Generic Name: Piroxicam
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
Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).1 Risk may increase with duration of use.1 Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.1 (See Cardiovascular Effects under Cautions.)
Contraindicated for the treatment of pain in the setting of CABG surgery.1
- 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.)
Introduction
Prototypical NSAIA; an oxicam derivative.1 2 3 4
Uses for Feldene
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
Inflammatory Diseases
Symptomatic treatment of rheumatoid arthritis and osteoarthritis.1
Has been used for the symptomatic relief of acute gouty arthritis†2 38 and ankylosing spondylitis†;2 40 has also been used for symptomatic treatment of acute musculoskeletal disorders†.2 3
Pain
Has been used for symptomatic relief of postoperative†2 or postpartum pain†.2 3
Dysmenorrhea
Has been used for the management of dysmenorrhea†.41
Feldene Dosage and Administration
General
Consider potential benefits and risks of piroxicam therapy as well as alternative therapies before initiating therapy with the drug.1
Administration
Oral Administration
Administered orally, usually as a single daily dose.1 May be administered in divided doses daily.1
Dosage
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
Adults
Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral
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
Prescribing Limits
Adults
Inflammatory Diseases
Oral
Dosages >20 mg daily associated with increased frequency of adverse GI effects.1 2 3
Special Populations
Hepatic Impairment
Inflammatory Diseases
Oral
Dosage reduction may be required.1
Cautions for Feldene
Contraindications
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
Treatment of perioperative pain in the setting of CABG surgery.1
Warnings/Precautions
Warnings
Cardiovascular Effects
Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.112 Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.115 116 117 Current evidence (based on limited data from observational studies) suggests that use of piroxicam is not associated with increased cardiovascular risk.115
Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dose for the shortest duration necessary.1
Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).112
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.1 (See Specific Drugs under Interactions.)
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 certain diuretics may occur.1 (See Specific Drugs under Interactions.)
Fluid retention and edema reported.1 Caution in patients with fluid retention or heart failure.1
GI Effects
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
Renal Effects
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.)
Sensitivity Reactions
Hypersensitivity Reactions
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
Dermatologic Reactions
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
General Precautions
Hepatic Effects
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
Hematologic Effects
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
Ocular Effects
Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur. 1
Other Precautions
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
Specific Populations
Pregnancy
Category C.1 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.1
Lactation
Distributed into milk in humans; use not recommended.1
Pediatric Use
Safety and efficacy not established.1
Geriatric Use
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
Hepatic Impairment
Monitor closely.1 (See Hepatic Impairment under Dosage and Administration.)
Renal Impairment
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 Feldene
Protein-bound Drugs
Pharmacokinetic interaction possible with other highly protein-bound drugs; monitor patient; dosage adjustment may be needed.1
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
ACE inhibitors | Reduced BP response to ACE inhibitor1 | Monitor BP1 |
Angiotensin II receptor antagonists | Reduced BP response to angiotensin II receptor antagonist118 | Monitor BP118 |
Antacids (magnesium- or aluminum-containing) | Pharmacokinetic interaction unlikely1 13 | |
Anticoagulants (warfarin) | 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 |
Lithium | 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 |
Methotrexate | Increased plasma methotrexate concentrations,1 100 particularly with high methotrexate dosage99 100 | Use with caution1 |
NSAIAs | 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 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 |
Feldene Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration;1 3 peak plasma concentrations usually attained within 3 to 5 hours.1
Food
Decreases rate but not extent of absorption.2 12 28
Distribution
Extent
Distributed into synovial fluid.3
Distributed into human milk.1 43 95
May accumulate slowly in cartilage.2 5
Plasma Protein Binding
99.3%.3 13
Elimination
Metabolism
Extensively metabolized,2 principally by hydroxylation and glucuronide conjugation of the hydroxy metabolite.1 28
Elimination Route
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
Half-life
50 hours1 (range: 14–158 hours).2 13
Stability
Storage
Oral
Capsules
Tight, light-resistant containers34 35 at <30°C.34 36
ActionsActions
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 with long-term use.1
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 notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.1
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
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.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 10 mg* | Feldene | Pfizer |
20 mg* | Feldene | Pfizer |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Feldene 20MG Capsules (PFIZER U.S.): 30/$145.98 or 90/$429.95
Piroxicam 10MG Capsules (NOSTRUM LABORATORIES): 30/$39.99 or 60/$69.98
Piroxicam 20MG Capsules (TEVA PHARMACEUTICALS USA): 30/$89.99 or 60/$159.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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