Overview of Aceclofenac: Uses, Mechanism of Action, DMF

  • Admin
  • Drug Master File (DMF)
  • 29 March 2024

Introduction:

Aceclofenac is a prescribed medicinal product for pain relief and inflammatory conditions. Being a nonsteroidal anti-inflammatory drug (NSAID), it has drawn significant interest for its effectiveness in managing diverse painful conditions and inflammatory disorders. This blog is intended to explore the ins and outs of aceclofenac, its uses, benefits, potential side effects, as well as Aceclofenac Drug Master Files.

Understanding Aceclofenac:

Aceclofenac comes under the class of medicines known as NSAIDs, generally used for pain relief, inflammation reduction and fever reduction. It blocks production of a specific body chemicals, prostaglandins, which is an integral part of inflammation response. Aceclofenac effectively reduces pain and swelling related to different conditions by reducing the activity of these chemicals.

Mechanism of Action:

  • Aceclofenac exerts a potent inhibition on the cyclo-oxygenase enzyme (COX), a pivotal player in prostaglandin synthesis. 
  • Prostaglandin contributes to pain, swelling, inflammation and fever by acting as an irritant mediator.
  • In targeting the COX pathway, aceclofenac is able to reduce pain and inflammation associated with a variety of diseases like osteoarthritis, rheumatology or ankylosing spondylitis.

Comparative Efficacy:

  • Aceclofenac showed a higher anti-inflammatory activity or at least equivalent effects compared to conventional NSAIDs in double blind studies.
  • In patients with osteoarthritis, where joint pain, tenderness, stiffness and local inflammation occur as a result of articular cartilage loss, this medicine is particularly effective.

Development and Analog:

  • Diclofenac and Aceclofenac were developed as an analogue of the widely used NSAID, with a view to improving GI tolerability.
  • Due to its poor aqueous solubility, it is classified as Class II of the BCS.
  • Interestingly, it’s more commonly prescribed in Europe.

Dosage and Administration:

  • Adhere to the instructions of your healthcare provider.
  • Take it as soon as possible if you are missing a dose. Skip the missing dose and continue with your usual schedule if it is only a matter of time before you have another dose.

Safety and Side Effects: These includes vomiting, stomach pain, nausea, indigestion, etc.

Safety Guidelines and Precautions:

While Aceclofenac may be effective in the treatment of pain and inflammation, caution should be exercised when using it to minimize potential side effects. It is of paramount importance to comply with the safety guidelines. Important considerations are given in the following paragraphs:

  • Dosage: Aceclofenac usage should align with the prescribed dose and treatment duration prescribed by the healthcare provider.
  • Avoid Alcohol: It's advisable to refrain from or limit alcohol intake when using aceclofenac, as it may elevate the likelihood of gastrointestinal side effects.

DMF Details of Aceclofenac:

  • It is known as a USDMF when Aceclofenac DMFs are presented to US regulators. 
  • The Aceclofenac USDMF contains information on the chemical properties of Aceclofenac, as well as facilities and procedures used to store it. 
  • In order to protect the manufacturer's Intellectual Property, Aceclofenac USDMF shall be kept under wraps.
  • Due to the various laws in each country, including USDMF, JDMF ASMEDMF and more, there are several forms of Aceclofenac Drug Master Files available.

Chemxpert Database on Aceclofenac

Chemxpert, a pharma database service provider in India, provides a valuable source of information on Aceclofenac. Its wealth of information has a significant impact on the development of pain management and pharmaceutical research.

Conclusion:

Aceclofenac provides relief from pain and inflammation when it used properly and as suggested by the safety guidelines. It significantly improves the quality of life for patient suffering from pain. To ensure safety, the use of aceclofenac should be carefully observed by healthcare professionals and everyone should be aware of the any risk or side effects that may arise.

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