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KETOPROFEN SR is a brand name for Ketoprofen, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR (Ketoprofen Capsules BP, Ketoprofen Enteric-coated Tablets and Ketoprofen Sustained-release Tablets) are indicated for: the treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, the treatment of primary dysmenorrhea, the relief of mild to moderate…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use of KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR should be limited to the lowest effective dose for the shortest possible duration of treatment (see 1 INDICATIONS). 2 Recommended Dose and Dosage Adjustment).
2 Recommended Dose and Dosage Adjustment Adults Rheumatoid arthritis and osteoarthritis The usual dosage for KETOPROFEN capsules or KETOPROFEN-E enteric-coated tablets is 150 to 200 mg per day in 3 or 4 divided doses. Once the maintenance dosage has been established, patients may be tried on a twice daily dosing regimen.
Clinical trials, however, show that some rheumatoid arthritis patients respond better to more frequent dosing. The usual maintenance dose is 100 mg twice daily. Patients with rheumatoid arthritis or osteoarthritis on a maintenance dose of 200 mg/day may be changed to a once daily dose of KETOPROFEN SR 200 mg tablets administered in the morning or evening.
KETOPROFEN SR tablets should be swallowed whole. KETOPROFEN-E and KETOPROFEN SR tablets provide alternative presentations for those who may prefer these dosage forms. No difference in toxicity profile was documented. The total daily dose of KETOPROFEN, KETOPROFEN-E or KETOPROFEN SR capsules or tablets should not exceed 200 mg per day.
When the patient's response warrants it, the dose may be decreased to the minimum effective level. In severe cases during a flare-up of rheumatic activity or if a satisfactory response cannot be obtained with the lower dose, a daily dosage in excess of 200 mg may be used, but a dose of 300 mg/day should not be exceeded.
Primary dysmenorrhea and mild to moderate pain The usual dose for KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR is 25 to 50 mg 3 or 4 times daily as necessary. A larger dose may be tried if the patient's response to a previous dose was less than satisfactory, but individual doses above 50 mg have not been shown to give added analgesia.
The total daily dose should not exceed 300 mg. In most types of acute pain, a course of 3 to 7 days has been shown to be sufficient.
Pediatrics (< 12 years of age):
Health Canada has not authorized an indication for pediatric patients. See 2 CONTRAINDICATIONS. PrKETOPROFEN, PrKETOPROFEN-E and PrKETOPROFEN SR (Ketoprofen) Page 8 of 49 Geriatrics (≥ 65 years of age): In the elderly, frail and debilitated, the dosage should be reduced to the lowest level providing control of symptoms, and adjusted when necessary.
1 Adverse Reaction Overview The most common adverse reactions encountered with nonsteroidal anti -inflammatory drugs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred on occasion, particularly in the elderly.
See 7 WARNINGS AND PRECAUTIONS, Gastrointestinal. 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 Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In clinical trials of ketoprofen involving 1,542 patients, the most common side effects reported were gastrointestinal (22%).
The most severe were peptic ulcer or GI bleeding wh ich occurred in controlled clinical trials in less than 1% of 1,076 patients; however, in open label continuation studies in 1,292 patients the rate was greater than 2%. 3 Less Common Clinical Trial Adverse Reactions Blood and lymphatic system disorders: hypocoagulability, agranulocytosis, anemia, hemolysis, purpura, thrombocytopenia.
Cardiac disorders: palpitation, congestive heart failure. Ear and labyrinth disorders: tinnitus, hearing impairment. Eye disorders: visual disturbance, conjunctivitis, conjunctivitis sicca. Gastrointestinal disorders: ulcer, GI bleeding and perforation, melena, hematemesi s, stomatitis, taste perversion.
, Cardiovascular and 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). Use of KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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, 7 WARNINGS AND PRECAUTIONS, Cardiovascular and 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).
KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR, as NSAIDs, does NOT treat clinical disease or prevent its progression. KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR, as NSAIDs, 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR are contraindicated in PrKETOPROFEN, PrKETOPROFEN-E and PrKETOPROFEN SR (Ketoprofen) Page 5 of 49 Patients who are hypersensitive to KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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.
1 Pregnant women). 2 Breast-feeding). Severe uncontrolled heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/ angioedema, nasal polyps, asthma).
, 7 WARNINGS AND PRECAUTIONS, Cardiovascular and 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). Use of KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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, 7 WARNINGS AND PRECAUTIONS, Cardiovascular and 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).
KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR, as NSAIDs, does NOT treat clinical disease or prevent its progression. KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR, as NSAIDs, 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR are contraindicated in PrKETOPROFEN, PrKETOPROFEN-E and PrKETOPROFEN SR (Ketoprofen) Page 5 of 49 Patients who are hypersensitive to KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Geriatrics. Initial dosage should be reduced by 1/2 to 1/3 in the elderly. Renal Impairment Initial dosage should be reduced by 1/2 to 1/3 in patients with impaired renal function. 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 2 CONTRAINDICATIONS. Hepatic impairment Patients with impaired hepatic function should be carefully monitored and kept at the minimal effective daily dosage. KETOPROFEN, KETOPROFEN-E, and KETOPROFEN SR are contraindicated in severe liver impairment or active liver disease.
See 2 CONTRAINDICATIONS. 4 Administration KETOPROFEN should be taken with meals to minimize gastrointestinal intolerance. KETOPROFEN-E and KETOPROFEN SR should be taken 1 to 2 hours before meals or at least 2 hours after meals. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember.
If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule. The patient should be instructed not to take 2 doses at the same time.
Hepatobiliary disorders: hepatic dysfunction, jaundice. Immune system disorders: anaphylaxis. Metabolism and nutrition disorders: anorexia. Nervous System disorders: dizziness, drowsiness, vertigo, migraine, paresthesia. Psychiatric disorders: tension, anxiety, depression, impotence.
Skin and subcutaneous tissue disorders: angioedema, pruritus, flushing, excessive perspiration, alopecia, bullous rash, exfoliative dermatitis, photosensitivity, purpuric rash, urticaria, onycholysis. Renal and urinary disorders: interstitial nephritis, hematuria, nephrotic syndrome, impairment of renal function, acute renal failure.
Respiratory, thoracic and mediastinal disorders: asthma, life threatening bronchospasm. Vascular disorders: hypertension. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Laboratory Tests: Abnormal alkaline phosphatase, lactic dehydrogenase, glutamic oxaloacetic transaminase and blood urea nitrogen values were found in some patients receiving ketoprofen therapy.
The abnormalities did not lead to discontinuation of treatment and, in some cases, returned to normal while the drug was continued. There have been sporadic reports of decreased hematocrit and hemoglobin values without progressive deterioration on prolonged administration of the drug.
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, Immune).
Active gastric / duodenal / peptic ulcer, active GI bleeding (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). Cerebrovascular bleeding or other bleeding disorders. Inflammatory bowel disease. Severe liver impairment or active liver disease (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
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 12 years of age. PrKETOPROFEN, PrKETOPROFEN-E and PrKETOPROFEN SR (Ketoprofen) Page 6 of 49 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) (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR are non-steroidal anti-inflammatory drugs (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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR, 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR have not been designed to detect differences in cardiovascular events in a chronic setting.
Therefore, caution should be exercised when prescribing KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR. Risk of Gastrointestinal (GI) Adverse Events (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). Use of NSAIDs, such as KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR, 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 KETOPROFEN, KETOPROFEN-E and KETOPROFEN SR during the […]
1 Pregnant women). 2 Breast-feeding). Severe uncontrolled heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). 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, Immune).
Active gastric / duodenal / peptic ulcer, active GI bleeding (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). Cerebrovascular bleeding or other bleeding disorders. Inflammatory bowel disease. Severe liver impairment or active liver disease (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
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 12 years of age. PrKETOPROFEN, PrKETOPROFEN-E and PrKETOPROFEN SR (Ketoprofen) Page 6 of 49