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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 NEWS HIGHLIGHTS Media Articles Related to Cataflam (Diclofenac)
Xanodyne Receives Approval From The U.S. Food And Drug Administration For ZIPSOR(TM) (diclofenac Potassium) Liquid Filled Capsules
Source: Pain / Anesthetics News From Medical News Today [2009.06.18]
Xanodyne Pharmaceuticals, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zipsor (diclofenac potassium) Liquid Filled Capsules, a new treatment option indicated for relief of mild to moderate acute pain in adults (18 years of age or older). "Zipsor is a drug with several unique features," said Gary A. Shangold, Chief Medical Officer of Xanodyne.
diclofenac and misoprostol, Arthrotec
Source: MedicineNet misoprostol Specialty [2005.12.13]
Title: diclofenac and misoprostol, Arthrotec
Category: Medications
Created: 11/22/1998 6:38:00 PM
Last Editorial Review: 12/13/2005
FDA Approves Cambia™ For Migraine
Source: Headache / Migraine News From Medical News Today [2009.06.24]
Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved Cambia™, a diclofenac-based non-steroidal anti-inflammatory drug ("NSAID") combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.
Published Studies Related to Cataflam (Diclofenac)
Lower gastrointestinal events in a double-blind trial of the cyclo-oxygenase-2 selective inhibitor etoricoxib and the traditional nonsteroidal anti-inflammatory drug diclofenac. [2008.11]
BACKGROUND & AIMS: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause lower gastrointestinal (GI) clinical events such as bleeding. Cyclo-oxygenase (COX)-2 selective inhibitors decrease upper GI events, but no prospective trial has prespecified assessment of lower GI clinical events... CONCLUSIONS: A statistically significant decrease in lower GI clinical events was not seen with the COX-2 selective inhibitor etoricoxib versus the traditional NSAID diclofenac [generic for Cataflam]. The risk of a lower GI clinical event with NSAID use seems to be constant over time, and the major risk factors are a prior lower GI event and older age.
Diclofenac sodium and occlusal splint therapy in TMJ osteoarthritis: a randomized controlled trial. [2008.10]
The aim of the study was to compare treatment with diclofenac [generic for Cataflam] sodium (Voltaren 3 x 50 mg) to occlusal splint therapy in a randomized, single-blind controlled trial of patients with a diagnosis of temporomandibular joint (TMJ) osteoarthritis (OA) in accordance with Research Diagnostic Criteria for temporomandibular disorders... Diclofenac gave a more rapid improvement, but both treatments gave a significant reduction of symptoms of TMJ OA within 3 months which remained at the one-year follow-up.
[Diclofenac/orphenadrine as a combined analgetic in post-operative relief of pain] [2008.09.28]
The authors compared the potency, safety and tolerability of combined infusion containing non-steroid anti-inflammation diclofenac [generic for Cataflam] and central muscle relaxant orphenadrine, and those of tramadol HCl, during postoperative pain relief after low and middle category operations. The test was an open, group- and self-controlled, prospective, randomised, IV...
Effect of diclofenac suppository on tramadol consumption in posthysterectomy pain. [2008.09]
OBJECTIVE: To determine reduction in dose of tramadol and side effects in posthysterectomy patients on addition of diclofenac [generic for Cataflam] on rectal suppository... CONCLUSION: This study did not show any reduction in tramadol consumption, given via patient controlled intravenous analgesia when rectal suppository of 100 mg diclofenac was added.
Diclofenac sodium 3% gel in the treatment of actinic keratoses postcryosurgery. [2008.07]
BACKGROUND: Actinic keratoses are increasingly common skin lesions that are evaluated and treated by dermatologists on a daily basis. It is estimated that more than 90% of actinic keratoses in the US are treated by destructive therapies, such as cryosurgery. The purpose of this study was to evaluate the efficacy of sequential therapy of cryosurgery followed by diclofenac [generic for Cataflam] sodium 3% gel... CONCLUSIONS: With the increased prevalence of actinic keratoses, it is important to consider and evaluate emerging therapeutic options. The sequential treatment with cryosurgery followed by diclofenac sodium 3% gel for 90 days is well tolerated and can provide a therapeutic modality that may provide patients with actinic keratoses a more successful outcome than monotherapy with cryosurgery by effectively treating clinical and subclinical lesions.
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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