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APO-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: APO-CELECOXIB (celecoxib capsules) is indicated for relief of symptoms associated with: Osteoarthritis, Adult Rheumatoid Arthritis, and Ankylosing Spondylitis APO-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 APO-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 APO-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 APO-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 APO-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 APO-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:
APO-CELECOXIB capsules should be introduced at the lowest dose in patients with mild hepatic impairment (Child-Pugh 5 to 6). 3 Pharmacokinetics, Special Populations and Conditions). APO-CELECOXIB is contraindicated in patients with severe hepatic impairment (Child-Pugh > 9) (see 2 CONTRAINDICATIONS).
3 Pharmacokinetics, Special Populations and Conditions). APO- 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 celecoxib with caution. APO-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 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 1 INDICATIONS .................................................................................................................
1 Pediatrics.................................................................................................................. 2 Geriatrics ..................................................................................................................
5 2 CONTRAINDICATIONS .................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................... 5 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 ........................... 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 APO- CELECOXIB, should be considered first (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
Use of APO-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).
APO-CELECOXIB, as a NSAID, does NOT treat clinical disease or prevent its progression. APO-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 APO-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 ductu s 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 celecoxib with caution. 1 Special Populations). 4 Administration APO-CELECOXIB can be taken with or without food.
5 Missed Dose Patients who miss one or more doses of APO-CELECOXIB should not increase the dose of APO-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 Pregnant Women................................................................................................ 2 Breast-feeding .................................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics............................................................................................................ 19 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 APO-CELECOXIB (Celecoxib Capsules) Page 3 of 58 9 DRUG INTERACTIONS.................................................................................................
2 Overview................................................................................................................. 4 Drug-Drug Interactions ............................................................................................
5 Drug-Food Interactions............................................................................................ 6 Drug-Herb Interactions ............................................................................................
7 Drug-Laboratory Test Interactions ........................................................................... 32 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ..........................................................................................
2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ............................................................................................... 33 11 STORAGE, STABILITY AND DISPOSAL ......................................................................
35 12 SPECIAL HANDLING INSTRUCTIONS......................................................................... 35 PART II: SCIENTIFIC INFORMATION ................................................................................. 36 13 PHARMACEUTICAL INFORMATION............................................................................
36 14 CLINICAL TRIALS ........................................................................................................ 3 Comparative Bioavailability Studies ....................................................................
46 15 MICROBIOLOGY .......................................................................................................... 47 16 NON-CLINICAL TOXICOLOGY.....................................................................................
47 17 SUPPORTING PRODUCT M ONOGRAPHS .................................................................. 50 PATIENT MEDICATION INFORMATION ............................................................................. 51 APO-CELECOXIB (Celecoxib Capsules) Page 4 of 58 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-CELECOXIB (celecoxib capsules) is indicated for relief of symptoms associated with: Osteoarthritis, Adult Rheumatoid […]
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.