Aspirin

Name: Aspirin

Description

Active ingredient (in each tablet)
Aspirin (acetylsalicylic acid). Pain reliever/fever reducer

Inactive ingredients
carnauba wax*, corn starch, hypromellose, powdered cellulose, triacetin

* may contain this ingredient

Warnings

Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Introduction

NSAIA; salicylate ester of acetic acid.a

Uses for Aspirin

Pain

Symptomatic relief of mild to moderate pain.a

Self-medication in children for the temporary relief of minor aches and pains and headache.841

Self-medication in adolescents and adults for the temporary relief of minor aches and pains associated with headache, common cold, toothache, muscular aches, backache, arthritis, menstrual cramps,836 and sore throat.837 840

Self-medication in fixed combination with acetaminophen and caffeine for the temporary relief of mild to moderate pain associated with migraine headache;701 702 703 also can be used for the treatment of severe migraine headache if previous attacks have responded to similar non-opiate analgesics or NSAIAs.701 702 703 778

Fever

Self-medication for reduction of fever associated with colds, sore throats, and teething.837 841 (See Contraindications and see Pediatric Use under Cautions.)

Inflammatory Diseases

Symptomatic treatment of rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, spondyloarthropathies, and systemic lupus erythematosus (SLE).906 938 943 a

Rheumatic Fever

Symptomatic treatment of rheumatic fever†.a A drug of choice in patients with mild carditis (without cardiomegaly or CHF, with or without polyarthritis) or with polyarthritis only.h

Transient Ischemic Attacks and Ischemic Stroke

Reduction of the risk of recurrent TIAs or stroke or of death in patients with a history of TIAs or ischemic stroke (secondary prevention).646 682 842 906 938 1009

Also used in fixed combination with extended-release dipyridamole to reduce the risk of recurrent stroke, death from all vascular causes, or nonfatal MI in patients who have had TIAs or completed ischemic stroke caused by thrombosis.738 739 743 1009

The American College of Chest Physicians (ACCP), the American Stroke Association (ASA), and AHA consider aspirin or the combination of aspirin and extended-release dipyridamole acceptable antiplatelet regimens for secondary prevention of noncardioembolic ischemic stroke and TIAs; other options include cilostazol or clopidogrel.990 1009 When selecting an appropriate antiplatelet regimen, consider factors such as the patient's individual risk for recurrent stroke, tolerance, and cost of the different agents.990

Oral anticoagulation (e.g., dabigatran, warfarin) rather than antiplatelet therapy is recommended in patients with a history of ischemic stroke or TIA and concurrent atrial fibrillation; however, in patients who cannot take or choose not to take oral anticoagulants (e.g., those with difficulty maintaining stable INRs, compliance issues, dietary restrictions, or cost limitations), dual antiplatelet therapy with aspirin and clopidogrel is recommended.1009

Also used for acute treatment of ischemic stroke in children†.1013

Secondary Prevention of Coronary Artery Disease and Myocardial Infarction

Recommended by AHA and the American College of Cardiology Foundation (ACCF) for reduction of the risk of vascular events (e.g., stroke, recurrent MI) in all patients with CAD, unless contraindicated.992

Reduction of the risk of vascular mortality in patients with suspected acute ST-segment-elevation MI (STEMI).579 635 636 646 821 906 938

Reduction of the risk of stroke and recurrent infarction in patients surviving an STEMI (secondary prevention).579 635 646 821 842 906 938 1010

Recommended by American Diabetes Association (ADA) for the prevention of cardiovascular events in diabetic patients who have evidence of large-vessel disease (e.g., history of MI, CABG, stroke or TIA, peripheral vascular disease, claudication, angina). 830 901

Use in conjunction with a P2Y12 platelet adenosine diphosphate (ADP)-receptor antagonist (e.g., clopidogrel, prasugrel, ticagrelor) following acute coronary syndrome (ACS), including STEMI.992 993 994 1010

The addition of warfarin to antiplatelet therapy is recommended in patients with STEMI who have indications for anticoagulation (e.g., atrial fibrillation, left ventricular dysfunction, cerebral emboli, extensive wall-motion abnormality, mechanical heart valves).993 996 1007 1010

Primary Prevention of Ischemic Cardiac Events

May reduce the risk of a first cardiac event (e.g., STEMI)† in certain patient populations (primary prevention).573 574 575 576 658 659 660 661 666 667 668 670 671 783 785 786 848 851 Balance of risks and benefits is most favorable in patients at moderate to high risk of CHD783 (based on age and 10-year risk of cardiac event >10%).668 832 Use of aspirin in such patients is suggested over either warfarin or no antithrombotic therapy.

Recommended by ADA for primary prevention in patients with type 1 or type 2 diabetes mellitus who are at high risk for cardiovascular events (i.e., familial history of CHD, smoking, hypertension, obesity, albuminuria, elevated blood cholesterol or triglyceride concentrations) and in whom aspirin is not contraindicated.760 830 901

Benefit appears to be minimal or lacking in women at low risk for CHD, except possibly those ≥65 years of age; further study needed.846 847 848 849 850 851

Not currently recommended for primary prevention in the general population without known risk factors.646 658 661 674 675 676 783 784 847

ACCP suggests primary prevention with low-dose aspirin in individuals ≥50 years of age who do not have symptomatic cardiovascular disease.1010

Unstable Angina or Non-ST-Segment-Elevation Myocardial Infarction

Reduction of the risk of death and/or nonfatal MI in patients with unstable angina or non-ST-segment-elevation MI (NSTEMI).581 613 614 615 616 617 618 619 620 621 682 684 728 736 906 938

Dual-drug antiplatelet therapy with aspirin and a P2Y12-receptor antagonist (e.g., clopidogrel, prasugrel, ticagrelor) is considered part of the current standard of care for treatment and secondary prevention in patients with unstable angina or NSTEMI.992 993 994 1010

Chronic Stable Angina

Reduction of the risk of MI and/or sudden death in patients with chronic stable angina.646 680 728 736 822 906 938

Percutaneous Coronary Intervention and Revascularization Procedures

Reduction of cardiovascular risks (e.g., early ischemic complications, graft closure) in patients with ACS undergoing PCI (e.g., coronary angioplasty, coronary artery stent implantation)646 866 887 888 889 992 993 994 1010 or CABG.646 683 687 781 782

Pretreatment with aspirin prior to PCI recommended by ACCF, AHA, and the Society for Cardiovascular Angiography and Interventions (SCAI).994 Adjunctive therapy with a P2Y12-receptor antagonist (e.g., clopidogrel, prasugrel, ticagrelor) also recommended in patients undergoing PCI with stent placement.994

Continue low-dose aspirin therapy indefinitely (as part of dual-drug antiplatelet therapy with a P2Y12-receptor antagonist for at least 12 months and possibly longer) as secondary prevention against cardiovascular events, including stent thrombosis, following PCI.993 994 1010 1019 1020

Embolism Associated with Atrial Fibrillation

Used as an alternative or adjunct to warfarin therapy for reduction of the incidence of thromboembolism in selected patients with chronic atrial fibrillation†.749 880 999 1007

ACCP, ASA, ACC, AHA, and other experts currently recommend that antithrombotic therapy be given to all patients with nonvalvular atrial fibrillation (i.e., atrial fibrillation in the absence of rheumatic mitral stenosis, a prosthetic heart valve, or mitral valve repair) who are considered to be at increased risk of stroke, unless such therapy is contraindicated.989 990 999 1007 1017 1021 1022 1023

Choice of antithrombotic therapy is based on patient's risk for stroke and bleeding.999 1007 1021 1022 1023 In general, oral anticoagulant therapy (traditionally warfarin) is recommended in patients with high risk for stroke and acceptably low risk of bleeding, while aspirin or no antithrombotic therapy may be considered in patients at low risk of stroke.999 1007 1017 1021 1022 1023

In patients with atrial fibrillation at increased risk of stroke who cannot take or choose not to take oral anticoagulants for reasons other than concerns about major bleeding (e.g., those with difficulty maintaining stable INRs), combination therapy with clopidogrel and aspirin rather than aspirin alone is recommended.998 1007

Antithrombotic therapy in patients with atrial flutter generally managed in the same manner as in patients with atrial fibrillation.999 1007

Peripheral Arterial Disease

Has been used for primary and secondary prophylaxis of cardiovascular events in patients with peripheral arterial disease, including those with intermittent claudication or carotid stenosis and those undergoing revascularization procedures (peripheral artery percutaneous transluminal angioplasty or peripheral arterial bypass graft surgery).1011

ACCP suggests the use of low-dose aspirin for primary prevention in patients with asymptomatic peripheral arterial disease.1011

For patients with symptomatic peripheral arterial disease or those undergoing revascularization procedures, single-drug antiplatelet therapy with aspirin or clopidogrel generally is recommended.1011

Valvular Heart Disease

Recommended by ACC and AHA for use in selected patients with mitral valve prolapse and atrial fibrillation, and also in symptomatic patients with mitral valve prolapse who experience TIAs.996

Prosthetic Heart Valves

Used for the prevention of thromboembolism in selected patients with prosthetic heart valves†.996 1008

ACCP and ACC/AHA suggest the use of low-dose aspirin for initial (i.e., first 3 months after valve insertion) and long-term antithrombotic therapy in patients with a bioprosthetic heart valve in the aortic position who are in sinus rhythm and have no other indications for warfarin.996 1008 Aspirin also may be considered after initial (3 months) warfarin therapy in patients with a bioprosthetic heart valve in the mitral position who are in sinus rhythm.1008

Addition of an antiplatelet agent such as low-dose aspirin to warfarin therapy recommended in all patients with mechanical heart valves who are at low risk of bleeding.996 1008 Combination therapy with aspirin and warfarin also recommended in patients with bioprosthetic heart valves who have additional risk factors for thrombosis (e.g., atrial fibrillation, previous thromboembolism, left ventricular dysfunction, hypercoagulable condition).996

May be added to therapy with a low molecular weight heparin (LMWH) or heparin (referring throughout this monograph to unfractionated heparin) in pregnant women with prosthetic heart valves† who are at high risk for thrombosis.1012

Thrombosis Associated with Fontan Procedure in Children

Has been used for prevention of thromboembolic complications following Fontan procedure† (definitive palliative surgical treatment for most congenital univentricular heart lesions) in children.1013

Thromboprophylaxis in Orthopedic Surgery

Has been used for the prevention of venous thromboembolism in patients undergoing major orthopedic surgery (total-hip replacement, total-knee replacement, or hip-fracture surgery†).1003 Aspirin generally not considered the drug of choice for this use;1003 however, some evidence suggests some benefit over placebo or no antithrombotic prophylaxis in patients undergoing major orthopedic surgery.953 954 1003

ACCP considers aspirin an acceptable option for pharmacologic thromboprophylaxis in patients undergoing major orthopedic surgery.1003

When selecting an appropriate thromboprophylaxis regimen, consider factors such as relative efficacy and bleeding risk in addition to other logistics and compliance issues.1003

Thromboprophylaxis in General Surgery

Has been used for thromboprophylaxis in patients undergoing general (e.g., abdominal) surgery who are at high risk of venous thromboembolism;1002 however, generally recommended as an alternative to LMWHs and low-dose heparin.1002

Pericarditis

Drug of choice for the management of pain associated with acute pericarditis† following MI.635 821

Kawasaki Disease

Treatment of Kawasaki disease; used in conjunction with immune globulin IV (IGIV).636 637 638 1013

Complications of Pregnancy

Has been used alone or in combination with other drugs (e.g., heparin, corticosteroids, immune globulin) for prevention of complications of pregnancy† (e.g., preeclampsia, pregnancy loss in women with a history of antiphospholipid syndrome and recurrent fetal loss).594 595 596 597 599 600 601 605 626 627 628 648 650 651 652 653 654 705 706 707 708 709 710 711 712 713 714 715 726 817 857 1012

Low-dose aspirin in combination with sub-Q heparin or an LMWH is recommended by ACCP in women with antiphospholipid antibody (APLA) syndrome† and a history of multiple (≥3) pregnancy losses.1012

Routine use of aspirin prophylaxis to reduce the incidence and severity of preeclampsia (even in patients at increased risk of preeclampsia) generally not recommended; 634 705 706 707 712 713 715 can consider prophylaxis in women with prior severe or early-onset preeclampsia, chronic hypertension, severe diabetes, or moderate to severe renal disease.815 816 817 In women at high risk for preeclampsia, ACCP recommends low-dose aspirin during pregnancy, starting from the second trimester.1012 (See Pregnancy under Cautions.)

Prevention of Cancer

Limited data (observational studies) suggest that aspirin or other NSAIAs may reduce the risk of various cancers† (e.g., colorectal, breast, gastric cancer);864 870 871 872 873 such results generally not confirmed in randomized controlled trials.864 874 875 876

Regular use (e.g., daily) associated with a reduction in the risk of recurrent colorectal adenomas and colorectal cancer† in some studies.789 790 791 792 793 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 Beneficial effects of NSAIAs in reducing colorectal cancer risk dissipate following discontinuance of such therapy.791 792 793 794 795 Preventive therapy with aspirin currently not recommended because aspirin does not completely eliminate adenomas; aspirin therapy should not be considered a replacement for colorectal cancer screening and surveillance.790 793 794 795 796 814

Aspirin Dosage and Administration

Administration

Administer orally; may administer rectally as suppositories in patients who cannot tolerate oral therapy.a

Do not use aspirin preparation if strong vinegar-like odor is present.a

Oral Administration

Usually administer orally with food or a full glass of water (240 mL).a 836 906

Film-coated, extended-release, or enteric-coated may be associated with less GI irritation and/or symptomatic GI disturbances than uncoated tablets.a

Do not use delayed-release or extended-release tablets if rapid response is required.a

Swallow delayed-release and extended-release tablets whole; do not crush or chew.a

Prepare oral solution by dissolving 2 tablets for solution (Alka-Seltzer) in 120 mL of water; ingest the entire solution to ensure adequate dosing.838 843 844

Do not chew aspirin preparations for ≥7 days following tonsillectomy or oral surgery;841 837 do not place preparations directly on tooth or gum surface (possible tissue injury from prolonged contact).a

Rectal Administration

Do not administer aspirin tablets rectally.a

Dosage

When used for pain, fever, or inflammatory diseases, attempt to titrate to the lowest effective dosage.a

When used in anti-inflammatory dosages, development of tinnitus can be used as a sign of elevated plasma salicylate concentrations (except in patients with high-frequency hearing impairment).a

Pediatric Patients

Dosage in children should be guided by body weight or body surface area.a 841

Do not use in children and teenagers with varicella or influenza, unless directed by a clinician.841 (See Contraindications under Cautions.)

Pain Oral

Children 2–11 years of age: 1.5 g/m2 daily administered in 4–6 divided doses (maximum 2.5 g/m2 daily).a

Dose may be given every 4 hours as necessary (up to 5 times in 24 hours).841

Dosage for Self-medication of Pain in Children <12 Years of Age841

Age

Weight

Oral Dose

<3 years of age

<14.5 kg

Consult clinician

3–<4 years

14.5–16 kg

160 mg

4–<6 years

16–20.5 kg

240 mg

6–<9 years

20.5–30 kg

320 mg

9–<11 years

30–35 kg

320–400 mg

11 years

35–38 kg

320–480 mg

For self-medication in children ≥12 years of age, 325–650 mg every 4 hours (maximum 4 g daily) or 1 g every 6 hours as necessary.836 940

For self-medication in children ≥12 years of age, 454 mg (as chewing gum pieces) every 4 hours as necessary (maximum 3.632 g daily).837

For self-medication in children ≥12 years of age, 650 mg (as highly buffered effervescent solution [Alka-Seltzer Original]) every 4 hours (maximum 2.6 g daily); alternatively, 1 g (Alka-Seltzer Extra Strength) every 6 hours (maximum 3.5 g daily).843 844

Rectal

Children 2–11 years of age: 1.5 g/m2 daily administered in 4–6 divided doses (maximum 2.5 g/m2 daily).a

Children ≥12 years of age: 325–650 mg every 4 hours as necessary (maximum 4 g daily).a

Fever Oral

Children 2–11 years of age: 1.5 g/m2 daily administered in 4–6 divided doses (maximum 2.5 g/m2 daily).a

Dose may be given every 4 hours as necessary (up to 5 times in 24 hours).841

Dosage for Self-medication of Fever in Children <12 Years of Age841

Age

Weight

Oral Dose

<3 years of age

<14.5 kg

Consult physician

3–<4 years

14.5–16 kg

160 mg

4–<6 years

16–20.5 kg

240 mg

6–<9 years

20.5–30 kg

320 mg

9–<11 years

30–35 kg

320–400 mg

11 years

35–38 kg

320–480 mg

Children ≥12 years of age: 325–650 mg every 4 hours as necessary (maximum 4 g daily).a

For self-medication in children ≥12 years of age, 454 mg (as chewing gum pieces) every 4 hours as necessary (maximum 3.632 g daily).837

Rectal

Children 2–11 years of age: 1.5 g/m2 daily administered in 4–6 divided doses (maximum 2.5 g/m2 daily).a

Children ≥12 years of age: 325–650 mg every 4 hours as necessary (maximum 4 g daily).a

Inflammatory Diseases Juvenile Rheumatoid Arthritis Oral

Initially, 90–130 mg/kg daily in divided doses.906 938 Increase dosage as necessary for anti-inflammatory efficacy; target plasma salicylate concentration is 150–300 mcg/mL.906 938 Plasma concentrations >200 mcg/mL associated with an increased incidence of toxicity.906 938

Rheumatic Fever† Oral

Initially, 90–130 mg/kg daily given in divided doses every 4–6 hours for up to 1–2 weeks for maximal suppression of acute inflammation, followed by 60–70 mg/kg daily in divided doses for 1–6 weeks.a Adjust dosage based on response, tolerance, and plasma salicylate concentrations.a Gradually withdraw over 1–2 weeks.a

Various regimens suggested depending on severity of initial manifestations.a Consult published protocols for more information on specific dosages and schedules.a

Thrombosis Acute Arterial Ischemic Stroke† Oral

ACCP recommends 1–5 mg/kg daily initially until cerebral arterial dissection and cardioembolic causes have been excluded; subsequently, continue same dosage for ≥2 years.1013

In children with acute arterial ischemic stroke secondary to non-Moyamoya vasculopathy, at least 3 months of therapy recommended; ongoing antithrombotic therapy should be guided by repeat cerebrovascular imaging.1013

Fontan Procedure† Oral

1–5 mg/kg daily recommended by ACCP; optimal duration of therapy unknown.1013

Prosthetic Heart Valves (Mechanical or Biological)† Oral

ACCP recommends that clinicians follow same recommendations as in adults.1013

Kawasaki Disease Oral

Initially, 80–100 mg/kg daily given in 4 equally divided doses (in combination with IGIV) for up to 14 days; initiate within 10 days of onset of fever.636 637 638 639 640 1013 When fever subsides, decrease dosage to 1–5 mg/kg once daily.636 637 638 950 1013

Continue indefinitely in those with coronary artery abnormalities;638 950 1013 in the absence of such abnormalities, continue low-dose aspirin for 6–8 weeks.638 950 1013

Adults

Pain Oral

For self-medication, 325–650 mg every 4 hours (maximum 4 g daily) or 0.5–1 g every 6 hours as necessary.836 940

For self-medication, 454 mg (as chewing gum pieces) every 4 hours as necessary (maximum 3.632 g daily).837

Adults <60 years of age for self-medication: 650 mg (as a highly buffered effervescent solution [Alka-Seltzer Lemon-Lime or Original]) every 4 hours (maximum 2.6 g daily); alternatively, 1 g (Alka-Seltzer Extra Strength) every 6 hours (maximum 3.5 g daily).838 843 844

Adults ≥60 years of age for self-medication: 650 mg (as a highly buffered effervescent solution [Alka-Seltzer Lemon-Lime or Original]) every 4 hours (maximum 1.3 g daily); alternatively, 1 g (Alka-Seltzer Extra Strength) every 6 hours (maximum 1.5 g daily).838 843 844

Rectal

325–650 mg every 4 hours as necessary (maximum 4 g daily).a

Pain Associated with Migraine Headache Oral

For self-medication, 500 mg (combined with acetaminophen 500 mg and caffeine 130 mg) as a single dose.701

Fever Oral

325–650 mg every 4 hours as necessary (maximum 4 g daily).a

For self-medication, 454 mg (as chewing gum pieces) every 4 hours as necessary (maximum 3.632 g daily).837

Rectal

325–650 mg every 4 hours as necessary (maximum 4 g daily).a

Inflammatory Diseases Rheumatoid Arthritis and Arthritis and Pleurisy of SLE Oral

Initially, 3 g daily in divided doses.906 938 943 Increase dosage as necessary for anti-inflammatory efficacy; target plasma salicylate concentration is 150–300 mcg/mL.906 938 943 Plasma concentrations >200 mcg/mL associated with an increased incidence of toxicity.906 938 943

Osteoarthritis Oral

Up to 3 g daily in divided doses.906 938

Spondyloarthropathies Oral

Up to 4 g daily in divided doses.906 938

Rheumatic Fever† Oral

Initially, 4.9–7.8 g daily in divided doses given for maximal suppression of acute inflammation.a Adjust dosage based on response, tolerance, and plasma salicylate concentrations.a

Various regimens suggested depending on severity of initial manifestations.a Consult published protocols for more information on specific dosages and schedules.a

Transient Ischemic Attacks and Acute Ischemic Stroke Secondary Prevention Oral

50–325 mg daily;a 646 906 990 some data suggest lower dosages (75–81 mg daily) may have similar benefits and possibly less bleeding risk.907

In patients with noncardioembolic ischemic stroke or TIA, 75–100 mg daily (or 25 mg twice daily, in combination with extended-release dipyridamole 200 mg twice daily) recommended; continue long term.738 1009

Acute Treatment† Oral

ACCP recommends 160–325 mg daily, initiated ideally within 48 hours of stroke onset; may decrease dosage after 1–2 weeks to reduce bleeding risk. 1009 (See Transient Ischemic Attacks and Acute Ischemic Stroke: Secondary Prevention, under Dosage.)ACCP states that initiation of aspirin therapy should be delayed for 24 hours following administration of recombinant tissue-type plasminogen activator (r-tPA, e.g., alteplase).1009

Coronary Artery Disease and Myocardial Infarction Acute STEMI Oral

160–325 mg as soon as acute STEMI is suspected (no later than 24 hours after symptom onset), continued daily thereafter at a reduced dosage.579 635 646 821 906 938 (See Established Coronary Artery Disease under Dosage and Administration.)

Use in conjunction with a P2Y12-receptor antagonist (e.g., clopidogrel, prasugrel, ticagrelor) following ACS.992 993 994 1010 If used with ticagrelor, do not exceed aspirin maintenance dosage of 100 mg daily; possible reduced efficacy of ticagrelor with such aspirin dosages.955

Rectal

300 mg daily may be considered for patients with severe nausea, vomiting, or upper GI tract disorders.821

Primary Prevention† of STEMI Oral

Some experts recommend 75–162 mg once daily.681 682 760 783 Continue indefinitely, provided there are no contraindications.681 682 760 783

ACCP suggests primary prevention with low-dose aspirin (75–100 mg daily) in individuals ≥50 years of age who do not have symptomatic cardiovascular disease.1010

Established Coronary Artery Disease Oral

75–100 mg daily recommended by ACCP; continue indefinitely.1010 Some data suggest lower dosages (75–81 mg daily) may have similar benefits and possibly less bleeding risk.907

Unstable Angina and NSTEMI Oral

ACCF and AHA recommend an initial dose of 162–325 mg as soon as possible after diagnosis, unless contraindicated or not tolerated.991 993 Continue with maintenance dosage of 75–162 mg daily.991 1010

Use in conjunction with a P2Y12-receptor antagonist (e.g., clopidogrel, prasugrel, ticagrelor) following ACS.991 992 993 994 1010 If used with ticagrelor, do not exceed aspirin maintenance dosage of 100 mg daily; possible reduced efficacy of ticagrelor with such aspirin dosages.955

Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting Surgery Oral

PCI in patients already receiving aspirin: 81–325 mg initiated ≥2 hours, and preferably 24 hours, before the procedure in conjunction with a P2Y12-receptor antagonist.994

PCI in patients not already receiving long-term aspirin therapy: 325 mg daily (as non-enteric-coated formulation), initiated ≥2 hours, preferably 24 hours, prior to PCI in conjunction with a P2Y12-receptor antagonist.994

Maintenance therapy following PCI and stent placement (drug-eluting or bare-metal): 75–162 mg daily in combination with a P2Y12-receptor antagonist.992 994 1010 If used with ticagrelor, do not exceed aspirin maintenance dosage of 100 mg daily; possible reduced efficacy of ticagrelor with such aspirin dosages.955 Administer P2Y12-receptor antagonist for ≥12 months; continue aspirin indefinitely.994

CABG: Some manufacturers recommend 325 mg daily, initiated 6 hours after surgery.906 938 AHA and ACCF recommend 100–325 mg daily, initiated within 6 hours after CABG and continued for up to 1 year.992 For long-term therapy after 1 year, ACCP recommends aspirin 75–100 mg daily.1010

Embolism Associated with Atrial Fibrillation† Oral

75–325 mg daily suggested for prevention of thromboembolism.1007

Manage atrial flutter in the same manner as atrial fibrillation.999 1007

Mitral Valve Prolapse† Oral

75–325 mg daily.996

Peripheral Arterial Disease Oral

Primary prevention of cardiovascular events in patients with asymptomatic disease: 75–100 mg daily.1011

Secondary prevention of cardiovascular events in patients with symptomatic disease: 75–100 mg daily; continue long term.1011

Patients with refractory intermittent claudication: ACCP suggests the use of cilostazol in addition to aspirin therapy.1011

Peripheral Artery Bypass Graft Surgery Oral

To reduce graft occlusion: 75–100 mg daily recommended by ACCP; initiate preoperatively and continue long term.1011

ACCP suggests addition of clopidogrel 75 mg daily to aspirin therapy in patients undergoing below-the-knee prosthetic graft bypass surgery.1011

Prosthetic Heart Valves Mechanical Prosthetic Heart Valves† Oral

Aspirin 50–100 mg daily in addition to warfarin therapy recommended in all patients with a mechanical heart valve who have a low risk of bleeding.996 1008

Aspirin 75–325 mg once daily as monotherapy recommended as an alternative to warfarin in patients who are unable to take warfarin.996

Bioprosthetic Heart Valves† Oral

Patients with bioprosthetic valves in the aortic position: 50–100 mg daily suggested by ACCP for initial (i.e., first 3 months after valve insertion) and long-term therapy.1008

Patients with bioprosthetic heart valves in the mitral position: 50–100 mg daily may be used for long-term antithrombotic therapy after initial 3-month treatment with warfarin.1008

Combination aspirin (75–100 mg daily) and warfarin therapy recommended by ACC/AHA for patients with bioprosthetic heart valves and additional risk factors for thromboembolism.996

Aspirin 75–325 mg once daily also recommended as an alternative to warfarin therapy in any patient who is unable to take warfarin.996

Pericarditis Acute Pericarditis† Following MI Oral

162–325 mg daily.635 821 Higher dosages (e.g., 650 mg every 4–6 hours) may be required.635 821

Complications of Pregnancy† Oral

Antiphospholipid syndrome† and a history of multiple (≥ 3) pregnancy losses: Antepartum prophylaxis with aspirin (75–100 mg daily) in combination with sub-Q heparin or an LMWH recommended by ACCP.1012

Patients at risk for preeclampsia: ACCP recommends low-dose aspirin during pregnancy (starting from the second trimester).1012

Prescribing Limits

Pediatric Patients

Pain Oral

Children 2–11 years of age: Maximum 2.5 g/m2 daily.a

Children ≥12 years of age: Maximum 4 g daily.836 Maximum 2.6 g as highly buffered effervescent solution (Alka-Seltzer Original) or 3.5 g (Alka-Seltzer Extra Strength) in 24 hours.843 844

For self-medication, do not exceed recommended daily dosage.841 Treatment duration for self-medication for pain: ≤ 5 days.841 (See Advice to Patients.) Treatment duration for self-medication of sore throat pain using chewing gum: ≤2 days.837

Rectal

Children 2–11 years of age: Maximum 2.5 g/m2 daily.a

Children ≥12 years of age: Maximum 4 g daily.a

Fever Oral

Children 2–11 years of age: Maximum 2.5 g/m2 daily.a

Children ≥12 years of age: Maximum 4 g daily.836

For self-medication, do not exceed recommended daily dosage.841 Treatment duration for self-medication: <3 days.841 (See Advice to Patients.)

Rectal

Children 2–11 years of age: Maximum 2.5 g/m2 daily.a

Children ≥12 years of age: Maximum 4 g daily.a

Adults

Pain Oral

Maximum 4 g daily.a Treatment duration for self-medication for pain: ≤10 days.841 Aspirin chewing gum should not be used for self-medication of sore throat pain for longer than 2 days.837 (See Advice to Patients.)

Adults <60 years of age taking highly buffered effervescent solutions: Maximum 2.6 g (Alka-SeltzerLemon-lime or Original) or 3.5 g (Alka-Seltzer Extra Strength) in 24 hours.838 843 844

Adults ≥60 years of age taking highly buffered effervescent solutions: Maximum 1.3 g (Alka-SeltzerLemon-lime or Original) or 1.5 g (Alka-Seltzer Extra Strength) in 24 hours.838 843 844

Rectal

Maximum 4 g daily.a

Pain Associated with Migraine Headache Oral

For self-medication, maximum 500 mg (in combination with acetaminophen 500 mg and caffeine 130 mg) in 24 hours.701

Fever Oral or Rectal

Maximum 4 g daily.a

Special Populations

Geriatric Patients

Highly buffered effervescent solution: Maximum 1.3 g (Alka-SeltzerLemon-Lime or Original) or 1.5 g (Alka-Seltzer Extra Strength) in 24 hours.838 843 844

Cautions for Aspirin

Contraindications

  • Known hypersensitivity to aspirin or any ingredient in the formulation.906 938

  • History of asthma, urticaria, or other sensitivity reaction precipitated by other NSAIAs.906 938

  • Syndrome of asthma, rhinitis, and nasal polyps.938

  • Children or adolescents with viral infections (with or without fever) because of the possibility that the infection may be one associated with an increased risk of Reye’s syndrome.906 938 (See Pediatric Use under Cautions.)

Warnings/Precautions

Warnings

Alcohol

Long-term heavy alcohol use (≥3 alcoholic beverages daily) associated with an increased risk of aspirin-induced bleeding.906 938 941 (See Advice to Patients.)

Hematologic Effects

Inhibits platelet aggregation and may prolong bleeding time.906 938 These effects may be particularly important in patients with inherited (e.g., hemophilia) or acquired (e.g., liver disease, vitamin K deficiency) bleeding disorders.906 938

Because of the increased risk of bleeding, avoid aspirin-containing chewing gum tablets or gargles for ≥1 week after tonsillectomy or oral surgery.h

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms.938 Increased risk in those with a history of GI bleeding or ulceration, geriatric patients, and those receiving an anticoagulant or corticosteroid, receiving excessive dosages or prolonged therapy, taking multiple NSAIAs concomitantly, or consuming ≥3 alcohol-containing beverages daily.941 1035

Avoid in patients with active peptic ulcer disease; can cause gastric mucosal irritation and bleeding.906 938

Despite current warnings on OTC product labels, serious bleeding events continue to occur in patients receiving aspirin in fixed combination with antacids for self-medication.1035 FDA is evaluating whether additional actions are needed to address this safety concern.1035

Thrombosis Associated with Drug-eluting Stents

Stent thrombosis with potentially fatal sequelae, particularly with drug-eluting stents (DES),886 890 891 associated with premature discontinuance (<12 months) of dual-drug therapy with a thienopyridine derivative and aspirin.886 890 891 892 893 894 895 896 897 898 899 900 (See Percutaneous Coronary Intervention and Revascularization Procedures under Uses.)

At least 12 months of dual-drug antiplatelet therapy is recommended in patients with any type of coronary artery stent (bare-metal or drug-eluting).993 994 1010 Preliminary evidence from a randomized controlled study suggests that an even longer duration (up to 30 months) of dual-drug antiplatelet therapy may be beneficial in reducing stent thrombosis and other cardiovascular events in patients with a drug-eluting stent; however, such prolonged therapy was associated with increased bleeding and an unexpected finding of increased all-cause mortality.1019 1020 FDA is continuing to evaluate these findings and will communicate final conclusions and recommendations once the analysis is complete.1019

For non-elective procedures that mandate premature discontinuance of thienopyridine-derivative therapy, continue aspirin therapy if at all possible.886 Restart thienopyridine therapy as soon as possible after the procedure.886 (See Advice to Patients.)

Sensitivity Reactions

Anaphylactoid reactions, severe urticaria, angioedema, or bronchospasm reported.836 906 938 h

Immediate medical intervention and discontinuance for anaphylaxis.836

Contraindicated in patients with syndrome of asthma, rhinitis, and nasal polyps;906 938 caution in patients with asthma.938

General Precautions

Sodium Content

Avoid highly buffered aspirin preparations in patients with CHF, renal failure, or other conditions in which high sodium content would be harmful.906 938

Individuals with Phenylketonuria

Some preparations contain aspartame (NutraSweet), which is metabolized in the GI tract to phenylalanine.a 838

Use of Fixed Combinations

When aspirin is used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the other agent(s).a

Specific Populations

Pregnancy

Category C (Category D in third trimester).

Use only if clearly needed.906 938 Avoid use in the third trimester because of possible premature closure of the ductus arteriosus.906 938 Avoid 1 week prior to and during labor and delivery; aspirin use prior to and during labor associated with excessive blood loss at delivery.906 938

Maternal and fetal hemorrhagic complications observed with maternal ingestion of large doses (e.g., 12–15 g daily) of aspirin594 595 597 611 612 generally have not been observed in studies in which low doses (60–150 mg daily) of the drug were used for prevention of complications of pregnancy†.594 595 596 597 598 599 600 601 605 626 627 629 630 631 632

Lactation

Distributed into milk; use not recommended.906 938 High doses may result in adverse effects (rash, platelet abnormalities, bleeding) in nursing infants.906 938

Pediatric Use

Dosing recommendations for juvenile rheumatoid arthritis based on well controlled clinical studies.906 938 High dosages that result in plasma concentrations >200 mcg/mL associated with an increased incidence of toxicity.906 938

Use in children with varicella infection or influenza-like illnesses reportedly is associated with an increased risk of developing Reye’s syndrome.166 167 168 169 468 538 549 638 US Surgeon General, AAP Committee on Infectious Diseases, FDA, and other authorities advise that salicylates not be used in children and teenagers with varicella or influenza, unless directed by a clinician.466 467 554 638 Generally avoid salicylates in children and teenagers with suspected varicella or influenza and during presumed outbreaks of influenza, since accurate diagnosis of these diseases may be impossible during the prodromal period;466 use of salicylates in the management of viral infections in children or adolescents is contraindicated, since the infection may be one associated with an increased risk of Reye’s syndrome.646 906

Use with caution in pediatric patients who are dehydrated (increased susceptibility to salicylate intoxication).h

Safety and efficacy of aspirin in fixed combination with extended-release dipyridamole not established.738

Risk of overdosage and toxicity (including death) in children <2 years of age receiving preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.937 939 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.937 Use such preparations in children <2 years of age with caution and only as directed by clinician.937 939 Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.937

Hepatic Impairment

Avoid in patients with severe hepatic impairment.906 938

Renal Impairment

Avoid in patients with GFR <10 mL/minute.906 938

Common Adverse Effects

Minor upper GI symptoms (dyspepsia).938

Inactive ingredients

carnauba wax1, corn starch, hypromellose, powdered cellulose, triacetin

1 may contain this ingredient

Pronunciation

(AS pir in)

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.

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)

Bottom Line

Aspirin relieves pain and inflammation and helps to thin the blood. It is used to treat and prevent a wide range of different conditions. Higher dosages are associated with stomach irritation and an increased bleeding risk.

(web3)