Cardiovascular Risk
-
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).
-
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
-
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)
Keratosis Pilaris Source: MedicineNet Acne Specialty [2017.08.01] Title: Keratosis Pilaris Category: Diseases and Conditions Created: 8/4/2008 12:00:00 AM Last Editorial Review: 8/1/2017 12:00:00 AM
Published Studies Related to Flector (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
Randomized, open-label, 5-way crossover study to evaluate the pharmacokinetic/pharmacodynamic interaction between furosemide and the non-steroidal anti-inflammatory drugs diclofenac and ibuprofen in healthy volunteers. [2011.08] OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) can induce renal complications in patients taking loop diuretics. This study investigated the pharmacokinetic/pharmacodynamic effects and safety profile of orally administered diclofenac sodium, ibuprofen and diclofenac epolamine topical patch (DETP) on furosemide in healthy adult subjects... CONCLUSIONS: Pharmacodynamic effects were seen with oral diclofenac (urine output) and ibuprofen (urine sodium excretion). Furosemide also affected plasma and urine pharmacokinetic profiles. Pharmacologic effects of DETP on furosemide were not observed under these conditions. Additional research is warranted to delineate the potential interactions of other NSAIDs with furosemide and other loop diuretics.
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.
Clinical Trials Related to Flector (Diclofenac Topical)
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
Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries [Recruiting]
The primary purpose of this study is to determine whether Flector Patch is safe for use in
children. The secondary purpose is to assess blood levels of diclofenac, the active
ingredient in Flector Patch.
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).
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.
A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain [Recruiting]
The study is designed to assess the efficacy and tolerability of diclofenac potassium soft
gelatin capsules compared with ibuprofen tablets in patients with moderate to severe
postoperative dental pain.
Reports of Suspected Flector (Diclofenac Topical) Side Effects
Drug Ineffective (201),
Pain (53),
Dizziness (43),
Nausea (39),
Rash (32),
Pruritus (29),
Headache (25),
Abdominal Discomfort (23),
Malaise (23),
Application Site Pain (17), more >>
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Page last updated: 2017-08-01
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