Extended release capsule: Oral: 162.5 mg once daily

Percutaneous coronary intervention (PCI) (off-label dosing): Immediate release: Oral:

Non-emergent PCI: Preprocedure: 81 to 325 mg (325 mg [nonenteric coated] in aspirin-naive patients) starting at least 2 hours (preferably 24 hours) before procedure. Postprocedure: 81 mg once daily continued indefinitely (in combination with a P2Y12 inhibitor [eg, clopidogrel, prasugrel, ticagrelor] up to 12 months) (ACCF/AHA/SCAI [Levine 2011])

Primary PCI: Preprocedure: 162 to 325 mg as early as possible prior to procedure; 325 mg preferred. Postprocedure: 81 mg once daily continued indefinitely (in combination with a P2Y12 inhibitor [eg, clopidogrel] for at least 14 days and up to 12 months) (ACCF/AHA [O’Gara 2013]).

Alternatively, in patients who have undergone elective PCI with either bare metal or drug-eluting stent placement: The American College of Chest Physicians recommends the use of 75 to 325 mg once daily (in combination with clopidogrel) for 1 month in patients receiving a bare metal stent or 3 to 6 months (dependent upon drug eluting stent type) followed by 75 to 100 mg once daily (in combination with clopidogrel) for up to 12 months. For patients who underwent PCI but did not have stent placement, 75 to 325 mg once daily (in combination with clopidogrel) for 1 month is recommended. In either case, single antiplatelet therapy (either aspirin or clopidogrel) is recommended indefinitely (ACCP [Guyatt 2012]).

Pericarditis (off-label use): Immediate release: Oral: Initial: 2.4 to 3.6 g daily in 3 to 4 divided doses; usual maintenance: 3.6 to 5.4 g daily in divided doses; gradually taper over 2- to 3-week period as appropriate (Imazio 2004; Imazio 2009).

Pericarditis in association with myocardial infarction (off-label use): Immediate release: Oral: Initial: 650 mg 4 times daily; may increase after 24 hours to 975 mg 4 times daily if necessary (ACCF/AHA [O’Gara 2013]; Berman 1981).

Peripheral arterial disease (off-label use): Immediate release: Oral: 75 to 100 mg once daily (ACCP [Guyatt 2012]) or 75 to 325 mg once daily (AHA/ACC [Gerhard-Herman 2016]). The use in combination with clopidogrel may be considered in patients with symptomatic PAD after lower extremity revascularization (AHA/ACC [Gerhard-Herman 2016]). Note: These recommendations also pertain to patients with intermittent claudication or critical limb ischemia, prior lower extremity revascularization, or prior amputation for lower extremity ischemia (Rooke 2011).

Peripheral artery percutaneous transluminal angioplasty (with or without stenting) or peripheral artery bypass graft surgery, postprocedure (off-label use): Immediate release: Oral: 75 to 100 mg once daily (ACCP [Guyatt 2012]). Note: For below-knee bypass graft surgery with prosthetic grafts, combine with clopidogrel (ACCP [Guyatt 2012]).

Polycythemia vera (off-label use): Immediate release: Oral: 75 or 100 mg once daily (Barbui 2006; McMullin 2005).

Pregnant women: 75 mg once daily (Barbui 2011; McMullin 2005).

Preeclampsia prevention (women at risk) (off-label use): Immediate release: Oral: One low-dose aspirin daily. The definition of low-dose varies by guideline and study; recommended ranges are 75 mg (ACCP [Guyatt 2012]) to 150 mg once daily (Roberge 2017; Rolnik 2017). A dose of 100 to 150 mg once daily may be more effective than lower doses (Roberge 2017). Treatment is generally started ~12 weeks gestation; however, therapy initiated after 16 weeks gestation but prior to the development of symptoms is effective (Meher 2017; Roberge 2016; Roberge 2017). Most studies discontinue therapy at ~36 to 37 weeks gestation (Roberge 2016).

Prevention (primary) of cardiovascular disease (off-label use): Immediate release: Oral:

American College of Chest Physicians: Select individuals ≥50 years of age (without symptomatic cardiovascular disease): 75 to 100 mg once daily (ACCP [Vandvik 2012])

American Diabetes Association: Individuals ≥50 years of age with diabetes (type 1 or 2) and at least one additional risk factor: 75 to 162 mg once daily (ADA 2019)

Prevention (secondary) of cardiovascular disease (patients with diabetes) (off-label use): Immediate release: Oral: 75 to 162 mg once daily (ADA 2019)

Prevention (secondary) after coronary artery bypass graft (CABG) surgery (off-label dosing): Immediate release: Oral: 81 to 325 mg once daily administered preoperatively and within 6 hours postoperatively; continue indefinitely. Following off-pump CABG, administer aspirin 81 to 162 mg in combination with clopidogrel for 12 months (AHA [Kulik 2015]).

Prosthetic heart valve replacement (thromboprophylaxis) (off-label use): Immediate release: Oral:

Bioprosthetic aortic or mitral valve: 75 to 100 mg daily (AHA/ACC [Nishimura 2014]) is reasonable in all patients; patients may also receive anticoagulation with warfarin for the first 3 to 6 months after surgery. Note: Patients with a history of ischemic stroke or TIA before valve insertion and who are at a low risk of bleeding and no other indication for anticoagulation therapy beyond 3 to 6 months from the valve placement are recommended to continue aspirin in preference to long-term anticoagulation (AHA/ASA [Kernan 2014]).

Mechanical aortic or mitral valve: 75 to 100 mg once daily (in combination with warfarin) (AHA/ACC [Nishimura 2014]). Note: For patients with an ischemic stroke or systemic embolism despite adequate antithrombotic therapy, it may be reasonable to increase to 325 mg once daily (AHA/ASA [Kernan 2014]).

Pregnant women, mechanical or bioprosthetic: 75 to 100 mg once daily during the second and third trimesters (when used for mechanical prosthetic valve, combine with warfarin) (AHA/ACC [Nishimura 2014]).

Transcatheter aortic valve replacement (TAVR): 75 to 100 mg once daily (in combination with clopidogrel) (AHA/ACC [Nishimura 2014]). Note: For patients who require anticoagulation for another indication post-TAVR, practice varies and local protocols should be established. It may be reasonable to use anticoagulation (warfarin or a non-warfarin oral anticoagulant) plus aspirin or clopidogrel (eg, not dual antiplatelet therapy) after the procedure (Kalich 2018).

Stroke/TIA: Oral:

Acute ischemic stroke/TIA:

Immediate release (off-label dosing): Initial: 160 to 325 mg within 48 hours of stroke/TIA onset, followed by 75 to 100 mg once daily (ACCP [Guyatt 2012]). The AHA/ASA recommends an initial dose of 325 mg within 24 to 48 hours after stroke; do not administer aspirin within 24 hours after administration of alteplase (Jauch 2013). The combination of aspirin and clopidogrel might be considered within 24 hours of a minor ischemic stroke or TIA and continued for 21 days (AHA/ASA [Kernan 2014]).

Extended-release capsule: Maintenance (secondary prevention): 162.5 mg once daily. Note: Not for initial dosing during acute ischemic stroke or TIA (use immediate release)

Cardioembolic, secondary prevention (oral anticoagulation unsuitable) (off-label): Immediate release: 75 to 100 mg once daily (AHA/ASA [Kernan 2014])

Cryptogenic with patent foramen ovale (PFO) or atrial septal aneurysm (off-label use): Immediate release: 50 to 100 mg once daily (ACCP [Guyatt 2012])

Intracranial atherosclerosis (50% to 99% stenosis of a major intracranial artery), secondary prevention (off-label): 325 mg once daily (consider the addition of clopidogrel for 90 days in patients with recent stroke/TIA due to severe stenosis [70% to 99%]) (AHA/ASA [Kernan 2014]).

Noncardioembolic, secondary prevention (off-label use): Immediate release: 75 to 325 mg once daily (Smith, 2011) or 75 to 100 mg once daily (ACCP [Guyatt 2012]). Note:Combination aspirin/extended release dipyridamole or clopidogrel is preferred over aspirin alone (ACCP [Guyatt 2012]).

Women at high risk for first stroke, primary prevention: Immediate release: 81 mg once daily or 100 mg every other day (AHA/ASA [Meschia 2014]).

Venous thromboembolism (VTE), extended therapy to prevent recurrence (in patients who have completed anticoagulation treatment and decided to stop oral anticoagulation) (off-label use): Oral: 100 mg once daily (Becattini 2012; Brighton 2012; Simes 2014)

Venous thromboembolism (VTE) prophylaxis for total hip (THA) or knee (TKA) arthroplasty (off-label use): Note: This is a hybrid strategy using rivaroxaban followed by aspirin. Limit this strategy (rivaroxaban followed by aspirin) to low-risk patients who undergo elective unilateral THA or TKA, ambulate within 24 hours after surgery, and who do not have additional risk factors for VTE, indications for long-term anticoagulation, lower limb or hip fracture in the previous 3 months, or expected major surgery in the upcoming 3 months (Pai 2018).

Oral: After a 5-day course of postoperative rivaroxaban prophylaxis, initiate aspirin at 81 mg once daily starting on postoperative day 6 and continue for 9 days for TKA (total duration: 14 days) or 30 days for THA (total duration: 35 days) (Anderson 2018).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Analgesia or anti-inflammatory uses: The manufacturer recommends avoiding in patients with CrCl <10 mL/minute. However, may use with caution and monitor renal function or consider the use of an alternative analgesic/anti-inflammatory agent (NKF [Henrich 1996], Whelton 2000).

Antiplatelet uses: The manufacturer recommends avoiding in patients with CrCl <10 mL/minute. However, in general, the benefit of low-dose aspirin outweighs any risk associated with nephropathy or other adverse effects even in the setting of severe renal impairment; the recommended aspirin dose should not be reduced in any patient with suspected or documented ACS, other cardiovascular disease, or other antithrombotic indication (Fernandez 2001, Harter 1979, Summaria 2015). In patients with diabetes and chronic kidney disease or in dialysis patients, the National Kidney Foundation recommends the use of antithrombotic doses of aspirin (ie, 75 to 162 mg daily) for prevention and management of ischemic heart disease or primary prevention of atherosclerotic disease (KDOQI 2005, KDOQI 2007).

Hemodialysis: Dialyzable (concentration dependent; higher salicylate concentrations are more readily dialyzable: 50% to 60%) (Juurlink 2015; Rosenberg 1981); consider administration after hemodialysis on dialysis days (Aronoff 2007).

Dosing: Hepatic Impairment: Adult

Avoid use in severe liver disease.

Dosing: Pediatric

Note: Doses are typically rounded to a convenient amount (eg, 1/4 of 81 mg tablet):

Analgesic: Oral, rectal: Note: Do not use aspirin in pediatric patients <18 years who have or who are recovering from chickenpox or flu symptoms (eg, viral illness) due to the association with Reye syndrome (APS 2016):

Infants, Children, and Adolescents weighing <50 kg: Limited data available: 10 to 15 mg/kg/dose every 4 to 6 hours; maximum daily dose: 90 mg/kg/day or 4,000 mg/daywhichever is less (APS 2016)

Children ≥12 years and Adolescents weighing ≥50 kg: 325 to 650 mg every 4 to 6 hours; maximum daily dose: 4,000 mg/day

Anti-inflammatory: Limited data available: Infants, Children, and Adolescents: Oral: Initial: 60 to 90 mg/kg/day in divided doses; usual maintenance: 80 to 100 mg/kg/day divided every 6 to 8 hours; monitor serum concentrations (Levy 1978)

Antiplatelet effects: Limited data available: Infants, Children, and Adolescents: Oral: Adequate pediatric studies have not been performed; pediatric dosage is derived from adult studies. Usual adult maximum daily dose for antiplatelet effects is 325 mg/day.

Acute ischemic stroke (AIS):

Noncardioembolic: 1 to 5 mg/kg/dose once daily for ≥2 years; patients with recurrent AIS or TIAs should be transitioned to clopidogrel, LMWH, or warfarin (ACCP [Monagle 2012])

Secondary to Moyamoya and non-Moyamoya vasculopathy: 1 to 5 mg/kg/dose once daily; Note: In non-Moyamoya vasculopathy, continue aspirin for 3 months, with subsequent use guided by repeat cerebrovascular imaging (ACCP [Monagle 2012]).

Prosthetic heart valve:

Bioprosthetic aortic valve (with normal sinus rhythm): 1 to 5 mg/kg/dose once daily for 3 months (AHA [Giglia 2013]; ACCP [Guyatt 2012]; ACCP [Monagle 2012])

Mechanical aortic and/or mitral valve: 1 to 5 mg/kg/dose once daily combined with vitamin K antagonist (eg, warfarin) is recommended as first-line antithrombotic therapy (ACCP [Guyatt 2012]; ACCP [Monagle 2012]). Alternative regimens: 6 to 20 mg/kg/dose once daily in combination with dipyridamole (Bradley 1985; el Makhlouf 1987; LeBlanc 1993; Serra 1987; Solymar 1991)

Shunts: Blalock-Taussig; Glenn; postoperative; primary prophylaxis: 1 to 5 mg/kg/dose once daily (ACCP [Monagle 2012]; AHA [Giglia 2013])

Norwood, Fontan surgery, postoperative; primary prophylaxis: 1 to 5 mg/kg/dose once daily (ACCP [Monagle 2012]; AHA [Giglia 2013])

Transcatheter Atrial Septal Defect (ASD) or Ventricular Septal Defect (VSD) devices, postprocedure prophylaxis: 1 to 5 mg/kg/dose once daily starting one to several days prior to implantation and continued for at least 6 months. For older children and adolescents, after device closure of ASD, an additional anticoagulant may be given with aspirin for 3 to 6 months, but the aspirin should continue for at least 6 months (AHA [Giglia 2013]).

Ventricular assist device (VAD) placement: 1 to 5 mg/kg/dose once daily initiated within 72 hours of VAD placement; should be used with heparin (initiated between 8 to 48 hours following implantation) and with or without dipyridamole (ACCP [Monagle 2012])

Kawasaki disease: Limited data available; optimal dose not established: Note: Patients with Kawasaki disease and presenting with influenza or viral illness should not receive aspirin; acetaminophen is suggested as an antipyretic in these patients and an alternate antiplatelet agent suggested for a minimum of 2 weeks (AHA [McCrindle 2017]).

Infants, Children, and Adolescents: Oral:

Initial therapy (acute phase): Recommended dosing regimens vary. Use in combination with IV immune globulin (within first 10 days of symptom onset) and corticosteroids in some cases.

High dose: 80 to 100 mg/kg/day divided every 6 hours for up to 14 days until fever resolves for at least 48 to 72 hours (AAP [Red Book 2015]; ACCP [Monagle 2012]; AHA [Giglia 2013]; AHA [McCrindle 2017])

Moderate dose: 30 to 50 mg/kg/day divided every 6 hours for up to 14 days until fever resolves for at least 48 to 72 hours (AHA [McCrindle 2017])

Subsequent therapy (low-dose; antiplatelet effects): 3 to 5 mg/kg/day once daily; reported dosing range: 1 to 5 mg/kg/day; initiate after fever resolves for at least 48 to 72 hours (or after 14 days). In patients without coronary artery abnormalities, administer the lower dose for 6 to 8 weeks. In patients with coronary artery abnormalities, low-dose aspirin should be continued indefinitely (in addition to therapy with warfarin) (AAP [Red Book 2015]; ACCP [Monagle 2012]; AHA [Giglia 2013]; AHA [McCrindle 2017]).

Rheumatic fever: Limited data available: Infants, Children, and Adolescents: Oral: Initial: 100 mg/kg/day divided into 4 to 5 doses; if response inadequate, may increase dose to 125 mg/kg/day; continue for 2 weeks; then decrease dose to 60 to 70 mg/kg/day in divided doses for an additional 3 to 6 weeks (WHO Guidelines 2004)

Migratory polyarthritis, with carditis without cardiomegaly or congestive heart failure: Initial: 100 mg/kg/day in 4 divided doses for 3 to 5 days, followed by 75 mg/kg/day in 4 divided doses for 4 weeks

Carditis and cardiomegaly or congestive heart failure: At the beginning of the tapering of the prednisone dose, aspirin should be started at 75 mg/kg/day in 4 divided doses for 6 weeks

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: There are no recommendations in the manufacturer’s labeling; however, the following adjustments have been recommended (Aronoff 2007):

GFR ≥10 mL/minute/1.73 m2: No dosage adjustment necessary.

GFR <10 mL/minute/1.73 m2: Avoid use.

Intermittent hemodialysis: Dialyzable: 50% to 100% (concentration dependent; higher salicylate concentrations are more readily dialyzable) (Juurlink 2015; Rosenberg 1981); administer daily dose after dialysis session on dialysis days (Aronoff 2007).

Peritoneal dialysis: Avoid use.

CRRT: No dosage adjustment necessary; monitor serum concentrations.

Dosing: Hepatic Impairment: Pediatric

All ages: Avoid use in severe liver disease.

Use: Labeled Indications

Immediate release:

Analgesic/Antipyretic: For the temporary relief of headache, pain, and fever caused by colds, muscle aches and pains, menstrual pain, toothache pain, and minor aches and pains of arthritis.

Revascularization procedures: In patients who have undergone revascularization procedures (ie, coronary artery bypass graft [CABG], percutaneous transluminal coronary angioplasty, or carotid endarterectomy).

Rheumatoid disease: For the relief of the signs and symptoms of rheumatoid arthritis (RA), juvenile idiopathic arthritis (formerly called juvenile RA), osteoarthritis, spondyloarthropathies, and arthritis and pleurisy associated with systemic lupus erythematosus.

Vascular indications (ischemic stroke, transient ischemic attack, acute myocardial infarction, prevention of recurrent myocardial infarction, unstable angina, and chronic stable angina): To reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; to reduce the risk of vascular mortality in patients with a suspected acute myocardial infarction (MI); to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina; to reduce the combined risk of MI and sudden death in patients with chronic stable angina.

Extended-release capsules:

Chronic coronary artery disease: To reduce the risk of death and MI in patients with chronic coronary artery disease (eg, history of MI, unstable angina, or chronic stable angina).

History of ischemic stroke or transient ischemic attack: To reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack (TIA).

Limitations of use: Do not use extended-release capsules in situations for which a rapid onset of action is required (such as acute treatment of MI or before percutaneous coronary intervention); use immediate-release formulations instead.

Use: Off-Label: Adult

  Acute coronary syndromes (ST-elevation MI, non-ST-elevation MI, unstable angina)Level of Evidence [G]

Based on the 2013 American College of Cardiology/American Heart Association (ACCF/AHA) guidelines for the management of ST-elevation myocardial infarction (STEMI)and the 2014 ACCF/AHA guidelines for the management of non-ST-elevation acute coronary syndromes, the use of aspirin for the immediate treatment of patients presenting with symptoms suggestive of STEMI or unstable angina/non-ST-elevation myocardial infarction (UA/NSTEMI) is recommended. Patients should be instructed to chew nonenteric-coated aspirin while emergency medical services personnel are en route.

  Acute ischemic stroke/transient ischemic attackLevel of Evidence [G]

Based on the American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy and prevention of thrombosis (9th edition) and the American Heart Association/American Stroke Association Guidelines for the Early Management of Patients with Acute Ischemic Stroke, the use of aspirin within 24 to 48 hours after acute ischemic stroke or transient ischemic attack onset is recommended for the treatment of most patients.

  Atrial fibrillation (prevention of thromboembolism)Level of Evidence [G]

Primary prevention: Based on the American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guidelines for the management of atrial fibrillation, aspirin may be considered for use in patients with a CHA2DS2-VASc score of 1 as an alternative to other oral anticoagulants (eg, warfarin) to prevent thromboembolism associated with nonvalvular atrial fibrillation.

  Carotid artery stenosis (asymptomatic)Level of Evidence [G]

Based on the American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy and prevention of thrombosis (9th edition), daily aspirin is suggested over no aspirin therapy in patients with asymptomatic carotid artery stenosis based on a slight reduction in total mortality observed when aspirin is taken over 10 years (regardless of cardiovascular risk profile). The American Heart Association/American Stroke Association (AHA/ASA) guidelines for the primary prevention of stroke recommend daily aspirin (in combination with a statin) for patients with asymptomatic carotid stenosis to reduce the risk of a first stroke occurring.

  Colorectal cancer risk reduction (primary/secondary prevention)Level of Evidence [A]

Data from a large randomized double-blind trial supports the use of aspirin for the prevention of colorectal adenomas in patients previously diagnosed with colorectal cancer Ref. Two meta-analyses also support the use of aspirin for the primary prevention of colorectal cancer Ref.

  Colorectal cancer risk reduction in hereditary nonpolyposis colon cancer carriers (Lynch syndrome)Level of Evidence [A, G]

Data from a large randomized phase 3 trial (CAPP2) supports the use of high-dose aspirin (600 mg daily) for the prevention of colorectal cancer in patients who are carriers of hereditary nonpolyposis colon cancer Ref.

The American Society of Clinical Oncology Guideline (Endorsement) for Hereditary Colorectal Cancer Syndromes states that although current data is based on a single trial, chemoprevention with aspirin may be used to reduce the incidence of colorectal cancer among carriers of Lynch Syndrome.

  Percutaneous coronary interventionLevel of Evidence [G]

Based on the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention (PCI), aspirin in conjunction with other antiplatelet agents (eg P2Y12 inhibitors and glycoprotein IIb/IIIa inhibitors) is effective in reducing the frequency of ischemic complications after PCI and recommended for use prior to the procedure and continued indefinitely.

  PericarditisLevel of Evidence [C]

Data from a prospective open-label clinical trial supports the use of high-dose aspirin treatment in patients with acute low-risk pericarditis Ref. Clinical experience also suggests the utility of high-dose aspirin in managing patients with pericarditis Ref. Additional data may be necessary to further define the role of aspirin in this condition.

  Pericarditis associated with MILevel of Evidence [C, G]

Data from a small prospective, randomized, single-blinded study comparing aspirin to indomethacin demonstrated that most patients achieve discomfort relief from pericarditis after STEMI with aspirin Ref.

Based on the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines for the management of ST-elevation myocardial infarction, aspirin is recommended for the treatment of pericarditis after STEMI.

  Peripheral arterial diseaseLevel of Evidence [G]

Based on the 2016 American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of lower extremity peripheral arterial disease (PAD), aspirin is recommended to reduce the risk of vascular events (ie, MI, stroke and vascular death) in patients with symptomatic PAD. The use of aspirin is reasonable in asymptomatic PAD patients with an ankle-to-brachial index ≤0.90 to reduce the risk of vascular events Ref.

Based on the American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy in PAD (9th edition), aspirin is recommended for patients with symptomatic or asymptomatic PAD to prevent cardiovascular events ARef.

  Polycythemia veraLevel of Evidence [B, G]

Aspirin may be used in all patients with polycythemia vera without a history of major bleeding or gastric intolerance. Aspirin has been studied in more than 1,000 patients and is recommended in multiple polycythemia vera guidelines. Clinicians must consider the potential risk for bleeding and monitor for signs and symptoms of bleeding. Access Full Off-Label Monograph

  Preeclampsia (prevention)Level of Evidence [G]

Based on the American College of Chest Physicians guidelines, the American College of Obstetricians and Gynecologists, and the US Preventive Services Task Force Ref, low-dose aspirin is effective and recommended for use in patients at risk of preeclampsia.

  Prevention (primary) of cardiovascular diseaseLevel of Evidence [G]

Based on the American College of Chest Physicians guidelines and the American Diabetes Association (ADA) Standards of Medical Care in Diabetes, aspirin is effective and recommended for the primary prevention of cardiovascular disease. According to ACCP, aspirin is recommended in select patients (individuals ≥50 years without symptomatic cardiovascular disease). According to ADA, in patients with type 1 or 2 diabetes, aspirin should be considered for primary prevention in patients who have an increased cardiovascular risk, which includes most men and women ≥50 years old with at least one additional risk factor (eg, hypertension, dyslipidemia, albuminuria, family history of premature atherosclerotic cardiovascular disease, smoking).

  Prevention (secondary) of cardiovascular disease (patients with diabetes)Level of Evidence [G]

Based on the American Diabetes Association (ADA) Standards of Medical Care in Diabetes, aspirin is effective and recommended for the secondary prevention of cardiovascular disease in patients with diabetes and a history of atherosclerotic disease.

  Prevention (secondary) after CABG surgeryLevel of Evidence [G]

Based on a scientific statement from the American Heart Association on secondary prevention after coronary artery bypass graft surgery, the use of aspirin preoperatively and within 6 hours after CABG is effective and recommended for use in patients undergoing CABG. Aspirin should be continued indefinitely to reduce graft occlusion and adverse cardiac events.

  Prosthetic heart valve replacement (thromboprophylaxis)Level of Evidence [G]

Based on the 2014 American Heart Association/American College of Cardiology (AHA/ACC) guideline for the management of patients with valvular heart disease and the American Heart Association/American Stroke Association (AHA/ASA) guidelines for the primary prevention of stroke, aspirin in addition to a vitamin K antagonist (eg, warfarin) is effective and recommended in patients with a mechanical prosthetic valve (ie, aortic or mitral position) to reduce the risk of thromboembolism (eg, stroke) and mortality. The use of aspirin is also reasonable in all patients with a bioprosthetic aortic or mitral valve.

  Venous thromboembolism, extended therapy to prevent recurrence (in patients who have completed anticoagulation treatment and decided to stop oral anticoagulation)Level of Evidence [A, G]

Data from randomized, double-blind, placebo-controlled trials have demonstrated that low-dose aspirin reduces the overall risk of VTE recurrence in patients with a first unprovoked VTE (DVT or PE) following completion and discontinuation of oral anticoagulant therapy Ref. However, data from a double-blind, randomized, placebo-controlled trial did not demonstrate a significant reduction in the rate of VTE recurrence, although it did show a significant reduction in the rate of major vascular events Ref.

Based on the American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy for VTE disease, aspirin may be considered for extended treatment, after 3 months of anticoagulant therapy, to prevent VTE recurrence in patients who are stopping anticoagulant therapy following an unprovoked DVT or PE. Aspirin is not considered a reasonable alternative to anticoagulation for extended treatment because aspirin is expected to be much less effective at preventing recurrent VTE; however, in patients who have decided to stop anticoagulants, aspirin may be considered over no aspirin therapy.

  Venous thromboembolism (VTE) prophylaxis for total hip (THA) or knee (TKA) arthroplastyLevel of Evidence [A]

Data from a large multicenter, randomized, double-blind, controlled trial supports the use of aspirin as part of a hybrid VTE prophylaxis strategy after THA or TKA. In this trial, patients undergoing THA or TKA received rivaroxaban for VTE prophylaxis for the first 5 postoperative days then switched to aspirin or continued rivaroxaban for an additional 30 days (35 days total) for THA or an additional 9 days (14 days total) for TKA. Aspirin was found to be non-inferior to rivaroxaban at preventing symptomatic VTE, with no difference in bleeding Ref. Some experts recommend limiting this strategy to low-risk patients who undergo elective unilateral THA or TKA, ambulate within 24 hours after surgery and who have none of the following: Additional risk factors for VTE, indications for long-term anticoagulation, lower limb or hip fracture in the previous 3 months, or expected major surgery in the upcoming 3 months Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Atrial Fibrillation:

AAN, “Prevention of Stroke in Nonvalvular Atrial Fibrillation,” February 2014.

AHA/ACC/HRS, “2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation,” March 2014.

“Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report,” July 2018

Canadian Cardiovascular Society, “2016 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation,” 2016

Coronary Artery Bypass Graft Surgery:

“AHA Scientific Statement, Secondary Prevention After Coronary Artery Bypass Graft Surgery,” February 2015

Coronary Artery Stent Thrombosis Prevention:

ACC/AHA “Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease,” March 2016

“AHA/ACC/SCAI/ACS/ADA Science Advisory, Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery Stents,” February 2007

Ischemic Heart Disease:

ACC/AHA/AATS/PCNA/SCAI/STS, “2014 Focused Update of the Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” July 2014

ACCF/AHA/ACP/AATS/PCNA/SCAI/STS, “2012 Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” November 2012

Juvenile idiopathic arthritis:

American College of Rheumatology, “2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis” 2013

Non-ST-Elevation Acute Coronary Syndromes:

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes,” September 2014.

Percutaneous Coronary Intervention:

ACCF/AHA/SCAI, “2011 Guideline for Percutaneous Coronary Intervention,” November 2011

Peripheral Arterial Disease:

ACC/AHA, “2005 Guidelines for the Management of Patients with Peripheral Arterial Disease,” March 2006

ACCF/AHA, “2011 Focused Update of the Guideline for the Management of Patients with Peripheral Artery Disease (Updating the 2005 Guideline),” September 2011

Preeclampsia:

“Low-Dose Aspirin Use for the Prevention of Morbidity and Mortality From Preeclampsia; U.S. Preventive Services Task Force Recommendation Statement,” September 2014

Prevention:

“AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2011 Update,” November 2011

American Diabetes Association, “Standards of Medical Care in Diabetes – 2019,” January 2019

“ASCO Hereditary Colorectal Cancer Syndromes Clinical Practice Guideline [Endorsement],” December 2014

“Aspirin for the Prevention of Cardiovascular Disease: U.S. Preventive Services Task Force Recommendation Statement,” March 2009

ST-Elevation Myocardial Infarction:

ACCF/AHA, “2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction,” December 2012

Stroke:

AHA/ASA , “Guidelines for the Early Management of Patients With Acute Ischemic Stroke,” February 2013

AHA/ASA, “Guidelines for the Prevention of Stroke in Women,” 2014

AHA/ASA, “Guidelines for Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack,” May 2014.

AHA/ASA, “Guidelines for the Primary Prevention of Stroke,” December 2014

Surgery:

ACC/AHA, “2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery,” August 2014

STS, “2012 Update to the Society of Thoracic Surgeons Guideline on Use of Antiplatelet Drugs in Patients Having Cardiac and Noncardiac Operations,” November 2012

Valvular Heart Disease:

AHA/ACC, “2017 AHA/ACC Focused Update of the 2014 Guideline for the Management of Patients with Valvular Heart Disease,” 2017

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease,” March 2014

VTE:

Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report,” February 2016

American Society of Clinical Oncology Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer, Clinical Practice Guideline Update, 2013

American Society of Clinical Oncology Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer, Clinical Practice Guideline Update, 2014

Other:

AHA, “Prevention and Treatment of Thrombosis in Pediatric and Congenital Heart Disease,” December 2013

Canadian Cardiovascular Society, “The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” May 2011

Canadian Cardiovascular Society, “Focused 2012 Update of the Canadian Cardiovascular Society Guidelines for the Use of Antiplatelet Therapy,” November 2013

Administration: Oral

Immediate-release tablets: Do not crush enteric-coated tablet. Administer with food or a full glass of water to minimize GI distress. In situations for which a rapid onset of action is required (eg, acute treatment of MI), have patient chew immediate-release tablet.

Preeclampsia (prevention): Administration as an evening dose may be more beneficial than administration in the morning (Ayala 2013; Rolnik 2017)

Extended-release capsules: Do not cut, crush, or chew. Administer with a full glass of water at the same time each day. Do not administer 2 hours before or 1 hour after alcohol consumption.

Administration: Rectal

Remove suppository from plastic packet and insert into rectum as far as possible.

Administration: Pediatric

Oral: Immediate release: Administer with water, food, or milk to decrease GI upset. Do not crush or chew enteric-coated tablets; these preparations should be swallowed whole. For acute myocardial infarction, have patient chew immediate-release tablet.

Rectal: Remove suppository from plastic packet and insert into rectum as far as possible.

Storage/Stability

Store oral dosage forms (caplets, tablets, capsules) at room temperature; protect from moisture; see product-specific labeling for details. Keep suppositories in refrigerator; do not freeze. Hydrolysis of aspirin occurs upon exposure to water or moist air, resulting in salicylate and acetate, which possess a vinegar-like odor. Do not use if a strong odor is present.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience heartburn, vomiting, or nausea. Have patient report immediately to prescriber signs of abdominal ulcers (severe abdominal or back pain; black, tarry, or bloody stools; vomiting blood or vomit that looks like coffee grounds; or weight gain or abnormal swelling), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), severe dizziness, passing out, confusion, severe headache, tinnitus, hearing impairment, severe abdominal pain, agitation, seizures, severe rectal pain or irritation, or rectal bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient.You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  International issues:
  Geriatric Patients: High-Risk Medication:
Contraindications

Hypersensitivity to NSAIDs; patients with asthma, rhinitis, and nasal polyps; use in children or teenagers for viral infections, with or without fever.

Documentation of allergenic cross-reactivity for salicylates is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Salicylate sensitivity: Patients with sensitivity to tartrazine dyes, nasal polyps, and asthma may have an increased risk of salicylate sensitivity.

• Tinnitus: Discontinue use if tinnitus or impaired hearing occurs.

• Upper gastrointestinal (UGI) events (eg, symptomatic or complicated ulcers): Low-dose aspirin for cardioprotective effects is associated with a two- to fourfold increase in UGI events. The risks of these events increase with increasing aspirin dose; during the chronic phase of aspirin dosing, doses >81 mg are not recommended unless indicated (Bhatt 2008).

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with platelet and bleeding disorders.

• Dehydration: Use with caution in patients with dehydration.

• Ethanol use: Heavy ethanol use (>3 drinks/day) can increase bleeding risks and may enhance gastric mucosal damage.

• Gastrointestinal disease: Use with caution in patients with erosive gastritis. Avoid use in patients with active peptic ulcer disease.

• Hepatic impairment: Avoid use in severe hepatic failure.

• Renal impairment: When using high dosages (eg, analgesic or anti-inflammatory uses), use with caution and monitor renal function or consider the use of an alternative analgesic/anti-inflammatory agent (NKF [Henrich 1996]; Whelton 2000). Low-dose aspirin (eg, 75 to 162 mg daily) may be safely used in patients with any degree of renal impairment (KDOQI 2005; KDOQI 2007).

Concurrent drug therapy issues:

• Alteplase: In the treatment of acute ischemic stroke, avoid aspirin for 24 hours following administration of alteplase; administration within 24 hours increases the risk of hemorrhagic transformation (Jauch 2013).

• COX-2 inhibitors/NSAIDs: When used concomitantly with ≤325 mg of aspirin, NSAIDs (including selective COX-2 inhibitors) substantially increase the risk of gastrointestinal complications (eg, ulcer); concomitant gastroprotective therapy (eg, proton pump inhibitors) is recommended (Bhatt 2008).

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Lower GI bleed patients: An individualized and multidisciplinary approach should be used to manage patients with an acute lower GI bleed (LGIB) who are on antiplatelet medications. Aspirin for primary prevention of cardiovascular events should be avoided in most patients with LGIB who do not have established cardiovascular disease and do not have high risk factors for cardiovascular events. However, aspirin for secondary cardiovascular prevention should generally not be discontinued in patients with established cardiovascular disease and a history of lower GI bleeding (Strate 2016).

• Pediatric: When used for self-medication (OTC labeling): Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. Changes in behavior (along with nausea and vomiting) may be an early sign of Reye syndrome; patients should be instructed to contact their healthcare provider if these occur.

• Surgical patients: Aspirin should be avoided (if possible) in surgical patients for 1 to 2 weeks prior to elective surgery, to reduce the risk of excessive bleeding. In patients with cardiac stents or who have recently (within the previous 14 days) undergone balloon angioplasty that have not completed their full course of antiplatelet therapy (eg, dual antiplatelet therapy), antiplatelet therapy should be continued and elective surgery should be delayed until course of antiplatelet therapy is complete; patient specific situations should be discussed with cardiologist (ACC/AHA [Fleisher 2014]; ACC/AHA [Levine 2016]; AHA/ACC/SCAI/ACS/ADA [Grines 2007]).

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Resistance: Aspirin resistance is defined as measurable, persistent platelet activation that occurs in patients prescribed a therapeutic dose of aspirin. Clinical aspirin resistance, the recurrence of some vascular event despite a regular therapeutic dose of aspirin, is considered aspirin treatment failure. Proposed mechanisms of aspirin resistance include poor adherence with therapy, poor absorption, inadequate dosage, drug interactions, increased isoprostane activity, platelet hypersensitivity to agonists, increased COX-2 activity, COX-1 polymorphism, and platelet alloantigen 2 polymorphism of platelet glycoprotein IIIa. Estimates of biochemical aspirin resistance range from 5.5% to 60% depending on the population studied and the assays used (Gasparyan 2008). Patients with aspirin resistance may have a higher risk of cardiovascular events compared to those who are aspirin sensitive (Gum 2003). Aspirin resistance is likely dose-related but may be influenced by dynamic factors yet to be identified; further research is required.

Geriatric Considerations

Elderly are a high-risk population for adverse effects from nonsteroidal anti-inflammatory agents. As much as 60% of elderly with GI complications to NSAIDs can develop peptic ulceration and/or hemorrhage asymptomatically. The concomitant use of H2 blockers and sucralfate is not effective as prophylaxis with the exception of NSAID-induced duodenal ulcers which may be prevented by the use of ranitidine. Misoprostol and proton pump inhibitors are the only prophylactic agents proven to help prevent the development of NSAID-induced ulcers. Also, concomitant disease and drug use contribute to the risk for GI adverse effects. Use lowest effective dose for shortest period possible. Consider renal function decline associated with age. Use of NSAIDs can compromise existing renal function especially when CrCl is ≤30 mL/minute. Tinnitus may be a difficult and unreliable indication of toxicity due to age-related hearing loss or eighth cranial nerve damage. CNS adverse effects such as confusion, agitation, and hallucination are generally seen in overdose or high dose situations, but elderly may demonstrate these adverse effects at lower doses than younger adults.

Warnings: Additional Pediatric Considerations

Do not use aspirin in pediatric patients <18 years of age (APS 2016) who have or who are recovering from chickenpox or flu symptoms (due to the association with Reye syndrome); when using aspirin, changes in behavior (along with nausea and vomiting) may be an early sign of Reye syndrome; instruct patients and caregivers to contact their health care provider if these symptoms occur; patients should be kept current on their influenza and varicella immunizations. Although Reye syndrome has been observed in patients receiving prolonged, high-dose aspirin therapy after Kawasaki disease presentation; it has not been observed in pediatric patients receiving low (antiplatelet) dosing regimens. Patients with Kawasaki disease and presenting with influenza or viral illness should not receive aspirin; acetaminophen is suggested as an antipyretic in these patients, and an alternate antiplatelet agent is suggested for a minimum of 2 weeks (AHA [McCrindle 2017]).

Pregnancy Considerations

Salicylates have been noted to cross the placenta and enter fetal circulation. Adverse effects reported in the fetus include mortality, intrauterine growth retardation, salicylate intoxication, bleeding abnormalities, and neonatal acidosis. Use of aspirin close to delivery may cause premature closure of the ductus arteriosus. Adverse effects reported in the mother include anemia, hemorrhage, prolonged gestation, and prolonged labor (Østensen 1998).

Low-dose aspirin may be used to prevent preeclampsia in women with a history of early-onset preeclampsia and preterm delivery (<34 0/7 weeks), or preeclampsia in ≥1 prior to pregnancy (ACOG 2013). Treatment is started after 12 weeks’ gestation in women at risk for preeclampsia (ACCP [Bates 2012]; LeFevre 2014). Low-dose aspirin is used to treat complications resulting from antiphospholipid syndrome in pregnancy (either primary or secondary to SLE) (ACCP [Bates 2012]; Carp 2004; Tincani 2003). Low-dose aspirin to prevent thrombosis may also be used during the second and third trimesters in women with prosthetic valves (mechanical or bioprosthetic). The use of warfarin is recommended, along with low-dose aspirin, in those with mechanical prosthetic valves (AHA/ACC [Nishimura 2014]). Low-dose aspirin may also be used after the first trimester in women with low-risk conditions requiring antiplatelet therapy (AHA/ASA [Kernan 2014]). When needed in doses required for the management of pain, agents other than aspirin are preferred in pregnant women and use in the third trimester is not recommended (Källén 2016; Shah 2015).

Breast-Feeding Considerations

Salicylic acid is present in breast milk following maternal use of aspirin (Bailey 1982; Findlay 1981; Jamali 1981).

The relative infant dose (RID) of aspirin is 8% when calculated using the highest breast milk concentration located and compared to an infant therapeutic dose of 90 mg/kg/day.

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID of aspirin was calculated using a milk concentration of 48.1 mcg/mL, providing an estimated daily infant dose via breast milk of 7.2 mg/kg/day. This milk concentration was obtained following maternal administration of aspirin 1,500 mg as a single dose (Jamali 1981). The reported time to peak milk concentration is variable (2 to 9 hours), milk concentrations decline slowly, and do not correlate strongly to maternal serum concentration (Bailey 1982; Bar-Oz 2003; Findlay 1981; Jamali 1981). Salicylate is measurable in the serum (Unsworth 1987) and urine (Clark 1981) of breastfed infants following maternal use of oral aspirin. Higher salicylate concentrations may be present in breast milk following multiple maternal doses. In addition, salicylate concentrations may be higher than reported as metabolite concentrations of salicylic acid were not evaluated in most studies; the longer elimination half-life in infants compared to adults should also be considered (Bar-Oz 2003; Spigset 2000).

Metabolic acidosis was reported in a 16-day old breastfed full-term infant following maternal doses of aspirin 3.9 g/day (Clark 1981). Thrombocytopenic purpura was also reported in one infant following salicylate exposure via breast milk (Spigset 2000). There were no cases of diarrhea, drowsiness, or irritability noted in breastfed infants in the study which included 15 mother-infant pairs following aspirin exposure (dose, duration, and relationship to breastfeeding not provided) (Ito 1993).

Breastfeeding is not recommended by the manufacturer. When a nonopioid analgesic is needed in postpartum women who wish to breastfeed, agents other than aspirin are preferred (Montgomery 2012). The WHO considers occasional doses of aspirin to be compatible with breastfeeding, but recommends to avoid long-term therapy and consider monitoring the infant for adverse effects (hemolysis, prolonged bleeding, metabolic acidosis) (WHO 2002). Other sources suggest avoiding aspirin while breastfeeding due to the theoretical risk of Reye syndrome (Bar-Oz 2003; Spigset 2000). When used for vascular indications, breastfeeding may be continued during low-dose aspirin therapy (ACCP [Bates 2012]; AHA/ASA [Kernan 2014]; WHO 2002).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

As with all drugs which may affect hemostasis, bleeding is associated with aspirin. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables including dosage, concurrent use of multiple agents which alter hemostasis, and patient susceptibility. Many adverse effects of aspirin are dose related, and are rare at low dosages. Other serious reactions are idiosyncratic, related to allergy or individual sensitivity. Accurate estimation of frequencies is not possible. The reactions listed below have been reported for aspirin.

Cardiovascular: Cardiac arrhythmia, edema, hypotension, tachycardia

Central nervous system: Agitation, cerebral edema, coma, confusion, dizziness, fatigue, headache, hyperthermia, insomnia, lethargy, nervousness, Reye’s syndrome

Dermatologic: Skin rash, urticaria

Endocrine & metabolic: Acidosis, dehydration, hyperglycemia, hyperkalemia, hypernatremia (buffered forms), hypoglycemia (children)

Gastrointestinal: Gastrointestinal ulcer (6% to 31%), duodenal ulcer, dyspepsia, epigastric distress, gastritis, gastrointestinal erosion, heartburn, nausea, stomach pain, vomiting

Genitourinary: Postpartum hemorrhage, prolonged gestation, prolonged labor, proteinuria, stillborn infant

Hematologic & oncologic: Anemia, blood coagulation disorder, disseminated intravascular coagulation, hemolytic anemia, hemorrhage, iron deficiency anemia, prolonged prothrombin time, thrombocytopenia

Hepatic: Hepatitis (reversible), hepatotoxicity, increased serum transaminases

Hypersensitivity: Anaphylaxis, angioedema

Neuromuscular & skeletal: Acetabular bone destruction, rhabdomyolysis, weakness

Otic: Hearing loss, tinnitus

Renal: Increased blood urea nitrogen, increased serum creatinine, interstitial nephritis, renal failure (including cases caused by rhabdomyolysis), renal insufficiency, renal papillary necrosis

Respiratory: Asthma, bronchospasm, dyspnea, hyperventilation, laryngeal edema, noncardiogenic pulmonary edema, respiratory alkalosis, tachypnea

Miscellaneous: Low birth weight

Postmarketing and/or case reports: Anorectal stenosis (suppository), atrial fibrillation (toxicity), cardiac conduction disturbance (toxicity), cerebral infarction (ischemic), cholestatic jaundice, colitis, colonic ulceration, coronary artery vasospasm, delirium, esophageal obstruction, esophagitis (with esophageal ulcer), hematoma (esophageal), macular degeneration (age-related) (Li 2014), periorbital edema, rhinosinusitis

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

Substrate of CYP2C9 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Risk C: Monitor therapy

Ajmaline: Salicylates may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy

Alcohol (Ethyl): May enhance the adverse/toxic effect of Aspirin. Specifically, alcohol may increase the bleeding risk of aspirin. Alcohol (Ethyl) may diminish the therapeutic effect of Aspirin. Specifically, alcohol may interfere with the controlled release mechanism of extended release aspirin. Management: Monitor patients who drink 3 or more alcoholic drinks a day for increased bleeding while taking aspirin. Counsel patients about the risk of bleeding and discourage such consumption. Give extended release aspirin 2 hours before, or 1 hour after, alcohol. Risk D: Consider therapy modification

Alendronate: Aspirin may enhance the adverse/toxic effect of Alendronate. Specifically, the incidence of upper gastrointestinal adverse events may be increased Risk C: Monitor therapy

Ammonium Chloride: May increase the serum concentration of Salicylates. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Salicylates may enhance the nephrotoxic effect of Angiotensin-Converting Enzyme Inhibitors. Salicylates may diminish the therapeutic effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Anticoagulants: Salicylates may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Apixaban: Aspirin may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely. Risk D: Consider therapy modification

Benzbromarone: Salicylates may diminish the therapeutic effect of Benzbromarone. Risk C: Monitor therapy

Blood Glucose Lowering Agents: Salicylates may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): May enhance the antiplatelet effect of Aspirin. Risk C: Monitor therapy

Carbonic Anhydrase Inhibitors: Salicylates may enhance the adverse/toxic effect of Carbonic Anhydrase Inhibitors. Salicylate toxicity might be enhanced by this same combination. Management: Avoid these combinations when possible.Dichlorphenamide use with high-dose aspirin as contraindicated. If another combination is used, monitor patients closely for adverse effects. Tachypnea, anorexia, lethargy, and coma have been reported. Exceptions: Brinzolamide; Dorzolamide. Risk D: Consider therapy modification

Carisoprodol: Aspirin may increase serum concentrations of the active metabolite(s) of Carisoprodol. Specifically, Meprobamate concentrations may be increased. Aspirin may decrease the serum concentration of Carisoprodol. Risk C: Monitor therapy

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Risk C: Monitor therapy

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Risk C: Monitor therapy

Corticosteroids (Systemic): Salicylates may enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor therapy

Dabigatran Etexilate: Aspirin may enhance the adverse/toxic effect of Dabigatran Etexilate. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling states that low dose aspirin could be considered, but the use of antiplatelets are not recommended for stroke prevention in patients with atrial fibrillation. Risk D: Consider therapy modification

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Risk C: Monitor therapy

Dexibuprofen: Aspirin may enhance the adverse/toxic effect of Dexibuprofen. Dexibuprofen may diminish the cardioprotective effect of Aspirin. Risk X: Avoid combination

Dexketoprofen: Salicylates may enhance the adverse/toxic effect of Dexketoprofen. Dexketoprofen may diminish the therapeutic effect of Salicylates. Salicylates may decrease the serum concentration of Dexketoprofen. Management: The use of high-dose salicylates (3 g/day or more in adults) together with dexketoprofen is inadvisable. Consider administering dexketoprofen 30-120 min after or at least 8 hrs before cardioprotective doses of aspirin to minimize any possible interaction. Risk X: Avoid combination

Edoxaban: Aspirin may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Aspirin may increase the serum concentration of Edoxaban. Management: Carefully consider the anticipated risks and benefits of this combination. If combined, increased monitoring for bleeding is recommended. Risk D: Consider therapy modification

Fat Emulsion (Fish Oil Based): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Felbinac: May enhance the adverse/toxic effect of Aspirin. Risk C: Monitor therapy

Floctafenine: May enhance the adverse/toxic effect of Aspirin. An increased risk of bleeding may be associated with use of this combination. Floctafenine may diminish the cardioprotective effect of Aspirin. Risk X: Avoid combination

Ginkgo Biloba: May enhance the anticoagulant effect of Salicylates. Management: Consider alternatives to this combination of agents. Monitor for signs and symptoms of bleeding (especially intracranial bleeding) if salicylates are used in combination with ginkgo biloba. Risk D: Consider therapy modification

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Heparin: Aspirin may enhance the anticoagulant effect of Heparin. Risk C: Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Risk D: Consider therapy modification

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Salicylates. Bleeding may occur. Risk D: Consider therapy modification

Hyaluronidase: Salicylates may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving salicylates (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification

Ibritumomab Tiuxetan: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Influenza Virus Vaccine (Live/Attenuated): May enhance the adverse/toxic effect of Salicylates. Specifically, Reye’s syndrome may develop. Risk X: Avoid combination

Inotersen: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Ketorolac (Nasal): May enhance the adverse/toxic effect of Aspirin. An increased risk of bleeding may be associated with use of this combination. Ketorolac (Nasal) may diminish the cardioprotective effect of Aspirin. Risk X: Avoid combination

Ketorolac (Systemic): May enhance the adverse/toxic effect of Aspirin. An increased risk of bleeding may be associated with use of this combination. Ketorolac (Systemic) may diminish the cardioprotective effect of Aspirin. Risk X: Avoid combination

Lesinurad: Aspirin may diminish the therapeutic effect of Lesinurad. Risk C: Monitor therapy

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Loop Diuretics: Salicylates may diminish the diuretic effect of Loop Diuretics. Loop Diuretics may increase the serum concentration of Salicylates. Risk C: Monitor therapy

Macimorelin: Aspirin may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Methotrexate: Salicylates may increase the serum concentration of Methotrexate. Salicylate doses used for prophylaxis of cardiovascular events are not likely to be of concern. Risk D: Consider therapy modification

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Aspirin. Aspirin may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Specifically, aspirin may decrease the absorption of ascorbic acid. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Aspirin. Aspirin may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, aspirin may decrease absorption of ascorbic acid. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Aspirin. Aspirin may decrease the serum concentration of Multivitamins/Minerals (with AE, No Iron). Specifically, aspirin may decrease the absorption of ascorbic acid. Risk C: Monitor therapy

Nicorandil: Aspirin may enhance the adverse/toxic effect of Nicorandil. Specifically, the risk of gastrointestinal ulceration and hemorrhage may be increased. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Aspirin may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Management: Concurrent use of aspirin at doses beyond cardioprotective levels is not recommended. While concurrent use of low-dose aspirin with a COX-2 inhibitor is permissable, patients should be monitored closely for signs/symptoms of GI ulceration/bleeding. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (Nonselective): May enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination. Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk D: Consider therapy modification

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased.Risk C: Monitor therapy

Omacetaxine: Aspirin may enhance the adverse/toxic effect of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of aspirin with omacetaxine in patients with a platelet count of less than 50,000/uL. Risk X: Avoid combination

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Risk C: Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Potassium Phosphate: May increase the serum concentration of Salicylates. Risk C: Monitor therapy

PRALAtrexate: Salicylates may increase the serum concentration of PRALAtrexate. Salicylate doses used for prophylaxis of cardiovascular events are unlikely to be of concern. Risk D: Consider therapy modification

Probenecid: Salicylates may diminish the therapeutic effect of Probenecid. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Rivaroxaban: Aspirin may enhance the adverse/toxic effect of Rivaroxaban. Specifically, the risk of bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely. Risk D: Consider therapy modification

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy

Salicylates: May enhance the anticoagulant effect of other Salicylates. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the antiplatelet effect of Aspirin. Risk C: Monitor therapy

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the antiplatelet effect of Aspirin. Risk C: Monitor therapy

Spironolactone: Aspirin may diminish the therapeutic effect of Spironolactone. Risk C: Monitor therapy

Sucroferric Oxyhydroxide: May decrease the serum concentration of Aspirin. Management: Administer aspirin at least 1 hour before administration of sucroferric oxyhydroxide. Risk D: Consider therapy modification

Sulfinpyrazone: Salicylates may decrease the serum concentration of Sulfinpyrazone. Risk X: Avoid combination

Talniflumate: Aspirin may enhance the adverse/toxic effect of Talniflumate. Management: When possible, consider alternatives to this combination. Concurrent use is generally not recommended. Risk D: Consider therapy modification

Thiopental: Aspirin may decrease the protein binding of Thiopental. Risk C: Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy

Thrombolytic Agents: Salicylates may enhance the adverse/toxic effect of Thrombolytic Agents. An increased risk of bleeding may occur. Risk C: Monitor therapy

Ticagrelor: Aspirin may enhance the antiplatelet effect of Ticagrelor. Aspirin may diminish the therapeutic effect of Ticagrelor. More specifically, the benefits of ticagrelor relative to clopidogrel may be diminished in adult patients receiving daily aspirin doses greater than 100-150 mg daily. Management: Avoid daily aspirin doses greater than 100 mg in adults receiving ticagrelor. Canadian recommendations are to avoid adult daily aspirin doses greater than 150 mg. Daily low-dose aspirin (U.S.: 75-100 mg; Canada: 75-150 mg) is recommended. Risk D: Consider therapy modification

Tiludronate: Aspirin may decrease the serum concentration of Tiludronate. Risk C: Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Tricyclic Antidepressants (Tertiary Amine): May enhance the antiplatelet effect of Aspirin. Risk C: Monitor therapy

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Risk X: Avoid combination

Valproate Products: Salicylates may increase the serum concentration of Valproate Products. Risk C: Monitor therapy

Varicella Virus-Containing Vaccines: Salicylates may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. Reye’s Syndrome may develop. Risk D: Consider therapy modification

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Salicylates may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification

Food Interactions

Food may decrease the rate but not the extent of oral absorption. Benedictine liqueur, prunes, raisins, tea, and gherkins have a potential to cause salicylate accumulation. Fresh fruits containing vitamin C may displace drug from binding sites, resulting in increased urinary excretion of aspirin. Curry powder, paprika, licorice; may cause salicylate accumulation. These foods contain 6 mg salicylate/100 g. An ordinary American diet contains 10-200 mg/day of salicylate. Management: Administer with food or large volume of water or milk to minimize GI upset. Limit curry powder, paprika, licorice.

Test Interactions

False-negative results for glucose oxidase urinary glucose tests (Clinistix); false-positives using the cupric sulfate method (Clinitest); also, interferes with Gerhardt test, VMA determination; 5-HIAA, xylose tolerance test and T3 and T4; may lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016)

Reference Range

Timing of serum samples: Peak levels usually occur 2 hours after ingestion. Salicylate serum concentrations correlate with the pharmacological actions and adverse effects observed. The serum salicylate concentration (mcg/mL) and the corresponding clinical correlations are as follows: See table.

Serum Salicylate: Clinical Correlations
Serum Salicylate Concentration

(mcg/mL)

Desired Effects Adverse Effects / Intoxication
~100 Antiplatelet

Antipyresis

Analgesia

GI intolerance and bleeding, hypersensitivity, hemostatic defects
150-300 Anti-inflammatory Mild salicylism
250-400 Treatment of rheumatic fever Nausea/vomiting, hyperventilation, salicylism, flushing, sweating, thirst, headache, diarrhea, and tachycardia
>400-500 Respiratory alkalosis, hemorrhage, excitement, confusion, asterixis, pulmonary edema, convulsions, tetany, metabolic acidosis, fever, coma, cardiovascular collapse, renal and respiratory failure
Advanced Practitioners Physical Assessment/Monitoring

Obtain CBC, iron studies, ferritin, stools for occult blood, liver function tests, and renal function tests with prolonged therapy. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. Assess for signs and symptoms of bleeding. Discuss risks/benefits of taking aspirin during pregnancy. Order serial growth scans of fetus. Consider consultation with Maternal Fetal Medicine if complications suspected.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor and instruct patients to report any signs of bleeding, signs of abdominal ulcer, or hypersensitivity reactions. Educate patient to avoid alcohol consumption within 1 hour before and 2 hours after aspirin administration. Educate pregnant patient about the correct way to perform fetal kick counts and to monitor fetal movement. Report any concerns of decreased fetal movement to physician.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Caplet, oral: 500 mg

Bayer Aspirin Extra Strength: 500 mg

Bayer Genuine Aspirin: 325 mg

Bayer Women’s Low Dose Aspirin: 81 mg [contains elemental calcium 300 mg]

Caplet, oral [buffered]:

Ascriptin Maximum Strength: 500 mg [contains aluminum hydroxide, calcium carbonate, magnesium hydroxide] [DSC]

Bayer Plus Extra Strength: 500 mg [contains calcium carbonate]

Caplet, enteric coated, oral:

Bayer Aspirin Regimen Regular Strength: 325 mg

Capsule Extended Release, oral:

Durlaza: 162.5 mg

Suppository, rectal: 300 mg (12s); 600 mg (12s)

Tablet, oral: 325 mg

Aspercin: 325 mg

Aspirtab: 325 mg

Bayer Genuine Aspirin: 325 mg

Tablet, oral [buffered]: 325 mg

Ascriptin Regular Strength: 325 mg [contains aluminum hydroxide, calcium carbonate, magnesium hydroxide]

Buffasal: 325 mg [contains magnesium oxide]

Bufferin: 325 mg [contains calcium carbonate, magnesium carbonate, magnesium oxide]

Bufferin Extra Strength: 500 mg [contains calcium carbonate, magnesium carbonate, magnesium oxide]

Buffinol: 324 mg [sugar free; contains magnesium oxide]

Tri-Buffered Aspirin: 325 mg [contains calcium carbonate, magnesium carbonate, magnesium oxide]

Tablet, chewable, oral: 81 mg

Bayer Aspirin Regimen Children’s: 81 mg [cherry flavor]

Bayer Aspirin Regimen Children’s: 81 mg [orange flavor]

St Joseph Adult Aspirin: 81 mg

Tablet, delayed release, oral: 81 mg

Aspirin Adult Low Dose: 81 mg

Aspirin Adult Low Strength: 81 mg

Aspirin EC Low Strength: 81 mg

Bayer Aspirin EC Low Dose: 81 mg

Tablet, enteric coated, oral: 81 mg, 325 mg, 650 mg

Aspir-low: 81 mg

Bayer Aspirin Regimen Adult Low Strength: 81 mg

Ecotrin: 325 mg

Ecotrin Arthritis Strength: 500 mg

Ecotrin Low Strength: 81 mg

Halfprin: 81 mg [DSC]

St Joseph Adult Aspirin: 81 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A01AD05
  • B01AC06
  • N02BA01
Generic Available (US)

May be product dependent

Pricing: US

Capsule ER 24 Hour Therapy Pack (Durlaza Oral)

162.5 mg (per each): $7.20

Chewable (Aspirin Oral)

81 mg (per each): $0.02 – $0.06

Chewable (CareAll Aspirin Oral)

81 mg (per each): $0.02

Chewable (St Joseph Low Dose Oral)

81 mg (per each): $0.05

Pack (Stanback Headache Powders Oral)

650-200-32 mg (per each): $0.17

Suppository (Aspirin Rectal)

300 mg (per each): $1.46

600 mg (per each): $1.51

Tablet, EC (Aspir-Low Oral)

81 mg (per each): $0.05

Tablet, EC (Aspirin Oral)

81 mg (per each): $0.02 – $0.04

325 mg (per each): $0.02

Tablet, EC (Bayer Aspirin EC Low Dose Oral)

81 mg (per each): $0.05

Tablet, EC (Ecotrin Maximum Strength Oral)

500 mg (per each): $0.08

Tablet, EC (EcPirin Oral)

325 mg (per each): $0.03

Tablet, EC (Miniprin Low Dose Oral)

81 mg (per each): $0.03

Tablets (Ascriptin Oral)

325 mg (per each): $0.08

Tablets (Aspirin Oral)

325 mg (per each): $0.01 – $0.05

Tablets (Bayer Aspirin Oral)

325 mg (per each): $0.05

Tablets (Bufferin Extra Strength Oral)

500 mg (per each): $0.10

Tablets (Bufferin Low Dose Oral)

81 mg (per each): $0.04

Tablets (Bufferin Oral)

325 mg (per each): $0.07

Tablets (Medique Aspirin Oral)

325 mg (per each): $0.02

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Irreversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, via acetylation, which results in decreased formation of prostaglandin precursors; irreversibly inhibits formation of prostaglandin derivative, thromboxane A2, via acetylation of platelet cyclooxygenase, thus inhibiting platelet aggregation; has antipyretic, analgesic, and anti-inflammatory properties

Pharmacodynamics/Kinetics

Onset: Immediate release: Platelet inhibition: Within 1 hour (nonenteric-coated). Onset of enteric-coated aspirin expected to be delayed (Eikelboom 2012). Note: Chewing nonenteric-coated or enteric-coated tablets results in inhibition of platelet aggregation within 20 minutes; therefore, nonenteric-coated tablets should be chewed in settings where a more rapid onset is required (eg, acute MI) and enteric-coated tablets may be chewed when a rapid effect is required and immediate release nonenteric-coated tablets are not available (Eikelboom 2012; Feldman 1999; Sai 2011).

Duration: Immediate release: 4 to 6 hours; however, platelet inhibitory effects last the lifetime of the platelet (~10 days) due to its irreversible inhibition of platelet COX-1 (Eikelboom 2012).

Absorption: Immediate release: Rapidly absorbed in stomach and upper intestine (Eikelboom 2012); Extended-release capsule: Rate of absorption is dependent upon food, alcohol, and gastric pH.

Distribution: Vd: 10 L; readily into most body fluids and tissues; hydrolyzed to salicylate (active) by esterases in the GI mucosa, red blood cells, synovial fluid and blood

Protein binding: Concentration dependent; as salicylate concentration increases, protein binding decreases: ~90% to 94% (to albumin) at concentrations ≤80 mcg/mL (Rosenberg 1981; Juurlink 2015); ~30% with concentrations seen in overdose (Juurlink 2015).

Metabolism: Hydrolyzed to salicylate (active) by esterases in GI mucosa, red blood cells, synovial fluid, and blood; metabolism of salicylate occurs primarily by hepatic conjugation; metabolic pathways are saturable

Bioavailability: Immediate release: 50% to 75% reaches systemic circulation

Half-life elimination: Parent drug: Plasma concentration: 15 to 20 minutes; Salicylates (dose dependent): 3 hours at lower doses (300 to 600 mg), 5 to 6 hours (after 1 g), 10 hours with higher doses

Time to peak, serum: Immediate release: ~1 to 2 hours (nonenteric-coated), 3 to 4 hours (enteric-coated) (Eikelboom 2012); Extended-release capsule: ~2 hours. Note: Chewing nonenteric-coated tablets results in a time to peak concentration of 20 minutes (Feldman 1999). Chewing enteric-coated tablets results in a time to peak concentration of 2 hours (Sai 2011).

Excretion: Urine (75% as salicyluric acid, 10% as salicylic acid)

Dental Use

Treatment of postoperative pain

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Dental Health Professional Considerations

The Food and Drug Administration (FDA), has issued a letter updating information and considerations regarding the use of ibuprofen (400 mg doses) in patients who are taking low dose aspirin (81 mg, immediate release; not enteric coated) for cardioprotection and stroke prevention. Ibuprofen, at these doses, may interfere with aspirin’s antiplatelet effect depending upon when it is administered. Patients initiated on aspirin first (for ~1 week) then ibuprofen (400 mg 3 times/day for 10 days) seem to maintain aspirin’s platelet effect (Cryer, 2005). Ibuprofen has the greatest impact on aspirin if administered less than 8 hours before aspirin (Catella-Lawson, 2001).

Patients may require counseling about the appropriate timing of ibuprofen dosing in relationship to aspirin therapy. With occasional use of ibuprofen, a clinically-significant interaction with aspirin in unlikely. To avoid interference during chronic dosing, a single dose of ibuprofen should be taken 30 to 120 minutes after aspirin ingestion or at least 8 hours should elapse after ibuprofen dosing before giving aspirin (Catella-Lawson, 2001; FDA, 2006).

The clinical implications of the interaction are unclear. There have not been any clinical endpoint studies conducted at this time. Avoidance of this interaction is potentially important because aspirin’s vascular protection could be decreased or negated.

Other nonselective NSAIDs may have potential for a similar interaction with aspirin. Such has been described with naproxen (Capone, 2005). Acetaminophen does not appear to interfere with the antiplatelet effect of aspirin. Other clinical scenarios (use of smaller ibuprofen doses, other aspirin products, other doses of aspirin) have not been evaluated.

Additional information is available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm125222.htm

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: As with all drugs which may affect hemostasis, bleeding is associated with aspirin. Hemorrhage may occur at virtually any site; risk is dependent on multiple variables including dosage, concurrent use of multiple agents which alter hemostasis, and patient susceptibility. Many adverse effects of aspirin are dose related, and are rare at low dosages. Other serious reactions are idiosyncratic, related to allergy or individual sensitivity (see Dental Health Professional Considerations).

Aspirin as sole antiplatelet agent: Patients taking aspirin for ischemic stroke prevention are safe to continue it during dental procedures (Armstrong, 2013).

Concurrent aspirin use with other antiplatelet agents: Aspirin in combination with clopidogrel (Plavix), prasugrel (Effient), or ticagrelor (Brilinta) is the primary prevention strategy against stent thrombosis after placement of drug-eluting metal stents in coronary patients. Premature discontinuation of combination antiplatelet therapy (ie, dual antiplatelet therapy) strongly increases the risk of a catastrophic event of stent thrombosis leading to myocardial infarction and/or death, so says a science advisory issued in January 2007 from the American Heart Association in collaboration with the American Dental Association and other professional healthcare organizations. The advisory stresses a 12-month therapy of dual antiplatelet therapy after placement of a drug-eluting stent in order to prevent thrombosis at the stent site. Any elective surgery should be postponed for 1 year after stent implantation, and if surgery must be performed, consideration should be given to continuing the antiplatelet therapy during the perioperative period in high-risk patients with drug-eluting stents.

This advisory was issued from a science panel made up of representatives from the American Heart Association (AHA), the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, the American College of Surgeons, the American Dental Association (ADA), and the American College of Physicians (Grines, 2007).

Effects on Bleeding

Aspirin irreversibly inhibits platelet aggregation which can prolong bleeding. Upon discontinuation, normal platelet function returns only when new platelets are released (~7 to 10 days). However, in the case of dental surgery, there is no scientific evidence to support discontinuation of aspirin. This was recently supported by the American Academy of Neurology in patients with ischemic cerebrovascular disease (Armstrong, 2013). A recent study compared blood loss after a single tooth extraction in coronary artery disease patients who were either on aspirin (100 mg daily) or off aspirin for the extraction. The mean volume of bleeding was not statistically different between the groups. Local hemostatic measures were sufficient to control bleeding and there were no reported episodes of hemorrhaging intra- or postoperatively (Medeiros, 2011).

Dental Usual Dosing

Postoperative pain:

Analgesic and antipyretic: Oral, rectal:

Children: 10 to 15 mg/kg/dose every 4 to 6 hours, up to a total of 4 g/day

Adults: 325 to 650 mg every 4 to 6 hours up to 4 g/day

Anti-inflammatory: Oral: Initial:

Children: 60 to 90 mg/kg/day in divided doses; usual maintenance: 80 to 100 mg/kg/day divided every 6 to 8 hours; monitor serum concentrations

Adults: 2.4 to 3.6 g/day in divided doses; usual maintenance: 3.6 to 5.4 g/day; monitor serum concentrations

Index Terms

Acetylsalicylic Acid; ASA; Baby Aspirin

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Brand Names: International

AAS (AR, BR, ES); Acard (PL); Aceprin (HK, MY); Acetard (FI); Aceticil (BR); Acetysal (BG); Acitab (MX); Adiprin (QA); Adiprin EC (JO); Adiro (ES, MX, VE); Albyl-E (NO); Alexoprine (EG); Algina (PY); Andol (HR); Ansin (TW); Antacsal-E (MX); Anthrom (PH); Aptor (ID); Artebin (KR); Asactal (HU); Asam (LK); Asapor (FI); Asawin (CO); Ascardia (ID); ASP (HK); Aspa (TW); Aspec (LK, NZ); Aspen (PH); Aspenorm (UA); Aspent (TH); Aspeter (UA); Aspicard (ET, SA); Aspico (EG); Aspicot (KW, LB); Aspilets (ID, PH, VN); Aspilets EC (PH); Aspimed (AE); Aspin (BD, LK); Aspinal (EG, QA); Aspirax (RO); Aspire (TW); Aspirem (BB, BM, BS, BZ, CY, GY, JM, PR, SR, TT); Aspirin (AE, BF, BJ, CI, CY, ET, GH, GM, GN, HK, IL, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW); Aspirin Bayer (HK); Aspirin Cardio (IL, SG); Aspirina (CL, CO, CU, EC); Aspirina efervescente (MX); Aspirina Junior (MX); Aspitor (PH); Aspro (AT, CH, CZ, FR, GB, IT, NL, NZ, SA); Aspro Junior (QA); Asprovit (EE); Asrina (TH); ASS (DE); Asthromed (PH); Astrix (HU, KR, LK, PH); B-Aspirin (TH); Bamyl (SE); Bayaspirin Protect 100 (CN); Bayaspirina (AR); Bayer Aspirin Cardio (ZA); Bayprin EC (PH); Besprin (PH); Bokey (SG, TW); Bufferin (JO, UY); Cafemol Childrens Size (ZW); Caprin (GB, IE); Cardioaspirina (CO, PE); Cardiomagnyl (UA); Cardioprin (HR, TW); Cardioprin 100 (IL); Cardioton (PE); Cardiprin (HK, LK); Cartia (PT); Caspirin (MY); Circlevein (KR); Colfarit (CZ, HN); Comoprin (TH); Cortal (PH); Dispril (AE, CY, IQ, IR, JO, LB, LY, OM, QA, SA, SY, TR, YE); Disprin (BB, BF, BH, BJ, BM, BS, BZ, CI, ET, GB, GH, GM, GN, GY, HK, IE, IN, JM, KE, KW, LR, MA, ML, MR, MU, MW, NE, NG, NZ, PK, PR, SC, SD, SG, SL, SN, SR, TN, TT, TZ, UG, ZM, ZW); Ecasil (BR); Ecorin (LK); Ecosprin (BD); Ecotrin (AR, CL, MX, NZ, TW); Encine EM (TW); Eskotrin (VE); Frosit (ID); Globentyl (DK); Glocar (ID); Godamed (IL); Jusprin (BH); Kardegic (HU); Kidiprin (JO); Lodosprin (BD); Lopirin (TW); Magnecyl (SE); Melabon (DE); Micropirin (MT); Miniaspi 80 (ID); Naspro (ID); Neospin (BD); Norspirinal (ID); Novasen (KW); Nu-Seals (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IE, IQ, IR, JO, KE, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TR, TZ, UG, YE, ZM, ZW); Nuasa (IE); Nuprin (IE); Plaquetasa (CR, GT, SV); Proprin (GB); Remin (AE); Rhonal (KR, QA, VE); Salisal (BH); Salisalido (AE, CY, IQ, IR, JO, LB, LY, OM, QA, SA, SY, YE); Salospir (GR); Sedergine (BE); Tevapirin (IL); Thomapyrin (AT); Thrombo-Aspilets (ID); Thrombo-ASS (EE); Tromcor (PH); V-AS (TH)

Aspirin (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(AS pir in)

Brand Names: US

Ascriptin Maximum Strength [OTC]; Ascriptin Regular Strength [OTC]; Aspercin [OTC]; Aspir-low [OTC]; Aspirin Adult Low Dose [OTC]; Aspirin Adult Low Strength [OTC]; Aspirin EC Low Strength [OTC]; Aspirtab [OTC]; Bayer Aspirin EC Low Dose [OTC]; Bayer Aspirin Extra Strength [OTC]; Bayer Aspirin Regimen Adult Low Strength [OTC]; Bayer Aspirin Regimen Children’s [OTC]; Bayer Aspirin Regimen Regular Strength [OTC]; Bayer Genuine Aspirin [OTC]; Bayer Plus Extra Strength [OTC]; Bayer Women’s Low Dose Aspirin [OTC]; Buffasal [OTC]; Bufferin Extra Strength [OTC]; Bufferin [OTC]; Buffinol [OTC]; Durlaza; Ecotrin Arthritis Strength [OTC]; Ecotrin Low Strength [OTC]; Ecotrin [OTC]; Halfprin [OTC] [DSC]; St Joseph Adult Aspirin [OTC]; Tri-Buffered Aspirin [OTC]

Brand Names: Canada

Asaphen; Asaphen E.C.; Entrophen; Novasen; Praxis ASA EC 81 Mg Daily Dose; Pro-AAS EC-80

What is this drug used for?
  • It is used to ease pain, swelling, and fever.
  • It is used to treat arthritis.
  • It is used to treat rheumatic fever.
  • It is used to protect bypass grafts and stents in the heart.
  • It is used to lower the chance of heart attack, stroke, and death in some people.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • For all patients taking this drug:
  • If you have an allergy to aspirin or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Asthma, bleeding problems, nose polyps, or rhinitis.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have a stomach or bowel ulcer.
  • If you are taking another drug that has the same drug in it.
  • If you are taking any other NSAID.
  • If you are pregnant or may be pregnant. Do not take this drug if you are in the third trimester of pregnancy. You may also need to avoid this drug at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this drug during pregnancy.
  • If you are breast-feeding or plan to breast-feed.
  • Children:
  • If your child has or is getting better from flu signs, chickenpox, or other viral infections.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye’s syndrome. Reye’s syndrome causes very bad problems to the brain and liver.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this drug for longer than you were told by your doctor.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
  • If you are over the age of 60, use this drug with care. You could have more side effects.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Long-acting capsules:
  • This drug is not for use if you have chest pain and need to take aspirin quickly. Take a fast-acting form of aspirin. If you are not sure which form of aspirin is fast-acting, talk with the doctor.
  • Do not take this drug within 2 hours before or 1 hour after drinking alcohol.
  • Do not stop taking this drug without calling the doctor who ordered it for you.
  • All other products:
  • If you take this drug on a regular basis, do not stop taking it without calling the doctor who ordered it for you.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Very bad headache.
  • Ringing in ears.
  • Hearing loss.
  • Very bad belly pain.
  • Feeling agitated.
  • Seizures.
  • Suppository:
  • Very bad rectal irritation.
  • Bleeding from rectum or rectal pain.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • All oral products:
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Suppository:
  • Rectal irritation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • Take with a full glass of water.
  • Modified-release tablets:
  • Swallow whole. Do not chew, break, or crush.
  • Long-acting capsules:
  • Swallow whole. Do not chew, open, or crush.
  • Take this drug at the same time of day.
  • Chewable tablet:
  • This drug may be chewed or swallowed whole.
  • Suppository:
  • Use suppository rectally.
  • If suppository is soft, chill in a refrigerator or run cold water over it.
  • Lie down on your side.
  • To use, take off foil wrapper and wet suppository with cold water. Use your finger to push the suppository well up into the rectum.
What do I do if I miss a dose?
  • Long-acting capsules:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • All other products:
  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Suppository:
  • Store in a refrigerator. Do not freeze.
  • Do not use suppositories if they have a vinegar smell.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Aspirin (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(AS pir in)

Brand Names: US

Ascriptin Maximum Strength [OTC]; Ascriptin Regular Strength [OTC]; Aspercin [OTC]; Aspir-low [OTC]; Aspirin Adult Low Dose [OTC]; Aspirin Adult Low Strength [OTC]; Aspirin EC Low Strength [OTC]; Aspirtab [OTC]; Bayer Aspirin EC Low Dose [OTC]; Bayer Aspirin Extra Strength [OTC]; Bayer Aspirin Regimen Adult Low Strength [OTC]; Bayer Aspirin Regimen Children’s [OTC]; Bayer Aspirin Regimen Regular Strength [OTC]; Bayer Genuine Aspirin [OTC]; Bayer Plus Extra Strength [OTC]; Bayer Women’s Low Dose Aspirin [OTC]; Buffasal [OTC]; Bufferin Extra Strength [OTC]; Bufferin [OTC]; Buffinol [OTC]; Durlaza; Ecotrin Arthritis Strength [OTC]; Ecotrin Low Strength [OTC]; Ecotrin [OTC]; Halfprin [OTC] [DSC]; St Joseph Adult Aspirin [OTC]; Tri-Buffered Aspirin [OTC]

Brand Names: Canada

Asaphen; Asaphen E.C.; Entrophen; Novasen; Praxis ASA EC 81 Mg Daily Dose; Pro-AAS EC-80

What is this drug used for?
  • It is used to ease pain, swelling, and fever.
  • It is used to treat arthritis.
  • It is used to treat rheumatic fever.
  • It is used to protect bypass grafts and stents in the heart.
  • It is used to lower the chance of heart attack, stroke, and death in some people.
  • It may be given to your child for other reasons. Talk with the doctor.
  • Long-acting capsules:
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: Asthma, bleeding problems, nose polyps, or rhinitis.
  • If your child has any of these health problems: Kidney disease or liver disease.
  • If your child has a stomach or bowel ulcer.
  • If your child has or is getting better from flu signs, chickenpox, or other viral infections.
  • If your child is taking another drug that has the same drug in it.
  • If your child is taking any other NSAID.
  • If your child is pregnant:
  • Do not give this drug to your child if she is in the third trimester of pregnancy. You may also need to avoid giving this drug to your child at other times during pregnancy. Talk with your child’s doctor to see when you need to avoid giving this drug to your child during pregnancy.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye’s syndrome. Reye’s syndrome causes very bad problems to the brain and liver.
  • Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
  • Do not have your child use longer than you have been told by your child’s doctor.
  • If your child takes this drug on a regular basis, do not stop giving it without calling the doctor who ordered it for your child.
  • Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child smokes, talk with the doctor.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
  • If your child is pregnant:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Very bad headache.
  • Ringing in ears.
  • Hearing loss.
  • Very bad belly pain.
  • Feeling agitated.
  • Seizures.
  • Suppository:
  • Very bad rectal irritation.
  • Bleeding from rectum or rectal pain.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • All oral products:
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Suppository:
  • Rectal irritation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Give this drug with a full glass of water.
  • Modified-release tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Chewable tablet:
  • This drug may be chewed or swallowed whole.
  • Suppository:
  • Suppositories are for rectal use only.
  • If suppository is soft, chill in a refrigerator or run cold water over it.
  • To use, take off foil wrapper and wet suppository with cold water. Have your child lie down on his/her side. Use your finger to push the suppository well up into the rectum.
What do I do if my child misses a dose?
  • If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Suppository:
  • Store in a refrigerator. Do not freeze.
  • Do not use suppositories if they have a vinegar smell.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.