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TEVA-PIROXICAM is a brand name for Piroxicam, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TEVA-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.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use of TEVA-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, 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. TEVA-PIROXICAM Page 8 of 45 In osteoarthritis the usual maintenance dose is 10-20 mg daily. The total daily dose of TEVA-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 TEVA-PIROXICAM and its biotransformation products (less than 5% of the daily dose excreted unchanged), lower doses of TEVA-PIROXICAM should be anticipated in patients with impaired renal function and they should be carefully monitored.
TEVA-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 TEVA- PIROXICAM. TEVA-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 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. TEVA-PIROXICAM Page 14 of 45 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:
TEVA-PIROXICAM, in common with other NSAIDs, may mask signs and symptoms of an underlying infectious disease.
Aseptic Meningitis:
Rarely, with some NSAIDs, including TEVA-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 08/2022 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 .........................................................................................................
5 3 SERIOUS WARNING AND PRECAUTIONS .............................................................................. 6 4 DOSAGE AND ADMINISTRATION .........................................................................................
1 Dosing Considerations .................................................................................................... 2 Recommended Dose and Dose Adjustment .................................................................. 4 Administration ................................................................................................................
5 Missed Dose ................................................................................................................... 8 5 OVERDOSAGE .....................................................................................................................
and 7 WARNINGS AND PRECAUTIONS) Use of TEVA-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) TEVA-PIROXICAM (piroxicam), as a NSAID, does NOT treat clinical disease or prevent its progression. TEVA-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 TEVA- 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 TEVA-PIROXICAM is contraindicated in: the peri-operative setting of coronary artery bypass graft surgery (CABG). Although TEVA-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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Piroxicam in Canada.
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4 Administration TEVA-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 TEVA-PIROXICAM is taken once a day and a dose of this medicine is missed, a dose of TEVA-PIROXICAM should be taken right away if remembered by the patient within 8 hours of the missed dose.
If TEVA-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.
Also, see Sensitivity/Resistance. 1 Special Populations). TEVA- PIROXICAM is contraindicated for use in the third trimester of pregnancy.
Cardiovascular:
Blood Pressure should be monitored regularly during treatment with TEVA- PIROXICAM (See 7 Warnings and Precautions - Cardiovascular).
Hematologic:
Patients should have their hemoglobin or hematocrit checked periodically. Concurrent therapy of TEVA-PIROXICAM with warfarin requires close monitoring of the international normalilized ratio (INR) (See 7 Warnings and Precautions - Haematology).
TEVA-PIROXICAM Page 15 of 45 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 7 Warnings and Precautions - Ophthalmologic). g. urine output, serum creatinine, creatinine clearance and serum urea) during therapy with TEVA- 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
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................... 9 7 WARNINGS AND PRECAUTIONS........................................................................................... 1 Special Populations ......................................................................................................
1 Pregnant Women ...................................................................................................... 2 Nursing Women: .......................................................................................................
3 Pediatrics: .................................................................................................................. 4 Geriatrics ...................................................................................................................
20 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 ................................................................................... 24 9 DRUG INTERACTIONS .........................................................................................................
3 Drug-Behaviour Interactions ........................................................................................ 4 Drug-Drug Interactions.................................................................................................
5 Drug-Food Interactions ................................................................................................ 6 Drug-Herb Interactions ................................................................................................
7 Drug-Laboratory Test Interactions ............................................................................... 29 10 CLINICAL PHARMACOLOGY...............................................................................................
1 Mechanism of Action ................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 29 11 STORAGE, STABILITY AND DISPOSAL .................................................................................
31 12 SPECIAL HANDLING INSTRUCTIONS .................................................................................. 31 PART II: SCIENTIFIC INFORMATION .......................................................................................
32 13 PHARMACEUTICAL INFORMATION ................................................................................... 32 14 CLINICAL TRIALS ...............................................................................................................
1 Clinical Trials by Indication ......................................................................................... 2 Comparative Bioavailability Studies ...........................................................................
33 15 MICROBIOLOGY ............................................................................................................... 33 16 NON-CLINICAL TOXICOLOGY […]
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 Warnings and Precautions - Renal - Fluid and Electrolyte Balance) children and adolescents less than 16 years of age 3 SERIOUS WARNING AND PRECAUTIONS Risk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (See 7 WARNINGS AND PRECAUTIONS – Cardiovascular) TEVA-PIROXICAM is a non-steroidal anti-inflammatory drug (NSAID).
Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors may be at greater risk.
Caution should be exercised in prescribing TEVA-PIROXICAM to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV).
Use of TEVA-PIROXICAM can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure. (See also 7 WARNINGS AND PRECAUTIONS – Renal- Fluid and Electrolyte Balance) Randomized clinical trials with piroxicam have not been designed to detect differences in cardiovascular events in a chronic setting.
Therefore, caution should be exercised when prescribing TEVA-PIROXICAM. TEVA-PIROXICAM Page 7 of 45 Risk of Gastrointestinal (GI) Adverse Events (See 7 WARNINGS AND PRECAUTIONS - Gastrointestinal) Use of TEVA-PIROXICAM is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).
Risk in Pregnancy:
Caution should be exercised in prescribing TEVA-PIROXICAM during the first and second trimesters of pregnancy. 1 Pregnant Women). TEVA-PIROXICAM is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see 2 CONTRAINDICATIONS).