WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
Cardiovascular Risk
- Nonsteroidal anti-inflammatory drugs (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 and Precautions] .
- Voltaren® Gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4)] .
Gastrointestinal Risk
- 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 and Precautions(5.2)].
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VOLTAREN GEL SUMMARY
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
Voltaren® Gel (diclofenac sodium topical gel) is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, in an opaque, white gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzene–acetic acid derivative.
Voltaren® Gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
- Voltaren® Gel has not been evaluated for use on the spine, hip, or shoulder.
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NEWS HIGHLIGHTSMedia Articles Related to Voltaren Gel (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 Voltaren Gel (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 Voltaren Gel (Diclofenac Topical)
Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip [Recruiting]
The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab
added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently
experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.
Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis [Not yet recruiting]
This is a randomised, controlled, multi-centre clinical trial on 360 AS patients.
Experimental intervention: continuous (daily) treatment of 180 patients with diclofenac
cholestyramine 150 mg (Voltaren Resinate), divided into 75mg Voltaren twice dailyControl
intervention: treatment on-demand (as needed) of 180 patients with
diclofenac-cholestyramine 75 to 150 mg (Voltaren Resinate). The treatment strategy of the
control intervention (on-demand) reflects current clinical practice in AS. Duration of
intervention per patient: 2 years Follow-up per patient: safety assessment 3 months
after termination of the trial.
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Post-surgical Pain Following Dental Surgery [Not yet recruiting]
The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD
75mg/1ml s. c. with the marketed reference product, Voltarol® 75mg/3ml i. m. in the treatment
of acute moderate-to-severe pain after dental impaction surgery.
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain [Recruiting]
The main purpose of this trial is to compare the efficacy and safety of diclofenac
diethylamine 2. 32% gel applied twice (b. i.d) or three times a day (t. i.d.) with placebo in
the treatment of acute ankle sprains (distortions).
Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients [Recruiting]
Inflammation of the pancreas (pancreatitis) is an uncommon but potentially serious
complication of endoscopic retrograde cholangiopancreatography (ERCP), a specialized
endoscopic examination of the ducts draining the liver and pancreas. Although many different
strategies have been tried and studied in attempts to reduce this risk, few have been shown
to make a significant difference. Those that have are either very expensive, difficult to
administer, or both.
Diclofenac, an anti-inflammatory medication most often used to treat arthritis, has shown
potential to decrease the risk of post-ERCP pancreatitis. It can be given after the
procedure to patients at most risk for the complication, and has few side effects. This
study will randomize people in the study to placebo or active medication, to determine if
Diclofenac reduces the incidence of pancreatitis.
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Page last updated: 2009-10-20
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