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BIO-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: Bio-CELECOXIB (celecoxib capsules) is indicated for relief of symptoms associated with: Osteoarthritis, Adult Rheumatoid Arthritis, and Ankylosing Spondylitis Bio-CELECOXIB is also indicated for the short-term ( 7 days) management of moderate to severe acute pain in adults in conditions such as the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use of Bio-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 Bio-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 Bio-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 Bio-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 Bio-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:
Bio-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). Bio- CELECOXIB is contraindicated in patients with severe hepatic impairment (Child-Pugh > 9) (see 2 CONTRAINDICATIONS).
3 Pharmacokinetics, Special Populations and Conditions). Bio-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. Bio-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 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 ...................................................................................................................
2 Geriatrics.................................................................................................................... 4 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.............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................... 8 7 WARNINGS AND PRECAUTIONS ...................................................................................
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 Bio-CELECOXIB, should be considered first (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
Use of Bio-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).
Bio-CELECOXIB, as a NSAID, does NOT treat clinical disease or prevent its progression. Bio-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). Page 5 of 57 2 CONTRAINDICATIONS Bio-CELECOXIB is contraindicated in: The peri-operative setting of Coronary Artery Bypass Graft Surgery (CABG). Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
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.
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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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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 Bio-CELECOXIB can be taken with or without food.
5 Missed Dose Patients who miss one or more doses of Bio-CELECOXIB should not increase the dose of Bio-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.
1 Special Populations .................................................................................................. 1 Pregnant Women .................................................................................................
2 Breast-feeding ...................................................................................................... 3 Pediatrics ..............................................................................................................
4 Geriatrics .............................................................................................................. 17 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 .............................................................................. 23 9 DRUG INTERACTIONS................................................................................................. 2 Overview ..................................................................................................................
4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food Interactions ............................................................................................
6 Drug-Herb Interactions ............................................................................................ 7 Drug-Laboratory Test Interactions........................................................................... 33 10 CLINICAL PHARMACOLOGY ........................................................................................
1 Mechanism of Action ............................................................................................... 2 Pharmacodynamics..................................................................................................
3 Pharmacokinetics..................................................................................................... 34 11 STORAGE, STABILITY AND DISPOSAL .............................................................................
35 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 35 PART II: SCIENTIFIC INFORMATION........................................................................................
36 13 PHARMACEUTICAL INFORMATION............................................................................. 36 14 CLINICAL TRIALS ........................................................................................................
46 15 MICROBIOLOGY ........................................................................................................ 47 16 NON-CLINICAL TOXICOLOGY ......................................................................................
47 17 SUPPORTING PRODUCT MONOGRAPHS………………………………………………………………………………49 PATIENT MEDICATION INFORMATION................................................................................... 50 Page 4 of 57 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Bio-CELECOXIB (celecoxib capsules) is indicated for relief of symptoms associated […]