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Solaraze (Diclofenac Sodium Topical) - Summary

 
 



SOLARAZE SUMMARY

Solaraze® (diclofenac sodium) Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether.

Solaraze® (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.


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NEWS HIGHLIGHTS

Media Articles Related to Solaraze (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

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Published Studies Related to Solaraze (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.

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Clinical Trials Related to Solaraze (Diclofenac Topical)

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze« Gel 3% in the Treatment of Actinic Keratosis [Completed]
The objective of this study is to compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation Solaraze« (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis. Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.

Pharmacokinetics, Bioavailability and Safety of PENNSAID´┐Ż 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).

Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head [Completed]
Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze« is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses. Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze« applied twice daily to the face and head over 3 or 6 months of treatment.

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

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.

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Reports of Suspected Solaraze (Diclofenac Topical) Side Effects

Headache (2)Erythema (2)Hallucination (2)Glaucoma (1)Seborrhoeic Dermatitis (1)Tachycardia (1)Application Site Exfoliation (1)Basal Cell Carcinoma (1)Application Site Erythema (1)Swelling Face (1)more >>


Page last updated: 2017-08-01

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