Voltaren (Diclofenac Sodium) - Summary

VOLTAREN SUMMARY

CARDIOVASCULAR RISK

Voltaren^® (diclofenac sodium enteric-coated tablets), is a benzene-acetic acid derivative. Voltaren is available as Delayed-Release (enteric-coated) Tablets of 25 mg (yellow), 50 mg (light brown), and 75 mg (light pink) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt.

Voltaren^® (diclofenac sodium enteric-coated tablets), is indicated:

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

See all Voltaren indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Voltaren (Diclofenac)

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.

Onset of action of diclofenac potassium liquid-filled capsules in dental surgery patients. [2011.09]
CONCLUSIONS: These results indicate that DPSGC was efficacious in providing a rapid onset of confirmed perceptible pain relief within 30 minutes of administration in these single dose postoperative dental pain studies.

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.

more studies >>

Clinical Trials Related to Voltaren (Diclofenac)

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 Voltaren (Diclofenac) Side Effects

OFF Label USE (117),  Drug Administered AT Inappropriate Site (100),  Therapeutic Response Unexpected (78),  Wrong Technique in Drug Usage Process (67),  Pain (45),  Renal Failure Acute (45),  Nausea (45),  Malaise (43),  Erythema (41),  Dyspnoea (40), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Voltaren review by 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		bursitis and tennis elbow
Dosage & duration:		100mg taken one daily for the period of 30 days
Other conditions:		rosacea on face
Other drugs taken:		none
		Reported Results
Benefits:		I experienced almost immediate relief of both bursitis in my left thigh and tennis elbow in my right aarm. I also had a strained muscle in lower back area which I also experienced relief from. The bursitis had been bothering me for quite some time (8mths)and mainly at nighttime when I was lying down in bed. I found it difficult to get comfortable and often used a hot water bottle to soothe it.
Side effects:		Just after taking the pill (with food) I felt a bit dopey in the head which lasted for up to an hour, and sometimes a slight nausea (but not often).
Comments:		Take with a large glass of water (i must say I did not notice this instruction until now). Take 1 tablet daily (with food) when required to relieve pain and inflammation. Swallow whole. Do not crush or chew.

Voltaren review by 61 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		osteoarthritis
Dosage & duration:		50mg taken 2x each day for the period of 6 years
Other conditions:		none
Other drugs taken:		hormone replacement
		Reported Results
Benefits:		Severe debilitating pain associated with inflammation and joint pain through out the body is alleviated, enabling more normal living. eg being able to do all housework tasks, gardening, running around and picking up grandchildren, enjoying social life plus taking part in daily fitness activities.
Side effects:		occaional stomach pains
Comments:		Always only take the medication with meals so as to minimize the likelihood of the stomach being affected.

Voltaren review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Reactive Arthritis (leg joint swelling/stiffness)
Dosage & duration:		4x 50mg tablets taken 2 morning & 2 evening for the period of Approx 5 weeks
Other conditions:		Recent BCG wash after Polyps removed in baldder
Other drugs taken:		Sulfasalazine
		Reported Results
Benefits:		Slight decrease in stiffness, and better degree of mobility of legs joints (ankles, knees and hips)
Side effects:		Small bowel perforation and lesion(wall thickened)
Comments:		Approx. 5 weeks into course of VOLTAREN at dosage of 4/day, felt pain in right side which increased to severe pain within 1/2 hour. Admitted as Emergency into hospital(Australia). CT scan showed air in abdomen. Open surgery: small bowel resection - for lesion(wall thickened) plus perforation.