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Voltaren Gel (Diclofenac Sodium Topical) - Summary

 
 



WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

Cardiovascular Risk

  • Non-steroidal 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] .

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. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions] .
 

VOLTAREN GEL SUMMARY

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.

See all Voltaren Gel indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Voltaren Gel (Diclofenac Topical)

Brief, Broad-Area Treatment Clears Actinic Keratosis
Source: MedPage Today Dermatology [2017.03.08]
(MedPage Today) -- High patient satisfaction with ingenol disoxate

Bacterial Spray Promising for Keratosis Pilaris
Source: MedPage Today Allergy & Immunology [2017.03.06]
(MedPage Today) -- Topical Nitrosomonas eutropha improved skin texture in small trial

Actinic Keratosis
Source: MedicineNet diclofenac Specialty [2016.09.02]
Title: Actinic Keratosis
Category: Diseases and Conditions
Created: 10/29/2001 12:00:00 AM
Last Editorial Review: 9/2/2016 12:00:00 AM

Keratosis Pilaris
Source: MedicineNet adapalene Specialty [2016.07.28]
Title: Keratosis Pilaris
Category: Diseases and Conditions
Created: 8/4/2008 12:00:00 AM
Last Editorial Review: 7/28/2016 12:00:00 AM

more news >>

Published Studies Related to Voltaren Gel (Diclofenac Topical)

Postoperative treatment with topical diclofenac versus topical dexamethasone after combined phacotrabeculectomy with mitomycin C. [2013]
(Voltaren Ophthalmic) after combined phacotrabeculectomy with mitomycin C... CONCLUSIONS: In this preliminary study, diclofenac sodium is at least as good as

Comparison of topical 3% diclofenac sodium gel and 5% imiquimod cream for the treatment of actinic keratoses. [2011.07]
BACKGROUND: There is a wide spectrum of treatments available for actinic keratosis (AK). Topical diclofenac sodium and imiquimod are two topical treatments, which are noninvasive, easily applied, well-tolerated and effective. AIM: To compare the effects of topical 3% diclofenac sodium plus hyaluranon (DFS) gel, 5% imiquimod (IMQ) cream, and base cream (BC) in patients with AK... CONCLUSIONS: Although DFS and IMQ each had considerable efficacy in the treatment of AK, the efficacy of DFS seemed to decrease after cessation of treatment. (c) The Author(s). CED (c) 2011 British Association of Dermatologists.

A new topical formulation enhances relative diclofenac bioavailability in healthy male subjects. [2011.06]
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: * Therapy with topical non-steroidal anti-inflammatory drugs (NSAIDs) relies on the ability of the active drug to penetrate the skin in sufficiently high amounts to exert a clinical effect, which is linked to the specific galenic properties of the formulation. WHAT THIS STUDY ADDS: * This phase 1 study characterizes the transdermal penetration and plasma exposure of different dose levels with galenic differences of a novel topical diclofenac formulation under development and indicates greater diclofenac penetration through the skin when compared with a commercially available formulation. AIMS: To evaluate the relative plasma and tissue availability of diclofenac after repeated topical administration of a novel diclofenac acid-based delivery system under development (DCF100C)... CONCLUSION: DCF100C formulations were safe and facilitated greater diclofenac penetration through the skin compared with the commercial comparator. DCF100C represents a promising alternative to oral and topical diclofenac treatments that warrants further development. (c) 2011 The Authors. British Journal of Clinical Pharmacology (c) 2011 The British Pharmacological Society.

A comparative subjective assessment study of PENNSAID(R) and Voltaren Gel(R), two topical formulations of diclofenac sodium. [2011.05]
Osteoarthritis (OA) is a chronic degenerative joint disease that is debilitating for many individuals... Mean subjective responses to topical diclofenac solution with DMSO were also more favorable for most items in the questionnaire, and more subjects preferred or highly preferred topical diclofenac solution with DMSO over diclofenac sodium gel.

Comparison of lignocaine gel-soaked Falope rings vs rectal diclofenac suppository for pain relief in laparoscopic sterilization. [2011.01]
STUDY OBJECTIVE: To compare the analgesic efficacy of lignocaine gel-soaked Silastic bands compared with rectal diclofenac suppositories in patients undergoing interval laparoscopic sterilization under conscious sedation... CONCLUSION: Application of lignocaine gel to Falope rings and preoperative insertion of a rectal diclofenac suppository are simple and effective measures for pain control in the early postoperative period in patients undergoing day-case laparoscopic sterilization under conscious sedation. Either method could be incorporated into routine practice, depending on patient and physician choice. Copyright A(c) 2010 AAGL. Published by Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Voltaren Gel (Diclofenac Topical)

Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium [Completed]
This research study is being conducted to characterize the pharmacokinetic properties of a new topical medication (MFC51123) that contains two active ingredients (diclofenac and menthol) in two formulation packages. One formulation package is in the form of a gel in aluminum tube and the other one in the form of a gel in roll-on applicator bottle. Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol gel has being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains. The rationale for conducting the study is to prove that repeated topical treatment of the new diclofenac + menthol formulation in either of the two packages does not result in unsafe systemic exposure.

Pharmacokinetics, Bioavailability and Safety of PENNSAID� Gel [Completed]
It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution administered four times a day (QID).

An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) [Terminated]
The purpose of the study is to investigate the clinical benefit of tramadol/acetaminophen versus non-steroidal anti-inflammatory drugs (NSAID) (diclofenac 50 milligram [mg]) in the treatment of pain in participants with ankylosing spondylitis (inflammation of the spine causing pain and stiffness) receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs).

Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain [Completed]
To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against Flector patch in the treatment of pain in subjects with minor ankle sprain

Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin [Terminated]
The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.

more trials >>


Page last updated: 2017-03-08

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