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ETODOLAC is a brand name for Etodolac, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ETODOLAC (Etodolac capsules) is indicated for: acute or long–term use in the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis (degenerative joint disease). For patients with an increased risk of developing cardiovascular and/or gastrointestinal adverse events, other management strategies that…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics. 2 CONTRAINDICATIONS ETODOLAC is contraindicated in: Patients who are hypersensitive to ETODOLAC or to other NSAIDs or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
). Patients taking any NSAID including this drug should be instructed to contact a physician immediately if they experience symptoms or signs suggestive of peptic ulceration or gastrointestinal bleeding. These reactions can occur at any time during treatment, without warning symptoms or signs.
Genitourinary Some NSAIDs are associated with persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with a NSAID.
Should urinary symptoms occur, in the absence of an alternate explanation, treatment with ETODOLAC should be stopped to ascertain if symptoms ETODOLAC (etodolac) Page 12 of 43 disappear. This should be done before urological investigations or treatments are carried out.
Hematologic NSAIDs inhibiting prostaglandin biosynthesis interfere with platelet function to varying d egrees; patients who may be adversely affected by such an action, such as those on anti -coagulants or suffering from haemophilia or platelet disorders should be carefully observed when ETODOLAC is administered.
Anti-coagulants:
Numerous studies have shown that the concomitant use of NSAIDs and anti- coagulants increases the risk of bleeding. Concurrent therapy of ETODOLAC with warfarin requires close monitoring of the international normalized ratio (INR). Even with therapeutic INR monitoring, increased bleeding may occur.
See
Use of ETODOLAC 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.
ETODOLAC, as a NSAID, does NOT treat clinical disease or prevent its progression. ETODOLAC, 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 ETODOLAC 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 post market experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 4 Geriatrics.
2 CONTRAINDICATIONS ETODOLAC is contraindicated in: Patients who are hypersensitive to ETODOLAC or to other NSAIDs 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.
The peri-operative setting of coronary artery bypass graft surgery (CABG). Although ETODOLAC 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. ETODOLAC (etodolac) Page 5 of 43 Women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants.
and 7 WARNINGS AND PRECAUTIONS. Use of ETODOLAC 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. ETODOLAC, as a NSAID, does NOT treat clinical disease or prevent its progression. ETODOLAC, 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 ETODOLAC 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 post market experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Severe uncontrolled heart failure. 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, Sensitivity/Resistance, Anaphylactoid Reactions. Active gastric / duodenal / peptic ulcer, active GI bleeding. Cerebrovascular bleeding or other bleeding disorders.
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, Renal, Fluid and Electrolyte Balance. Children and adolescents less than < 18 years of age since ETODOLAC has not been studied in subjects under the age of 18.
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): ETODOLAC is a non-steroidal anti-inflammatory drug (NSAID).
Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Caution should be exercised in prescribing ETODOLAC 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 limite d to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or ETODOLAC (etodolac) Page 6 of 43 congestive heart failure (NYHA II-IV).
Use of NSAIDs, such as ETODOLAC, 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 7 WARNINGS AND PRECAUTIONS, Renal, Fluid and Electrolyte Balance.
Randomized clinical trials with ETODOLAC have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing ETODOLAC. See 7 WARNINGS AND PRECAUTIONS. Risk of Gastrointestinal (GI) Adverse Events: Use of NSAIDs, such as ETODOLAC, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).
Risk in Pregnancy: Caution should be exercised in prescribing ETODOLAC during the first and second trimesters of pregnancy. 1 Pregnant Women). ETODOLAC is contraindicated for use during the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition).
See 2 CONTRAINDICATIONS. 1 Dosing Considerations Use of ETODOLAC should be limited to the lowest effective dose for the shortest possible duration of treatment. See 1 INDICATIONS. For all indications, treatment must be initiated with the lowest dose.
Caution should be exercised in prescribing ETODOLAC to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history […]