APO PIROXICAM CAP

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 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.

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 .................................................................................................

2 Recommended Dose and Dose Adjustment ................................................................ 4 Administration ............................................................................................................. 5 Missed Dose .................................................................................................................

7 5 OVERDOSAGE ............................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 8 7 WARNINGS AND PRECAUTIONS ....................................................................................

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.