Cardiovascular Risk
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NSAIDs1 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 and CLINICAL TRIALS).
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Flector® Patch is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
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NSAIDs cause an increased risk of serious gastrointestinal adverse events including 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).
1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.
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FLECTOR SUMMARY
Flector® Patch (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin.
Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Flector® Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
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NEWS HIGHLIGHTSMedia Articles Related to Flector (Diclofenac Topical)
Actinic Keratosis
Source: MedicineNet Psoriasis Specialty [2009.07.29]
Title: Actinic Keratosis
Category: Diseases and Conditions
Created: 10/29/2001 12:05:00 PM
Last Editorial Review: 7/29/2009
Understanding Actinic Keratosis
Source: MedicineNet Actinic Keratosis Specialty [2008.09.18]
Title: Understanding Actinic Keratosis
Category: Doctor's Views
Created: 9/18/2008
Last Editorial Review: 9/18/2008
Keratosis Pilaris
Source: MedicineNet Chronic Rhinitis Specialty [2008.08.06]
Title: Keratosis Pilaris
Category: Diseases and Conditions
Created: 8/4/2008
Last Editorial Review: 8/6/2008
Published Studies Related to Flector (Diclofenac Topical)
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).
Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis. [2009.06]
While topical non-steroidal anti-inflammatory drugs are considered safe, their long-term efficacy for osteoarthritis has been suspect. We conducted a 12-week, double-blind, double-dummy, randomized controlled trial of topical diclofenac (TDiclo) in a vehicle solution containing dimethyl sulfoxide (DMSO) in 775 subjects with radiologically confirmed, symptomatic primary osteoarthritis of the knee...
Oral versus topical diclofenac for pain prevention during panretinal photocoagulation. [2009.06]
PURPOSE: To investigate the effect of pretreatment oral and topical diclofenac on pain reduction during panretinal laser photocoagulation (PRP) for proliferative diabetic retinopathy (PDR). DESIGN: Prospective, randomized, double-masked, placebo-controlled clinical trial. PARTICIPANTS AND CONTROLS: A total of 90 patients with PDR requiring PRP for the first time were assigned randomly to 1 of 3 study groups: oral diclofenac (n = 30), topical diclofenac (n = 31), or placebo (n = 29)... CONCLUSIONS: When given in a single dose, oral diclofenac is an effective pretreatment analgesic agent for reducing the pain experienced during PRP for PDR. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Effects of diclofenac epolamine patch on postoperative sore throat in parturients after cesarean delivery under endotracheal general anesthesia. [2009.03]
BACKGROUND: Postoperative sore throat is a common problem. The efficacy of topical application of non-steroidal anti-inflammatory drugs in alleviating postoperative sore throat has not been established. Our aim was to evaluate the analgesic effects of diclofenac epolamine patch on postoperative sore throat... CONCLUSION: The diclofenac epolamine patch is effective and safe in prevention of sore throat following intubation general anesthesia in cesarean section.
Evaluation of polysulfated glycosaminoglycan or sodium hyaluronan administered intra-articularly for treatment of horses with experimentally induced osteoarthritis. [2009.02]
OBJECTIVE: To assess clinical, biochemical, and histologic effects of polysulfated glycosaminoglycan (PSGAG) or sodium hyaluronan administered intra-articularly in treatment of horses with experimentally induced osteoarthritis.
Clinical Trials Related to Flector (Diclofenac Topical)
Management of the Sprained Ankle by Help of NSAID-Plaster [Recruiting]
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Page last updated: 2009-10-20
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