Uses

Consider potential benefits and risks of piroxicam therapy as well as alternative therapies before initiating therapy with the drug. Use lowest possible effective dosage and shortest duration of therapy consistent with patient's treatment goals.

Inflammatory Diseases

Symptomatic treatment of rheumatoid arthritis and osteoarthritis.

Has been used for the symptomatic relief of acute gouty arthritis† and ankylosing spondylitis†; has also been used for symptomatic treatment of acute musculoskeletal disorders†.

Pain

Has been used for symptomatic relief of postoperative† or postpartum pain†.

Dysmenorrhea

Has been used for the management of dysmenorrhea†.

Dosage and Administration

General

• Consider potential benefits and risks of piroxicam therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Oral Administration

Administered orally, usually as a single daily dose. May be administered in divided doses daily.

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. Adjust dosage based on individual requirements and response; attempt to titrate to lowest effective dosage.

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Initially, 20 mg daily.Adjust dosage based on response and tolerance; 30 or 40 mg daily may be required for maintenance therapy, although 20 mg daily is usually adequate.

Prescribing Limits

Adults

Inflammatory Diseases

Oral

Dosages >20 mg daily associated with increased frequency of adverse GI effects.

Special Populations

Hepatic Impairment

Inflammatory Diseases

Oral

Dosage reduction may be required.

Cautions

Contraindications

• Known hypersensitivity to piroxicam or any ingredient in the formulation.
• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.
• Treatment of perioperative pain in the setting of CABG surgery.

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. Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events. Current evidence (based on limited data from observational studies) suggests that use of piroxicam is not associated with increased cardiovascular risk.

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.

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).

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs. (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP. Impaired response to certain diuretics may occur. (See Specific Drugs under Interactions.)

Fluid retention and edema reported. Caution in patients with fluid retention or heart failure.

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.

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol; alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole) or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.

Potential for overt renal decompensation. 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. (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.

Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.

Elevations of serum ALT or AST reported.

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. 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.

Hematologic Effects

Anemia reported rarely.Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.

May inhibit platelet aggregation and prolong bleeding time.

Ocular Effects

Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur.

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.

May mask certain signs of infection.

Obtain CBC and chemistry profile periodically during long-term use.

Specific Populations

Pregnancy

Category C. Avoid use in third trimester because of possible premature closure of the ductus arteriosus.

Lactation

Distributed into milk in humans; use not recommended.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

Caution advised. Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals. Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.

Consider lowest effective dosage for the shortest possible duration.

Hepatic Impairment

Monitor closely. (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.

Common Adverse Effects

Dyspepsia, nausea, diarrhea, constipation, rash, dizziness, headache, edema, tinnitus.