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MAR-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.
Verbatim from this product's HC label. Tap a section to expand.
1 Adverse Reaction Overview Page 18 of 55 PrMAR-CELECOXIB (celecoxib) Of the celecoxib capsules treated patients in controlled trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post- surgical pain.
More than 8,500 patients have received a total daily dose of celecoxib capsules of 200 mg (100 mg BID or 200 mg QD) or more, including more than 400 treated at 800 mg (400 mg BID). Approximately 3,900 patients have received celecoxib capsules at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.
Celecoxib capsules has been studied in elderly patients. Of the total number of patients who received celecoxib capsules in clinical trials, more than 3,300 patients were 65-74 years of age, while approximately 1,300 additional patients were 75 years and over.
While the incidence of adverse experiences tended to be higher in elderly patients, no substantial differences in safety and effectiveness were observed between these subjects and younger patients. In GI endoscopy studies involving over 800 elderly patients, the rate of gastroduodenal ulceration was not different in elderly patients compared to the young.
Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In clinical studies comparing renal function as measured by the GFR, urea and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers.
2 Clinical Trial Adverse Reactions New Drug Submission (NDS) Arthritis Trials Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Table 1 lists all adverse events, regardless of causality, occurring in ≥ 2% of patients receiving celecoxib capsules from 12 controlled studies conducted in patients with osteoarthritis and rheumatoid arthritis that included a placebo and/or a positive control group.
Table 1. 1% for patients receiving placebo. 7% of celecoxib capsules patients, respectively). 6% withdrew due to abdominal pain. The adverse event profile from the long-term outcomes trial (at 4- and 2-fold the recommended doses for OA and RA, respectively) is similar to those reported in the arthritis-controlled trials.
In the arthritis- controlled trials, the celecoxib capsules endoscopic gastroduodenal ulceration rate was consistently less than what was seen with the NSAID comparators. In the long-term outcome study however, there was no statistically significant difference for the incidence of complicated ulcers (perforation, obstruction, or bleeding) among the celecoxib capsules 400 mg BID and NSAID comparators (see 14 CLINICAL TRIALS, Special Studies) The major differences in study design and patient populations preclude direct comparison between the GI endpoint results in the arthritis controlled and the long-term outcome trials.
). 1 Adverse Reaction Overview). 8 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.
MAR-CELECOXIB should be introduced at half the lowest recommended dose in CYP2C9 poor metabolizers, with a maximum recommended dose of 100 mg daily (see
). For patients with an increased risk of developing gastrointestinal adverse events, other management strategies that do NOT include the use of NSAIDs, including MAR-CELECOXIB, should be considered first (see 2 CONTRAINDICATIONS and 7 WARNINGSAND PRECAUTIONS).
Use of MAR-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 WARNINGSAND PRECAUTIONS).
MAR-CELECOXIB, as a NSAID, does NOT treat clinical disease or prevent its progression. MAR-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). PrMAR-CELECOXIB (celecoxib) Page 5 of 55 2 Contraindications MAR-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 .
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 MAR-CELECOXIB, should be considered first (see 2 CONTRAINDICATIONS and 7 WARNINGSAND PRECAUTIONS).
Use of MAR-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 WARNINGSAND PRECAUTIONS).
MAR-CELECOXIB, as a NSAID, does NOT treat clinical disease or prevent its progression. MAR-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). PrMAR-CELECOXIB (celecoxib) Page 5 of 55 2 Contraindications MAR-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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, those causing hospitalization or felt to be life-threatening or otherwise medically significant) observed in this trial are shown in Table 2. No significant differences were seen across treatment groups in the incidences of serious adverse events (see Table 2).
Table 2. 0 Page 20 of 55 PrMAR-CELECOXIB (celecoxib) All Patients Celecoxib 400 mg BID (n = 3987) Diclofenac 75 mg BID (n = 1996) Ibuprofen 800 mg TID (n = 1985) Myocardial infarction […]
• 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. PrMAR-CELECOXIB (celecoxib) Page 6 of 55 3 Serious Warnings and Precautions Box Serious Warnings and Precautions • Risk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV): MAR-CELECOXIB is a non-steroidal anti-inflammatory drug (NSAID).
Celecoxib capsules, particularly at doses higher than 200 mg per day, is associated with an increased incidence of serious cardiovascular (CV) thrombotic events (such as myocardial infarction and stroke), which can be fatal. This increased risk is comparable to that with high doses of diclofenac (≥ 150 mg per day) or ibuprofen (≥ 2400 mg per day).
Doses of MAR-CELECOXIB > 200 mg/day should NOT be used in patients 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), congestive heart failure (NYHA II-IV), and/or risk factors for cardiovascular disease.
A meta-analysis of randomized clinical trials comparing several different NSAIDs, concluded that celecoxib capsules is associated with higher cardiovascular risk when compared with placebo. Large population-based observational studies also support these findings.
See 14 CLINICAL TRIALS, Cardiovascular Safety) An increased risk of CV thrombotic events may occur early in the treatment and become higher with the duration of treatment. Patients with CV disease or risk factors for CV disease may be at greater risk (see 7 WARNINGSAND PRECAUTIONS, Cardiovascular).
To minimize the potential for an adverse cardiovascular event, the lowest effective dose should be used for the shortest possible duration. For patients with a high risk of developing an adverse cardiovascular event, other management strategies that do NOT include NSAIDs, particularly celecoxib, diclofenac, or ibuprofen, should be considered first.
Use of NSAIDs, such as MAR-CELECOXIB, 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 WARNINGSAND PRECAUTIONS, Fluid and Electrolyte Balance Risk of Gastrointestinal (GI) Adverse Events: Use of NSAIDs, such as celecoxib capsules, is associated with an increased incidence of […]
• 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. PrMAR-CELECOXIB (celecoxib) Page 6 of 55 3 Serious Warnings and Precautions Box Serious Warnings and Precautions • Risk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV): MAR-CELECOXIB is a non-steroidal anti-inflammatory drug (NSAID).
Celecoxib capsules, particularly at doses higher than 200 mg per day, is associated with an increased incidence of serious cardiovascular (CV) thrombotic events (such as myocardial infarction and stroke), which can be fatal. This increased risk is comparable to that with high doses of diclofenac (≥ 150 mg per day) or ibuprofen (≥ 2400 mg per day).
Doses of MAR-CELECOXIB > 200 mg/day should NOT be used in patients 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), congestive heart failure (NYHA II-IV), and/or risk factors for cardiovascular disease.
A meta-analysis of randomized clinical trials comparing several different NSAIDs, concluded that celecoxib capsules is associated with higher cardiovascular risk when compared with placebo. Large population-based observational studies also support these findings.
See 14 CLINICAL TRIALS, Cardiovascular Safety) An increased risk of CV thrombotic events may occur early in the treatment and become higher with the duration of treatment. Patients with CV disease or risk factors for CV disease may be at greater risk (see 7 WARNINGSAND PRECAUTIONS, Cardiovascular).
To minimize the potential for an adverse cardiovascular event, the lowest effective dose should be used for the shortest possible duration. For patients with a high risk of developing an adverse cardiovascular event, other management strategies that do NOT include NSAIDs, particularly celecoxib, diclofenac, or ibuprofen, should be considered first.
Use of NSAIDs, such as MAR-CELECOXIB, 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 WARNINGSAND PRECAUTIONS, Fluid and Electrolyte Balance Risk of Gastrointestinal (GI) Adverse Events: Use of NSAIDs, such as celecoxib capsules, is associated […]