Piroxicam is an active pharmaceutical ingredient in the Oxicams group (M01AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised July 4, 2025[1]
Feldene Gel is a non-steroidal anti-inflammatory agent indicated for a variety of conditions characterised by pain and inflammation, or stiffness. It is effective in the treatment of osteoarthritis of superficial joints such as the knee, acute musculoskeletal injuries, periarthritis, epicondylitis, tendinitis and tenosynovitis.
How to take
CACanada· Health Canada
4 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
APO-PIROXICAM (piroxicam) is indicated for the symptomatic treatment of: • rheumatoid arthritis, • osteoarthritis (degenerative joint disease) and • ankylosing spondylitis. Throughout this document, the term NSAIDs refers to both non-selective NSAIDs and selective COX-2 inhibitor NSAIDs, unless otherwise indicated.
For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first. (See
How to take
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised October 25, 2023[3]
1 INDICATIONS AND USAGE Piroxicam capsules are indicated: • For relief of the signs and symptoms of osteoarthritis. • For relief of the signs and symptoms of rheumatoid arthritis. Piroxicam capsules are a nonsteroidal anti-inflammatory drug indicated for •Relief of the signs and symptoms of osteoarthritis (OA) ( 1 )•Relief of the signs and symptoms of rheumatoid arthritis (RA) ( 1 )
How to take
Drug interactions
Known interactions involving Piroxicam. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 438. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 00642886 · revised March 22, 2025
[3]FDA DailyMed · 0373da3a-7779-4e… · revised October 25, 2023 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology Adults No occlusive dressings should be employed. Apply 1 g of Gel, corresponding to 3cm, and rub into the affected site three to four times daily leaving no residual material on the skin. Therapy should be reviewed after 4 weeks.
Paediatric population Dosage recommendations and indications for the use of Feldene Gel in children have not been established. Elderly No special precautions are required. Method of administration Feldene Gel is for external use only.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised July 4, 2025[1]
Feldene Gel is well tolerated. Mild to moderate local irritation, erythema, pruritus and dermatitis may occur at the application site. The systemic absorption of Feldene Gel is very low. In common with other topical non-steroidal anti-inflammatory agents, systemic reactions occur infrequently and have included minor gastro-intestinal side-effects such as nausea and dyspepsia.
Cases of abdominal pain and gastritis have been reported rarely. 3). 4). Contact dermatitis, eczema and photosensitivity skin reaction have also been observed from post-marketing experience. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised July 4, 2025[1]
Life-threatening cutaneous reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of systemic administration of piroxicam.
These reactions have not been associated with topical piroxicam, but the possibility of occurring with topical piroxicam cannot be ruled out. Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
The highest risk for occurrence of SJS or TEN is within the first week of treatment. g. progressive skin rash often with blisters or mucosal lesions) are present, piroxicam treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug.
Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be re- started in this patient at any time. Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open skin lesions, dermatoses or infection.
NSAIDs, including piroxicam, may cause interstitial nephritis, nephrotic syndrome and renal failure. There have also been reports of interstitial nephritis, nephrotic syndrome and renal failure with topical piroxicam, although the causal relationship to treatment with topical piroxicam has not been established.
As a result, the possibility that these events may be related to the use of topical piroxicam cannot be ruled out. This medicinal product contains propylene glycol and may cause skin irritation. If local irritation develops, the use of the Feldene Gel should be discontinued and appropriate therapy instituted as necessary.
Because this medicine contains propylene glycol, Feldene Gel should not be used on open wounds or large areas of broken or damaged skin (such as burns). This medicinal product contains benzyl alcohol which may cause mild local irritation.
Benzyl alcohol may cause allergic reactions.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised July 4, 2025[1]
1. The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory agents (NSAIDs). Feldene Gel should not be given to patients in whom aspirin and other non- steroidal anti-inflammatory agents induce the symptoms of asthma, nasal polyps, angioneurotic oedema or urticaria.
This is not medical advice. Consult a qualified healthcare professional.
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations Use of APO-PIROXICAM should be limited to the lowest effective dose for the shortest possible duration of treatment. See 1 INDICATIONS. For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first.
(See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS) Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse event the lowest effective dose should be used for the shortest possible duration.
As with other NSAIDs, APO-PIROXICAM (Piroxicam capsules) Page 7 of 44 caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. Consideration should be given to a starting dose that is lower than usual and to an increase of the dose only if symptoms remain uncontrolled.
Such patients must be carefully supervised. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. d. In rheumatoid arthritis and ankylosing spondylitis most patients will be maintained on 20 mg daily.
Some patients may be maintained on 10 mg daily. In osteoarthritis the usual maintenance dose is 10 to 20 mg daily. The total daily dose of APO-PIROXICAM should not exceed 20 mg per day.
Pediatrics (< 16 years of age):
Health Canada has not authorized an indication for pediatric use (See 2 CONTRAINDICATIONS). 4 Geriatrics).
Renal Insufficiency:
Because of the extensive renal excretion of APO-PIROXICAM and its biotransformation products (less than 5% of the daily dose excreted unchanged), lower doses of APO-PIROXICAM should be anticipated in patients with impaired renal function and they should be carefully monitored.
APO-PIROXICAM is contraindicated in severe renal impairment and in deteriorating renal disease (See 2 CONTRAINDICATIONS).
Hepatic Insufficiency:
A substantial portion of piroxicam elimination occurs by hepatic metabolism. Consequently, patients with hepatic disease may require reduced doses of APO- PIROXICAM. APO-PIROXICAM is contraindicated in severe liver impairment or active liver disease.
4 Administration APO-PIROXICAM capsules should be taken immediately after a meal or with food or milk. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, a doctor should be consulted. 5 Missed Dose If a dose of APO-PIROXICAM is taken once a day and a dose of this medicine is missed, a dose of APO-PIROXICAM (Piroxicam capsules) Page 8 of 44 APO-PIROXICAM should be taken right away if remembered by the patient within 8 hours of the missed dose.
If APO-PIROXICAM is taken twice a day and a dose is missed, which the patient remembers within 2 hours of the missed dose then the dose should be taken right away and the patient should go back to the regular dosing schedule.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
4 Clinical Trial Adverse Drug Reactions –Hematologic). At the recommended dose of 20 mg/day of piroxicam, reductions in hemoglobin and hematocrit values are observed in about 4% of the patients treated with piroxicam alone or concomitantly with ASA.
These observations occurred in the absence of fecal blood loss due to gastrointestinal APO-PIROXICAM (Piroxicam capsules) Page 13 of 44 irritation. Therefore, hematocrit and hemoglobin values should be determined periodically. Hepatic/Biliary/Pancreatic As with other NSAIDs, borderline elevations of one or more liver enzyme tests (AST, ALT, alkaline phosphatase) may occur in up to 15% of patients.
These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Elevations of ALT and AST 3 times the upper limit of normal, occurred in controlled clinical trials in less than 1% of patients.
Hepatitis and jaundice occurred in less than 1% of patients. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with this drug.
Severe hepatic reactions including jaundice and cases of fatal hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes, have been reported with piroxicam. g. g. ), this drug should be discontinued. If there is a need to prescribe this drug in the presence of impaired liver function, it must be done under strict observation.
Immune Infection:
APO-PIROXICAM, in common with other NSAIDs, may mask signs and symptoms of an underlying infectious disease.
Aseptic Meningitis:
Rarely, with some NSAIDs, including APO-PIROXICAM, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. ) seem to be pre-disposed. Therefore, in such patients, the health care provider must be vigilant to the development of this complication.
Also, see Sensitivity/Resistance. 1 Special Populations). APO-PIROXICAM is contraindicated for use in the third trimester of pregnancy.
Cardiovascular:
Blood Pressure should be monitored regularly during treatment with APO- PIROXICAM (See 7 WARNINGS AND PRECAUTIONS - Cardiovascular).
Hematologic:
Patients should have their hemoglobin or hematocrit checked periodically. Concurrent therapy of APO-PIROXICAM with warfarin requires close monitoring of the international normalilized ratio (INR) (See 7 WARNINGS AND PRECAUTIONS - Haematology).
Hepatic:
Liver function tests should be monitored periodically (See 7 WARNINGS AND PRECAUTIONS – Hepatic/Biliary/Pancreatic).
Opthalmologic:
Opthalmic examination should be performed at periodic intervals. (See 7WARNINGS AND PRECAUTIONS - Ophthalmologic). g. urine output, serum creatinine, creatinine clearance and serum urea) during therapy with APO- PIROXICAM (See 7 WARNINGS AND PRECAUTIONS - Renal).
Serum electrolytes should be monitored periodically, especially in those patients who are at risk (7 WARNINGS AND PRECAUTIONS – Renal – Fluid and Electrolyte Balance).
Drug interactions:
See
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
1 Special Populations 05/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ........................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics (< 16 years of age): ......................................................................................
2 Geriatrics (> 65 years of age): ...................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS ...................................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations .................................................................................................
7 5 OVERDOSAGE ............................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 8 7 WARNINGS AND PRECAUTIONS ....................................................................................
1 Special Populations .................................................................................................... 1 Pregnant Women .......................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
and 7 WARNINGS AND PRECAUTIONS). Use of APO-PIROXICAM (piroxicam) should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events.
(See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS). APO-PIROXICAM (piroxicam), as a NSAID, does NOT treat clinical disease or prevent its progression. APO-PIROXICAM (piroxicam), as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it.
1 Pediatrics (< 16 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of APO- PIROXICAM in pediatric patients has not been established; therefore Health Canada has not authorized an indication for pediatric use (see 2 CONTRAINDICATIONS).
4 Geriatrics). 2 CONTRAINDICATIONS APO-PIROXICAM is contraindicated in: • the peri-operative setting of coronary artery bypass graft surgery (CABG). Although APO-PIROXICAM (Piroxicam capsules) Page 5 of 44 piroxicam has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications.
• the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition • women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants • severe uncontrolled heart failure • known hypersensitivity to piroxicam or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/ angioedema, nasal polyps, asthma). Fatal anaphylactoid reactions have occurred in such individuals.
Individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction. The potential for cross-reactivity between different NSAIDs must be kept in mind (see 7 WARNINGS AND PRECAUTIONS – Hypersensitivity Reactions – Anaphylactoid Reactions).
• active gastric / duodenal / peptic ulcer or active inflammatory disease of the gastrointestinal system, active GI bleeding or patients with a recent or recurrent history of these conditions. 5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see 7 WARNINGS AND PRECAUTIONS - Renal) • known hyperkalemia (see 7 WARNINGS AND PRECAUTIONS - Renal - Fluid and Electrolyte Balance) • children and adolescents less than 16 years of age
This is not medical advice. Consult a qualified healthcare professional.
2 DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ] .
After observing the response to initial therapy with piroxicam capsules, the dose and frequency should be adjusted to suit an individual patient’s needs. For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once per day.
If desired, the daily dose may be divided. Because of the long half-life of piroxicam capsules, steady-state blood levels are not reached for 7 to 12 days. Therefore, although the therapeutic effects of piroxicam capsules are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.
• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2 ) • OA and RA: 20 mg once daily ( 2 )
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 366 reports total. [4]
USOfficial regulatory label· Adverse reactions· revised October 25, 2023[3]
11) ] Most common adverse reactions (incidence > 2% from clinical trials) are: nausea, constipation, flatulence, abdominal pain, diarrhea, headache, dizziness, edema, rash. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Nostrum Laboratories, Inc.
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
2 Postmarketing Experience The following adverse reactions have been identified during post approval use of piroxicam capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
USOfficial regulatory label· Warnings and precautions· revised October 25, 2023[3]
5 WARNINGS AND PRECAUTIONS • Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. 3 ) • Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
5 ) • Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. 7 ) • Exacerbation of Asthma Related to Aspirin Sensitivity : Piroxicam capsules are contraindicated in patients with aspirin-sensitive asthma.
1 Cardiovascular Thrombotic Events Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal.
Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. 2) ] . Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised October 25, 2023[3]
9) ] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. 1) ] • Known hypersensitivity to piroxicam or any components of the drug product ( 4 ) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) • In the setting of CABG surgery ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
4 Geriatrics (> 65 years of age): .................................................................................... 19 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Drug Reaction Overview .............................................................................. 2 Clinical Trial Adverse Drug Reactions......................................................................... 3 Less Common Clinical Trial Adverse Drug Reactions .................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .............................................................................................................. 5 Post-Market Adverse Reactions .................................................................................
23 9 DRUG INTERACTIONS .................................................................................................. 3 Drug-Behaviour Interactions ......................................................................................
29 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 30 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 30 PART II: SCIENTIFIC INFORMATION ...................................................................................
31 13 PHARMACEUTICAL INFORMATION .............................................................................. 31 14 CLINICAL TRIALS..........................................................................................................
1 Clinical Trials by Indication ......................................................................................... 2 Comparative Bioavailability Studies...........................................................................
NSAIDs are contraindicated in the setting of CABG [see Contraindications (4) ] . Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.
In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of piroxicam capsules in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If piroxicam capsules are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
2 Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including piroxicam capsules, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year.
However, even short-term NSAID therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.
Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, antiplatelet drugs (such as aspirin), anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status.
Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding. Strategies to Minimize the GI Risks in NSAID-treated patients: • Use the lowest effective dosage for the shortest possible duration.
• Avoid administration of more than one NSAID at a time. • Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs.
• Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy. • If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue piroxicam capsules until a serious GI adverse event is ruled out.
• In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding [see Drug Interactions (7) ] . 3 Hepatotoxicity Elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials.
In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including piroxicam.
, nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). , eosinophilia, rash), discontinue piroxicam capsules immediately, and perform a clinical evaluation of the patient.
4 Hypertension NSAIDs, including piroxicam capsules, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs [see Drug Interactions (7) ] .
Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy. 5 Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients.
In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
, diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) [see Drug Interactions (7) ] . Avoid the use of piroxicam capsules in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
If piroxicam capsules are used in patients with severe heart failure, monitor patients for signs of worsening heart failure. 6 Renal Toxicity and Hyperkalemia Renal Toxicity Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.
Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
No information is available from controlled clinical studies regarding the use of piroxicam capsules in patients with advanced renal disease. The renal effects of piroxicam capsules may hasten the progression of renal dysfunction in patients with preexisting renal disease.
Correct volume status in dehydrated or hypovolemic patients prior to initiating piroxicam capsules. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of piroxicam capsules [see Drug Interactions (7) ].
Avoid the use of piroxicam capsules in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. If piroxicam capsules are used in patients with advanced renal disease, monitor patients for signs of worsening renal function.
Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.
8) ] . Seek emergency help if an anaphylactic reaction occurs. 8 Exacerbation of Asthma Related to Aspirin Sensitivity A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs.
Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, piroxicam capsules are contraindicated in patients with this form of aspirin sensitivity [see Contraindications (4) ] .
When piroxicam capsules are used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma. 9 Serious Skin Reactions NSAIDs, including piroxicam, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of piroxicam capsules at the first appearance of skin rash or any other sign of hypersensitivity.
Piroxicam capsules are contraindicated in patients with previous serious skin reactions to NSAIDs [see Contraindications (4) ] . 10 Premature Closure of Fetal Ductus Arteriosus Piroxicam may cause premature closure of the fetal ductus arteriosus.
1) ] . 11 Hematologic Toxicity Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with piroxicam capsules has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including piroxicam capsules, may increase the risk of bleeding events. , aspirin), SSRIs, and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [see Drug Interactions (7) ] .
12 Masking of Inflammation and Fever The pharmacological activity of piroxicam capsules in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections. 6) ] . 14 Ophthalmologic Effects Because of reports of adverse eye findings with nonsteroidal anti-inflammatory agents, it is recommended that patients who develop visual complaints during treatment with piroxicam capsules have ophthalmic evaluations.