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Cataflam

Diclofenac (marketed as Voltaren®, Voltarol®, Diclon® and Cataflam®) is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation, such as in arthritis or acute injury. It can also be used to reduce menstrual pain. more...

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Voltaren and Voltarol contain the sodium salt of diclofenac. In the United Kingdom Voltarol can be supplied with either the sodium salt or potassium salt, while Cataflam in some other countries is the potassium salt only. Diclofenac is available in stomach acid resistant formulations (25 and 50 mg), fast disintegrating oral formulations (50 mg), slow- and controlled-release forms (75, 100 or 150 mg), suppositories (50 and 100 mg), and injectable forms (50 and 75 mg). Diclofenac is also available over the counter (OTC) in some countries: Voltaren® dolo (12.5 mg diclofenac as potassium salt) in Switzerland and Germany, and preparations with 25 mg diclofenac are OTC in New Zealand. OTC use is approved for minor aches and pains and fever associated with common infections.

Diclofenac is available as a generic drug in a number of formulations.

Mechanism of action

The exact mechanism of action is not entirely known, but it is thought that the primary mechanism responsible for its anti-inflammatory/antipyretic/analgesic action is inhibition of prostaglandin synthesis by inhibition of cyclooxygenase (COX).

Diclofenac, it seems, may also be a unique member of the NSAIDs. There is some evidence that diclofenac inhibits the lipooxygenase pathways, thus reducing formation of the leukotrienes (also pro-inflammatory autacoids). There is also speculation that diclofenac may inhibit phospholipase A₂ as part of its mechanism of action. These additional actions may explain the high potency of diclofenac - it is the most potent NSAID on a molar basis.

Inhibition of COX also decreases prostaglandins in the epithelium of the stomach, making it more sensitive to corrosion by gastric acid. This is also the main side effect of diclofenac. Diclofenac has a low to moderate preference to block the COX2-isoenzyme (approximately 10-fold) and is said to have therefore a somewhat lower incidence of gastrointestinal complaints than noted with indomethacin and aspirin.

The action of one single dose is much longer (6 to 8 hours) than the very short half-life of the drug indicates. This could partly be due to a particular high concentration achieved in synovial fluids.

Common uses

Diclofenac is used for musculoskeletal complaints, especially arthritis (rheumatoid arthritis, osteoarthritis, spondylarthritis, ankylosing spondylitis), gout attacks, and pain management in case of kidney stones and gallstones. An additional indication is the treatment of acute migraines. Diclofenac is used commonly to treat mild to moderate post-operative or post-traumatic pain, particular when inflammation is also present, and is effective against menstrual pain.

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IDDS to Host Conference Call to Discuss Positive Pivotal Phase II/III Dyloject™ Results
From Business Wire, 7/25/05

NEW YORK -- Intrac, Inc. (OTC BB: ITRD.OB) and its wholly-owned subsidiary Innovative Drug Delivery Systems (IDDS) will host a conference call on Tuesday, July 26, 2005 beginning at 10:00 AM EDT to discuss the recently reported pivotal European Phase II/III study of Dyloject(TM) (diclofenac sodium injection). Results from the study demonstrated that Dyloject provided superior pain relief over 4 hours compared to placebo and therapeutic non-inferiority to Voltarol(R). These findings were the primary endpoints necessary to meet requirements for the Marketing Authorization Approval of Dyloject(TM). Additionally, preliminary analysis of the data did not reveal any unexpected safety signals and reported incidents of phlebitis in patients receiving Dyloject were half the rate of Voltarol.

IDDS invites all those interested in hearing management's discussion of the Phase II/III study results to join the call by dialing (877) 407-9210 for domestic participants or (201) 689-8049 for international participants. Participants are asked to call the above numbers 5-10 minutes prior to the starting time.

A telephonic replay of this call will be available until 11:59 PM on Wednesday, July 27, 2005. To hear the replay, please call (877) 660-6853 for domestic participants or (201) 612-7415 for international participants. The account number for the replay is 286 and the conference ID is 162152.

Interested parties can also access a webcast of the conference call through the investor relations section of IDDS' website, www.idds.com. The webcast will be archived for 90 days following the call.

About Dyloject(TM)

Dyloject(TM) is an injectable non-steroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory and antipyretic activity. Diclofenac, the same active ingredient in Dyloject(TM), Voltaren(R), Cataflam(R) and Voltarol(R), is a leading analgesic, with a demonstrated history of efficacy and safety since its approval in 1981. Historically, diclofenac has been used to treat pain from inflammatory and degenerative forms of osteoarthritis, musculoskeletal conditions, acute attacks of gout, kidney stones, and pain after operations or trauma. Currently, the only injectable form of diclofenac in Europe and other parts of the world is Voltarol(R). However, Voltarol(R) requires either injection into the very large gluteal muscle, or a slow (30 minutes or longer) infusion that must be freshly prepared for each patient. Voltarol(R) is not available in the United States. Dyloject(TM) is a new IDDS formulation utilizing the same active ingredient as Voltarol(R), but dissolved in a very small volume, stabilized for a long shelf life, and given as a single, brief injection. Worldwide, no comparable formulation of diclofenac has been available previously.

About IDDS

IDDS is a specialty pharmaceutical company, applying innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. For additional information please visit our website, www.idds.com.

Forward-Looking Statements

This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.

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