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APO-IBUPROFEN TAB is a brand name for Ibuprofen, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-IBUPROFEN (ibuprofen tablets) is indicated for the following: • The relief of the signs and symptoms of rheumatoid arthritis • The relief of the signs and symptoms of osteoarthritis Throughout this document, the term NSAIDs refers to both non-selective NSAIDs and selective COX-2 inhibitor NSAIDs, unless otherwise…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics. 2 CONTRAINDICATIONS APO-IBUPROFEN is contraindicated in: • the peri-operative setting of coronary artery bypass graft surgery (CABG). Although APO-IBUPROFEN 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 • 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
1 Adverse Reaction Overview The most common adverse reactions encountered with non-steroidal anti-inflammatory drugs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred, particularly in the elderly.
As with all drugs in this class, the frequency and severity of adverse events depends on several factors: the dose of the drug and duration of treatment; the age, the sex, physical condition of the patient; any concurrent medical diagnoses or individual risk factors.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates APO-IBUPROFEN (Ibuprofen tablets) Page 19 of 40 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. No data is available. 5 Post-Market Adverse Reactions Additional reports of serious adverse events temporally associated with ibuprofen during worldwide post-marketing experience are included below.
Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or clearly establish a causal relationship to ibuprofen exposure. g. prupura, epistaxis, hematuria, menorrhagia), auto-immune hematological anemia, fatal aplastic anemia Immune System Disorders: anaphylaxis, lupus erythematosus syndrome, fever, serum sickness Metabolic and Nutrition Disorders: decreased appetite, edema, fluid retention, hypoglycemic reaction Nervous System Disorders: dizziness, headache, nervousness, depression, insomnia, paresthesias, hallucinations, dream abnormalities, cognitive dysfunction Eye Disorders: amblyopia, conjunctivitis, diplopia, optic neuritis Ear and Labyrinth Disorders: tinnitus Cardiac Disorders: congestive heart failure in patients with marginal cardiac function, elevated blood pressure, arterial thrombotic events, arrhythmias Skin and Subcutaneous Tissue Disorders: rash, pruritis, vesiculobullous eruptions, urticarial, erythema multiforme, alopecia, Stevens-Johnson Syndrome Renal and Urinary Disorders: decreased creatinine clearance, polyuria, azotemia, renal papillary necrosis Reproductive System and Breast Disorders: menstrual delays, gynecomastia APO-IBUPROFEN (Ibuprofen tablets) Page 20 of 40
For patients with increased risk of developing gastrointestinal adverse events, other management strategies that do not include NSAIDs should be considered first. See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS. Use of APO-IBUPROFEN 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-IBUPROFEN, as a NSAID, does NOT treat clinical disease or prevent its progression. APO-IBUPROFEN, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it.
1 Pediatrics Pediatrics (<12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ibuprofen 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-IBUPROFEN is contraindicated in: • the peri-operative setting of coronary artery bypass graft surgery (CABG). Although APO-IBUPROFEN 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 • 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. e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/angioedema, nasal polyps, asthma). Fatal anaphylactoid reactions have occurred in such individuals.
and 7 WARNINGS AND PRECAUTIONS. For patients with increased risk of developing gastrointestinal adverse events, other management strategies that do not include NSAIDs should be considered first. See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS.
Use of APO-IBUPROFEN 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-IBUPROFEN, as a NSAID, does NOT treat clinical disease or prevent its progression. APO-IBUPROFEN, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it. 1 Pediatrics Pediatrics (<12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ibuprofen in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
See 2 CONTRAINDICATIONS. 2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggest that use in APO-IBUPROFEN (Ibuprofen tablets) Page 5 of 40 the geriatric population is associated with differences in safety or effectiveness and a brief discussion can be found in the appropriate sections See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ibuprofen 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.
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.
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 APO-IBUPROFEN (Ibuprofen tablets) Page 6 of 40 monitored) See 7 WARNINGS AND PRECAUTIONS • known hyperkalemia.
See 7 WARNINGS AND PRECAUTIONS • children and adolescents less than 12 years of age • patients with systemic lupus erythematosus as an anaphylaxis-like reaction with fever may occur, particularly when ibuprofen has been administered previously.
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) APO-IBUPROFEN is a non-steroidal anti-inflammatory drug (NSAID).
Ibuprofen, particularly at higher doses (2400 mg/day), is associated with an increased risk of serious cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events, which can be fatal), comparable to COX-2 inhibitors, as evidenced by meta-analyses of randomized clinical trials.
Large population-based observational studies conducted in the general population also support these findings. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
g. hypertension, hyperlipidemia, diabetes mellitus and smoking). For patients with a high risk of developing an adverse cardiovascular event, other management strategies that do NOT include NSAIDs, particularly COX-2 inhibitors, ibuprofen or diclofenac, should be considered first.
To minimize the potential for an adverse cardiovascular event, the lowest effective dose should be used for the shortest possible duration. Caution should be exercised in prescribing APO-IBUPROFEN to any patient 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) and/or congestive heart failure (NYHA II-IV).
Use of NSAIDs, such as APO-IBUPROFEN, 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. Randomized clinical trials with ibuprofen have not been designed to detect differences in cardiovascular events in a chronic setting.
Therefore, caution should be exercised when APO-IBUPROFEN (Ibuprofen tablets) Page 7 of 40 prescribing APO-IBUPROFEN. See 7 WARNINGS […]