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Diclofenac Delayed Release (Diclofenac Sodium) - Summary

 
 



BOXED WARNING

Cardiovascular Risk

  • 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.)
  • Diclofenac sodium delayed-release tablets is contraindicated for the treatment of perioperative 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 inflammation, 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.)

 

SUMMARY

Diclofenac sodium delayed-release tablets is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities.

Carefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Diclofenac is indicated:

  • For relief of the signs and symptoms of osteoarthritis
  • For relief of the signs and symptoms of rheumatoid arthritis
  • For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis


See all Diclofenac Delayed Release indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Diclofenac Delayed Release (Diclofenac)

Diclofenac with or without an antiemetic for acute migraine headaches in adults. [2013]
CONCLUSIONS: Oral diclofenac potassium 50 mg is an effective treatment

Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo. [2013]
medication... CONCLUSION: In a subgroup of patients with acute nonspecific LBP, spinal

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

Diacerein as adjuvant to diclofenac sodium in osteoarthritis knee. [2012]
sodium in treatment of Indian patients with symptomatic osteoarthritis (OA) knee... CONCLUSION: Use of diacerein and diclofenac sodium together decreases pain and

Wound Infiltration with Bupivacaine and Intramuscular Diclofenac Reduces Postoperative Tramadol Consumption in Patients Undergoing Radical Retropubic Prostatectomy: A Prospective, Double-blind, Placebo-controlled, Randomized Study. [2011.12]
OBJECTIVES: To assess the impact of wound infiltration with bupivacaine and i.m. diclofenac administration on patient-controlled analgesia (PCA) tramadol consumptions and postoperative pain in patients who underwent radical retropubic prostatectomy (RRP) under general anesthesia. Previous studies have found only limited or no benefits of local anesthetics for postoperative opioid consumption and pain relief after RRP... CONCLUSIONS: This prospective, double-blind, placebo-controlled, randomized study demonstrated that wound infiltration with bupivacaine during surgical closure combined with i.m. diclofenac administration might decrease in 24 hours with PCA tramadol consumption in patients who underwent RRP under general anesthesia. Copyright (c) 2011 Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Diclofenac Delayed Release (Diclofenac)

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).

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.

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

Topical Diclofenac on Macular Thickness After Phacoemulsification [Active, not recruiting]
Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens implantation surgery have enrolled. Fifty four eyes have received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) have given a preoperative diclofenac drop four times daily in addition to steroid drop and continued six weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT) preoperatively and days 1, 30, and 90. The outcome measures including best corrected visual acuity (BCVA) and OCT findings were compared in and between both groups.

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.

more trials >>


Page last updated: 2014-11-30

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