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M-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: M-CELECOXIB (celecoxib capsules) is indicated for relief of symptoms associated with: • Osteoarthritis, • Adult Rheumatoid Arthritis, and • Ankylosing Spondylitis M-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 M-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).
, 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 M-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 M-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 M-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.
Management of Acute Pain:
The recommended dose of M-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:
M-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). M-CELECOXIB is contraindicated in patients with severe hepatic impairment (Child-Pugh >9) (see 2 CONTRAINDICATIONS).
3 Pharmacokinetics, Special Populations and Conditions). M-CELECOXIB is contra-indicated 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 celecoxib with caution. M-CELECOXIB should be introduced at half the lowest M-CELECOXIB Product Monograph Page 19 of 58 recommended dose in CYP2C9 poor metabolizers, with a maximum recommended dose of 100 mg daily (see
1 Pregnant women 07/2023 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........................................................................................................................
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 ................................................................................................................
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 M-CELECOXIB, should be considered first (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
Use of M-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).
M-CELECOXIB, as a NSAID, does NOT treat clinical disease or prevent its progression. M-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 celecoxib capsules 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 M-CELECOXIB is contraindicated in: • The peri-operative setting of Coronary Artery Bypass Graft Surgery (CABG). Although celecoxib capsules 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 (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.
• 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.
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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M-CELECOXIB Product Monograph Page 8 of 58 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 celecoxib with caution. 1 Special Populations). 4 Administration M-CELECOXIB can be taken with or without food.
5 Missed Dose Patients who miss one or more doses of M-CELECOXIB should not increase the dose of M-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.
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................... 8 7 WARNINGS AND PRECAUTIONS ..................................................................................... 1 Special Populations ......................................................................................................
1 Pregnant Women ......................................................................................................... 2 Breast-feeding ..............................................................................................................
3 Pediatrics...................................................................................................................... 4 Geriatrics ......................................................................................................................
18 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................................................................................... 25 9 DRUG INTERACTIONS ...................................................................................................
2 Drug Interactions Overview ......................................................................................... 4 Drug-Drug Interactions ................................................................................................
5 Drug-Food Interactions ................................................................................................ 6 Drug-Herb Interactions ................................................................................................
7 Drug-Laboratory Test Interactions............................................................................... 31 10 CLINICAL PHARMACOLOGY ..........................................................................................
1 Mechanism of Action ................................................................................................... 2 Pharmacodynamics ......................................................................................................
3 Pharmacokinetics ......................................................................................................... 32 11 STORAGE, STABILITY AND DISPOSAL ............................................................................
33 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 34 PART II: SCIENTIFIC INFORMATION ..........................................................................................
35 13 PHARMACEUTICAL INFORMATION ............................................................................... 35 14 CLINICAL TRIALS ...........................................................................................................
3 Comparative Bioavailability Studies ............................................................................ 45 15 MICROBIOLOGY ...........................................................................................................
46 16 NON-CLINICAL TOXICOLOGY......................................................................................... 46 17 SUPPORTING PRODUCT MONOGRAPHS ....................................................................... 49 […]
• 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. M-CELECOXIB Product Monograph Page 6 of 58