Solaraze (Diclofenac Sodium Topical) - Summary

SOLARAZE SUMMARY

SOLARAZE^® GEL
Diclofenac Sodium-3%

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.

See all Solaraze indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Solaraze (Diclofenac Topical)

Keratosis Pilaris
Source: MedicineNet Atopic Dermatitis Specialty [2012.06.04]
Title: Keratosis Pilaris
Category: Diseases and Conditions
Created: 8/4/2008 12:00:00 AM
Last Editorial Review: 6/4/2012 12:00:00 AM

more news >>

Published Studies Related to Solaraze (Diclofenac Topical)

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.

Effect of preemptive topical diclofenac on postoperative pain relief after photorefractive keratectomy. [2011.04]
PURPOSE: To assess the prophylactic effect of preoperative application of topical diclofenac on postoperative pain control in patients having photorefractive keratectomy (PRK). SETTING: Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran. DESIGN: Randomized masked clinical trial... CONCLUSION: Administration of a single drop of topical diclofenac 0.1% 2 hours before PRK seemed to increase the efficacy of postoperative pain management in a clinically and statistically significant manner. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. Copyright (c) 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Solaraze (Diclofenac Topical)

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium [Completed]
The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18. 75 mg and 37. 5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.

Assess Platelet Function and Safety After Administration of Injectable Diclofenac Compared to Ketorolac and Aspirin in Adult Male Volunteers [Completed]
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to cataflam, intravenous ketorolac and aspirin.

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze� Gel 3% in the Treatment of Actinic Keratosis [Recruiting]
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.

A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions [Recruiting]
The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human adult male subjects under fasting conditions.

Effects of Pennsaid on Clinical Neuropathic Pain [Recruiting]
The purpose of this study is to see if the drug Pennsaid (Diclofenac) can help reduce pain felt by people with chronic nerve pain. The drug will be used 2-4 times each day for 2 weeks.

The U. S. Food and Drug Administration (FDA) has approved Pennsaid to treat osteoarthritis (bone pain), but the FDA has not approved Pennsaid to treat neuropathic (nerve) pain.

The research study will compare Pennsaid to placebo.

more trials >>

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 >>