CARDIOVASCULAR RISK
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See WARNINGS.)
• Cataflam® (diclofenac potassium immediate-release tablets) is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
• NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS.)
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CATAFLAM SUMMARY
CARDIOVASCULAR RISK
Cataflam® (diclofenac potassium immediate-release tablets), is a benzeneacetic acid derivative. Cataflam is available as immediate-release Tablets of 50 mg (light brown) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt.
Cataflam® (diclofenac potassium immediate-release tablets) is indicated:
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For treatment of primary dysmenorrhea
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For relief of mild to moderate pain
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For relief of signs and symptoms of osteoarthritis
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For relief of signs and symptoms of rheumatoid arthritis
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NEWS HIGHLIGHTS
Published Studies Related to Cataflam (Diclofenac)
Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. [2009.09]
OBJECTIVE: To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA)... CONCLUSION: Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665).
Diclofenac potassium restores objective and subjective measures of sleep quality in women with primary dysmenorrhea. [2009.08.01]
STUDY OBJECTIVES: Primary dysmenorrhea is a common gynecological disorder that disrupts daytime functioning and nighttime sleep quality. We determined the effectiveness of diclofenac potassium, compared to placebo, in alleviating nighttime pain and restoring sleep architecture in women with primary dysmenorrhea... CONCLUSION: Diclofenac potassium effectively attenuates nighttime dysmenorrheic pain and restores subjective and objective measures of sleep quality to values recorded in a pain-free phase of the menstrual cycle.
Pupil size with and without adrenaline with diclofenac use before cataract surgery. [2009.08]
PURPOSE: To determine whether adrenaline in the irrigating solution is necessary when diclofenac eyedrops are used before cataract surgery. SETTING: Pasqua Hospital, Regina, Saskatchewan, Canada... CONCLUSIONS: When diclofenac eyedrops were used before cataract surgery, the smaller preoperative pupils constricted significantly less when adrenaline was added to the irrigating solution. This was not true for larger pupils. Thus, adrenaline in the irrigating solution does not appear necessary in eyes with large preoperative pupils.
Intramuscular diclofenac for analgesia after cesarean delivery: a randomized controlled trial. [2009.06]
OBJECTIVE: To evaluate the effectiveness of intramuscular diclofenac in postoperative cesarean section pain control... CONCLUSION: Diclofenac can be used safely to reduce the requirement of rescue drugs for pain control in postoperative cesarean section.
Baseline factors associated with congestive heart failure in patients receiving etoricoxib or diclofenac: multivariate analysis of the MEDAL program. [2009.06]
CONCLUSION: History of CHF was highly associated with risk for CHF hospitalization. Hypertension, diabetes, and older age also increased risk modestly. There appeared to be a dose-related increase in CHF with etoricoxib compared with diclofenac, which reached statistical significance when the etoricoxib 90 mg groups (osteoarthritis and rheumatoid arthritis) were pooled.
Clinical Trials Related to Cataflam (Diclofenac)
Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium [Completed]
The purpose of this study is to assess the pharmacokinetic parameters of intravenous
diclofenac sodium (DIC075V) 18. 75 mg and 37. 5 mg following single- and multiple-dose
administration, as compared to oral diclofenac potassium (CataflamĀ® 50 mg), the approved
reference product.
Assess Platelet Function and Safety After Administration of Injectable Diclofenac Compared to Ketorolac and Aspirin in Adult Male Volunteers [Completed]
This study will assess platelet function and safety in healthy male volunteers following
doses of intravenous diclofenac compared to cataflam, intravenous ketorolac and aspirin.
Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain [Active, not recruiting]
The primary purpose of this study is to assess the effectiveness of once daily application of
a diclofenac sodium patch to the skin near or over the painful area. In this study, the
location being studied will be either the left or right ankle.
The secondary purpose of this study is to assess the safety and tolerability of a diclofenac
patch on the skin.
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis [Completed]
The primary purpose of this study is to assess the effectiveness of once daily application of
a diclofenac sodium patch to the skin near or over the painful area. In this study, the
location being studied will be one of the following: the affected shoulder, elbow, or wrist.
The secondary purpose of this study is to assess the safety and tolerability of the
diclofenac patch on the subject's skin, in the location being studied.
Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis [Completed]
This study will test the efficacy and safety of topical diclofenac sodium gel in the
treatment of knee osteoarthritis.
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Page last updated: 2009-10-20
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