Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
Chemical Name: 4-Hydroxy-2-methyl-N2-pyridinyl-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide
Molecular Formula: C15H13N3O4S
CAS Number: 36322-90-4
- Cardiovascular Risk
Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).1 500 502 508 Risk may occur early in treatment and may increase with duration of use.500 502 505 506 508 (See Cardiovascular Thrombotic Effects under Cautions.)
Contraindicated in the setting of CABG surgery.508
- GI Risk
Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).1 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.1 Geriatric individuals are at greater risk for serious GI events.1 (See GI Effects under Cautions.)
Prototypical NSAIA; an oxicam derivative.1 2 3 4
Uses for Piroxicam
Consider potential benefits and risks of piroxicam therapy as well as alternative therapies before initiating therapy with the drug.1 Use lowest possible effective dosage and shortest duration of therapy consistent with patient's treatment goals.1
Symptomatic treatment of rheumatoid arthritis and osteoarthritis.1
Has been used for the management of dysmenorrhea†.41
Piroxicam Dosage and Administration
Consider potential benefits and risks of piroxicam therapy as well as alternative therapies before initiating therapy with the drug.1
Administered orally, usually as a single daily dose.1 May be administered in divided doses daily.1
To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with patient's treatment goals.1 Adjust dosage based on individual requirements and response; attempt to titrate to lowest effective dosage.1
Osteoarthritis or Rheumatoid ArthritisOral
Initially, 20 mg daily.1 Adjust dosage based on response and tolerance; 30 or 40 mg daily may be required for maintenance therapy, 2 although 20 mg daily is usually adequate.1 2
Dosages >20 mg daily associated with increased frequency of adverse GI effects.1 2 3
Dosage reduction may be required.1
Cautions for Piroxicam
Known hypersensitivity to piroxicam or any ingredient in the formulation. 1
History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.1
In the setting of CABG surgery.508
Cardiovascular Thrombotic Effects
NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.500 502 508
Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information500 501 502 indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.500
Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.500 502 506 508
Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.500 502 505 506 508
In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.508
In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.505 508
Increased 1-year mortality rate observed in patients receiving NSAIAs following MI;500 508 511 absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.508 511
Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs.115 116 117 119 500 501 502 503 506 FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.500
Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dose for the shortest duration necessary.1 500 508
Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease.505 511 512 516 Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia.508 Contraindicated in the setting of CABG surgery.508
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.1 502 508 (See Specific Drugs under Interactions.)
Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.1 94 102 109
For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;16 47 68 94 102 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)16 68 94 or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).16
Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.1 Use with caution in patients with hypertension; monitor BP.1
Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur.1 508 (See Specific Drugs under Interactions.)
Heart Failure and Edema
Fluid retention and edema reported.1 508
NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.500 501 504 507 508
NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema.508 (See Specific Drugs under Interactions.)
Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.508
Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.507
Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.1
Potential for overt renal decompensation.1 31 48 49 50 65 Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.1 31 48 65 114 (See Renal Impairment under Cautions.)
Anaphylactoid reactions reported. 1
Immediate medical intervention and discontinuance for anaphylaxis.1
Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.1
Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.1 Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).1
Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs. 1
Elevations of serum ALT or AST reported.1
Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.1 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.1
Anemia reported rarely.1 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.1
May inhibit platelet aggregation and prolong bleeding time. 1
Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur. 1
Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.1
May mask certain signs of infection.1
Obtain CBC and chemistry profile periodically during long-term use.1
Category C.1 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.1
Distributed into milk in humans; use not recommended.1
Safety and efficacy not established.1
Caution advised.1 Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals.96 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.96
Consider lowest effective dosage for the shortest possible duration.1
Monitor closely.1 (See Hepatic Impairment under Dosage and Administration.)
Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.1
Common Adverse Effects
Dyspepsia, nausea, diarrhea, constipation, rash, dizziness, headache, edema, tinnitus.1
Interactions for Piroxicam
Pharmacokinetic interaction possible with other highly protein-bound drugs; monitor patient; dosage adjustment may be needed.1
Reduced BP response to ACE inhibitor1
Angiotensin II receptor antagonists
Reduced BP response to angiotensin II receptor antagonist118
Antacids (magnesium- or aluminum-containing)
Pharmacokinetic interaction unlikely1 13
Possible bleeding complications1
Use with caution;1 37 97 monitor PT; adjust anticoagulant dosage as needed1 97
Diuretics (furosemide, thiazides)
Reduced natriuretic effects1 98
Monitor for diuretic efficacy and renal failure1
Increased plasma lithium concentrations1 72 73 74 75 76 77 78 79
Monitor plasma lithium concentrations when initiating or discontinuing piroxicam;1 72 73 76 77 79 monitor for lithium toxicity29 72 73 76
Increased plasma methotrexate concentrations,1 100 particularly with high methotrexate dosage99 100
Use with caution1
NSAIAs including aspirin: Increased risk of GI ulceration and other complications 1
Aspirin: No consistent evidence that use of low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs112 502 508
Decreased plasma piroxicam concentrations with concomitant use of 20 mg piroxicam and 3.9 g aspirin daily 1
Concomitant use not recommended1
Thrombolytic agents (streptokinase)
Possible bleeding complications26
Use with caution26
Well absorbed following oral administration;1 3 peak plasma concentrations usually attained within 3 to 5 hours.1
Decreases rate but not extent of absorption.2 12 28
Distributed into synovial fluid.3
Distributed into human milk.1 43 95
May accumulate slowly in cartilage.2 5
Plasma Protein Binding
Extensively metabolized,2 principally by hydroxylation and glucuronide conjugation of the hydroxy metabolite.1 28
Excreted principally in urine and feces, 1 with urinary excretion approximately twice the fecal excretion.1 Excreted principally as metabolites; <5% excreted unchanged.1 28
50 hours1 (range: 14–158 hours).2 13
Tight, light-resistant containers34 35 at <30°C.34 36
Inhibits cyclooxygenase-1 (COX-1) and COX-2.88 89 90 91 92 93
Pharmacologic actions similar to those of other prototypical NSAIAs;2 4 exhibits anti-inflammatory, analgesic, and antipyretic activity.1 2 4
Advice to Patients
Importance of reading the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed.1
Risk of serious cardiovascular events (e.g., MI, stroke).1 500 508
Risk of GI bleeding and ulceration.1
Risk of serious skin reactions.1 Risk of anaphylactoid and other sensitivity reactions.1
Risk of hepatotoxicity.1
Importance of seeking immediate medical attention if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.1 500 508
Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.1
Importance of discontinuing piroxicam and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.1 Importance of seeking immediate medical attention if an anaphylactic reaction occurs.1
Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.1
Risk of heart failure or edema; importance of reporting dyspnea, unexplained weight gain, or edema.508
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Importance of avoiding piroxicam in late pregnancy (third trimester).1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS DI Essentials. © Copyright 2018, Selected Revisions November 21, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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