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PMSC-CELECOXIB is a brand name for Celecoxib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pmsc-CELECOXIB (celecoxib capsules) is indicated for relief of symptoms associated with: • Osteoarthritis, • Adult Rheumatoid Arthritis, and • Ankylosing Spondylitis pmsc-CELECOXIB is also indicated for the short-term (≤ 7 days) management of moderate to severe acute pain in adults in conditions such as the following:…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use of pmsc-CELECOXIB 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).
g. hypertension, hyperlipidemia, diabetes mellitus and smoking) (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). 2 Recommended Dose and Dosage Adjustment Osteoarthritis: The recommended daily dose of pmsc-CELECOXIB is 200 mg administered as a single dose or as two divided doses (100 mg twice per day).
Maximum dose = 200 mg a day.
Rheumatoid Arthritis:
The recommended starting dose of pmsc-CELECOXIB is 100 mg twice per day, which may be increased to 200 mg twice per day if necessary. Maximum dose = 200 mg twice a day.
Ankylosing Spondylitis:
The recommended daily dose of pmsc-CELECOXIB is 200 mg administered as a single dose or as two divided doses (100 mg twice a day). Maximum dose = 200 mg a day. ______________________________________________________________________________ pmsc-CELECOXIB Product Monograph Page 8 of 67 Management of Acute Pain: The recommended dose of pmsc-CELECOXIB is 400 mg as a single dose on the first day followed by 200 mg once daily on subsequent days up to a maximum of 7 days.
Patients may be instructed to take an additional dose of 200 mg on any given day, if needed. Maximum dose = 400 mg a day for up to 7 days.
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use. See 2 CONTRAINDICATIONS Hepatic Impairment: pmsc-CELECOXIB capsules should be introduced at the lowest dose in patients with mild hepatic impairment (Child-Pugh 5-6).
3 Pharmacokinetics, Special Populations and Conditions). pmsc-CELECOXIB is contraindicated in patients with severe hepatic impairment (Child-Pugh > 9) (see 2 CONTRAINDICATIONS). 3 Pharmacokinetics, Special Populations and Conditions).
pmsc-CELECOXIB is contraindicated in patients with severe renal impairment (estimated creatinine clearance < 30 mL/min) (see 2 CONTRAINDICATIONS). 4 Geriatrics).
). 1 Adverse Reaction Overview).
CYP2C9 Poor Metabolizers:
Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered pmsc-CELECOXIB with caution. pmsc-CELECOXIB should be introduced at half the lowest recommended dose in CYP2C9 poor metabolizers, with a maximum recommended dose of 100 mg daily (see
1 Pregnant women 04/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS....................................................................................................................... 1 Pediatrics ...........................................................................................................................
2 Geriatrics ........................................................................................................................... 5 2 CONTRAINDICATIONS .........................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................... 6 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations .......................................................................................................
2 Recommended Dose and Dosage Adjustment .................................................................. 4 Administration ...................................................................................................................
5 Missed Dose ...................................................................................................................... 8 5 OVERDOSAGE .....................................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................................... 9 7 WARNINGS AND PRECAUTIONS ........................................................................................ 1 Special Populations..........................................................................................................
and 7 WARNINGS AND PRECAUTIONS). For patients with an increased risk of developing gastrointestinal adverse events, other management strategies that do NOT include the use of NSAIDs, including pmsc-CELECOXIB, should be considered first (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
Use of pmsc-CELECOXIB 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).
pmsc-CELECOXIB, as a NSAID, does NOT treat clinical disease or prevent its progression. pmsc-CELECOXIB, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it. 1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of pmsc-CELECOXIB 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 pmsc-CELECOXIB is contraindicated in: • The peri-operative setting of Coronary Artery Bypass Graft Surgery (CABG). Although celecoxib capsules have 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 (see 14 CLINICAL TRIALS, Cardiovascular Safety- Meta-analysis from Chronic Usage Studies).
• 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Celecoxib in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
CYP2C9 Poor Metabolizers:
Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered pmsc-CELECOXIB with caution. 1 Special Populations). 4 Administration pmsc-CELECOXIB can be taken with or without food.
5 Missed Dose Patients who miss one or more doses of pmsc-CELECOXIB should not increase the dose of pmsc-CELECOXIB to compensate for the missed dose or doses, but should continue therapy as soon as possible, then take the next dose at the scheduled time.
______________________________________________________________________________ pmsc-CELECOXIB Product Monograph Page 9 of 67
1 Pregnant Women ..................................................................................................... 2 Breast-feeding ..........................................................................................................
3 Pediatrics .................................................................................................................. 4 Geriatrics ..................................................................................................................
20 8 ADVERSE REACTIONS ........................................................................................................ 1 Adverse Reaction Overview .............................................................................................
2 Clinical Trial Adverse Reactions ....................................................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.........................................................................................................................................
5 Post-Market Adverse Reactions ...................................................................................... 28 9 DRUG INTERACTIONS ........................................................................................................
2 Overview ......................................................................................................................... 4 Drug-Drug Interactions ....................................................................................................
5 Drug-Food Interactions.................................................................................................... 6 Drug-Herb Interactions ....................................................................................................
7 Drug-Laboratory Test Interactions................................................................................... 36 10 CLINICAL PHARMACOLOGY .............................................................................................
1 Mechanism of Action ..................................................................................................... 2 Pharmacodynamics .......................................................................................................
3 Pharmacokinetics .......................................................................................................... 37 11 STORAGE, STABILITY AND DISPOSAL ...............................................................................
39 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................. 39 PART II: SCIENTIFIC INFORMATION ........................................................................................
40 13 PHARMACEUTICAL INFORMATION .................................................................................. 40 14 CLINICAL TRIALS ..............................................................................................................
41 15 MICROBIOLOGY .............................................................................................................. 54 16 NON-CLINICAL TOXICOLOGY ...........................................................................................
54 17 SUPPORTING PRODUCT […]
• Patients who are hypersensitive to this drug 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.
• Demonstrated allergic-type reactions to sulfonamides. 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, Anaphylactoid Reactions).
• Active gastric / duodenal / peptic ulcer, active gastrointestinal bleeding. • Cerebrovascular bleedings. • Inflammatory bowel disease. • Severe liver impairment or active liver disease. 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, Fluid and Electrolyte Balance). • Children and adolescents less than 18 years of age.