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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.)
- Voltaren® (diclofenac sodium enteric-coated 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).
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VOLTAREN SUMMARY
Voltaren®
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:
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For relief of signs and symptoms of osteoarthritis
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For relief of signs and symptoms of rheumatoid arthritis
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For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
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VOLTAREN NEWS HIGHLIGHTS Media Articles Related to Voltaren (Diclofenac)
Xanodyne Receives Approval From The U.S. Food And Drug Administration For ZIPSOR(TM) (diclofenac Potassium) Liquid Filled Capsules
Source: Pain / Anesthetics News From Medical News Today [2009.06.18]
Xanodyne Pharmaceuticals, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zipsor (diclofenac potassium) Liquid Filled Capsules, a new treatment option indicated for relief of mild to moderate acute pain in adults (18 years of age or older). "Zipsor is a drug with several unique features," said Gary A. Shangold, Chief Medical Officer of Xanodyne.
diclofenac and misoprostol, Arthrotec
Source: MedicineNet misoprostol Specialty [2005.12.13]
Title: diclofenac and misoprostol, Arthrotec
Category: Medications
Created: 11/22/1998 6:38:00 PM
Last Editorial Review: 12/13/2005
FDA Approves Cambia™ For Migraine
Source: Headache / Migraine News From Medical News Today [2009.06.24]
Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved Cambia™, a diclofenac-based non-steroidal anti-inflammatory drug ("NSAID") combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.
Published Studies Related to Voltaren (Diclofenac)
Lower gastrointestinal events in a double-blind trial of the cyclo-oxygenase-2 selective inhibitor etoricoxib and the traditional nonsteroidal anti-inflammatory drug diclofenac. [2008.11]
BACKGROUND & AIMS: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause lower gastrointestinal (GI) clinical events such as bleeding. Cyclo-oxygenase (COX)-2 selective inhibitors decrease upper GI events, but no prospective trial has prespecified assessment of lower GI clinical events... CONCLUSIONS: A statistically significant decrease in lower GI clinical events was not seen with the COX-2 selective inhibitor etoricoxib versus the traditional NSAID diclofenac [generic for Voltaren]. The risk of a lower GI clinical event with NSAID use seems to be constant over time, and the major risk factors are a prior lower GI event and older age.
Diclofenac sodium and occlusal splint therapy in TMJ osteoarthritis: a randomized controlled trial. [2008.10]
The aim of the study was to compare treatment with diclofenac sodium (Voltaren 3 x 50 mg) to occlusal splint therapy in a randomized, single-blind controlled trial of patients with a diagnosis of temporomandibular joint (TMJ) osteoarthritis (OA) in accordance with Research Diagnostic Criteria for temporomandibular disorders... Diclofenac gave a more rapid improvement, but both treatments gave a significant reduction of symptoms of TMJ OA within 3 months which remained at the one-year follow-up.
[Diclofenac/orphenadrine as a combined analgetic in post-operative relief of pain] [2008.09.28]
The authors compared the potency, safety and tolerability of combined infusion containing non-steroid anti-inflammation diclofenac [generic for Voltaren] and central muscle relaxant orphenadrine, and those of tramadol HCl, during postoperative pain relief after low and middle category operations. The test was an open, group- and self-controlled, prospective, randomised, IV...
Effect of diclofenac suppository on tramadol consumption in posthysterectomy pain. [2008.09]
OBJECTIVE: To determine reduction in dose of tramadol and side effects in posthysterectomy patients on addition of diclofenac [generic for Voltaren] on rectal suppository... CONCLUSION: This study did not show any reduction in tramadol consumption, given via patient controlled intravenous analgesia when rectal suppository of 100 mg diclofenac was added.
Diclofenac sodium 3% gel in the treatment of actinic keratoses postcryosurgery. [2008.07]
BACKGROUND: Actinic keratoses are increasingly common skin lesions that are evaluated and treated by dermatologists on a daily basis. It is estimated that more than 90% of actinic keratoses in the US are treated by destructive therapies, such as cryosurgery. The purpose of this study was to evaluate the efficacy of sequential therapy of cryosurgery followed by diclofenac [generic for Voltaren] sodium 3% gel... CONCLUSIONS: With the increased prevalence of actinic keratoses, it is important to consider and evaluate emerging therapeutic options. The sequential treatment with cryosurgery followed by diclofenac sodium 3% gel for 90 days is well tolerated and can provide a therapeutic modality that may provide patients with actinic keratoses a more successful outcome than monotherapy with cryosurgery by effectively treating clinical and subclinical lesions.
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.
Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain [Active, not recruiting]
The primary purpose of this study is to assess the effectiveness of once daily application of
a diclofenac sodium patch to the skin near or over the painful area. In this study, the
location being studied will be either the left or right ankle.
The secondary purpose of this study is to assess the safety and tolerability of a diclofenac
patch on the skin.
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis [Completed]
The primary purpose of this study is to assess the effectiveness of once daily application of
a diclofenac sodium patch to the skin near or over the painful area. In this study, the
location being studied will be one of the following: the affected shoulder, elbow, or wrist.
The secondary purpose of this study is to assess the safety and tolerability of the
diclofenac patch on the subject's skin, in the location being studied.
Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis [Completed]
This study will test the efficacy and safety of topical diclofenac sodium gel in the
treatment of knee osteoarthritis.
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VOLTAREN PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Voltaren has an overall score of 7.40. The effectiveness score is 8 and the side effect score is 9.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | 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. |
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| | Voltaren review by 24 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | eryhema nodosum |
| Dosage & duration: | | 50mg taken when ever pain occurred for the period of 1 week |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Reduced pain caused by erythema, ability to carry out day to day activities without too much discomfort. Though tiredness was on of the side effects of the problem this could not be resolved with drugs, though blood tests did show whether the situation was improving or not. |
| Side effects: | | None were experienced at the time. there are side affects, but as i didn't really take the drug unless i couldn't cope this did not really seem to affect me. I tried to deal with the pain so that i could monitor if i was beginning to feel better or not. |
| Comments: | | Gentle exercise was encouraged to keep the circulation going. Keeping the erythema affected are rested, by keeping it resting up when sitting down or lying down with a cushion to aid. When swelling occurred anti-inflammatory medication and pain killers were useful in giving some relief. |
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| | Voltaren review by 48 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Primary dysmenorrhea |
| Dosage & duration: | | 25mg/tablet taken 3 times/day with food for the period of 3 days each time for about 12 months |
| Other conditions: | | None |
| Other drugs taken: | | Ibuprofen | | |
Reported Results |
| Benefits: | | Hardly any- it was much less effective than paracetamol against the pain. I still had to take the maximum dose of ibuprofen to reduce the pain. I hoped taking Voltaren as well would extend the analgesic effects of the ibuprofen but it was fairly ineffective. |
| Side effects: | | None |
| Comments: | | 75 mg Voltaren & 2.4g ibuprofen a day during periods of extreme pain |
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Page last updated: 2009-06-24
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